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## Complete Summary

#### GUIDELINE TITLE

Post-traumatic stress disorder. The management of PTSD in adults and
children in primary and secondary care.

#### BIBLIOGRAPHIC SOURCE(S)

National Collaborating Centre for Mental Health. Post-traumatic stress
disorder: the management of PTSD in adults and children in primary and
secondary care. London (UK): National Institute for Clinical Excellence
(NICE); 2005. 167 p. \[69 references\]

#### GUIDELINE STATUS

This is the current release of the guideline.

### \*\* REGULATORY ALERT \*\*

#### FDA WARNING/REGULATORY ALERT

**Note from the National Guideline Clearinghouse**: This guideline
references a drug(s) for which important revised regulatory and/or
warning information has been released.

-   [May 2, 2007, Antidepressant
    drugs](http://www.fda.gov/medwatch/safety/2007/safety07.htm#Antidepressant):
    Update to the existing black box warning on the prescribing
    information on all antidepressant medications to include warnings
    about the increased risks of suicidal thinking and behavior in young
    adults ages 18 to 24 years old during the first one to two months of
    treatment.

-   [May 12, 2006, Paxil (paroxetine) and Paxil
    CR](http://www.fda.gov/medwatch/safety/2006/safety06.htm#paxil):
    Changes to the Clinical Worsening and Suicide Risk subsection of the
    WARNINGS section in the prescribing Information related to adult
    patients, particularly those who are younger adults.

-   [December 8, 2005, Paxil
    (paroxetine)](http://www.fda.gov/medwatch/safety/2005/safety05.htm#Paxil3):
    Pregnancy category changed from C to D and new data and
    recommendations added to the WARNINGS section of prescribing
    information.

-   [September 27, 2005, Paxil (paroxetine) and Paxil
    CR](http://www.fda.gov/medwatch/safety/2005/safety05.htm#Paxil2):
    Changes to the Pregnancy/PRECAUTIONS section of the Prescribing
    Information to describe the results of a retrospective epidemiologic
    study of major congenital malformations in infants born to women
    taking antidepressants during the first trimester of pregnancy.

### COMPLETE SUMMARY CONTENT

 \*\* REGULATORY ALERT \*\*\
 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Post-traumatic stress disorder (PTSD)

#### GUIDELINE CATEGORY

Diagnosis\
Evaluation\
Management\
Prevention\
Screening\
Treatment

#### CLINICAL SPECIALTY

Family Practice\
Internal Medicine\
Pediatrics\
Psychiatry\
Psychology

#### INTENDED USERS

Advanced Practice Nurses\
Allied Health Personnel\
Emergency Medical Technicians/Paramedics\
Hospitals\
Nurses\
Occupational Therapists\
Patients\
Physicians\
Psychologists/Non-physician Behavioral Health Clinicians\
Social Workers

#### GUIDELINE OBJECTIVE(S)

To make recommendations and suggest good practice points for the
treatment and management of post-traumatic stress disorder (PTSD).
Specifically, the guideline aims to:

-   Evaluate the role of specific psychological interventions in the
    treatment and management of PTSD

-   Evaluate the role of specific pharmacological interventions in the
    treatment and management of PTSD

-   Evaluate the role of early psychological and pharmacological
    interventions shortly after traumatic event

-   Address the issues of diagnosis, detection and the use of screening
    techniques in high-risk situations

-   Provide key review criteria for audit, which will enable objective
    measurements to be made of the extent and nature of local
    implementation of this guidance, particularly its impact upon
    practice and outcomes for people with PTSD.

#### TARGET POPULATION

Adults and children of all ages, who meet the diagnostic criteria for,
or are at risk for, post-traumatic stress disorder (PTSD)

#### INTERVENTIONS AND PRACTICES CONSIDERED

**Screening and Diagnosis of Post-Traumatic Stress Disorder (PTSD)**

1.  Symptom assessment and coordination of care (including determination
    of need for emergency or psychiatric assessment)

2.  Screening of individuals involved in major disasters, refugees, and
    asylum seekers

3.  Assessment of comorbid conditions

4.  Familiarisation with ethnic and cultural background of patient

5.  Special considerations for assessing PTSD symptoms in children

**Psychological Interventions**

1.  Trauma-focused cognitive behavioural therapy

2.  Eye movement desensitisation and reprocessing (EMDR)

**Pharmacologic Therapy**

1.  Antidepressants

    -   Mirtazapine

2.  Selective serotonin reuptake inhibitors

    -   Paroxetine

3.  Tricyclic antidepressants

    -   Amitriptyline

4.  Monoamine oxidase inhibitors

    -   Phenelzine

5.  Hypnotic medication

6.  Antipsychotic agents

    -   Olanzapine

7.  Management of side effects of therapy and discontinuation/withdrawal
    symptoms

**Other Practices**

1.  Watchful waiting

**Supportive Measures**

1.  Family and carer support

2.  Disaster planning (organization of social and psychological support)

**Interventions Considered But Not Recommended**

Sertraline, fluoxetine, imipramine, venlafaxine, risperidone relaxation
therapy, hypnotherapy, supportive therapy, non-directive therapy,
systemic psychotherapy and psychodynamic therapy, debriefing, repetitive
transcranial magnetic stimulation (rTMS).

#### MAJOR OUTCOMES CONSIDERED

-   Incidence and prevalence of post-traumatic stress disorder (PTSD)

-   Symptom improvement (as measured by independent assessors or
    self-report)

-   Side effects of pharmacologic therapy

-   Relapse rate

-   Impact on patient carers

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Searches of Electronic Databases\
Searches of Unpublished Data

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

A stepwise, hierarchical approach was taken to locating and presenting
evidence to the Group. The National Collaborating Centre for Mental
Health (NCCMH) developed this process based on advice from the National
Institute for Health and Clinical Excellence (NICE) National Guidelines
Support and Research Unit and after considering recommendations from a
range of other sources. These included:

-   The Centre for Clinical Policy and Practice of the New South Wales
    Health Department (Australia)

-   Clinical Evidence Online

-   Cochrane Collaboration

-   New Zealand Guideline Group

-   National Health Service (NHS) Centre for Reviews and Dissemination

-   Oxford Centre for Evidence-Based Medicine

-   Scottish Intercollegiate Guidelines Network

-   United States Agency for Health Research and Quality

-   Oxford Systematic Review Development Programme

**The Review Process**

A brief search of the major bibliographic databases for recent
systematic reviews and existing guidelines was first conducted to help
inform the development of the scope. After the scope was finalised, a
more extensive search for systematic reviews was undertaken. At this
point, the review team, in conjunction with the Group, developed an
evidence map that detailed all comparisons necessary to answer the
clinical questions. The initial approach taken to locating primary-level
studies depended on the type of clinical question and availability of
evidence.

After consulting the Group, the review team decided which questions were
likely to have a good evidence base and which questions were likely to
have little or no directly relevant evidence. For questions in the
latter category, a brief descriptive review was initially undertaken by
a member of the Group. For questions with a good evidence base, the
review process depended on the type of clinical question.

**Search Process for Questions Concerning Interventions**

For questions related to interventions, the initial evidence base was
formed from well-conducted randomised controlled trials (RCTs) that
addressed at least one of the clinical questions. Although there are a
number of difficulties with the use of RCTs in the evaluation of
interventions in mental health, the RCT remains the most important
method for establishing treatment efficacy.

The initial search for RCTs involved searching the standard mental
health bibliographic databases (EMBASE, Medline, PsycINFO, Cochrane
Library) for all RCTs potentially relevant to the guideline.

After the initial search results were scanned liberally to exclude
irrelevant papers, the review team used a purpose-built \'study
information\' database to manage both the included and the excluded
studies (eligibility criteria were developed after consultation with the
Group). For questions without good-quality evidence (after the initial
search), a decision was made by the Group about whether to repeat the
search using subject-specific databases, such as CINAHL, the Allied and
Complementary Medicine Database (AMED), the System for Information on
Grey Literature in Europe (SIGLE) and the Publishers International
Literature on Traumatic Stress (PILOTS); conduct a new search for lower
levels of evidence; or adopt a consensus process (see section of the
original guideline document entitled Primary Care Focus Group). Future
guidelines will be able to update and extend the usable evidence base
starting from the evidence collected, synthesised and analysed for this
guideline.

Data from unpublished pharmacological trials held by the Medical and
Healthcare Products Regulatory Agency were routinely requested, and
where these data were available and could be released they are
considered within the review.

Recent high-quality English-language systematic reviews were used
primarily as a source of RCTs (see Appendix 7 of original guideline
document for quality criteria). However, where existing data-sets were
available from appropriate reviews, they were cross-checked for accuracy
before use.

New RCTs meeting inclusion criteria set by the Group were incorporated
into the existing reviews and fresh analyses performed. The review
process is illustrated in the Figure in the original guideline document
entitled \"Guideline Review Process\".

Additional searches were made of the reference lists of all eligible
systematic reviews and RCTs, and the list of evidence submitted by
stakeholders. Known experts in the field (see Appendix 2 of original
guideline document), based both on the references identified in early
steps and on advice from Group members, were sent letters requesting
systematic reviews or RCTs that were in the process of being published
(unpublished full trial reports were also accepted where sufficient
information was available to judge eligibility and quality). In
addition, the standard mental health bibliographic databases were
periodically checked for relevant studies.

**Search Process for Questions of Screening and Risk Factors**

For questions related to screening and risk factors, the search process
was the same as described above, except that the initial evidence base
was formed by identifying recent high-quality systematic reviews and
updating the searches for these systematic reviews. Additional searches
were run to cover aspects of screening and risk factors that the Group
felt had not been comprehensively covered by these earlier systematic
reviews. (Separate searches were run for screening tools and risk
factors of injury, compensation and litigation, and all studies of risk
factors with a longitudinal prospective design.) In situations in which
it was not possible to identify a substantial body of appropriately
designed studies that directly addressed each clinical question, a
consensus process was adopted (see the original guideline document for
details).

**Search Filters**

Search filters developed by the review team consisted of a combination
of subject heading and free-text phrases. Specific filters were
developed for the guideline topic, and where necessary, for each
clinical question. In addition, the review team used filters developed
for systematic reviews, RCTs and other appropriate research designs
(Appendix 6 of original guideline document).

**Study Selection**

All primary-level studies included after the first scan of citations
were acquired in full and reevaluated for eligibility at the time they
were being entered into the study information database. The inclusion
criteria for RCTs are listed below. For certain clinical questions these
inclusion criteria were amended (see Chapter 9 of original guideline
document). All eligible papers were then critically appraised for
methodological quality (see Appendix 8 of original guideline document).
The eligibility of each study was confirmed by at least one member of
the Group.

For some clinical questions, it was necessary to prioritise the evidence
with respect to the UK context. To make this process explicit, the Group
took into account the following factors when assessing the evidence:

-   participant factors (e.g. gender, age, ethnicity)

-   provider factors (e.g. model fidelity, the conditions under which
    the intervention was performed, the availability of experienced
    staff to undertake the procedure)

-   cultural factors (e.g. differences in standard care, differences in
    the welfare system).

The Group decided which prioritisation factors were relevant to each
clinical question in light of the UK context, and then how they should
modify the recommendations.

**Inclusion Criteria**

The review used the following inclusion criteria:

-   the study used a randomised controlled design

-   at least 70% of participants needed to have a diagnosis of PTSD,
    other participants must have PTSD symptoms following a traumatic
    event

-   the main target of treatment was PTSD

-   PTSD symptoms were measured pre- and post-treatment data were
    reported for continuous data at least 50% of the intent-to-treat
    sample were assessed at the relevant time point

-   double-blind administration of treatment (for pharmacological
    treatments only).

**Health Economics Review Search Strategy**

In January 2004, bibliographic electronic databases \-- Medline,
PreMedline, EMBASE, CINAHL, PsycINFO, the Cochrane Database of
Systematic Reviews (CDSR), Cochrane Controlled Trials Reports (CCTR),
Database of Abstracts of Reviews of Effectiveness (DARE) and the NHS
Health Technology Assessment (HTA) \-- and specific health economic
databases, the NHS Economic Evaluation Database (NHS EED) and the Office
of Health Economics Health Economic Evaluation Database (OHE HEED), were
searched for economic studies. For Medline, PreMedline, EMBASE, CINAHL,
PsycINFO, CDSR, CCTR and DARE, a combination of a specially developed
health economics search filter already tested in earlier NCCMH
guidelines and a general filter for post-traumatic stress disorder was
used. A combination of subject headings and free-text searches was used.
The HTA, NHS EED and OHE HEED databases were searched using shorter,
database-specific strategies.

In addition to searches of electronic databases, reference lists of
eligible studies and relevant reviews were searched by hand. Studies
included in the clinical evidence review were also screened for economic
evidence.

**Review Process**

The database searches for general health economic evidence for PTSD
resulted in a total of 345 references. Of these, 27 were identified as
potentially relevant. Secondary searches for additional
pharmaco-economic papers resulted in a further 46 references, of which 8
were initially considered relevant to criteria for health economic
appraisal. A further 6 potentially eligible references were found by
hand-searching. Full texts of all potentially eligible studies
(including those for which relevance or eligibility was not clear from
the abstract) were obtained: a total of 41 papers. (At this stage
inclusion was not limited to papers only from the UK.) These
publications were then assessed against a set of standard inclusion
criteria by the health economist, and papers eligible for inclusion as
economic evaluations were subsequently assessed for internal validity.
The quality assessment was based on the 32-point checklist used by the
*British Medical Journal* to assist referees in appraising economic
analyses (see Appendix 12 of original guideline document).

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**I**: Evidence obtained from a single randomised controlled trial or a
meta-analysis of randomised controlled trials

**IIa**: Evidence obtained from at least one well-designed controlled
study without randomisation

**IIb**: Evidence obtained from at least one other well-designed
quasi-experimental study

**III**: Evidence obtained from well-designed non-experimental
descriptive studies, such as comparative studies, correlation studies,
and case studies

**IV**: Evidence obtained from expert committee reports or opinions
and/or clinical experience of respected authorities.

#### METHODS USED TO ANALYZE THE EVIDENCE

Meta-Analysis\
Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

**Synthesising the Evidence**

Where possible, outcome data were extracted directly from all eligible
studies, which met the quality criteria, into Review Manager 4.2.
Meta-analysis was then used, where appropriate, to synthesise the
evidence using Review Manager. If necessary, reanalyses of the data or
sensitivity analyses were used to answer clinical questions not
addressed in the original studies or reviews. For continuous outcomes,
where more than 50% of the total number randomised in a particular study
were not accounted for, the data were excluded from the analysis because
of the risk of bias.

Included/excluded studies tables, generated automatically from the study
information database, were used to summarise general information about
each study (see Appendix 14 of original guideline document). Where
meta-analysis was not appropriate and/or possible, the reported results
from each primary-level study were also presented in the included
studies table.

