Trial Outcomes & Findings for Guided Self-help for Common Mental Disorders (NCT NCT04870099)
NCT ID: NCT04870099
Last Updated: 2025-08-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
141 participants
Primary outcome timeframe
Change from Baseline to Week 6
Results posted on
2025-08-03
Participant Flow
Participant milestones
| Measure |
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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|---|---|
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Overall Study
STARTED
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141
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Overall Study
COMPLETED
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97
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Overall Study
NOT COMPLETED
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44
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Guided Self-help for Common Mental Disorders
Baseline characteristics by cohort
| Measure |
Guided Self-help
n=141 Participants
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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|---|---|
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Age, Continuous
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40.36 years
STANDARD_DEVIATION 13.95 • n=5 Participants
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Sex/Gender, Customized
Gender identity · Men
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18 Participants
n=5 Participants
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Sex/Gender, Customized
Gender identity · Women
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120 Participants
n=5 Participants
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Sex/Gender, Customized
Gender identity · Genderqueer or non-binary
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3 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
Race/ethnicity · Non-Hispanic White
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110 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race/ethnicity · Non-Hispanic Black
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5 Participants
n=5 Participants
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|
Race/Ethnicity, Customized
Race/ethnicity · Hispanic
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11 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race/ethnicity · Asian
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8 Participants
n=5 Participants
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Race/Ethnicity, Customized
Race/ethnicity · Other (e.g., multiracial)
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7 Participants
n=5 Participants
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Kessler Psychological Distress 6 Scale (K6)
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10.99 units on a scale
STANDARD_DEVIATION 3.59 • n=5 Participants
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PRIMARY outcome
Timeframe: Change from Baseline to Week 6Population: Note: These analyses use imputed data.
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.
Outcome measures
| Measure |
Guided Self-help
n=141 Participants
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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|---|---|
|
6-week Change in Kessler 6 Psychological Distress Scale (K6)
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-5.68 score on a scale (K6)
Standard Deviation 3.61
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PRIMARY outcome
Timeframe: Change from Baseline to Week 6Population: Note: These analyses use imputed data.
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.
Outcome measures
| Measure |
Guided Self-help
n=141 Participants
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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|---|---|
|
6-week Change in the WHO 5 Well-being Index (WHO-5)
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13.61 score on a scale
Standard Deviation 18.20
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SECONDARY outcome
Timeframe: Change from Baseline to Week 6Population: Note: These analyses use imputed data.
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.
Outcome measures
| Measure |
Guided Self-help
n=141 Participants
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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|---|---|
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6-week Change in Emotion Regulation Scale (ERQ) - Reappraisal Subscale
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0.89 score on a scale
Standard Deviation 1.10
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SECONDARY outcome
Timeframe: Change from Baseline to Week 6Population: Note: These analyses use imputed data.
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.
Outcome measures
| Measure |
Guided Self-help
n=141 Participants
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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|---|---|
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6-week Change in the Emotion Regulation Scale (ERQ) - Suppression Subscale
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-0.46 score on a scale
Standard Deviation 1.18
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SECONDARY outcome
Timeframe: Change from Baseline to 3 Months post-treatmentPopulation: Note: These analyses use imputed data.
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.
Outcome measures
| Measure |
Guided Self-help
n=141 Participants
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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|---|---|
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3-month Change in Kessler 6 Psychological Distress Scale (K6; 0 - 24)
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-4.91 score on a scale
Standard Deviation 3.85
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SECONDARY outcome
Timeframe: Change from Baseline to 3 Months post-treatmentPopulation: Note: These analyses use imputed data.
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.
Outcome measures
| Measure |
Guided Self-help
n=141 Participants
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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|---|---|
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3-month Change in the WHO 5 Well-being Index (WHO-5)
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15.95 score on a scale
Standard Deviation 17.32
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Adverse Events
Guided Self-help
Serious events: 0 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Guided Self-help
n=141 participants at risk
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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|---|---|
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Psychiatric disorders
Study non-engagement
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29.1%
41/141 • Number of events 41 • 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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Psychiatric disorders
Study non-response
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31.2%
44/141 • Number of events 44 • 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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Additional Information
Prof. Lorenzo Lorenzo-Luaces, Assistant Professor
Indiana University
Phone: 8123456193
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place