- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05914025
The Effect of a Brief Online Behavioral Activation Intervention
June 12, 2023 updated by: Parker Benson, Palo Alto University
The Effect of a Brief Online Behavioral Activation Intervention by Activity Type
Depression is a worldwide phenomena that has a severe personal, social and societal impact.
One such impact is an over $200 billion worldwide economic cost.
While many treatments exist for depression, many individuals may not receive the support that they need for reasons such as stigma, financial restraints, or limited access to therapists.
As such, it is important to assess the efficacy of brief online treatments as an alternative to full length, in-person treatments.
A series of studies looking at a brief behavioral activation for depression treatment has shown that participants have reported temporarily improved mood, confidence, motivation and reduced depressive symptoms.
It is important to test this treatment in multiple groups of people to acquire additional information regarding brief online interventions.
This study seeks to collect participants from online social media sources and compare results to historical data that were collected from a prior research study which used Amazon Mechanical Turk as a recruitment source.
Study Overview
Study Type
Interventional
Enrollment (Actual)
106
Phase
- 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
-
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California
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Palo Alto, California, United States, 94304
- Online Recruitment/Palo Alto University Campus
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-
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
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18 years of age or older
- United States Resident
Exclusion Criteria:
- Non-US resident
- Younger than 18 years old
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Behavioral Activation Intervention
All individuals enrolled in the study will be assigned to this arm and will receive a brief behavioral activation psychoeducation module among other self-report assessments.
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Individuals will be provided with information about maladaptive patterns of behavior and how to correct these cycles with activity scheduling to elicit more positive emotional experiences.
Participants will be provided with categories/lists of activities and a downloadable calendar after receiving the psychoeducation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Depression level
Time Frame: 3 days
|
Changes in depression score as measured by the PROMIS scale.
The PROMIS is scored on a 5-point Likert scale with responses 1 to 5 corresponding to Never, Rarely, Sometimes, Often, and Always respectively.
|
3 days
|
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Self-reported mood
Time Frame: 3 days
|
Changes in mood as measured by a self-reported mood question.
This measure is scored on a 9-point Likert scale (1 = Extremely Negative to 9 = Extremely Positive)
|
3 days
|
|
Daily Enjoyment
Time Frame: At time of original survey
|
Changes in enjoyment as measured by a self-reported question around daily enjoyment.
This measure is scored on a 5-point Likert scale (1 = Not at all to 9 = Extremely)
|
At time of original survey
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Confidence, Motivation, and Usefulness
Time Frame: 3 days
|
Changes in confidence, motivation, and usefulness are measured with single self-reported measures for confidence, motivation, and usefulness of the intervention.
They are rated on a 9 point Likert scale (1 = Extremely Negative to 9 = Extremely Positive)
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 24, 2022
Primary Completion (Actual)
February 20, 2023
Study Completion (Actual)
April 18, 2023
Study Registration Dates
First Submitted
February 2, 2022
First Submitted That Met QC Criteria
June 12, 2023
First Posted (Actual)
June 22, 2023
Study Record Updates
Last Update Posted (Actual)
June 22, 2023
Last Update Submitted That Met QC Criteria
June 12, 2023
Last Verified
June 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-082
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.