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

NCT06894641 | Not Yet Recruiting

• 1 other identifier: 66920
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Keywords

CBT; CBT-OA; Depression; Major Depression; Major Depressive Disorder; Cognitive Behavior Therapy; Older Adults

Outcome Measures

Primary Outcomes (1)

• Beck Depression Inventory-II (BDI-II)

  The primary outcome measure will be patient-rated depression on the Beck Depression Inventory-II (BDI-II), a standardized patient-report scale commonly used in CBT depression intervention research.

  12 weeks

Study Arms (2)

CBT-OA Group Therapy

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavior Therapy for Older Adults (CBT-OA)

Treatment As Usual (TAU)

NO INTERVENTION

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

Interventions

Cognitive Behavior Therapy for Older Adults (CBT-OA) 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.

CBT-OA Group Therapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Interventions

Cognitive Behavioral Therapy; Aging

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Growth and Development; Physiological Phenomena

Central Study Contacts

Keri-Leigh Cassidy, M.D.

CONTACT

(902) 473-7799; keri-leigh.cassidy@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Geriatric Psychiatrist

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 25, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share