Clinical trial NCT01744548: A Pilot Trial Of Transdiagnostic Cognitive Behavioural Therapy (tCBT) For Depression And Anxiety In Older People
Official title: A Pilot Randomised Controlled Trial (RCT) Examining The Feasibility, Acceptability And Efficacy Of Transdiagnostic Cognitive Behavioural Therapy (tCBT) For Depression And Anxiety In Older People.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Anxiety
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2012-12-06
Enrollment: 22
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to evaluate the feasibility, acceptability and efficacy of transdiagnostic Cognitive Behavioural Therapy (tCBT) in comparison to delayed-treatment for depression and anxiety in older people. CBT is a form of 'talking therapy' that has been recommended by the National Institute of Clinical Excellence for the treatment of mood disorders. While traditional disorder-specific CBT has been found to be effective at alleviating individual mood disorders, it may be less effective when multiple mood disorders are present (i.e. when there is psychological comorbidity). tCBT is a form of CBT that targets cognitive and behavioural processes common to a range of mood disorders. Consequently, it may be better placed to address comorbidity than traditional CBT, both in terms of clinical and cost-effectiveness.

There is growing evidence that tCBT has beneficial effects on both depression and anxiety in working-age people. However, the potential benefits of this approach have not yet been examined in older people (in whom psychological comorbidity is a frequent problem). Therefore, this study will aim to recruit 22 older people who are experiencing symptoms of depression and anxiety from community mental health teams within the South London and Maudsley National Health Service Trust. Participants will be randomly allocated to receive either tCBT plus treatment-as-usual (TAU) or 7-week delayed tCBT plus TAU. tCBT will be delivered on an individual basis in 12 sessions, each lasting 1 hour, over 14 weeks. It will be delivered in outpatient clinics or within the participants residence, depending on mobility issues. A number of outcome measures will be used to evaluate the feasibility, acceptability and efficacy of tCBT, including ratings on mood questionnaires, rates of dropout and reasons for dropout. Outcome measures will be collected before the tCBT intervention starts (week 0/baseline), midway through the intervention (after the 6th tCBT session/week 7), at the end of the intervention (after the final tCBT session/week 14) and at 7-week follow-up (week 21) .

The main hypotheses are:

i. It will be feasible to adapt and establish a tCBT intervention for older people with comorbid depressive and anxiety disorders.

ii. The tCBT intervention will be acceptable to older people with comorbid depressive and anxiety disorders.

iii. The tCBT intervention will significantly reduce depression and anxiety symptoms relative to a delayed-treatment control condition.


Eligibility criteria: Inclusion Criteria:

* 60 years of age or older;
* Primary diagnosis of mild to severe depression or anxiety, together with clinical symptoms of another mood disorder (e.g. anxiety or depression respectively), or a diagnosis of mixed anxiety and depressive disorder;
* Scores between 8 to 30 (mild to severe range) on the Hamilton Anxiety Rating Scale (HARS) or between 8 to 22 (mild to severe range) on the Hamilton Depression Rating Scale (HDRS) for the primary diagnosis;
* Fluent in English;
* Sufficient literacy skills and sensory abilities to cope with the demands of the psychological intervention (e.g reading handouts, completing questionnaires etc).

Exclusion Criteria:

* Current diagnosis of Post Traumatic Stress Disorder (PTSD) or Complicated Grief;
* Presence of a severe and enduring mental health disorder (e.g. Schizophrenia);
* Presence of a developmental intellectual disability or cognitive impairment (e.g. a score below 26 on the Mini Mental State Examination);
* Presence of a personality disorder;
* Presence of a severe sensory impairment;
* Presence of a neurodegenerative disease (e.g. dementia) or neurological condition (e.g stroke);
* Current alcohol/substance abuse or dependence;
* Current suicidal risk;
* Receiving concurrent psychotherapy;
* Receiving concurrent pharmacotherapy where stabilisation of dosages has not occurred (e.g. where pharmacotherapy has been introduced or changed less than 8-weeks prior to recruitment).

Primary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS). This will assess symptom change over time in order to evaluate the efficacy of the tCBT intervention.
timeFrame: The HADS will be completed on a weekly basis throughout the tCBT intervention (from week 0 to week 14) and once again at 7-week follow-up (week 21).
measure: Hamilton Anxiety Rating Scale (HARS). This will assess symptom change over time in order to evaluate the efficacy of the tCBT intervention.
timeFrame: The HARS will be completed before the tCBT intervention starts (week 0/7), mid-way through the intervention (week 7/14), after the final tCBT session (week 14/21), and at 7-week follow-up (week 21/28).
measure: Hamilton Depression Rating Scale (HDRS). This will assess symptom change over time in order to evaluate the efficacy of the tCBT intervention.
timeFrame: The HDRS will be completed before the tCBT intervention starts (week 0/7), mid-way through the intervention (week 7/14), after the final tCBT session (week 14/21), and at 7-week follow-up (week 21/28).
Secondary outcomes:
measure: Clinical Outcomes of Routine Evaluation - 10 (CORE-10). This will assess symptom change over time in order to evaluate the efficacy of the tCBT intervention.
timeFrame: The CORE-10 will be completed before the tCBT intervention begins (week 0/7), after the final tCBT session (week 14/21), and at 7-week follow-up (week 21/28).
measure: Discharge Satisfaction Questionnaire (DSQ)
timeFrame: After the final tCBT session (week 14/21)
Other outcomes:
measure: Acceptability of tCBT
timeFrame: After the the final tCBT session (week 14/21)
measure: Feasibility of tCBT
timeFrame: After the final tCBT session (week 14/21)
Locations:
city: South London
country: United Kingdom
facility: South London and Maudsley NHS Trust
state: London
Study officials:
References: