An interventional study of Behavioural Activation in Major Depressive Disorder, sponsored by University of Manitoba. Terminated at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-28.
Sponsored by University of Manitoba · Not applicable, Interventional, and Treatment
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.
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.
4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.
This study's enrollment of 1 is below the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.
Browse Depressive Disorder studies →University of Manitoba is the lead sponsor of 542 studies on the registry; 87 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
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Exclusion Criteria:
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.
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.
Time frame: 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.
Time frame: Change in score from baseline to 6 weeks.
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.
Time frame: 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.
Time frame: 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.
Time frame: Change in score from baseline to 6 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: The engagement questionnaire will be completed six-weeks after baseline..
Plan to share: No
This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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University of Manitoba