A Randomized Control Trial of Enhanced Cognitive Behavioural Group Therapy for Older Adults with Depression: Efficacy Across Older Age-Groups

NCT ID: NCT06894641

Last Updated: 2025-03-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-31
• Study Completion Date: 2027-08-31

Brief Summary

This study is on a type of psychotherapy to treat depression in older adults called Cognitive Behavioural Therapy (CBT-OA). CBT is based on the idea that changing thoughts and behaviours can improve mood. CBT has been shown to treat depression in many types of people. CBT-OA changes the usual approaches used for older adults and offers the therapy in a group settings for 8 weeks, for 2 hours a week.

Participants will be randomly (by chance) placed into one of two study groups. One group will receive CBT-OA treatment right away. The other group (Treatment As Usual) will receive standard care from their doctor during the 12-week study period. Both groups will be closely monitored during the study period. The standard care group will be offered CBT-OA in a future session outside of the study.

Conditions

Major Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CBT-OA Group Therapy

Participants in this group receive 8 weeks of Cognitive Behavior Therapy for Older Adults (CBT-OA) from study clinicians

Group Type: ACTIVE_COMPARATOR

Cognitive Behavior Therapy for Older Adults (CBT-OA)

Intervention Type: BEHAVIORAL

CBT-OA integrates modifications to standard CBT to consider age-related physical, cognitive and psychological changes. CBT-OA also integrates positive psychiatry principles for older adults to promote behavioural change and health attitude change.

Treatment As Usual (TAU)

Individual routine care offered by the referring geriatric psychiatrist or the family physician attending to the patient.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Cognitive Behavior Therapy for Older Adults (CBT-OA)

CBT-OA integrates modifications to standard CBT to consider age-related physical, cognitive and psychological changes. CBT-OA also integrates positive psychiatry principles for older adults to promote behavioural change and health attitude change.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Ambulatory patients 65+ years of age and diagnosed with MDE per DSM-V criteria by a geriatric psychiatrist using a standard clinical biopsychosocial assessment and a Beck Depression Inventory (BDI) of >12.

Exclusion Criteria

• Patients with psychosis, those undergoing acute inpatient care or electroconvulsive therapy (ECT), those with dementia (Mini-Mental Status Examination (MMSE) score of < 26), and those with chronic personality disorders

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Keri-Leigh Cassidy

Professor, Geriatric Psychiatrist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Keri-Leigh Cassidy, M.D.

Role: CONTACT

keri-leigh.cassidy@nshealth.ca

(902) 473-7799

Other Identifiers

66920

Identifier Type: -

Identifier Source: org_study_id