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NCT Number: NCT04226742

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

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.

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Key information

Conditions

Depression, Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Irvine

Irvine, California, 92697, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jan 13, 2020
Registry last updated
Jun 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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