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

NCT ID: NCT01744548

Last Updated: 2013-01-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2014-05-31

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.

Conditions

Depression; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

tCBT treatment

Participants randomised to the tCBT treatment arm will receive 12 individual, 1-hour tCBT sessions based upon Barlow et al.'s (2011) Unifed Protocol for emotional disorders (UP).

Group Type: EXPERIMENTAL

tCBT treatment

Intervention Type: BEHAVIORAL

The UP comprises 4 main treatment components: 1) psychoeducation about emotions and behaviour; 2) changing misappraisals about probabilities and consequences of negative experiences; 3) preventing avoidance of negative emotion triggers; and 4) modifying emotion-driven behaviours (e.g. hypervigilance, withdrawal). The manualised tCBT intervention will be adapted in order to account for a United Kingdom (UK) audience (as the manual was developed in the United States) and older people (as the manual was developed for working-age people).

7-week delayed tCBT treatment

Participants randomised to the delayed-treatment arm will receive a brief telephone call and complete the Hospital Anxiety and Depression Scale (HADS) in order to monitor risk and symptom deterioration during the 7-week delayed treatment phase. They will also receive TAU (e.g. Community Mental Health Team appointments, case reviews, etc) during this time. At the end of 7 weeks, participants in the delayed-treatment arm will crossover into the treatment arm and receive the tCBT intervention. This arm will serve as a control condition in order to enable between-group comparisons.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

tCBT treatment

The UP comprises 4 main treatment components: 1) psychoeducation about emotions and behaviour; 2) changing misappraisals about probabilities and consequences of negative experiences; 3) preventing avoidance of negative emotion triggers; and 4) modifying emotion-driven behaviours (e.g. hypervigilance, withdrawal). The manualised tCBT intervention will be adapted in order to account for a United Kingdom (UK) audience (as the manual was developed in the United States) and older people (as the manual was developed for working-age people).

Intervention Type: BEHAVIORAL

Other Intervention Names

transdiagnostic Cognitive Behavioural Therapy (tCBT)

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).

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

King's College London

OTHER

Sponsor Role: lead

Responsible Party

Siobhan Commins

Trainee Clinical Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

South London and Maudsley NHS Trust

South London, London, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Siobhan Commins

Role: CONTACT

siobhan.commins@kcl.ac.uk

02078480346

Rebecca Gould

Role: CONTACT

rebecca.gould@kcl.ac.uk

02078480346

Facility Contacts

Debbie Walker

Role: primary

debbie.walker@slam.nhs.uk

Other Identifiers

12/LO/1462

Identifier Type: -

Identifier Source: org_study_id