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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04226742
Recruitment Status : Not yet recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Mental Health America
Northwestern University
Information provided by (Responsible Party):
University of California, Irvine

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.

Condition or disease Intervention/treatment Phase
Depression, Anxiety Behavioral: ADAPT Platform (Treatment) Behavioral: ADAPT Comparison (Control) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Participants will be unaware of which condition they have been assigned.
Primary Purpose: Treatment
Official Title: Evaluation of the Crowd-Powered Web Platform for Accumulative Depression and Anxiety Plans and Treatment (ADAPT)
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Treatment
Participants randomly assigned to this condition will receive the ADAPT platform (treatment) for a treatment period of 8 weeks.
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.

Active Comparator: Control
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)
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 Outcome Measures :
  1. Change in Depression at 16 weeks [ Time Frame: Change from Baseline to Week 4, Week 8, and Week 16 ]
    The primary outcome of symptoms of depression will be measured with the self-report Depression Anxiety Stress Scale (DASS) which produces a single score from 0-56 as well as subscores for depression that ranges from 0-56.

  2. Change in Anxiety at 16 weeks [ Time Frame: Change from Baseline to Week 4, Week 8, and Week 16 ]
    The primary outcome of symptoms of anxiety will be measured with the self-report DASS, which produces a single score from 0-56.


Secondary Outcome Measures :
  1. Change in Diagnostic Status at 16 weeks [ Time Frame: Change from Baseline to Week 4, Week 8, and Week 16 ]
    A secondary outcome is diagnostic status as assessed using the Structured Clinical Interview for DSM-5 (SCID-5). Diagnostic status will also be used as a moderator of change in depressive and anxiety symptoms.

  2. Change in use of cognitive and behavioral skills at 16 weeks [ Time Frame: Change from Baseline to Week 4, Week 8, and Week 16 ]
    A secondary outcome is the Cognitive and Behavioral Response to Stress Scale (CB-RSS), which produces separate scores for frequency and usefulness of cognitive and behavioral skills. Scores for frequency and usefulness each range from 0-54.

  3. Change in Self-efficacy at 16 weeks [ Time Frame: Change from Baseline to Week 4, Week 8, and Week 16 ]
    A secondary outcome is the Coping Self-Efficacy (CSE), which produces a single score that ranges from 0-260.

  4. Change in Accountability at 16 weeks [ Time Frame: Change from Baseline to Week 4, Week 8, and Week 16 ]
    A secondary outcome is the Supportive Accountability Questionnaire (SAQ), which produces a single score than ranges from 7-91. The SAQ also produces scores of subscales including bond, accountability, and legitimacy.

  5. Change in Social Functioning at 16 weeks [ Time Frame: Change from Baseline to Week 4, Week 8 and 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 raw scores from 8 to 40. These scores can be standardized to be reported as T-scores that have a mean of 50 and a standard deviation of 10.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04226742


Contacts
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Contact: Stephen M Schueller, PhD 949-824-3850 s.schueller@uci.edu

Sponsors and Collaborators
University of California, Irvine
National Institute of Mental Health (NIMH)
Mental Health America
Northwestern University
Investigators
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Principal Investigator: Stephen M Schueller, PhD University of California, Irvine
Publications:
Lovibond, S. H., & Lovibond, P. F. (1993). Manual for the Depression Anxiety Stress Scales (DASS). Psychology Foundation Monograph, University of New South Wales.
Muñoz, R. F., Bunge, E. L., Chen, K., Schueller, S. M., Bravin, J. I., Shaughnessy, E. A., & Pérez- Stable, E. J. (2015). Massive open online interventions: A novel model for delivering behavioral-health services worldwide. Clinical Psychological Science. Advanced Online Publication. http://doi.org/10.1177/2167702615583840
MacArthur Foundation's Initiative (2004). The Macarthur initiative on depression and primary care at Dartmouth and Duke: Depression management toolkit. Hanover, NH: Dartmouth.
First, M. B., Williams, J. B. W., Karg, R. S., & Spitzer, R. L. (2015). Structured clinical interview for DSM-5 disorders, clinician version (SCID-5-CV). Arlington, VA: American Psychiatric Association.
Duffecy, J., Cai, X., & Mohr, D. C. (2013). Supportive accountability: Measurement of a framework for adherence to behavioral intervention technologies. International Society for Research on Internet Interventions, Chicago, IL.
O'Dea, B., Wan, S., Batterham, P. J., Calear, A. L., Paris, C., & Christensen, H. (2015). Detecting suicidality on Twitter. Internet Interventions, 2(2), 183-188. http://dx.doi.org/10.1016/j.invent.2015.03.005
Nguyen, T., O'Dea, B., Larsen, M., Phung, D., Venkatesh, S., & Christensen, H. (2015, November). Differentiating sub-groups of online depression-related communities using textual cues. In International Conference on Web Information Systems Engineering (pp. 216-224). Springer International Publishing.

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Responsible Party: University of California, Irvine
ClinicalTrials.gov Identifier: NCT04226742    
Other Study ID Numbers: HS#2019-4901
1R34MH113616-01A1 ( U.S. NIH Grant/Contract )
First Posted: January 13, 2020    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual Participant Data will be deposited into the NIH data repository.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will become available immediately following publication, no end date.
Access Criteria: Anyone who wishes to access the data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders