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Guided Self-help for Common Mental Disorders (DWM)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04870099
Recruitment Status : Enrolling by invitation
First Posted : May 3, 2021
Last Update Posted : November 16, 2021
Sponsor:
Collaborators:
Indiana Clinical and Translational Sciences Institute
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Lorenzo Lorenzo-Luaces, Indiana University

Brief Summary:
Common mental disorders (CMDs) like depression and anxiety account for a large proportion of disability worldwide. Access to effective treatments like cognitive-behavioral therapy (CBT) is limited and has not reduced the public health burden of psychopathology. For patients with mild-moderate CMDs, lower-intensity treatments like guided self-help CBT (GSH-CBT) are effective and more scalable (e.g., via the internet). The advent of social media has opened avenues for dissemination of GSH-CBTs and allows for passive sensing of mood, thinking, behavior, and social networks. We propose to leverage a social media platform used by over a fifth of the United States (Twitter) as a recruitment tool to virtually screen over 150 individuals, recruit N=60 to a 5-week course of GSH-CBT, and extract social media data from individuals engaged in GSH-CBT. Sociodemographic and social media data will be used to predict engagement, outcomes, and processes in GSH-CBT.

Condition or disease Intervention/treatment Phase
Bibliotherapy Behavioral: Doing What Matters in Times of Stress: An Illustrated Guide Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Guided self-help
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Leveraging Computational Social Sciences and Natural Language Processing to Optimize Engagement and Response to Low-intensity CBT for Depression and Anxiety
Actual Study Start Date : October 17, 2020
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : July 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Guided self-help
Participants are given access to the World Health Organization's (WHO) "Doing what matters in times of stress: An illustrated guide" (https://www.who.int/publications/i/item/9789240003927) virtually (i.e., as a pdf) and/or in print. Each participant is assigned an "eCoach" -- an undergraduate, post-baccalaureate, or graduate research assistant -- who will meet with the participant for a 60-minute welcome call describing the intervention and 3-6 sessions of guidance focused on promoting adherence to the manual and using skills in everyday life.
Behavioral: Doing What Matters in Times of Stress: An Illustrated Guide

From the WHO's website: Doing What Matters in Times of Stress: An Illustrated Guide is a stress management guide for coping with adversity. The guide aims to equip people with practical skills to help cope with stress. A few minutes each day are enough to practice the self-help techniques. The guide can be used alone or with the accompanying audio exercises.

Informed by evidence and extensive field testing, the guide is for anyone who experiences stress, wherever they live and whatever their circumstances.





Primary Outcome Measures :
  1. 6-week change in Kessler 6 Psychological Distress Scale (K6) [ Time Frame: 6 weeks ]
    Changes in K6 from baseline to Week 6. The K6 is a measure of distress and the measure is scored on a scale of 0 - 24 where higher scores indicate higher distress (i.e., are negative). Thus, lower scores relative to baseline indicate more positive outcomes.

  2. 6-week change in the WHO 5 Well-being Index (WHO-5) [ Time Frame: 6 weeks ]
    Changes in WHO-5 from baseline to Week 6. The WHO-5 is a measure of well-being and the measure is scored on a scale of 0 - 100 where higher scores indicate higher satisfaction with life (i.e., are positive). Thus, higher scores relative to baseline indicate more positive outcomes.


Secondary Outcome Measures :
  1. 6-week change in Emotion Regulation Scale (ERQ) - Reappraisal subscale [ Time Frame: Week 6 ]
    Changes in the ERQ Reappraisal subscale from baseline to Week 6. The Reappraisal scale is a measure of regulating emotions by engaging in reappraisal (i.e., changing the one one thinks about an emotion evoking stimuli), widely considered an adaptive strategy. The measured is scored on a 1-7 scale where higher scores indicate greater use of adaptive emotion regulation strategies (i.e., positive). Thus, higher scores relative to baseline indicate more positive outcomes.

  2. 6-week change in the Emotion Regulation Scale (ERQ) - Suppression subscale [ Time Frame: Week 6 ]
    Changes in the ERQ Suppression Scale from baseline to Week 6. The ERQ Suppression scale is a measure of regulating emotions by engaging in suppression (i.e., trying not to think or feel), which is considered a maldaptive emotion regulation strategy. The measure is scored on a scale of 1 - 7 where higher scores indicate higher use of suppression (i.e., negative). Thus, lower scores relative to baseline indicate more positive outcomes.

  3. 3-month change in Kessler 6 Psychological Distress Scale (K6; 0 - 24) [ Time Frame: 3-month ]
    Changes in K6 from baseline to 3 months after the termination of the study. The K6 is a measure of distress and the measure is scored on a scale of 0 - 24 where higher scores indicate higher distress (i.e., negative). Thus, lower scores relative to baseline indicate more positive outcomes.

  4. 3-month change in the WHO 5 Well-being Index (WHO-5) [ Time Frame: 3-month ]
    Changes in WHO-5 from baseline to 3 months after the termination of the study. The WHO-5 is a measure of well-being and the measure is scored on a scale of 0 - 100 where higher scores indicate higher satisfaction with life (i.e., are positive). Thus, higher scores relative to baseline indicate more positive outcomes.



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:   Yes
Criteria

Inclusion Criteria:

  • At least mild distress: K6 score ≥ 6
  • Having reasonably regular access to the internet or a telephone

Exclusion Criteria:

- Suicidality: PHQ9 item 9 ("thoughts that you would be better off dead, or of hurting yourself ") ≥ 2 ("more than half the days")


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): NCT04870099


Locations
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United States, Indiana
Indiana University
Bloomington, Indiana, United States, 47408
Sponsors and Collaborators
Indiana University
Indiana Clinical and Translational Sciences Institute
National Institutes of Health (NIH)
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Responsible Party: Lorenzo Lorenzo-Luaces, Assistant Professor Pyschological and Brain Sciences, Indiana University
ClinicalTrials.gov Identifier: NCT04870099    
Other Study ID Numbers: 2004321422
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No