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

Depression, Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04226742
• Other study ID #: HS#2019-4901, HS#2020-6071
• Secondary ID: 1R34MH113616-01A
• Status: Completed
• Phase: N/A
• Start date: February 18, 2021
• Est. completion date: January 4, 2022

Study information

• Verified date: June 2023
• Source: University of California, Irvine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: January 4, 2022
• Est. primary completion date: November 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depression, Anxiety
• Depressive Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of California Irvine	Irvine	California

Sponsors (4)

Lead Sponsor	Collaborator
University of California, Irvine	Mental Health America, National Institute of Mental Health (NIMH), Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (34)

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* Note: There are 34 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Cognitive and Behavioral Skills Scores at 16 Weeks	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
Secondary	Self-efficacy Scores at 16 Weeks	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
Secondary	Accountability Scores at 16 Weeks	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
Secondary	Social Functioning Scores at 16 Weeks	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