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

University of Manitoba1 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Major Depressive Disorder

Interventions

Behavioural ActivationBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Deer Lodge Centre

Winnipeg, Manitoba, Canada

Outcomes

Primary Outcomes

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.

Time frame: Change in score from baseline to 3 weeks

Change in depression symptoms as measured by the Patient Health Questionnaire-9 item (PHQ-9)

Time frame: Change in score from baseline to 6 weeks.

Secondary Outcomes

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.

Time frame: 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.

Time frame: Change in score from baseline to 3 weeks

Data from ClinicalTrials.gov

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