Consultation was used to overcome difficulties with coding. Data from
studies included in existing systematic reviews were extracted
independently by one reviewer directly into Review Manager and
cross-checked with the existing data-set. Two independent reviewers
extracted data from new studies, and disagreements were resolved with
discussion. Where consensus could not be reached, a third reviewer
resolved the disagreement. Masked assessment (i.e., masked to the
journal from which the paper came, the authors, the institution and the
magnitude of the effect) was not used, since it is unclear that doing so
reduces bias.

**Presenting the Data to the Guideline Development Group**

Where possible, meta-analysis was used to synthesise data. If necessary,
sub-analyses were used to answer clinical questions not addressed in the
original studies or reviews. The Group was given a graphical
presentation of the results using forest plots generated with the Review
Manager software. Each forest plot displayed the effect size and
confidence interval (CI) for each study as well as the overall summary
statistic. The graphs were organised so that the display of data in the
area to the left of the \'line of no effect\' indicated a \'favourable\'
outcome for the treatment in question. Dichotomous outcomes were
presented as relative risks (RR) with the associated 95% CI. A relative
risk (or risk ratio) is the ratio of the treatment event rate to the
control event rate. An RR of 1 indicates no difference between treatment
and control. If the CI does not cross the \'line of no effect\', the
effect is statistically significant.

All dichotomous outcomes were calculated on an intention-to-treat basis
(i.e., a \'once randomized always analyse\' basis). This assumes that
participants who ceased to engage in the study \-- from whatever group
\-- had an unfavourable outcome (with the exception of the outcomes of
death and certain adverse events). Continuous outcomes were analysed as
standardised mean differences (SMDs) to allow for ease of comparison
across studies. If provided, intention-to-treat data, using a method
such as \'last observation carried forward\', were preferred over data
from completers.

To check for heterogeneity between studies, both the *I*^2^ and Chi^2^
tests of heterogeneity (*P*\<0.10), as well as visual inspection of the
forest plots, were used. The *I*^2^ statistic describes the proportion
of total variation in study estimates that is due to heterogeneity. An
*I*^2^ of less than 30% was taken to indicate mild heterogeneity and a
fixed effects model was used to synthesise the results. An *I*^2^ of
more than 50% was taken as notable heterogeneity. In this case, an
attempt was made to explain the variation. If studies with heterogeneous
results were found to be comparable, a random effects model was used to
summarise the results. In the random effects analysis, heterogeneity is
accounted for both in the width of CIs and in the estimate of the
treatment effect. With decreasing heterogeneity the random effects
approach moves asymptotically towards a fixed effects model. An *I*^2^
of 30-50% was taken to indicate moderate heterogeneity. In this case,
both the Chi^2^ test of heterogeneity and a visual inspection of the
forest plot were used to decide between a fixed and random effects
model.

**Developing Statements**

For each outcome a clinical statement describing the evidence found was
developed. To assess clinical importance where a statistically
significant summary was obtained (after controlling for heterogeneity)
the Group set thresholds for determining clinical importance, in
addition to taking into account the trial population and nature of the
outcome.

Two separate thresholds for determining clinical importance were set.
For comparisons of one active treatment against waiting list or
non-active interventions, a higher threshold was applied than for
comparisons of active treatments against one another.

For comparisons of one active treatment against another treatment the
following thresholds were applied: for dichotomous outcomes an RR of
0.80 or less was considered clinically important and for continuous
outcomes an effect size of approximately 0.5 (a \'medium\' effect size)
or less was considered clinically important.

For comparisons of active treatment against waiting list the following
thresholds were applied: for dichotomous outcomes a RR of 0.65 or less
was considered clinically important and for continuous outcomes an
effect size of approximately 0.8 (a \'large\' effect size) or less was
considered clinically important.

In order to facilitate consistency in generating and drafting the
clinical statements the Group used a statement decision tree. This flow
chart was designed to assist with decision making, not to replace
clinical judgement. Using this procedure, the Group classified each
effect size as clinically important or not (i.e., whether or not the
treatment is likely to benefit PTSD sufferers), taking into account both
the comparison group and the outcome.

Where heterogeneity between studies was judged problematic, in the first
instance an attempt was made to explain the cause of the heterogeneity
(e.g., outliers were removed from the analysis, or sub-analyses were
conducted to examine the possibility of moderators). Where homogeneity
could not be achieved, a random effects model was used.

In cases where the point estimate of the effect was judged clinically
important, a further consideration was made about the precision of the
evidence by examining the range of estimates defined by the CI. For
level I evidence, where the effect size was judged clinically important
for the full range of plausible estimates, the result was described as
*evidence* favouring intervention *x* over intervention *y* (i.e.,
statement 1, or S1). For non-level-I evidence or in situations where the
point estimate was clinically important but the CI included clinically
unimportant effects, the result was described as *limited evidence*
favouring intervention *x* over intervention *y* (i.e., S2). Where a
point estimate was judged as *not* clinically important and the CI did
not include any clinically important effects, the result was described
as *unlikely to be clinically important* (i.e., S3). Alternatively, if
the range of estimates defined by the CI included clinically important
benefits as well as no effect or harmful effects, the result was
described as *inconclusive* (i.e., S4).

Where for a particular review very few trials meet the threshold for
clinical importance, further criteria are required to differentiate the
relative efficacy of treatments considered. In this case treatments are
evaluated according to whether they are both statistically significant
and reasonably well tolerated. Specifically, the most effective
treatments are identified as those for which, for the principal outcome
measures, the effect sizes are statistically significant (95% CI to the
left of the line of no effect).

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus\
Informal Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

**The Guideline Development Group**

The Guideline Development Group consisted of professionals in
psychiatry, clinical psychology, nursing, social work and general
practice; academic experts in psychiatry and psychology; and
post-traumatic stress disorder (PTSD) sufferers. The guideline
development process was supported by staff from the National
Collaborating Centre for Mental Health (NCCMH), who undertook the
clinical and health economics literature searches, reviewed and
presented the evidence to the Group, managed the process, and
contributed to the drafting of the guideline.

**Guideline Development Group Meetings**

Seventeen Group meetings were held between February 2003 and June 2004.
During each daylong meeting, in a plenary session, clinical questions
and clinical evidence were reviewed and assessed, statements developed
and recommendations formulated. At each meeting all Group members
declared any potential conflict of interest, and PTSD sufferer and carer
concerns were routinely discussed as part of a standing agenda.

**Topic Leads**

The Group divided its workload along clinically relevant lines to
simplify the guideline development process, and individual members took
responsibility for advising on guideline work for particular areas of
clinical practice (psychological interventions, pharmacological
interventions, early intervention, risk factors and screening, and
children).

**PTSD Sufferers and Carers**

Individuals with direct experience of services gave an integral PTSD
sufferer focus to the Group and to the guideline. The Group included two
PTSD sufferers, both of whom had contact with other PTSD sufferers and
carers. They contributed as full Group members to writing the clinical
questions, helping to ensure that the evidence addressed their views and
preferences, highlighting sensitive issues and terminology associated
with PTSD, and bringing PTSD sufferer research to the attention of the
Group. In drafting the guideline, they contributed to the editing of the
introduction and Chapter 3 (Experiences of PTSD Sufferers and Carers) of
the original guideline document, and identified good practice points
from the PTSD sufferer and carer perspectives.

**Special Advisers**

Special advisers who had specific expertise in one or more aspects of
treatment and management relevant to the guideline assisted the Group,
commenting on specific aspects of the developing guideline and making
presentations to the Group. The Acknowledgements section at the
beginning of this guideline lists those who agreed to act as special
advisers.

