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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Psychology Building 1835 Neil Avenue

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
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).
Up to 90 minutes to complete assessment. Assessed immediately pre- and post-intervention (on the same day)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
Up to 90 minutes to complete assessment. Assessed immediately pre- and post-intervention (on the same day)
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.
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)
The RFD is a valid and reliable measure for assessing one's beliefs on the etiology of depression.
Up to 90 minutes to complete assessment. Assessed immediately pre- and post-intervention (on the same day)
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.
Up to 90 minutes to complete assessment. Assessed at the end of the study questionnaires (same day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 28, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 11, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 20, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 5, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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