Responses to Information on Treatments for Depression

• Sponsor: Ohio State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04639765
• Collaborator: (none)
• Enrollment: 300
• Location: 1
• Arms: 7
• Actual Duration (Months): 2.1
• Patients Per Site Per Month: 144.9

Study Details

Study Description

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	N/A

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 Design

• Study Type: Interventional
• Actual 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: Oct 28, 2020
• Actual Primary Completion Date: Dec 30, 2020
• Actual Study Completion Date: Dec 30, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Regressed change from baseline in expectations on the Credibility/Expectancy Questionnaire (CEQ) [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) [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) [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) [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). [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). [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. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Psychology Building 1835 Neil Avenue	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University

Investigators

• Principal Investigator: Daniel Strunk, PhD, Professor

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daniel R. Strunk, Professor, Ohio State University
• ClinicalTrials.gov Identifier: NCT04639765
• Other Study ID Numbers: 2020B0259
• First Posted: Nov 20, 2020
• Last Update Posted: Sep 5, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Daniel R. Strunk, Professor, Ohio State University: depression; treatment preference; treatment information
• Additional relevant MeSH terms: Depression

Study Results

No Results Posted as of Sep 5, 2021