Clinical trial NCT05273983: 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
Overall status: TERMINATED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Behavioural activation
Psychological treatment
Primary care
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Feasibility Study
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in depression symptoms as measured by the Patient Health Questionnaire-9 item (PHQ-9)
timeFrame: Change in score from baseline to 3 weeks
measure: Change in depression symptoms as measured by the Patient Health Questionnaire-9 item (PHQ-9)
timeFrame: Change in score from baseline to 6 weeks.
Secondary outcomes:
measure: Change in anxiety symptoms as measured by the Generalized Anxiety Disorder-7 item Scale (GAD-7)
timeFrame: Change in score from baseline to 6 weeks
measure: Change in perceived life impairment as measured by the Work and Social Adjustment Scale (WSAS)
timeFrame: Change in score from baseline to 3 weeks
measure: Change in perceived life impairment as measured by the Work and Social Adjustment Scale (WSAS)
timeFrame: Change in score from baseline to 6 weeks
Other outcomes:
measure: Treatment credibility and expectancy as measured by the Treatment Credibility and Expectancy Questionnaire (CEQ)
timeFrame: Baseline
measure: Quality of service as measured by the Client Satisfaction Questionnaire (CSQ-8)
timeFrame: The CSQ-8 will be completed six-weeks after baseline
measure: Mobile app engagement as measured by an engagement questionnaire.
timeFrame: The engagement questionnaire will be completed six-weeks after baseline..
Locations:
city: Winnipeg
country: Canada
facility: Deer Lodge Centre
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Elizabeth Hebert, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.