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

March 19, 2025 updated by: Keri-Leigh Cassidy, Nova Scotia Health Authority

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: CBT-OA Group Therapy
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)
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.
No Intervention: Treatment As Usual (TAU)
Individual routine care offered by the referring geriatric psychiatrist or the family physician attending to the patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory-II (BDI-II)
Time Frame: 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nova Scotia Health Authority

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2025

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

March 19, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 66920

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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