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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05273983
Enrollment
1
Registered
2022-03-10
Start date
2022-01-14
Completion date
2023-02-23
Last updated
2023-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major Depressive Disorder

Keywords

Behavioural activation, Psychological treatment, Primary care

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.

Interventions

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.

Sponsors

University of Manitoba
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Feasibility Study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in depression symptoms as measured by the Patient Health Questionnaire-9 item (PHQ-9)Change in score from baseline to 3 weeksThis 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

MeasureTime frameDescription
Change in anxiety symptoms as measured by the Generalized Anxiety Disorder-7 item Scale (GAD-7)Change in score from baseline to 6 weeksThis 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 3 weeksThis 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.

Other

MeasureTime frameDescription
Treatment credibility and expectancy as measured by the Treatment Credibility and Expectancy Questionnaire (CEQ)BaselineThis 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.
Quality of service as measured by the Client Satisfaction Questionnaire (CSQ-8)The CSQ-8 will be completed six-weeks after baselineThis 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.
Mobile app engagement as measured by an engagement questionnaire.The engagement questionnaire will be completed six-weeks after baseline..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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026