- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04639765
Responses to Information on Treatments for Depression
September 3, 2021 updated by: Daniel R. Strunk, Ohio State University
The purpose of this study is to determine the impact of different messages about depression treatments.
Study Overview
Status
Completed
Conditions
Detailed Description
Participants recruited through Amazon Mechanical Turk (MTurk) will complete a screening questionnaire and provided the opportunity to consent to participate.
Upon entry to the study, eligible participants will complete several questionnaires pre- and post-randomization.
Randomization will be to view either a video detailing a type of depression treatment (cognitive behavioral therapy, antidepressant medication, or the combination of both treatments) with and without an emphasis on personalization.
A no video condition is also included.
Study Type
Interventional
Enrollment (Actual)
300
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
-
-
Ohio
-
Columbus, Ohio, United States, 43210
- Psychology Building 1835 Neil Avenue
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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
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- PHQ-9 Score indicating a history of elevated depression symptoms
- A high MTurk completion rate
- Must pass all attention checks inserted into the questionnaires
- No history of treatment for depression
Exclusion Criteria:
- none
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: OTHER
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
NO_INTERVENTION: No video
This condition involves no video presentation.
|
|
EXPERIMENTAL: CBT without Personalization
Video provides information about cognitive behavioral therapy.
|
Intervention involves a video describing CBT without a message about personalization.
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EXPERIMENTAL: CBT with Personalization
Video provides information about cognitive behavioral therapy and describes how treatment can be personalized.
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Intervention involves a video describing CBT with a message about personalization.
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EXPERIMENTAL: ADM without Personalization
Video provides information about antidepressant medications.
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Intervention involves a video describing antidepressant medication without a message about personalization.
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EXPERIMENTAL: ADM with Personalization
Video provides information about antidepressant medications and describes how treatment can be personalized.
|
Intervention involves a video describing antidepressant medication with a message about personalization.
|
EXPERIMENTAL: Combined Treatment without Personalization
Video provides information on the combined treatment of cognitive behavioral therapy with antidepressant medications.
|
Intervention involves a video describing the combination of cognitive behavior therapy and antidepressant medication without a message about personalization.
|
EXPERIMENTAL: Combined Treatment with Personalization
Video provides information on the combined treatment of cognitive behavioral therapy with antidepressant medications and describes how treatment can be personalized.
|
Intervention involves a video describing the combination of cognitive behavior therapy and antidepressant medication with a message about personalization.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Regressed change from baseline in expectations on the Credibility/Expectancy Questionnaire (CEQ)
Time Frame: Up to 90 minutes to complete assessment. Assessed immediately pre- and post-intervention (on the same day)
|
The CEQ is a validated, commonly used measure assessing views of the credibility and expectations for benefit from a treatment.
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Up to 90 minutes to complete assessment. Assessed immediately pre- and post-intervention (on the same day)
|
Regressed change from baseline in prognostic pessimism on an adapted version of the Perceptions of Depression Scale (PDS)
Time Frame: Up to 90 minutes to complete assessment. Assessed immediately pre- and post-intervention (on the same day)
|
Measured using an adapted version of the PDS, a validated scale measuring general prognostic pessimism.
Minor changes to wording were made to directly address the three different interventions in the study (CBT, ADM, Combined Treatment).
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Up to 90 minutes to complete assessment. Assessed immediately pre- and post-intervention (on the same day)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Regressed change from baseline in affect on the Positive and Negative Affectivity Scale (PANAS)
Time Frame: Up to 90 minutes to complete assessment. Assessed immediately pre- and post-intervention (on the same day)
|
The PANAS is a widely used measure for positive and negative affect, and has been shown to be valid and reliable.
|
Up to 90 minutes to complete assessment. Assessed immediately pre- and post-intervention (on the same day)
|
Regressed Change from baseline on the Beck Hopelessness Scale (BHS)
Time Frame: Up to 90 minutes to complete assessment. Assessed immediately pre- and post-intervention (on the same day)
|
The BHS is the most widely used measure for hopelessness, and has been shown to be valid and reliable.
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Up to 90 minutes to complete assessment. Assessed immediately pre- and post-intervention (on the same day)
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Regressed change from baseline in personal and perceived depression stigma on the Depression Stigma Scale (DSS).
Time Frame: Up to 90 minutes to complete assessment. Assessed immediately pre- and post-intervention (on the same day)
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The DSS is a valid and reliable measure for assessing personal and perceived stigma related to depression.
The scale contains two subscales: personal stigma and perceived stigma.
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Up to 90 minutes to complete assessment. Assessed immediately pre- and post-intervention (on the same day)
|
Regressed change from baseline in beliefs on the etiology of depression on the Reasons for Depression Questionnaire (RFD).
Time Frame: Up to 90 minutes to complete assessment. Assessed immediately pre- and post-intervention (on the same day)
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The RFD is a valid and reliable measure for assessing one's beliefs on the etiology of depression.
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Up to 90 minutes to complete assessment. Assessed immediately pre- and post-intervention (on the same day)
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Willingness to take a next step.
Time Frame: Up to 90 minutes to complete assessment. Assessed at the end of the study questionnaires (same day)
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Participants are given the option to learn more about finding cognitive behavioral therapy, antidepressant medications, or combination therapy.
Based on their responses, they are provided links to relevant websites.
This approach has been adopted from traditional marketing research to assess participants' responsiveness to a message.
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Up to 90 minutes to complete assessment. Assessed at the end of the study questionnaires (same day)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Daniel Strunk, PhD, Professor
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)
October 28, 2020
Primary Completion (ACTUAL)
December 30, 2020
Study Completion (ACTUAL)
December 30, 2020
Study Registration Dates
First Submitted
November 11, 2020
First Submitted That Met QC Criteria
November 19, 2020
First Posted (ACTUAL)
November 20, 2020
Study Record Updates
Last Update Posted (ACTUAL)
September 5, 2021
Last Update Submitted That Met QC Criteria
September 3, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020B0259
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Will share de-identified data upon reasonable request.
IPD Sharing Time Frame
Data available for two years post-publication or at the end of the project if no papers are published.
IPD Sharing Access Criteria
Will share de-identified data upon reasonable request.
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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