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Responses to Information on Treatments for Depression

Primary Purpose

Depressive Symptoms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CBT without Personalization
CBT with Personalization
ADM without Personalization
ADM with Personalization
Combined Treatment without Personalization
Combined Treatment with Personalization
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Depressive Symptoms focused on measuring depression, treatment preference, treatment information

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Psychology Building 1835 Neil Avenue

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

No Intervention

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

No video

CBT without Personalization

CBT with Personalization

ADM without Personalization

ADM with Personalization

Combined Treatment without Personalization

Combined Treatment with Personalization

Arm Description

This condition involves no video presentation.

Video provides information about cognitive behavioral therapy.

Video provides information about cognitive behavioral therapy and describes how treatment can be personalized.

Video provides information about antidepressant medications.

Video provides information about antidepressant medications and describes how treatment can be personalized.

Video provides information on the combined treatment of cognitive behavioral therapy with antidepressant medications.

Video provides information on the combined treatment of cognitive behavioral therapy with antidepressant medications and describes how treatment can be personalized.

Outcomes

Primary Outcome Measures

Regressed change from baseline in expectations on the Credibility/Expectancy Questionnaire (CEQ)
The CEQ is a validated, commonly used measure assessing views of the credibility and expectations for benefit from a treatment.
Regressed change from baseline in prognostic pessimism on an adapted version of the Perceptions of Depression Scale (PDS)
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

Regressed change from baseline in affect on the Positive and Negative Affectivity Scale (PANAS)
The PANAS is a widely used measure for positive and negative affect, and has been shown to be valid and reliable.
Regressed Change from baseline on the Beck Hopelessness Scale (BHS)
The BHS is the most widely used measure for hopelessness, and has been shown to be valid and reliable.
Regressed change from baseline in personal and perceived depression stigma on the Depression Stigma Scale (DSS).
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.
Regressed change from baseline in beliefs on the etiology of depression on the Reasons for Depression Questionnaire (RFD).
The RFD is a valid and reliable measure for assessing one's beliefs on the etiology of depression.
Willingness to take a next step.
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.

Full Information

First Posted
November 11, 2020
Last Updated
September 3, 2021
Sponsor
Ohio State University
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1. Study Identification

Unique Protocol Identification Number
NCT04639765
Brief Title
Responses to Information on Treatments for Depression
Official Title
Responses to Information on Treatments for Depression
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
October 28, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms
Keywords
depression, treatment preference, treatment information

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No video
Arm Type
No Intervention
Arm Description
This condition involves no video presentation.
Arm Title
CBT without Personalization
Arm Type
Experimental
Arm Description
Video provides information about cognitive behavioral therapy.
Arm Title
CBT with Personalization
Arm Type
Experimental
Arm Description
Video provides information about cognitive behavioral therapy and describes how treatment can be personalized.
Arm Title
ADM without Personalization
Arm Type
Experimental
Arm Description
Video provides information about antidepressant medications.
Arm Title
ADM with Personalization
Arm Type
Experimental
Arm Description
Video provides information about antidepressant medications and describes how treatment can be personalized.
Arm Title
Combined Treatment without Personalization
Arm Type
Experimental
Arm Description
Video provides information on the combined treatment of cognitive behavioral therapy with antidepressant medications.
Arm Title
Combined Treatment with Personalization
Arm Type
Experimental
Arm Description
Video provides information on the combined treatment of cognitive behavioral therapy with antidepressant medications and describes how treatment can be personalized.
Intervention Type
Other
Intervention Name(s)
CBT without Personalization
Intervention Description
Intervention involves a video describing CBT without a message about personalization.
Intervention Type
Other
Intervention Name(s)
CBT with Personalization
Intervention Description
Intervention involves a video describing CBT with a message about personalization.
Intervention Type
Other
Intervention Name(s)
ADM without Personalization
Intervention Description
Intervention involves a video describing antidepressant medication without a message about personalization.
Intervention Type
Other
Intervention Name(s)
ADM with Personalization
Intervention Description
Intervention involves a video describing antidepressant medication with a message about personalization.
Intervention Type
Other
Intervention Name(s)
Combined Treatment without Personalization
Intervention Description
Intervention involves a video describing the combination of cognitive behavior therapy and antidepressant medication without a message about personalization.
Intervention Type
Other
Intervention Name(s)
Combined Treatment with Personalization
Intervention Description
Intervention involves a video describing the combination of cognitive behavior therapy and antidepressant medication with a message about personalization.
Primary Outcome Measure Information:
Title
Regressed change from baseline in expectations on the Credibility/Expectancy Questionnaire (CEQ)
Description
The CEQ is a validated, commonly used measure assessing views of the credibility and expectations for benefit from a treatment.
Time Frame
Up to 90 minutes to complete assessment. Assessed immediately pre- and post-intervention (on the same day)
Title
Regressed change from baseline in prognostic pessimism on an adapted version of the Perceptions of Depression Scale (PDS)
Description
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).
Time Frame
Up to 90 minutes to complete assessment. Assessed immediately pre- and post-intervention (on the same day)
Secondary Outcome Measure Information:
Title
Regressed change from baseline in affect on the Positive and Negative Affectivity Scale (PANAS)
Description
The PANAS is a widely used measure for positive and negative affect, and has been shown to be valid and reliable.
Time Frame
Up to 90 minutes to complete assessment. Assessed immediately pre- and post-intervention (on the same day)
Title
Regressed Change from baseline on the Beck Hopelessness Scale (BHS)
Description
The BHS is the most widely used measure for hopelessness, and has been shown to be valid and reliable.
Time Frame
Up to 90 minutes to complete assessment. Assessed immediately pre- and post-intervention (on the same day)
Title
Regressed change from baseline in personal and perceived depression stigma on the Depression Stigma Scale (DSS).
Description
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.
Time Frame
Up to 90 minutes to complete assessment. Assessed immediately pre- and post-intervention (on the same day)
Title
Regressed change from baseline in beliefs on the etiology of depression on the Reasons for Depression Questionnaire (RFD).
Description
The RFD is a valid and reliable measure for assessing one's beliefs on the etiology of depression.
Time Frame
Up to 90 minutes to complete assessment. Assessed immediately pre- and post-intervention (on the same day)
Title
Willingness to take a next step.
Description
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.
Time Frame
Up to 90 minutes to complete assessment. Assessed at the end of the study questionnaires (same day)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Strunk, PhD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Psychology Building 1835 Neil Avenue
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

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