Clinical trial NCT01861769: Implementation of Evidence-based Psychotherapy for PTSD
Official title: Implementation of Evidence-based Psychotherapy for PTSD: An Empirical Investigation of Post-workshop Consultation in Treatment Fidelity and Patient Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: Cognitive Processing Therapy
Consultation
Lead sponsor: Toronto Metropolitan University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2013-05-24
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Approximately 9% of Canadians will have Posttraumatic Stress Disorder (PTSD) in their lifetime. In the military veteran population, the lifetime prevalence of PTSD has been estimated to be as high as 20%. Numerous research studies have demonstrated that short-term, cognitive-behavioral psychotherapies, such as Cognitive Processing Therapy (CPT), lead to substantial improvements in PTSD symptoms. However, research suggests that a minority of clinicians provide these therapies in clinical settings. The transfer of this research knowledge into clinical settings remains one of the largest hurdles to improving the health of Canadians with PTSD.

It is well established that attending a 2-day workshop on these therapies alone is insufficient to promote adequate knowledge transfer and sustained skillful use. The current study aims to contrast whether two forms of post-workshop support (6-month duration), with different levels of expert oversight, will result in superior levels of clinician skill and patient outcomes versus no formal post-workshop support. The three forms of post-workshop support are 1) technology-enhanced group tele-consultation 2) standard group tele-consultation 3) no tele consultation. The primary and secondary outcomes will be the assessment of the clinicians' competence in CPT and patient symptoms,respectively. This study will inform how best to transfer evidence based therapy outcomes to the clinical milieu to attain comparable outcomes as those observed in research.

The investigators' hypotheses are as follows: Hypothesis 1:The technology enhanced group tele-consultation condition will evidence the highest levels of fidelity, the standard group tele-consultation condition will evidence intermediate levels of fidelity, and the no-consultation/fidelity monitoring only condition will evidence the lowest fidelity. Hypothesis 2: Fidelity to the CPT protocol, irrespective of consultation condition, will be positively associated with improved client outcomes. Hypothesis 3: Organizational context variables, such as the organizational climate and readiness for change, will influence the uptake of CPT skills, as well as the extent to which these skills are utilized in practice.


Eligibility criteria: Inclusion Criteria:

* Clinician participants (n=120) recruited for this study will either be Operation Stress Injury (OSI) network clinicians, Operational Trauma and Stress Support Centre (OTSSC) network clinicians or community-based clinicians who treat military-related PTSD.
* Both male and female clinician participants will be recruited;
* Clinician participants will be greater than 18 years.

Mental health clinicians from the clinics and private practitioners will be eligible to participate in the study if they:

1. attend the CPT workshop;
2. are employees of an OSI or OTSSC clinic, are registered VAC clinicians, or are in private practice treating individuals with military-related PTSD;
3. currently provide psychotherapy to military soldiers or veterans with PTSD;
4. consent to be randomized to one of the three study conditions; and,
5. are willing to solicit patient participation.

Eligible patient participants are:

1. client of the clinician participant, who has a diagnosis of PTSD, as determined by clinician independent assessment, and total PCL score equal or greater to 45; and
2. willing to consent to have their sessions audiorecorded and listened to by a fidelity rater and potentially other clinicians teaching and learning CPT. Patients are permitted to continue other psychotherapeutic interventions if not specifically focused on treating PTSD symptoms. Patient participants must be over the age of 18.

Exclusion Criteria:

Ineligible patients will include those not eligible for CPT based on the state of research evidence, including those with:

1. current uncontrolled psychotic or bipolar disorder;
2. unremitted substance dependence diagnosis (substance abuse allowed);
3. current imminent suicidality or homicidality that requires imminent attention; and
4. significant cognitive impairment.

Primary outcomes:
measure: Cognitive Processing Therapy Fidelity Ratings
timeFrame: Clinician-participants' CPT session audio tapes from the 6 month study period will be assessed at the 6 month time point.
Secondary outcomes:
measure: PTSD Checklist (PCL-S)
timeFrame: At baseline, approximately once per week for approximately 12 weeks, and once at 3 month follow up
measure: SF-12 Health Survey
timeFrame: At baseline, approximately once every 2 weeks for approximately 12 weeks, and once at 3 month follow up
measure: Outcomes Questionnaire 45 (OQ-45)
timeFrame: At baseline, approximately once per week for 12 weeks, and once at 3 month follow up
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Edmonton Operational Stress Injury Clinic
state: Alberta
Study officials:
affiliation: Toronto Metropolitan University
name: Candice Monson, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wiltsey Stirman S, Shields N, Deloriea J, Landy MS, Belus JM, Maslej MM, Monson CM. A randomized controlled dismantling trial of post-workshop consultation strategies to increase effectiveness and fidelity to an evidence-based psychotherapy for Posttraumatic Stress Disorder. Implement Sci. 2013 Aug 1;8:82. doi: 10.1186/1748-5908-8-82.