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

NCT05273983 | Terminated

• 1 other identifier: HS25208
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Behavioural activation; Psychological treatment; Primary care

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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 3 weeks

• Change in perceived life impairment as measured by the Work and Social Adjustment Scale (WSAS)

  Change in score from baseline to 6 weeks

Other Outcomes (3)

• Treatment credibility and expectancy as measured by the Treatment Credibility and Expectancy Questionnaire (CEQ)

  Baseline

• Quality of service as measured by the Client Satisfaction Questionnaire (CSQ-8)

  The CSQ-8 will be completed six-weeks after baseline

• Mobile app engagement as measured by an engagement questionnaire.

  The engagement questionnaire will be completed six-weeks after baseline..

Study Arms (1)

Behavioural Activation Treatment

EXPERIMENTAL

Two intervention sessions with a psychologist and an use of a mobile scheduling app over the course of 6 weeks.

Behavioral: Behavioural Activation

Interventions

Behavioural Activation BEHAVIORAL

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.

Behavioural Activation Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Depression is the primary concern;
• Score of 10 or greater on a depression screening tool;
• Have access to an iPhone or iPad.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Deer Lodge Centre

Winnipeg, Manitoba, R3J 0L3, Canada

Location

Related Publications (5)

• 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.

  PMID: 11556941 RESULT

• 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.

  PMID: 11983645 RESULT

• 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.

  PMID: 16717171 RESULT

• 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.

  PMID: 11132119 RESULT

• 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.

  PMID: 10245370 RESULT

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Elizabeth Hebert, PhD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasibility Study

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: March 10, 2022
• Study Start: January 14, 2022
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)