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Responses to Information on Treatments for Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04639765
Recruitment Status : Recruiting
First Posted : November 20, 2020
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Daniel R. Strunk, Ohio State University

Brief Summary:
The purpose of this study is to determine the impact of different messages about depression treatments.

Condition or disease Intervention/treatment Phase
Depressive Symptoms Other: CBT without Personalization Other: CBT with Personalization Other: ADM without Personalization Other: ADM with Personalization Other: Combined Treatment without Personalization Other: Combined Treatment with Personalization Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Responses to Information on Treatments for Depression
Actual Study Start Date : October 28, 2020
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: No video
This condition involves no video presentation.
Experimental: CBT without Personalization
Video provides information about cognitive behavioral therapy.
Other: CBT without Personalization
Intervention involves a video describing CBT without a message about personalization.

Experimental: CBT with Personalization
Video provides information about cognitive behavioral therapy and describes how treatment can be personalized.
Other: CBT with Personalization
Intervention involves a video describing CBT with a message about personalization.

Experimental: ADM without Personalization
Video provides information about antidepressant medications.
Other: ADM without Personalization
Intervention involves a video describing antidepressant medication without a message about personalization.

Experimental: ADM with Personalization
Video provides information about antidepressant medications and describes how treatment can be personalized.
Other: ADM with Personalization
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.
Other: Combined Treatment without Personalization
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.
Other: Combined Treatment with Personalization
Intervention involves a video describing the combination of cognitive behavior therapy and antidepressant medication with a message about personalization.




Primary Outcome Measures :
  1. 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.

  2. 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).


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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) ]
    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.

  4. 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) ]
    The RFD is a valid and reliable measure for assessing one's beliefs on the etiology of depression.

  5. 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) ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04639765


Contacts
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Contact: Daniel Strunk, PhD 614-688-4891 strunk.20@osu.edu
Contact: Robert Zhou, BA 626-428-8721 zhou.3243@osu.edu

Locations
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United States, Ohio
Psychology Building 1835 Neil Avenue Recruiting
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: Daniel Strunk, PhD Professor
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Responsible Party: Daniel R. Strunk, Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT04639765    
Other Study ID Numbers: 2020B0259
First Posted: November 20, 2020    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Will share de-identified data upon reasonable request.
Time Frame: Data available for two years post-publication or at the end of the project if no papers are published.
Access Criteria: Will share de-identified data upon reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Daniel R. Strunk, Ohio State University:
depression
treatment preference
treatment information
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms