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

February 24, 2023 updated by: University of Manitoba
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3J 0L3
        • Deer Lodge Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in depression symptoms as measured by the Patient Health Questionnaire-9 item (PHQ-9)
Time Frame: 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 score from baseline to 3 weeks
Change in depression symptoms as measured by the Patient Health Questionnaire-9 item (PHQ-9)
Time Frame: 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.
Change in score from baseline to 6 weeks.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in anxiety symptoms as measured by the Generalized Anxiety Disorder-7 item Scale (GAD-7)
Time Frame: 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 score from baseline to 6 weeks
Change in perceived life impairment as measured by the Work and Social Adjustment Scale (WSAS)
Time Frame: 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 score from baseline to 3 weeks
Change in perceived life impairment as measured by the Work and Social Adjustment Scale (WSAS)
Time Frame: 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.
Change in score from baseline to 6 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Treatment credibility and expectancy as measured by the Treatment Credibility and Expectancy Questionnaire (CEQ)
Time Frame: 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.
Baseline
Quality of service as measured by the Client Satisfaction Questionnaire (CSQ-8)
Time Frame: 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.
The CSQ-8 will be completed six-weeks after baseline
Mobile app engagement as measured by an engagement questionnaire.
Time Frame: 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.
The engagement questionnaire will be completed six-weeks after baseline..

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Manitoba

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Elizabeth Hebert, PhD, University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 14, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 23, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 1, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 10, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS25208

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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