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

NCT ID: NCT05273983

Last Updated: 2023-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-14

Study Completion Date

2023-02-23

Brief Summary

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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

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Feasibility Study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Behavioural Activation Treatment

Two intervention sessions with a psychologist and an use of a mobile scheduling app over the course of 6 weeks.

Group Type EXPERIMENTAL

Behavioural Activation

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elizabeth Hebert, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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Deer Lodge Centre

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type RESULT
PMID: 11556941 (View on PubMed)

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.

Reference Type RESULT
PMID: 11983645 (View on PubMed)

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.

Reference Type RESULT
PMID: 16717171 (View on PubMed)

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.

Reference Type RESULT
PMID: 11132119 (View on PubMed)

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.

Reference Type RESULT
PMID: 10245370 (View on PubMed)

Other Identifiers

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HS25208

Identifier Type: -

Identifier Source: org_study_id

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