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

NCT ID: NCT04226742

Last Updated: 2023-06-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-18

Study Completion Date

2022-01-04

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Depression, Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to receive either the treatment condition (ADAPT platform, iCBT platform comprised of didactic and interactive content), or a control condition (iCBT comparison platform comprised only of didactic content).
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Participants will be unaware of which condition they have been assigned.

Study Groups

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Treatment

Participants randomly assigned to this condition will receive the ADAPT platform (treatment) for a treatment period of 8 weeks.

Group Type EXPERIMENTAL

ADAPT Platform (Treatment)

Intervention Type BEHAVIORAL

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.

Control

Participants randomly assigned to this condition will receive a similar self-guided platform (control) for a treatment period of 8 weeks.

Group Type ACTIVE_COMPARATOR

ADAPT Comparison (Control)

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Mental Health America

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

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Stephen Matthew Schueller

Assistant Proffessor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen M Schueller, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

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University of California Irvine

Irvine, California, United States

Site Status

Countries

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United States

References

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Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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1R34MH113616-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HS#2019-4901, HS#2020-6071

Identifier Type: -

Identifier Source: org_study_id

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