Pilot Study of a Brief Behavioural Activation Intervention for Depressed Patients in Primary Care

Study Overview
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Brief Summary
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This study will explore the effectiveness of a brief psychological intervention for depressed outpatients in primary care. Participants will attend two intervention sessions with a psychologist and use a mobile activity/goal setting application for 6 weeks.

Detailed Description
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This study will evaluate the feasibility and effectiveness of a two-session psychologist-led behavioural activation intervention, with adjunctive use of a free activity/goal setting app, for depressed patients in primary care. Outpatients in primary care with Major Depressive Disorder will be recruited to complete two intervention sessions with the primary care psychologist, as well as use the mobile activity scheduling app for 6 weeks. Symptom measures will be administered prior to both intervention sessions and 6-weeks after the first intervention session.

Official Title
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Pilot Study of a Brief Behavioural Activation Intervention for Depressed Patients in Primary Care

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Behavioral: Behavioural Activation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Depression is the primary concern; Score of 10 or greater on a depression screening tool; Have access to an iPhone or iPad. Exclusion Criteria: Another psychological disorder is the primary concern (e.g., anxiety disorder, personality disorder); Concurrent alcohol or drug use disorder; Unstable dose of psychotropic medication (i.e., any psychotropic medication doses will need to be stable for at least four weeks prior to enrolment); Current participation in other regular psychological treatment (e.g., cognitive behavioral therapy, counselling); At a high risk/emergent risk for suicide.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Feasibility Study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioural Activation Treatment<br>Two intervention sessions with a psychologist and an use of a mobile scheduling app over the course of 6 weeks. | Behavioral: Behavioural Activation<br>* The intervention will span 6 weeks, including two intervention sessions with the primary care psychologist, and 6-weeks use of a mobile activity scheduling app (Strides). In the first intervention session, the psychologist would provide psychoeducation about depression, therapeutic rationale of behavioural activation, aid the patient in identifying their values and corresponding activities that may correspond with their values, introduce the mobile app, and help the patient schedule initial activities/goals. The second intervention session, which would be flexibly scheduled according to patient need, would focus on troubleshooting/clarification of previously discussed topics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in depression symptoms as measured by the Patient Health Questionnaire-9 item (PHQ-9) | This survey will be completed online. Participants will answer 9-items assessing symptoms and severity of depression, on a four-option scale from 0 (not at all) to 3 (nearly every day). A sum of the items produces a Total Score from 0 to 27. Higher scores indicate greater depression symptomology. | Change in score from baseline to 3 weeks | 
| Change in depression symptoms as measured by the Patient Health Questionnaire-9 item (PHQ-9) | This survey will be completed online. Participants will answer 9-items assessing symptoms and severity of depression, on a four-option scale from 0 (not at all) to 3 (nearly every day). A sum of the items produces a Total Score from 0 to 27. Higher scores indicate greater depression symptomology. | Change in score from baseline to 6 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in anxiety symptoms as measured by the Generalized Anxiety Disorder-7 item Scale (GAD-7) | This survey will be completed online. Participants will answer 7-items assessing symptoms and severity of generalized anxiety, on a four-option scale from 0 (not at all) to 3 (nearly every day). A sum of the items produces a Total Score form 0 to 21. Higher scores indicate greater anxiety symptomology. | Change in score from baseline to 6 weeks | 
| Change in perceived life impairment as measured by the Work and Social Adjustment Scale (WSAS) | This survey will be completed online. Participants will answer 5-items assessing perceived impairment in important life domains due to their depression, on a eight-option scale from 0 (no impairment at all) to 8 (very severe impairment). A sum of the items produces a Total Score from 0 to 40. Higher scores indicate greater perceived impairment. | Change in score from baseline to 3 weeks | 
| Change in perceived life impairment as measured by the Work and Social Adjustment Scale (WSAS) | This survey will be completed online. Participants will answer 5-items assessing perceived impairment in important life domains due to their depression, on a eight-option scale from 0 (no impairment at all) to 8 (very severe impairment). A sum of the items produces a Total Score from 0 to 40. Higher scores indicate greater perceived impairment. | Change in score from baseline to 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Behavioural activation, Psychological treatment, Primary care