**National and International Experts**

National and international experts in the area under review were
identified through the literature search and through the experience of
the Group members. These experts were contacted to recommend unpublished
or soon-to-be published studies in order to ensure up-to-date evidence
was included in the development of the guideline. They informed the
group about completed trials at the pre-publication stage, systematic
reviews in the process of being published, studies relating to the
cost-effectiveness of treatment, and trial data if the Group could be
provided with full access to the complete trial report. Appendix 4 of
the original guideline document lists the researchers who were
contacted.

**Developing and Grading the Recommendations**

Once all evidence statements relating to a particular clinical question
were finalised and agreed by the Group, the associated recommendations
were produced and graded. Grading allowed the Group to distinguish
between the level of evidence and the strength of the associated
recommendation. This allowed the Group to moderate recommendations based
on factors other than the strength of evidence. Such considerations
include the applicability of the evidence to the people in question,
economic considerations, values of the development group and society,
and the group\'s awareness of practical issues.

Each clinical evidence statement was classified according to a
hierarchy. Recommendations were then graded A to C based on the level of
associated evidence, or as a good practice point (GPP). All evidence
statements and associated forest plots are presented in Appendices 16
and 15 respectively of the original guideline document, while a subset
of the key evidence statements are presented in the relevant chapters
for ease of reference.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

**Recommendation Grades**

**Grade A** - At least one randomised controlled trial as part of a body
of literature of overall good quality and consistency addressing the
specific recommendation (evidence levels I) without extrapolation

**Grade B** - Well-conducted clinical studies but no randomised clinical
trials on the topic of recommendation (evidence levels II or III); or
extrapolated from level I evidence

**Grade C** - Expert committee reports or opinions and/or clinical
experiences of respected authorities (evidence level IV) or extrapolated
from level I or II evidence. This grading indicates that directly
applicable clinical studies of good quality are absent or not readily
available

**Good practice point (GPP)** - Recommended good practice based on the
clinical experience of the Guideline Development Group (GDG)

#### COST ANALYSIS

**Health Economics Review Strategies**

A systematic review for health economic evidence was conducted. The aim
was threefold:

-   to identify all publications with information about the economic
    burden of post-traumatic stress disorder (PTSD) in the UK

-   to identify existing economic evaluations of any psychological or
    pharmacological interventions for the treatment of PTSD undertaken
    in the UK

-   to find studies with health state utility evidence generalisable to
    the UK context to facilitate a possible cost-utility modelling
    process.

Although no attempt was made to review systematically studies with only
resource use or cost data, relevant UK-based information was extracted
for future modelling exercises if it was considered appropriate.

**Selection Criteria**

Cost-of-illness/economic burden studies:

-   no restriction was placed on language or publication status of the
    papers

-   studies published between 1980 and 2003 were included (this date
    restriction was imposed in order to obtain data relevant to current
    healthcare settings and costs)

-   only studies from the UK were included, as the aim of the review was
    to identify economic burden information relevant to the national
    context

-   selection criteria based on types of clinical conditions and
    patients were identical to the clinical literature review (see
    Appendix 7 of the original guideline document)

-   studies were included provided sufficient details regarding methods
    and results were available to enable the methodological quality of
    the study to be assessed and provided the study\'s data and results
    were extractable.

Economic evaluations:

-   studies were included provided they had used cost-minimisation
    analysis, cost-effectiveness analysis, cost-utility analysis or
    cost-benefit analysis

-   only clinical evidence from a meta-analysis, a randomised controlled
    trial, a quasiexperimental trial or a cohort study was used

-   no restriction was placed on language or publication status of the
    papers

-   studies published between 1980 and 2003 were included (this date
    restriction was imposed in order to obtain data relevant to current
    healthcare settings and costs)

-   only studies from the UK were considered, as the aim of the review
    was to identify economic evaluation information relevant to the
    national context

-   selection criteria based on types of clinical conditions, patients,
    treatments and settings were identical to the clinical literature
    review (see Appendix 7 of the original guideline document)

-   studies were included provided sufficient details regarding methods
    and results were available to enable the methodological quality of
    the study to be assessed and provided the study\'s data and results
    were extractable.

Health state utility studies:

-   studies reporting health state utilities for PTSD were considered
    for inclusion

-   no restriction was placed on language or publication status of the
    papers

-   studies published between 1980 and 2003 were included

-   only studies from Organization for Economic Cooperation and
    Development countries were considered, to assure the
    generalisability of the results to the UK context

-   selection criteria based on types of clinical conditions, patients,
    treatments and settings were identical to the clinical literature
    review (see Appendix 7 of the original guideline document).

**Data Extraction**

Data were extracted by the health economist. Masked assessment, whereby
data extractors are masked to the details of journal, authors and so on
was not undertaken, because the evidence does not support the claim that
this minimises bias.

Details of the findings of the health economic analyses are provided in
the original guideline document.

#### METHOD OF GUIDELINE VALIDATION

Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The first draft of the guideline (The full guideline, National Institute
for Health and Clinical Excellence (NICE) guideline and Quick Reference
Guide) were consulted with Stakeholders and comments were considered by
the Guideline Development Group (GDG).

The final consultation draft of the Full guideline, the NICE guideline
and the Information for the Public were submitted to stakeholders for
final comments.

The final draft was submitted to the Guideline Review Panel for review
prior to publication.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Levels of evidence **(I-IV)** and grading of recommendations **(A-D,
GPP)** are defined at the end of the Major Recommendations field.

**Recognition of Post-traumatic Stress Disorder (PTSD)**

Effective treatment of PTSD can only take place if the disorder is
recognised. In some cases, for example following a major disaster,
specific arrangements to screen people at risk may be considered. For
the vast majority of people with PTSD, opportunities for recognition and
identification come as part of routine healthcare interventions, for
example, following an assault or an accident for which physical
treatment is required, or when a person discloses domestic violence or a
history of childhood sexual abuse. Identification of PTSD in children
presents particular problems but is improved if children are asked
directly about their experiences.

**Recognition in Primary Care**

PTSD can present with a range of symptoms, which in most adults are most
commonly in the form of very vivid, distressing memories of the event or
flashbacks (otherwise known as intrusive or re-experiencing symptoms).
However, at times the most prominent symptoms may be avoidance of
trauma-related situations or general social contacts. It is important
when recognising and identifying PTSD to ask specific questions in a
sensitive manner about both the symptoms and traumatic experiences. A
number of problems such as depression are often comorbid with PTSD.
Often these problems will improve with the treatment of the PTSD, but
where this does not happen or the comorbid disorder impedes the
effective treatment of the PTSD, it may be appropriate to consider
providing specific treatment for that disorder.

**GPP** - PTSD may present with a range of symptoms (including
re-experiencing, avoidance, hyperarousal, depression, emotional numbing,
drug or alcohol misuse and anger) and therefore, when assessing for
PTSD, members of the primary care team should ask in a sensitive manner
whether or not patients with such symptoms have suffered a traumatic
experience (which may have occurred many months or years before) and
give specific examples of traumatic events (for example, assaults, rape,
road traffic accidents, childhood sexual abuse and traumatic
childbirth).

**GPP** - General practitioners and other members of the primary care
team should be aware of traumas associated with the development of PTSD.
These include single events such as assaults or road traffic accidents,
and domestic violence and childhood sexual abuse.

