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

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.

Study Overview

• Status: Terminated
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: Behavioural Activation

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 Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3J 0L3
      • Deer Lodge Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Behavioural Activation Treatment; Two intervention sessions with a psychologist and an use of a mobile scheduling app over the course of 6 weeks.

Behavioral: Behavioural Activation; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment credibility and expectancy as measured by the Treatment Credibility and Expectancy Questionnaire (CEQ)	This survey will be completed online. Participants will answer six-items assessing their expectancy and credibility regarding the treatment, on a nine-option scale. A sum of the items produces a Total Score from 6 to 54. Higher scores indicate greater expectancy/credibility regarding the treatment and possible outcomes.	Baseline
Quality of service as measured by the Client Satisfaction Questionnaire (CSQ-8)	This survey will be completed online. Participants will answer eight-items assessing participant satisfaction with their treatment experience, on a four-option scale. A sum of the items produces a Total Score from 8 to 32. Higher scores indicate greater participant satisfaction.	The CSQ-8 will be completed six-weeks after baseline
Mobile app engagement as measured by an engagement questionnaire.	This survey will be completed online. Participants will answer two-items assessing how often they used the mobile app over the six-weeks and how many activities they scheduled a week on average, through multiple choice options. Higher frequency of usage will indicate higher levels of engagement or treatment adherence.	The engagement questionnaire will be completed six-weeks after baseline..

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Elizabeth Hebert, PhD, University of Manitoba

Publications and helpful links

General Publications

• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
• Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002 May;180:461-4. doi: 10.1192/bjp.180.5.461.
• Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
• Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD. Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann. 1979;2(3):197-207. doi: 10.1016/0149-7189(79)90094-6. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2022
• Primary Completion (Actual): February 23, 2023
• Study Completion (Actual): February 23, 2023

Study Registration Dates

• First Submitted: February 1, 2022
• First Submitted That Met QC Criteria: March 1, 2022
• First Posted (Actual): March 10, 2022

Study Record Updates

• Last Update Posted (Estimate): February 28, 2023
• Last Update Submitted That Met QC Criteria: February 24, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Primary care; Psychological treatment; Behavioural activation
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: HS25208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No