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| ID | Type | Description | Link |
|---|---|---|---|
| KL2TR002530 | U.S. NIH Grant/Contract | View source | |
| UL1TR002529 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Indiana Clinical and Translational Sciences Institute | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guided self-help | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Doing What Matters in Times of Stress: An Illustrated Guide | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-week Change in Kessler 6 Psychological Distress Scale (K6) | 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. | Change from Baseline to Week 6 |
| 6-week Change in the WHO 5 Well-being Index (WHO-5) | 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. | Change from Baseline to Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| 6-week Change in Emotion Regulation Scale (ERQ) - Reappraisal Subscale | 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. |
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Inclusion Criteria:
Exclusion Criteria:
- Suicidality: Patient Health Questionnaire-9 (PHQ9) item 9 ("thoughts that you would be better off dead, or of hurting yourself ") ≥ 2 ("more than half the days")
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Bloomington | Indiana | 47408 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
141 individuals qualified for the study and reached the onboarding call.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 6-week Change in Kessler 6 Psychological Distress Scale (K6) | 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. | Note: These analyses use imputed data. | Posted | Mean | Standard Deviation | score on a scale (K6) | Change from Baseline to Week 6 |
|
6-week assessment period
The adverse events we tracked systematically was withdrawal from the study which was operationalized in two different ways including: completing at least 50% of the scheduled GSH-CBT sessions and completing the post-treatment study follow-up.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Study non-engagement | Psychiatric disorders | Non-systematic Assessment | Did the participant fail to complete at least 50% of scheduled assessments? |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Lorenzo Lorenzo-Luaces, Assistant Professor | Indiana University | 8123456193 | lolorenz@indiana.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 10, 2020 | Jul 10, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 17, 2022 | Jul 5, 2023 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 10, 2021 | Jul 5, 2023 | ICF_002.pdf |
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Guided self-help
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|
| Change from Baseline to Week 6 |
| 6-week Change in the Emotion Regulation Scale (ERQ) - Suppression Subscale | 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. | Change from Baseline to Week 6 |
| 3-month Change in Kessler 6 Psychological Distress Scale (K6; 0 - 24) | 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. | Change from Baseline to 3 Months post-treatment |
| 3-month Change in the WHO 5 Well-being Index (WHO-5) | 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. | Change from Baseline to 3 Months post-treatment |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Kessler Psychological Distress 6 Scale (K6) | Mean | Standard Deviation | units on a scale |
|
|
|
| Primary | 6-week Change in the WHO 5 Well-being Index (WHO-5) | 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. | Note: These analyses use imputed data. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to Week 6 |
|
|
|
| Secondary | 6-week Change in Emotion Regulation Scale (ERQ) - Reappraisal Subscale | 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. | Note: These analyses use imputed data. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to Week 6 |
|
|
|
| Secondary | 6-week Change in the Emotion Regulation Scale (ERQ) - Suppression Subscale | 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. | Note: These analyses use imputed data. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to Week 6 |
|
|
|
| Secondary | 3-month Change in Kessler 6 Psychological Distress Scale (K6; 0 - 24) | 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. | Note: These analyses use imputed data. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to 3 Months post-treatment |
|
|
|
| Secondary | 3-month Change in the WHO 5 Well-being Index (WHO-5) | 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. | Note: These analyses use imputed data. | Posted | Mean | Standard Deviation | score on a scale | Change from Baseline to 3 Months post-treatment |
|
|
|
| 0 |
| 141 |
| 0 |
| 141 |
| 44 |
| 141 |
|
| Study non-response | Psychiatric disorders | Non-systematic Assessment | Did the participant fail to complete the last study assessment? |
|
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