Clinical trial NCT04226742: Evaluation of a Crowd-Powered Web Platform for Depression and Anxiety
Official title: Evaluation of the Crowd-Powered Web Platform for Accumulative Depression and Anxiety Plans and Treatment (ADAPT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Mental Health America
name: Northwestern University
First posted: 2020-01-13
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Depression Scores at Week 16
timeFrame: Absolute scores at Week 16
measure: Anxiety Scores at 16 Weeks
timeFrame: Absolute scores at Week 16
Secondary outcomes:
measure: Cognitive and Behavioral Skills Scores at 16 Weeks
timeFrame: Absolute scores at Week 16
measure: Self-efficacy Scores at 16 Weeks
timeFrame: Absolute scores at Week 16
measure: Accountability Scores at 16 Weeks
timeFrame: Absolute scores at Week 16
measure: Social Functioning Scores at 16 Weeks
timeFrame: Absolute scores at Week 16
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California Irvine
state: California
Study officials:
affiliation: University of California, Irvine
name: Stephen M Schueller, PhD
role: PRINCIPAL_INVESTIGATOR
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