**GPP** - For patients with unexplained physical symptoms who are
repeated attendees to primary care, members of the primary care team
should consider asking whether or not they have experienced a traumatic
event, and provide specific examples of traumatic events (for example,
assaults, rape, road traffic accidents, childhood sexual abuse and
traumatic childbirth).

**C** - When seeking to identify PTSD, members of the primary care team
should consider asking adults specific questions about re-experiencing
(including flashbacks and nightmares) or hyperarousal (including an
exaggerated startle response or sleep disturbance). For children,
particularly younger children, consideration should be given to asking
the child and/or the parents about sleep disturbance or significant
changes in sleeping patterns.

**Recognition in General Hospital Settings**

Many people attending for medical services in a general hospital setting
may have experienced traumatic events. This may be particularly so in
emergency departments and in orthopaedic and plastic surgery clinics.
For some people with PTSD, this may be the main point of contact with
the healthcare system and the opportunity that this presents for the
recognition and identification of PTSD should be taken.

**GPP** - PTSD may present with a range of symptoms (including
re-experiencing, avoidance, hyperarousal, depression, emotional numbing
and anger) and therefore when assessing for PTSD, members of secondary
care medical teams should ask in a sensitive manner whether or not
patients with such symptoms have suffered a traumatic experience and
give specific examples of traumatic events (for example, assaults, rape,
road traffic accidents, childhood sexual abuse and traumatic
childbirth).

**Screening of Individuals Involved in a Major Disaster, Programme
Refugees and Asylum Seekers**

Many individuals involved in a major disaster will suffer both short-
and long-term consequences of their involvement. Although the
development of single-session debriefing is not recommended, screening
of all individuals should be considered by the authorities responsible
for developing the local disaster plan. Similarly, the vast majority of
programme refugees (people who are brought to the UK from a conflict
zone through a programme organised by an agency such as the United
Nations High Commission for Refugees) will have experienced major trauma
and may benefit from a screening programme.

**C** - For individuals at high risk of developing PTSD following a
major disaster, consideration should be given (by those responsible for
coordination of the disaster plan) to the routine use of a brief
screening instrument for PTSD at 1 month after the disaster.

**C** - For programme refugees and asylum seekers at high risk of
developing PTSD, consideration should be given (by those responsible for
management of the refugee programme) to the routine use of a brief
screening instrument for PTSD as part of the initial refugee healthcare
assessment. This should be a part of any comprehensive physical and
mental health screen.

**Specific Recognition Issues for Children**

Children, particularly those aged under 8 years, may not complain
directly of PTSD symptoms such as re-experiencing or avoidance. Instead,
children may complain of sleeping problems. It is therefore vital that
all opportunities for identifying PTSD in children should be taken.
Questioning the children as well as parents or guardians will also
improve the recognition of PTSD. PTSD is common (up to 30%) in children
following attendance at emergency departments for a traumatic injury.
Emergency department staff should inform parents or guardians of the
risk of their child developing PTSD following emergency attendance for a
traumatic injury and advise them on what action to take if symptoms
develop.

**GPP** - When assessing a child or young person for PTSD, healthcare
professionals should ensure that they separately and directly question
the child or young person about the presence of PTSD symptoms. They
should not rely solely on information from the parent or guardian in any
assessment.

**GPP** - When a child who has been involved in a traumatic event is
treated in an emergency department, emergency staff should inform the
parents or guardians of the possibility of the development of PTSD,
briefly describe the possible symptoms (for example, sleep disturbance,
nightmares, difficulty concentrating and irritability) and suggest that
they contact their general practitioner if the symptoms persist beyond 1
month.

**Assessment and Coordination of Care**

**C** - For PTSD sufferers presenting in primary care, General
Practitioners (GPs) should take responsibility for the initial
assessment and the initial coordination of care. This includes the
determination of the need for emergency medical or psychiatric
assessment.

**GPP** - Assessment of PTSD sufferers should be conducted by competent
individuals and be comprehensive, including physical, psychological and
social needs and a risk assessment.

**C** - Patient preference should be an important determinant of the
choice among effective treatments. PTSD sufferers should be given
sufficient information about the nature of these treatments to make an
informed choice.

**C** - Where management is shared between primary and secondary care,
there should be clear agreement among individual healthcare
professionals about the responsibility for monitoring patients with
PTSD. This agreement should be in writing (where appropriate, using the
Care Programme Approach) and should be shared with the patient and,
where appropriate, their family and carers.

**Support for Families and Carers**

Families and carers have a central role in supporting people with PTSD.
However, depending on the nature of the trauma and its consequences,
many families may also need support for themselves. Healthcare
professionals should be aware of the impact of PTSD on the whole family.

**GPP** - In all cases of PTSD, healthcare professionals should consider
the impact of the traumatic event on all family members and, when
appropriate, assess this impact and consider providing appropriate
support.

**GPP** - Healthcare professionals should ensure, where appropriate and
with the consent of the PTSD sufferer where necessary, that the families
of PTSD sufferers are fully informed about common reactions to traumatic
events, including the symptoms of PTSD and its course and treatment.

**GPP** - In addition to the provision of information, families and
carers should be informed of self-help groups and support groups and
encouraged to participate in such groups where they exist.

**GPP** - When a family is affected by a traumatic event, more than one
family member may suffer from PTSD. If this is the case, healthcare
professionals should ensure that the treatment of all family members is
effectively coordinated.

**Practical Support and Social Factors**

Practical and social support can play an important part in facilitating
a person\'s recovery from PTSD, particularly immediately after the
trauma. Healthcare professionals should be aware of this and advocate
for such support when people present with PTSD.

**GPP** - Healthcare professionals should identify the need for
appropriate information about the range of emotional responses that may
develop and provide practical advice on how to access appropriate
services for these problems. They should also identify the need for
social support and advocate the meeting of this need.

**GPP** - Healthcare professionals should consider offering help or
advice to PTSD sufferers or relevant others on how continuing threats
related to the traumatic event may be alleviated or removed.

**Language and Culture**

People with PTSD treated in the National Health Service (NHS) come from
diverse cultural and ethnic backgrounds and some have no or limited
English, but all should be offered the opportunity to benefit from
psychological interventions. This can be achieved by the use of
interpreters and bicultural therapists. In all cases, healthcare
professionals must familiarise themselves with the cultural background
of the sufferer.

**GPP** - Where a PTSD sufferer has a different cultural or ethnic
background from that of the healthcare professionals who are providing
care, the healthcare professionals should familiarise themselves with
the cultural background of the PTSD sufferer.

**GPP** - Where differences of language or culture exist between
healthcare professionals and PTSD sufferers, this should not be an
obstacle to the provision of effective trauma-focused psychological
interventions.

**GPP** - Where language or culture differences present challenges to
the use of trauma-focused psychological interventions in PTSD,
healthcare professionals should consider the use of interpreters and
bicultural therapists.

**GPP** - Healthcare professionals should pay particular attention to
the identification of individuals with PTSD where the culture of the
working or living environment is resistant to recognition of the
psychological consequences of trauma.

**Care for All People with PTSD**

PTSD responds to a variety of effective treatments. All treatment should
be supported by appropriate information to sufferers about the likely
course of such treatment. A number of factors, which are described
below, may modify the nature, timing and course of treatment.

**Care Across All Conditions**

**GPP** - When developing and agreeing a treatment plan with a PTSD
sufferer, healthcare professionals should ensure that sufferers receive
information about common reactions to traumatic events, including the
symptoms of PTSD and its course and treatment.

**C** - Healthcare professionals should not delay or withhold treatment
for PTSD because of court proceedings or applications for compensation.

**C** - Healthcare professionals should be aware that many PTSD
sufferers are anxious about and can avoid engaging in treatment.
Healthcare professionals should also recognize the challenges that this
presents and respond appropriately, for example by following up PTSD
sufferers who miss scheduled appointments.

**GPP** - Healthcare professionals should treat PTSD sufferers with
respect, trust and understanding, and keep technical language to a
minimum.

**GPP** - Healthcare professionals should normally only consider
providing trauma-focused psychological treatment when the sufferer
considers it safe to proceed.

**C** - Treatment should be delivered by competent individuals who have
received appropriate training. These individuals should receive
appropriate supervision.

**Comorbidities**

**C** - When a patient presents with PTSD and depression, healthcare
professionals should consider treating the PTSD first, as the depression
will often improve with successful treatment of the PTSD.

**C** - For PTSD sufferers whose assessment identifies a high risk of
suicide or harm to others, healthcare professionals should first
concentrate on management of this risk.

**C** - For PTSD sufferers who are so severely depressed that this makes
initial psychological treatment of PTSD very difficult (for example, as
evidenced by extreme lack of energy and concentration, inactivity, or
high suicide risk), healthcare professionals should treat the depression
first.

**C** - For PTSD sufferers with drug or alcohol dependence or in whom
alcohol or drug use may significantly interfere with effective
treatment, healthcare professionals should treat the drug or alcohol
problem first.

**C** - When offering trauma-focused psychological interventions to PTSD
sufferers with comorbid personality disorder, healthcare professionals
should consider extending the duration of treatment.

**C** - People who have lost a close friend or relative due to an
unnatural or sudden death should be assessed for PTSD and traumatic
grief. In most cases, healthcare professionals should treat the PTSD
first without avoiding discussion of the grief.

**Treatment of PTSD**

**Early Interventions**

A number of sufferers with PTSD may recover with no or limited
interventions. However, without effective treatment, many people may
develop chronic problems over many years. The severity of the initial
traumatic response is a reasonable indicator of the need for early
intervention, and treatment should not be withheld in such
circumstances.

*Watchful Waiting*

**C** - Where symptoms are mild and have been present for less than 4
weeks after the trauma, watchful waiting, as a way of managing the
difficulties presented by individual sufferers, should be considered by
healthcare professionals. A follow-up contact should be arranged within
1 month.

*Immediate Psychological Interventions for All*

As described in this guideline, practical support delivered in an
empathetic manner is important in promoting recovery for PTSD, but it is
unlikely that a single session of a psychological intervention will be
helpful.

**GPP** - All health and social care workers should be aware of the
psychological impact of traumatic incidents in their immediate
post-incident care of survivors and offer practical, social and
emotional support to those involved.

**A** - For individuals who have experienced a traumatic event, the
systematic provision to that individual alone of brief, single-session
interventions (often referred to as debriefing) that focus on the
traumatic incident should *not* be routine practice when delivering
services.

*PTSD where Symptoms are Present Within 3 Months of a Trauma*

Brief psychological interventions (five sessions) may be effective if
treatment starts within the first month after the traumatic event.
Beyond the first month, the duration of treatment is similar to that for
chronic PTSD.

**B** - Trauma-focused cognitive-behavioural therapy should be offered
to those with severe post-traumatic symptoms or with severe PTSD in the
first month after the traumatic event. These treatments should normally
be provided on an individual out-patient basis.

**A** - Trauma-focused CBT should be offered to people who present with
PTSD within 3 months of a traumatic event.

**B** - The duration of the trauma-focused CBT should normally be 8-12
sessions, but if the treatment starts in the first month after the
event, fewer sessions (about 5) may be sufficient. When the trauma is
discussed in the treatment session, longer sessions (for example, 90
min) are usually necessary. Treatment should be regular and continuous
(usually at least once a week) and should be delivered by the same
person.

**C** - Drug treatment may be considered in the acute phase of PTSD for
the management of sleep disturbance. In this case, hypnotic medication
may be appropriate for short-term use but, if longer-term drug treatment
is required, consideration should also be given to the use of suitable
antidepressants at an early stage in order to reduce the later risk of
dependence.

**B** - Non-trauma-focused interventions such as relaxation or
non-directive therapy, which do not address traumatic memories, should
not routinely be offered to people who present with PTSD symptoms within
3 months of a traumatic event.

**PTSD Where Symptoms Have Been Present For More Than 3 Months After a
Trauma**

Most patients presenting with PTSD have had the problem for many months,
if not years. The interventions outlined below are effective in treating
such individuals and duration of the disorder does not itself seem an
impediment to benefiting from effective treatment provided by competent
healthcare professionals.

*Psychological Interventions*

**A** - All PTSD sufferers should be offered a course of trauma-focused
psychological treatment (trauma-focused CBT or eye movement
desensitisation and reprocessing). These treatments should normally be
provided on an individual out-patient basis.

**B** - Trauma-focused psychological treatment should be offered to PTSD
sufferers regardless of the time that has elapsed since the trauma.

**B** - The duration of trauma-focused psychological treatment should
normally be 8-12 sessions when the PTSD results from a single event.
When the trauma is discussed in the treatment session, longer sessions
than usual are generally necessary (for example, 90 min). Treatment
should be regular and continuous (usually at least once a week) and
should be delivered by the same person.

**C** - Healthcare professionals should consider extending the duration
of treatment beyond 12 sessions if several problems need to be addressed
in the treatment of PTSD sufferers, particularly after multiple
traumatic events, traumatic bereavement or where chronic disability
resulting from the trauma, significant comorbid disorders or social
problems are present. Trauma-focused treatment needs to be integrated
into an overall plan of care.

**C** - For some PTSD sufferers it may initially be very difficult and
overwhelming to disclose details of their traumatic events. In these
cases, healthcare professionals should consider devoting several
sessions to establishing a trusting therapeutic relationship and
emotional stabilisation before addressing the traumatic event.

**B** - Non-trauma-focused interventions such as relaxation or
non-directive therapy, which do not address traumatic memories, should
not routinely be offered to people who present with chronic PTSD.

**C** - For PTSD sufferers who have no or only limited improvement with
a specific trauma-focused psychological treatment, healthcare
professionals should consider the following options:

-   an alternative form of trauma-focused psychological treatment

-   the augmentation of trauma-focused psychological treatment with a
    course of pharmacological treatment.

**GPP** - When PTSD sufferers request other forms of psychological
treatment (for example, supportive therapy/non-directive therapy,
hypnotherapy, psychodynamic therapy or systemic psychotherapy), they
should be informed that there is as yet no convincing evidence for a
clinically important effect of these treatments on PTSD.

**Drug Treatment**

The evidence base for drug treatments in PTSD is limited. There is
evidence of clinically significant benefits for mirtazapine,
amitriptyline and phenelzine. (Dietary guidance is required with
phenelzine.) For paroxetine there were statistically but not clinically
significant benefits on the main outcome variables. Nevertheless, this
drug has also been included in the list of recommended drugs. This is
the only drug in the list of recommendations with a current UK product
licence for PTSD.

**A** - Drug treatments for PTSD should not be used as a routine
first-line treatment for adults (in general use or by specialist mental
health professionals) in preference to a trauma-focused psychological
therapy.

**B** - Drug treatments (paroxetine or mirtazapine for general use, and
amitriptyline or phenelzine for initiation only by mental health
specialists) should be considered for the treatment of PTSD in adults
where a sufferer expresses a preference not to engage in a
trauma-focused psychological treatment.

