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NCT Number: NCT06894641

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Keri-Leigh Cassidy, M.D.

CONTACT

[email protected]

(902) 473-7799

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 25, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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