Back to resultsPilot Study of a Brief Behavioural Activation Intervention for Depressed Patients in Primary Care
Primary Purpose
Major Depressive Disorder
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Behavioural Activation
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Behavioural activation, Psychological treatment, Primary care
Eligibility Criteria
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.
Sites / Locations
- Deer Lodge Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Behavioural Activation Treatment
Arm Description
Two intervention sessions with a psychologist and an use of a mobile scheduling app over the course of 6 weeks.
Outcomes
Primary Outcome Measures
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 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.
Secondary Outcome Measures
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 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 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.
Full Information
NCT ID
NCT05273983
First Posted
February 1, 2022
Last Updated
February 24, 2023
Sponsor
University of Manitoba
1. Study Identification
Unique Protocol Identification Number
NCT05273983
Brief Title
Pilot Study of a Brief Behavioural Activation Intervention for Depressed Patients in Primary Care
Official Title
Pilot Study of a Brief Behavioural Activation Intervention for Depressed Patients in Primary Care
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Terminated
Why Stopped
Principal Investigator medical leave
Study Start Date
January 14, 2022 (Actual)
Primary Completion Date
February 23, 2023 (Actual)
Study Completion Date
February 23, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Behavioural activation, Psychological treatment, Primary care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Feasibility Study
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Behavioural Activation Treatment
Arm Type
Experimental
Arm Description
Two intervention sessions with a psychologist and an use of a mobile scheduling app over the course of 6 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Behavioural Activation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in depression symptoms as measured by the Patient Health Questionnaire-9 item (PHQ-9)
Description
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
Title
Change in depression symptoms as measured by the Patient Health Questionnaire-9 item (PHQ-9)
Description
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.
Secondary Outcome Measure Information:
Title
Change in anxiety symptoms as measured by the Generalized Anxiety Disorder-7 item Scale (GAD-7)
Description
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
Title
Change in perceived life impairment as measured by the Work and Social Adjustment Scale (WSAS)
Description
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
Title
Change in perceived life impairment as measured by the Work and Social Adjustment Scale (WSAS)
Description
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
Other Pre-specified Outcome Measures:
Title
Treatment credibility and expectancy as measured by the Treatment Credibility and Expectancy Questionnaire (CEQ)
Description
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
Title
Quality of service as measured by the Client Satisfaction Questionnaire (CSQ-8)
Description
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
Title
Mobile app engagement as measured by an engagement questionnaire.
Description
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..
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Hebert, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Deer Lodge Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3J 0L3
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
11556941
Citation
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.
Results Reference
result
PubMed Identifier
11983645
Citation
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.
Results Reference
result
PubMed Identifier
16717171
Citation
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.
Results Reference
result
PubMed Identifier
11132119
Citation
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.
Results Reference
result
PubMed Identifier
10245370
Citation
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.
Results Reference
result
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Pilot Study of a Brief Behavioural Activation Intervention for Depressed Patients in Primary Care
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