Major DepressionNCT06894641
A Randomized Control Trial of Enhanced Cognitive Behavioural Group Therapy for Older Adults with Depression: Efficacy Across Older Age-Groups
A study testing Cognitive Behavior Therapy for Older Adults (CBT-OA) in people with Major Depression, run by Nova Scotia Health Authority.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Major Depression
- What is being tested?
- Cognitive Behavior Therapy for Older Adults (CBT-OA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Cognitive Behavior Therapy for Older Adults (CBT-OA)
- Keywords
- CBT, CBT-OA, Depression, Major Depression, Major Depressive Disorder, Cognitive Behavior Therapy, Older Adults
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavior Therapy for Older Adults (CBT-OA)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study startJul 2025 (estimated)
- Primary completionJul 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- More trials run by Nova Scotia Health AuthorityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keri-Leigh Cassidy, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894641
- Sponsor's protocol ID
- 66920
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2025
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Enhanced Cognitive Behavioural Group Therapy for Older Adults with Depression: Efficacy Across Older Age-Groups
- ClinicalTrials.gov ID
- NCT06894641
- Acronym / sponsor ID
- 66920
- Conditions
- Major Depression
- Keywords
- CBT, CBT-OA, Depression, Major Depression, Major Depressive Disorder, Cognitive Behavior Therapy, Older Adults
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-OA Group Therapy | Active comparator | Behavioral: Cognitive Behavior Therapy for Older Adults (CBT-OA)Participants in this group receive 8 weeks of Cognitive Behavior Therapy for Older Adults (CBT-OA) from study clinicians |
| Treatment As Usual (TAU) | No intervention | –Individual routine care offered by the referring geriatric psychiatrist or the family physician attending to the patient. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | CBT-OA Group Therapy |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavior Therapy for Older Adults (CBT-OA) in people with Major Depression, run by Nova Scotia Health Authority.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keri-Leigh Cassidy, M.D. ((902) 473-7799, keri-leigh.cassidy@nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory-II (BDI-II) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.