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

Not Applicable

Terminated

• Conditions: Major Depressive Disorder
• Interventions: Behavioral: Behavioural Activation

• Registration Number: NCT05273983
• Lead Sponsor: University of Manitoba

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-01-14
• Study First Submitted: 2022-02-01
• Study First Submitted QC: 2022-03-01
• Study First Posted: 2022-03-10
• Status Verified: 2023-02
• Primary Completion: 2023-02-23
• Study Completion: 2023-02-23
• Last Update Submitted: 2023-02-24
• Last Update Posted: 2023-02-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Behavioural Activation Treatment	Behavioural Activation	Two intervention sessions with a psychologist and an use of a mobile scheduling app over the course of 6 weeks.

Primary Outcome Measures

Name	Time	Method
Change in depression symptoms as measured by the Patient Health Questionnaire-9 item (PHQ-9)	Change in score from baseline to 6 weeks.	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.

Secondary Outcome Measures

Name	Time	Method
Change in anxiety symptoms as measured by the Generalized Anxiety Disorder-7 item Scale (GAD-7)	Change in score from baseline to 6 weeks	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 perceived life impairment as measured by the Work and Social Adjustment Scale (WSAS)	Change in score from baseline to 6 weeks	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.

Trial Locations

Locations (1)

Deer Lodge Centre; 🇨🇦 Winnipeg, Manitoba, Canada