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

NCT04226742 | Completed Results DMC

• 2 other identifiers: HS#2019-4901, HS#2020-60711R34MH113616-01A1
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (2)

• Depression 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

  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 Outcomes (4)

• Cognitive and Behavioral Skills Scores at 16 Weeks

  Absolute scores at Week 16

• Self-efficacy Scores at 16 Weeks

  Absolute scores at Week 16

• Accountability Scores at 16 Weeks

  Absolute scores at Week 16

• Social Functioning Scores at 16 Weeks

  Absolute scores at Week 16

Study Arms (2)

Treatment

EXPERIMENTAL

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

Behavioral: ADAPT Platform (Treatment)

Control

ACTIVE COMPARATOR

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)

Interventions

ADAPT Platform (Treatment) 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.

Treatment

ADAPT Comparison (Control) 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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) 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;
• \) able to speak and read English;
• \) at least 18 years of age.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Irvine: lead
• National Institute of Mental Health (NIMH): collaborator
• Mental Health America: collaborator
• Northwestern University: collaborator

Study Sites (1)

University of California Irvine

Irvine, California, 92697, United States

Location

Related Publications (34)

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  BACKGROUND

MeSH Terms

Conditions

Depression; Anxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Results Point of Contact

• Title: Stephen Schueller
• Organization: University of California, Irvine

s.schueller@uci.edu

949-824-3850

Study Officials

• Stephen M Schueller, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be unaware of which condition they have been assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Proffessor

Model Details: 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).

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: February 18, 2021
• Primary Completion: November 5, 2021
• Study Completion: January 4, 2022
• Last Updated: June 29, 2023
• Results First Posted: May 26, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will become available immediately following publication, no end date.
• Access Criteria: Anyone who wishes to access the data.

Locations

US (1)