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Clinical Trials/NCT05273983
NCT05273983
Terminated
Not Applicable

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

University of Manitoba1 site in 1 country1 target enrollmentJanuary 14, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Major Depressive Disorder
Sponsor
University of Manitoba
Enrollment
1
Locations
1
Primary Endpoint
Change in depression symptoms as measured by the Patient Health Questionnaire-9 item (PHQ-9)
Status
Terminated
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 14, 2022
End Date
February 23, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

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 Outcomes

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

Study Sites (1)

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