A Pilot Trial Of Transdiagnostic Cognitive Behavioural Therapy (tCBT) For Depression And Anxiety In Older People

Depression Clinical Trial

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.

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

• NCT number: NCT01744548
• Study type: Interventional
• Source: King's College London
• Contact: Siobhan Commins
• Phone: 02078480346
• Email: siobhan.commins@kcl.ac.uk
• Status: Recruiting
• Phase: N/A
• Start date: December 2012
• Completion date: May 2014