StressNCT04631887
The Delivery of "Doing What Matters in Times of Stress: An Illustrated Guide"
A study testing Doing What Matters in Times of Stress: An Illustrated Guide in people with Stress and Quality of Life, run by Koç University at 1 site in Turkey (Türkiye).
Trial summary
The feasibility study for the delivery of the "Doing What Matters in Times of Stress: An Illustrated Guide" will be carried out for Turkish and Syrian individuals with psychological stress. This feasibility study's sample will be adult Turkish and the Syrian refugees. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Quality of Life, Depressive Symptoms
- What is being tested?
- Doing What Matters in Times of Stress: An Illustrated Guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Nov 2020to 29 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being 18 years or above
- Being literate
- Being a Turkish citizen or a Syrian refugee
- Scoring 15 or above on Kessler Psychological Distress Scale (K10)
Who cannot join
- Imminent suicidal risk
- Being illiterate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Feasibility Study of The Delivery of The Book From Self Help Plus: "Doing What Matters in Times of Stress: An Illustrated Guide"
The feasibility study for the delivery of the "Doing What Matters in Times of Stress: An Illustrated Guide" will be carried out for Turkish and Syrian individuals with psychological stress. This feasibility study's sample will be adult Turkish and the Syrian refugees. The informed consent form and screening questionnaire of the feasibility study will be sent to the participants who have given this approval and 128 (64 Turkish and 64 Syrian) participants who meet the inclusion criteria will be included in the feasibility study. The psychological problems will be measured twice, before and after the intervention.
Read the detailed description
Studies about the impact of epidemics such as Severe acute respiratory syndrome (SARS) on the psychological health of individuals show that psychological problems have been observed in individuals who are affected by the epidemic. Today, studies on the effects of COVID-19 on psychological health are also available in the literature, and the results of these studies are in line with those of previous studies on epidemics.
The aim of this project is to deliver the "Doing What Matters in Times of Stress: An Illustrated Guide" that is developed by the World Health Organization within Self Help Plus (SH+) intervention to decrease their psychological problems for a feasibility study. The feasibility study for the delivery of the SH+ book will be carried out and the psychological problems of the participants will be measured twice, before and after the intervention to evaluate the results.
The most important contribution of the Project is conducting a feasibility study with the "Doing What Matters in Times of Stress: An Illustrated Guide" which will be adapted to the Turkish culture based on the determination of Turkey's current psychological status, provide a form of intervention to the Turkish psychological intervention literature and to improve the psychological status of the participants in this project.
- Conditions
- Stress, Quality of Life, Depressive Symptoms
- Being tested
- Doing What Matters in Times of Stress: An Illustrated Guide
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Doing What Matters in Times of Stress: An Illustrated GuideBehavioural
The "Doing What Matters in Times of Stress: An Illustrated Guide" is a booklet that is developed by World Health Organization. It is a stress management booklet formed to provide people skills for coping with stress and adversity. The booklet has accompanying audio exercises.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm: Doing What Matters in Times of Stress: An Illustrated Guide | Experimental | The intervention arm will receive the assigned intervention for five weeks. They will receive the intervention materials and will be called by psychologists three times (at the beginning, middle and end) during the intervention. Receives: Behavioral: Doing What Matters in Times of Stress: An Illustrated Guide |
| Control Arm: Wait List | No intervention | The control arm has no intervention. The participants in the control arm will receive the intervention after the post-assessments are completed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the Patient Health Questionnaire-9 (PHQ-9) over time
Patient Health Questionnaire-9 is a 9 item questionnaire that aims to measure the severity of depression symptoms. Each of the 9 items are scored as "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score. Higher scores indicate decreased functional status and increased symptom-related difficulties.
Measured: Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment)
Secondary outcomes (5)
Change of the General Anxiety Disorder-7 (GAD-7) over time
General Anxiety Disorder-7 is a 7-item questionnaire that aims to measure anxiety symptoms. Each of the 7 items are scored as 0, 1, 2, and 3 to the response categories (0 = "not at all," to 3= "nearly every day"). The total score for the seven items ranges from 0 to 21. Higher scores indicate higher levels of anxiety.
Measured: Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment)
Change of the PTSD Checklist for The Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5) (PCL-5) over time
The PTSD Checklist for DSM-5 is a 20-item questionnaire that assesses the symptoms of PTSD. In this study, a single question from each criteria of PTSD will be used. Overall four questions from PCL-5 will be assessed. Each of the 4 items are scored as 0, 1, 2, 3 and 4 (0 = "Not at all" to 4 = "Extremely"). The total score for the four items ranges from 0 to 16. Higher scores indicate higher levels of PTSD symptoms.
