Pilot Study of a Brief Behavioural Activation Intervention for Depressed Patients in Primary Care
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Change in depression symptoms as measured by the Patient Health Questionnaire-9 item (PHQ-9) [Change in score from baseline to 3 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.
- Change in depression symptoms as measured by the Patient Health Questionnaire-9 item (PHQ-9) [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 Outcome Measures
- Change in anxiety symptoms as measured by the Generalized Anxiety Disorder-7 item Scale (GAD-7) [Change in score from baseline to 6 weeks]
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 perceived life impairment as measured by the Work and Social Adjustment Scale (WSAS) [Change in score from baseline to 3 weeks]
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 perceived life impairment as measured by the Work and Social Adjustment Scale (WSAS) [Change in score from baseline to 6 weeks]
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.
Other Outcome Measures
- Treatment credibility and expectancy as measured by the Treatment Credibility and Expectancy Questionnaire (CEQ) [Baseline]
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.
- Quality of service as measured by the Client Satisfaction Questionnaire (CSQ-8) [The CSQ-8 will be completed six-weeks after baseline]
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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Depression is the primary concern;
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Score of 10 or greater on a depression screening tool;
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Have access to an iPhone or iPad.
Exclusion Criteria:
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Another psychological disorder is the primary concern (e.g., anxiety disorder, personality disorder);
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Concurrent alcohol or drug use disorder;
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Unstable dose of psychotropic medication (i.e., any psychotropic medication doses will need to be stable for at least four weeks prior to enrolment);
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Current participation in other regular psychological treatment (e.g., cognitive behavioral therapy, counselling);
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At a high risk/emergent risk for suicide.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Deer Lodge Centre | Winnipeg | Manitoba | Canada | R3J 0L3 |
Sponsors and Collaborators
- University of Manitoba
Investigators
- Principal Investigator: Elizabeth Hebert, PhD, University of Manitoba
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HS25208