Evaluation of a Crowd-Powered Web Platform for Depression and Anxiety

June 26, 2023 updated by: Stephen Matthew Schueller, University of California, Irvine

Evaluation of the Crowd-Powered Web Platform for Accumulative Depression and Anxiety Plans and Treatment (ADAPT)

100 participants will be enrolled in a two-armed randomized controlled trial of the Accumulated Depression and Anxiety Plans and Treatments (ADAPT) platform which integrates internet Cognitive Behavioral Therapy (iCBT) to determine impact on symptoms of depression and anxiety. This trial will pilot the effectiveness of the ADAPT platform, and evaluate the extent to which the ADAPT platform engages putative targets of personal relevance, skills use, and skills mastery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will enroll 100 participants in a two-armed randomized controlled trial of the ADAPT platform (iCBT). Participants will be randomly assigned to receive either the ADAPT platform (treatment) or a similar self-guided platform (control) that contains the didactic material (learning) but lacks the ADAPT platforms "crowd" features. Participants will use their assigned platform for a treatment period of 8 weeks. Participants will receive trial assessments at baseline, week 4, and week 8 (post-treatment). Follow-up evaluations will occur at 16 weeks to evaluate maintenance of gains. This pilot effectiveness trial aims to determine the impact on symptoms of depression and anxiety and whether the platform engages the putative targets of personal relevance, relationship, resulting in increased skills mastery and skills use.

Study Type

Interventional

Enrollment (Actual)

107

Phase

  • 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
    • California
      • Irvine, California, United States, 92697
        • University of California Irvine

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1) Completion of the Mental Health America Screening to Supports (MHA S2S) or significant mood and anxiety symptoms as defined by an accepted cut-off on a validated measure the Depression Anxiety and Stress Scale (DASS). The accepted cut-off is scores greater than 22;
  • 2) able to speak and read English;
  • 3) at least 18 years of age.

Exclusion Criteria:

  • 1) severe suicidality (has ideation, plan, and intent)

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
Participants randomly assigned to this condition will receive the ADAPT platform (treatment) for a treatment period of 8 weeks.
Behavioral: ADAPT Platform (Treatment)
The ADAPT platform consists of 2 modules based on evidence-based strategies from cognitive-behavioral therapy including cognitive restructuring and behavioral experiments. The platform includes didactic material, interactive tools, and crowd-features. Crowd-features are present to increase personal relevance of content and to promote engagement with the ADAPT platform through accountability. Crowd-features include requesting, responding, and exemplars.
Active Comparator: Control
Participants randomly assigned to this condition will receive a similar self-guided platform (control) for a treatment period of 8 weeks.
Behavioral: ADAPT Comparison (Control)
The control platform is a self-guided version of the ADAPT platform that includes no crowd-features. As such it will include only didactic material on cognitive restructuring and behavioral experiments and interactive tools.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression Scores at Week 16
Time Frame: Absolute scores at Week 16
The primary outcome of symptoms of depression will be measured with the self-report depression subscale of the Depression Anxiety Stress Scale (DASS). The subscale for depression ranges from 7 to 28 with lower values (lowest value = 7) indicating lower levels of depression and higher values (highest value = 28) indicating higher levels of depression.
Absolute scores at Week 16
Anxiety Scores at 16 Weeks
Time Frame: Absolute scores at Week 16
The primary outcome of symptoms of anxiety will be measured with the self-report anxiety subscale of the Depression Anxiety Stress Scale (DASS). The subscale for anxiety ranges from 7 to 28 with lower values (lowest value = 7) indicating lower levels of anxiety and higher values (highest value = 28) indicating higher levels of anxiety.
Absolute scores at Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive and Behavioral Skills Scores at 16 Weeks
Time Frame: Absolute scores at Week 16
A secondary outcome is the Frequency of Actions and Thoughts (FATS), which assesses the use of cognitive and behavioral skills. Total scores indicate the average of each item rating and range from 0-4. Lower scores indicate less frequent use of cognitive and behavioral skills and higher scores indicate more frequent use of cognitive and behavioral skills.
Absolute scores at Week 16
Self-efficacy Scores at 16 Weeks
Time Frame: Absolute scores at Week 16
A secondary outcome is the Coping Self-Efficacy (CSE), which produces a single score that ranges from 0-260 with lower scores representing lower coping self-efficacy and higher scores indicating higher coping self-efficacy.
Absolute scores at Week 16
Accountability Scores at 16 Weeks
Time Frame: Absolute scores at Week 16
A secondary outcome is the Supportive Accountability Questionnaire (SAQ), which produces a single score than ranges from 7-91. Data reported are the SAQ total scores with lower levels indicating less supportive accountability and higher values indicating greater supportive accountability.
Absolute scores at Week 16
Social Functioning Scores at 16 Weeks
Time Frame: Absolute scores at Week 16
Functioning will be assessed with the Patient-Reported Outcomes Measurement Information System (PROMIS) Ability to Participate in Social Roles and Activities Scale which produces T-scores that have a mean of 50 and a standard deviation of 10. Lower scores indicate lower participation in social roles and activities and higher scores indicate higher participation in social roles and activities.
Absolute scores at Week 16

Collaborators and Investigators

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

Sponsor

University of California, Irvine

Collaborators

National Institute of Mental Health (NIMH)
Northwestern University
Mental Health America

Investigators

  • Principal Investigator: Stephen M Schueller, PhD, University of California, Irvine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 18, 2021

Primary Completion (Actual)

November 5, 2021

Study Completion (Actual)

January 4, 2022

Study Registration Dates

First Submitted

January 8, 2020

First Submitted That Met QC Criteria

January 10, 2020

First Posted (Actual)

January 13, 2020

Study Record Updates

Last Update Posted (Actual)

June 29, 2023

Last Update Submitted That Met QC Criteria

June 26, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS#2019-4901, HS#2020-6071
  • 1R34MH113616-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual Participant Data will be deposited into the NIH data repository.

IPD Sharing Time Frame

Data will become available immediately following publication, no end date.

IPD Sharing Access Criteria

Anyone who wishes to access the data.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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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