Measured: Change from baseline (1 week before the intervention) to post assessment 6 weeks after the pre-assessment)
Change of the The World Health Organization Quality of Life (WHOQOL) over time
The World Health Organization Quality of Life questionnaire assesses various domains of life which are physical health, psychological health, social relationships, and environment. In this study, a single question from the questionnaire will be used which will be about the general quality of life. The question is scored from 1 to 5 on a response scale (1 = "Not at all" to 5 = "Completely"). A higher score indicate higher quality of life.
Measured: Change from baseline (1 week before the intervention) to post assessment 6 weeks after the pre-assessment)
Change of the The General Self-Efficacy Scale over time
The General Self-Efficacy Scale is a 10-item questionnaire that assesses the general sense of perceived self-efficacy. Each of the 10 items are scored as 1, 2, 3 and 4 on a response scale (1 = "Not at all true" to 4 = "Exactly true"). The total score for the four items ranges from 10 to 40. Higher scores indicate higher perceived general self-efficacy, lower scores indicate lower perceived general self-efficacy.
Measured: Change from baseline (1 week before the intervention) to post assessment 6 weeks after the pre-assessment)
Change of the The Acceptance and Action Questionnaire (AAQ-2) over time
The Acceptance and Action Questionnaire is a 7-item questionnaire that assesses the psychological flexibility. Each of the 7 items are scored as 1, 2, 3, 4, 5, 6 and 7 on a response scale (1 = "Never true" to 7 = "Always true"). The total score for the four items ranges from 7 to 49. Higher total scores mean less flexibility, while lower total scores mean more flexibility.
Measured: Change from baseline (1 week before the intervention) to post assessment 6 weeks after the pre-assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start9 Nov 2020
- Primary completion29 Jan 2021
- Study completion29 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceren Acarturk, Koç University
- Investigators
- Gülşah Kurt, PhD, Study chair, Koç UniversityZeynep Ilkkursun, MA, Study chair, Koç University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04631887
- Sponsor's protocol ID
- 2020.200.IRB3.080
- Status last verified
- Feb 2021
- First submitted
- 7 Nov 2020
- Last updated
- 21 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dong L, Bouey J. Public Mental Health Crisis during COVID-19 Pandemic, China. Emerg Infect Dis. 2020 Jul;26(7):1616-1618. doi: 10.3201/eid2607.200407. Epub 2020 Jun 21.
PubMed 32202993Epping-Jordan JE, Harris R, Brown FL, Carswell K, Foley C, Garcia-Moreno C, Kogan C, van Ommeren M. Self-Help Plus (SH+): a new WHO stress management package. World Psychiatry. 2016 Oct;15(3):295-296. doi: 10.1002/wps.20355. No abstract available.
PubMed 27717271Fledderus M, Bohlmeijer ET, Pieterse ME, Schreurs KM. Acceptance and commitment therapy as guided self-help for psychological distress and positive mental health: a randomized controlled trial. Psychol Med. 2012 Mar;42(3):485-95. doi: 10.1017/S0033291711001206. Epub 2011 Jul 11.
PubMed 21740624
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Feasibility Study of The Delivery of The Book From Self Help Plus: "Doing What Matters in Times of Stress: An Illustrated Guide"
- ClinicalTrials.gov ID
- NCT04631887
- Acronym / sponsor ID
- 2020.200.IRB3.080
- Conditions
- Stress, Quality of Life, Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 29 Jan 2021 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 17 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The feasibility study for the delivery of the "Doing What Matters in Times of Stress: An Illustrated Guide" will be carried out for Turkish and Syrian individuals with psychological stress. This feasibility study's sample will be adult Turkish and the Syrian refugees. The informed consent form and screening questionnaire of the feasibility study will be sent to the participants who have given this approval and 128 (64 Turkish and 64 Syrian) participants who meet the inclusion criteria will be included in the feasibility study. The psychological problems will be measured twice, before and after the intervention.
Detailed description
Studies about the impact of epidemics such as Severe acute respiratory syndrome (SARS) on the psychological health of individuals show that psychological problems have been observed in individuals who are affected by the epidemic. Today, studies on the effects of COVID-19 on psychological health are also available in the literature, and the results of these studies are in line with those of previous studies on epidemics.