**C** - Drug treatments (paroxetine or mirtazapine for general use, and
amitriptyline or phenelzine for initiation only by mental health
specialists) should be offered to adult PTSD sufferers who cannot start
a psychological therapy because of serious ongoing threat of further
trauma (for example, where there is ongoing domestic violence).

**C** - Drug treatments (paroxetine or mirtazapine for general use and
amitriptyline or phenelzine for initiation only by mental health
specialists) should be considered for adult PTSD sufferers who have
gained little or no benefit from a course of trauma-focused
psychological treatment.

**C** - Where sleep is a major problem for an adult PTSD sufferer,
hypnotic medication may be appropriate for short-term use but, if
longer-term drug treatment is required, consideration should also be
given to the use of suitable antidepressants at an early stage in order
to reduce the later risk of dependence.

**C** - Drug treatments (paroxetine or mirtazapine for general use and
amitriptyline or phenelzine for initiation only by mental health
specialists) for PTSD should be considered as an adjunct to
psychological treatment in adults where there is significant comorbid
depression or severe hyperarousal that significantly impacts on a
sufferer\'s ability to benefit from psychological treatment.

**C** - When an adult sufferer with PTSD has not responded to a drug
treatment, consideration should be given to increasing the dosage within
approved limits. If further drug treatment is considered, this should
generally be with a different class of antidepressant or involve the use
of adjunctive olanzapine.

**C** - When an adult sufferer with PTSD has responded to drug
treatment, it should be continued for at least 12 months before gradual
withdrawal.

*General Recommendations Regarding Drug Treatment*

**C** - All PTSD sufferers who are prescribed antidepressants should be
informed, at the time that treatment is initiated, of potential
side-effects and discontinuation/withdrawal symptoms (particularly with
paroxetine).

**GPP** - Adult PTSD sufferers started on antidepressants who are
considered to have an increased suicide risk and all patients aged
between 18 and 29 years (because of the potential increased risk of
suicidal thoughts associated with the use of antidepressants in this age
group) should normally be seen after 1 week and frequently thereafter
until the risk is no longer considered significant.

**GPP** - Particularly in the initial stages of SSRI treatment,
practitioners should actively seek out signs of akathisia, suicidal
ideation and increased anxiety and agitation. They should also advise
PTSD sufferers of the risk of these symptoms in the early stages of
treatment and advise them to seek help promptly if these are at all
distressing.

**GPP** - If a PTSD sufferer develops marked and/or prolonged akathisia
while taking an antidepressant, the use of the drug should be reviewed.

**GPP** - Adult PTSD sufferers started on antidepressants who are not
considered to be at increased risk of suicide should normally be seen
after 2 weeks and thereafter on an appropriate and regular basis, for
example, at intervals of 2-4 weeks in the first 3 months, and at greater
intervals thereafter, if response is good.

*Recommendations Regarding Discontinuation/Withdrawal Symptoms*

**C** - Discontinuation/withdrawal symptoms are usually mild and
self-limiting but occasionally can be severe. Prescribers should
normally gradually reduce the dosage of antidepressants over a 4-week
period, although some people may require longer periods.

**C** - If discontinuation/withdrawal symptoms are mild, practitioners
should reassure the PTSD sufferer and arrange for monitoring. If
symptoms are severe, the practitioner should consider reintroducing the
original antidepressant (or another with a longer half-life from the
same class) and reduce gradually while monitoring symptoms.

**Chronic Disease Management**

**C** - Chronic disease management models should be considered for the
management of people with chronic PTSD who have not benefited from a
number of courses of evidence-based treatment.

**Children**

It is particularly difficult to identify PTSD in children (see section
above titled \"Specific Recognition Issues for Children\"). The
treatments for children with PTSD are less developed but emerging
evidence provides an indication for effective interventions.

*Early Intervention*

**B** - Trauma-focused CBT should be offered to older children with
severe post-traumatic symptoms or with severe PTSD in the first month
after the traumatic event.

*PTSD Where Symptoms Have Been Present for More Than 3 Months After a
Trauma*

**B** - Children and young people with PTSD, including those who have
been sexually abused, should be offered a course of trauma-focused CBT
adapted appropriately to suit their age, circumstances and level of
development.

**C** - The duration of trauma-focused psychological treatment for
children and young people with chronic PTSD should normally be 8--12
sessions when the PTSD results from a single event. When the trauma is
discussed in the treatment session, longer sessions than usual are
usually necessary (for example, 90 min). Treatment should be regular and
continuous (usually at least once a week) and should be delivered by the
same person.

**C** - Drug treatments should not be routinely prescribed for children
and young people with PTSD.

**C** - Where appropriate, families should be involved in the treatment
of PTSD in children and young people. However, treatment programmes for
PTSD in children and young people that consist of parental involvement
alone are unlikely to be of any benefit for PTSD symptoms.

**C** - When considering treatments for PTSD, parents and, where
appropriate, children and young people should be informed that, apart
from trauma-focused psychological interventions, there is at present no
good evidence for the efficacy of widely used forms of treatment of PTSD
such as play therapy, art therapy or family therapy.

**Disaster Planning**

Both health and social services have a role in organising the
appropriate social and psychological support for those affected by
disasters.

**GPP** - Disaster plans should include provision for a fully
coordinated psychosocial response to the disaster. Those responsible for
developing the psychosocial aspect of a disaster plan should ensure it
contains the following: provision for immediate practical help, means to
support the affected communities in caring for those involved in the
disaster and the provision of specialist mental health, evidence based
assessment and treatment services. All healthcare workers involved in a
disaster plan should have clear roles and responsibilities, which should
be agreed in advance.

**Definitions**

**Levels of Evidence**

**I**: Evidence obtained from a single randomised controlled trial or a
meta-analysis of randomised controlled trials

**IIa**: Evidence obtained from at least one well-designed controlled
study without randomisation

**IIb**: Evidence obtained from at least one other well-designed
quasi-experimental study

**III**: Evidence obtained from well-designed non-experimental
descriptive studies, such as comparative studies, correlation studies,
and case studies

**IV**: Evidence obtained from expert committee reports or opinions
and/or clinical experience of respected authorities.

**Grading of Recommendation**

**Grade A** - At least one randomised controlled trial as part of a body
of literature of overall good quality and consistency addressing the
specific recommendation (evidence levels I) without extrapolation

**Grade B** - Well-conducted clinical studies but no randomised clinical
trials on the topic of recommendation (evidence levels II or III); or
extrapolated from level I evidence

**Grade C** - Expert committee reports or opinions and/or clinical
experiences of respected authorities (evidence level IV) or extrapolated
from level I or II evidence. This grading indicates that directly
applicable clinical studies of good quality are absent or not readily
available.

**Good practice point (GPP)** - Recommended good practice based on the
clinical experience of the Guideline Development Group (GDG)

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each
recommendation (see \"Major Recommendations\").

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Consistent and improved quality of care and outcomes for people with
post traumatic stress disorder

#### POTENTIAL HARMS

-   Side effects of paroxetine may include anxiety, agitation, suicidal
    thoughts and akathisia.

-   Dietary restrictions and careful monitoring are required for
    patients taking monoamine oxidase inhibitors.

-   Medication discontinuation/withdrawal symptoms may occur.

