NCT04639765

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 28, 2020

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 20, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

2 months

First QC Date

November 11, 2020

Last Update Submit

September 3, 2021

Conditions

Keywords

depressiontreatment preferencetreatment information

Outcome Measures

Primary Outcomes (2)

  • 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.

    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)

    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 Outcomes (5)

  • 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)

  • 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)

  • 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)

  • 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)

  • Willingness to take a next step.

    Up to 90 minutes to complete assessment. Assessed at the end of the study questionnaires (same day)

Study Arms (7)

No video

NO INTERVENTION

This condition involves no video presentation.

CBT without Personalization

EXPERIMENTAL

Video provides information about cognitive behavioral therapy.

Other: CBT without Personalization

CBT with Personalization

EXPERIMENTAL

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

Other: CBT with Personalization

ADM without Personalization

EXPERIMENTAL

Video provides information about antidepressant medications.

Other: ADM without Personalization

ADM with Personalization

EXPERIMENTAL

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

Other: ADM with Personalization

Combined Treatment without Personalization

EXPERIMENTAL

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

Other: Combined Treatment without Personalization

Combined Treatment with Personalization

EXPERIMENTAL

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

Interventions

Intervention involves a video describing CBT without a message about personalization.

CBT without Personalization

Intervention involves a video describing CBT with a message about personalization.

CBT with Personalization

Intervention involves a video describing antidepressant medication without a message about personalization.

ADM without Personalization

Intervention involves a video describing antidepressant medication with a message about personalization.

ADM with Personalization

Intervention involves a video describing the combination of cognitive behavior therapy and antidepressant medication without a message about personalization.

Combined Treatment without Personalization

Intervention involves a video describing the combination of cognitive behavior therapy and antidepressant medication with a message about personalization.

Combined Treatment with Personalization

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychology Building 1835 Neil Avenue

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Combined Modality Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Daniel Strunk, PhD

    Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 11, 2020

First Posted

November 20, 2020

Study Start

October 28, 2020

Primary Completion

December 30, 2020

Study Completion

December 30, 2020

Last Updated

September 5, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will share

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.

Locations