The aim of this project is to deliver the "Doing What Matters in Times of Stress: An Illustrated Guide" that is developed by the World Health Organization within Self Help Plus (SH+) intervention to decrease their psychological problems for a feasibility study. The feasibility study for the delivery of the SH+ book will be carried out and the psychological problems of the participants will be measured twice, before and after the intervention to evaluate the results.
The most important contribution of the Project is conducting a feasibility study with the "Doing What Matters in Times of Stress: An Illustrated Guide" which will be adapted to the Turkish culture based on the determination of Turkey's current psychological status, provide a form of intervention to the Turkish psychological intervention literature and to improve the psychological status of the participants in this project.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm: Doing What Matters in Times of Stress: An Illustrated Guide | Experimental | Behavioral: Doing What Matters in Times of Stress: An Illustrated GuideThe intervention arm will receive the assigned intervention for five weeks. They will receive the intervention materials and will be called by psychologists three times (at the beginning, middle and end) during the intervention. |
| Control Arm: Wait List | No intervention | –The control arm has no intervention. The participants in the control arm will receive the intervention after the post-assessments are completed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being 18 years or above
- Being literate
- Being a Turkish citizen or a Syrian refugee
- Scoring 15 or above on Kessler Psychological Distress Scale (K10)
Key exclusion criteria (2 listed)
- Imminent suicidal risk
- Being illiterate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Doing What Matters in Times of Stress: An Illustrated GuideThe "Doing What Matters in Times of Stress: An Illustrated Guide" is a booklet that is developed by World Health Organization. It is a stress management booklet formed to provide people skills for coping with stress and adversity. The booklet has accompanying audio exercises. | Behavioural | Intervention Arm: Doing What Matters in Times of Stress: An Illustrated Guide |
Primary outcome
Change of the Patient Health Questionnaire-9 (PHQ-9) over time
Time frame: Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment)
Patient Health Questionnaire-9 is a 9 item questionnaire that aims to measure the severity of depression symptoms. Each of the 9 items are scored as "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score. Higher scores indicate decreased functional status and increased symptom-related difficulties.
5 secondary outcomes
Change of the General Anxiety Disorder-7 (GAD-7) over time
Time frame: Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment)
Change of the PTSD Checklist for The Diagnostic and Statistical Manual of Mental Disorders 5 (DSM 5) (PCL-5) over time
Time frame: Change from baseline (1 week before the intervention) to post assessment 6 weeks after the pre-assessment)
Change of the The World Health Organization Quality of Life (WHOQOL) over time
Time frame: Change from baseline (1 week before the intervention) to post assessment 6 weeks after the pre-assessment)
Change of the The General Self-Efficacy Scale over time
Time frame: Change from baseline (1 week before the intervention) to post assessment 6 weeks after the pre-assessment)
Change of the The Acceptance and Action Questionnaire (AAQ-2) over time
Time frame: Change from baseline (1 week before the intervention) to post assessment 6 weeks after the pre-assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2021.
- Background: PubMed 32202993Dong L, Bouey J. Public Mental Health Crisis during COVID-19 Pandemic, China. Emerg Infect Dis. 2020 Jul;26(7):1616-1618. doi: 10.3201/eid2607.200407. Epub 2020 Jun 21.
- Background: PubMed 27717271Epping-Jordan JE, Harris R, Brown FL, Carswell K, Foley C, Garcia-Moreno C, Kogan C, van Ommeren M. Self-Help Plus (SH+): a new WHO stress management package. World Psychiatry. 2016 Oct;15(3):295-296. doi: 10.1002/wps.20355. No abstract available.
- Background: PubMed 21740624Fledderus M, Bohlmeijer ET, Pieterse ME, Schreurs KM. Acceptance and commitment therapy as guided self-help for psychological distress and positive mental health: a randomized controlled trial. Psychol Med. 2012 Mar;42(3):485-95. doi: 10.1017/S0033291711001206. Epub 2011 Jul 11.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülşah Kurt, PhD study chair
Koç University
Zeynep Ilkkursun, MA study chair
Koç University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Doing What Matters in Times of Stress: An Illustrated Guide in people with Stress and Quality of Life, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the Patient Health Questionnaire-9 (PHQ-9) over time (time frame: Change from baseline (1 week before the intervention) to post assessment (6 weeks after the pre-assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04631887, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.