-   Administration of some drugs to nursing mothers may lead to effects
    in breastfeeding infants.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

This guidance represents the view of the Institute, which was arrived at
after careful consideration of the evidence available. Health
professionals are expected to take it fully into account when exercising
their clinical judgement. The guidance does not, however, override the
individual responsibility of health professionals to make decisions
appropriate to the circumstances of the individual patient, in
consultation with the patient and/or guardian or carer.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

**Implementation in the National Health Service (NHS)**

**In General**

Local health communities should review their existing practice in the
treatment and management of post-traumatic stress disorder (PTSD)
against this guideline. The review should consider the resources
required to implement the recommendations set out in Section 1 of the
original guideline document (short version) and in the \"Major
Recommendations\" section of this summary, the people and processes
involved and the timeline over which full implementation is envisaged.
It is in the interests of PTSD sufferers that the implementation
timeline is as rapid as possible.

Relevant local clinical guidelines, care pathways and protocols should
be reviewed in the light of this guidance and revised accordingly.

This guideline should be used in conjunction with the National Service
Framework for Mental Health, which is available from
[www.dh.gov.uk](http://www.dh.gov.uk/).

**Audit**

Suggested audit criteria are listed below and in Appendix D of the short
version of the original guideline document. These can be used as the
basis for local clinical audit, at the discretion of those in practice.

**Possible Objectives for an Audit**

One or more audits could be carried out in different care settings to
ensure that:

-   individuals with PTSD are involved in their care

-   treatment options, including psychological interventions, are
    appropriately offered and provided for individuals with PTSD.

**People Who Could be Included in an Audit**

A single audit could include all individuals with PTSD. Alternatively,
individual audits could be undertaken on specific groups of individuals
such as:

-   people with a specific type of PTSD (for example, to study early
    intervention)

-   a sample of patients from particular populations in primary care.

**Measures That Could be Used as a Basis for an Audit**

Please see tables in Appendix D of the original guideline document.

#### IMPLEMENTATION TOOLS

Foreign Language Translations\
Patient Resources\
Quick Reference Guides/Physician Guides\
Slide Presentation

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

National Collaborating Centre for Mental Health. Post-traumatic stress
disorder: the management of PTSD in adults and children in primary and
secondary care. London (UK): National Institute for Clinical Excellence
(NICE); 2005. 167 p. \[69 references\]

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2005

#### GUIDELINE DEVELOPER(S)

National Collaborating Centre for Mental Health - National Government
Agency \[Non-U.S.\]

#### SOURCE(S) OF FUNDING

National Institute for Health and Clinical Excellence (NICE)

#### GUIDELINE COMMITTEE

Guideline Development Group

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Guideline Development Group Members*: Dr Jonathan Bisson (Co-Chair)
Clinical Senior Lecturer in Psychiatry, Cardiff University; Professor
Anke Ehlers (Co-Chair) Professor of Experimental Psychopathology,
Institute of Psychiatry, King\'s College London; Mrs Pamela Dix, PTSD
Sufferer Representative; Mrs S. Janet Johnston, MBE, Clinical Director,
Ashford Couselling Service, Retired Senior Social Worker, Kent County
Council, Founder, Dover Counselling Centre; Mr Christopher Jones, Health
Economist, National Collaborating Centre for Mental Health; Ms Rebecca
King, Project Manager, National Collaborating Centre for Mental Health;
Ms Rosa Matthews, Systematic Reviewer, National Collaborating Centre for
Mental Health; Mr Andrew Murphy, PTSD Sufferer Representative; Ms Peggy
Nuttall, Research Assistant, National Collaborating Centre for Mental
Health; Mr Cesar De Oliveira, Systematic Reviewer, National
Collaborating Centre for Mental Health; Mr Stephen Pilling (Guideline
Facilitator) Co-Director, National Collaborating Centre for Mental
Health, Director, Centre for Outcomes, Research and Effectiveness,
University College London, Consultant Clinical Psychologist, Camden and
Islington Mental Health and Social Care Trust; Professor David Richards,
Professor of Mental Health, University of York; Dr Clare Taylor, Editor,
National Collaborating Centre for Mental Health; Ms Lois Thomas,
Research Assistant, National Collaborating Centre for Mental Health; Dr
Stuart Turner, Consultant Psychiatrist, Capio Nightingale Hospital,
Chair of Trustees, Refugee Therapy Centre, Honorary Senior Lecturer,
University College London; Ms Heather Wilder, Information Scientist,
National Collaborating Centre for Mental Health; Professor William Yule,
Professor of Applied Child Psychology, Institute of Psychiatry, King\'s
College London

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

At each Guideline Development Group (GDG) meeting, all GDG members
declared any potential conflict of interests.

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format \[PDF\] format
from the [National Institute for Health and Clinical Excellence (NICE)
Web
site](http://www.nice.org.uk/guidance/index.jsp?action=byID&o=10966).

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   National Collaborating Centre for Mental Health. Post-traumatic
    stress disorder (PTSD). The management of PTSD in adults and
    children in primary and secondary care. NICE guideline (Clinical
    guideline 26). London (UK): National Institute for Health and
    Clinical Excellence (NICE); 2005 Mar. 41 p. Electronic copies:
    Available in Portable Document Format (PDF) from the [National
    Institute for Health and Clinical Excellence (NICE) Web
    site](http://www.nice.org.uk/guidance/index.jsp?action=download&o=29769).

-   National Collaborating Centre for Mental Health. Post-traumatic
    stress disorder (PTSD). The management of PTSD in adults and
    children in primary and secondary care. Quick reference guide.
    London (UK): National Institute for Health and Clinical Excellence
    (NICE); 2005 Mar. 17 p. Electronic copies: Available in Portable
    Document Format (PDF) from the [NICE Web
    site](http://www.nice.org.uk/guidance/index.jsp?action=download&o=29771).

-   Post-traumatic stress disorder\--presenter slides. Available from
    the [NICE Web
    site](http://www.nice.org.uk/guidance/index.jsp?action=download&o=29766).

#### PATIENT RESOURCES

The following is available:

-   Post-traumatic stress disorder (PTSD): the treatment of PTSD in
    adults and children. Understanding NICE guidance -- information for
    people with PTSD, their advocates and carers, and the public.
    National Institute for Health and Clinical Excellence (NICE), 2005
    Mar. 36 p. Available in Portable Document Format (PDF) from the
    [National Institute for Clinical Excellence (NICE) Web
    site](http://www.nice.org.uk/guidance/index.jsp?action=download&o=29782).

Print copies: Available from the National Health Service (NHS) Response
Line 0870 1555 455, ref N0849.

Please note: This patient information is intended to provide health
professionals with information to share with their patients to help them
better understand their health and their diagnosed disorders. By
providing access to this patient information, it is not the intention of
NGC to provide specific medical advice for particular patients. Rather
we urge patients and their representatives to review this material and
then to consult with a licensed health professional for evaluation of
treatment options suitable for them as well as for diagnosis and answers
to their personal medical questions. This patient information has been
derived and prepared from a guideline for health care professionals
included on NGC by the authors or publishers of that original guideline.
The patient information is not reviewed by NGC to establish whether or
not it accurately reflects the original guideline\'s content.

#### NGC STATUS

This summary was completed by ECRI on May 4, 2005. The information was
verified by the guideline developer on February 8, 2006. This summary
was updated by ECRI on May 31, 2006 following the U.S. Food and Drug
Administration advisory on Paxil (paroxetine hydrochloride). This
summary was updated by ECRI Institute on November 9, 2007, following the
U.S. Food and Drug Administration advisory on Antidepressant drugs.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions.

### DISCLAIMER

#### NGC DISCLAIMER

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<http://www.guideline.gov/about/inclusion.aspx> .

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Date Modified: 11/3/2008