Traumatic Stress, Post-Traumatic GrowthNCT04217863
To Observe the Psychophysiological Alterations in Traumatic Stress Subjects
A study testing GDP in people with Traumatic Stress, Post-Traumatic Growth, run by University of Karachi at 1 site in Pakistan.
Trial summary
This Multicenter study is planned to investigate the effectiveness of the guided disclosure protocol for the promotion of post-traumatic growth (PTG), in the traumatic stress subjects and to determine whether PTG is associated with psychophysiological alterations i.e. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Stress, Post-Traumatic Growth
- What is being tested?
- GDP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 sitePakistan
- Study dates
- 2 Dec 2019to 10 Aug 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Must be disease free, there must be no evidence of any metastatic disease
- Property of written and spoken the English language.
- Experienced any traumatic event in the last 12 Months
Who cannot join
- Subjects who received a structured psychological intervention for at least 6 months during the last 3 years performed by a psychologist or psychiatrist will be excluded.
- Those with a codified psychiatric disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) who received Psychopharmacological treatment during the last 3 years will also be excluded from the study sample.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of the Guided Disclosure Protocol on Post-Traumatic Growth: A Randomized Control Trial Designed to Observe Psychophysiological Alterations in Traumatic Stress Subjects
This Multicenter study is planned to investigate the effectiveness of the guided disclosure protocol for the promotion of post-traumatic growth (PTG), in the traumatic stress subjects and to determine whether PTG is associated with psychophysiological alterations i.e. (C-Reactive Protein, Brain Derived Neurotropic Factor, Interlukin-6, Cortisol, Heart Rate Variability and brain waves). Study subjects meeting eligibility criteria will be randomized into two groups. Guided disclosure protocol (GDP) will be used as intervention vs the control. Blinded treatment will be provided and the subjects will be made to complete study questionnaires (Screening, Traumatic Stress Scale SSS, Trauma Symptom Checklist, Post-traumatic growth Inventory) at baseline and at post-intervention (3-months later).
Read the detailed description
Study design:
The study will be conducted as multicenter randomized controlled trial. On the basis of eligibility criteria subjects providing consent to participate in the study will be randomized into two groups, experimental group including those who receive the intervention and a control group receiving control intervention. The study outcomes will be monitored in subjects of both groups at different intervals i.e. at baseline and at 3-month follow-up (post-interventional).
Participants Subjects for the present study will be recruited from 5 centers (based in Karachi, Pakistan). The targeted population includes subjects from diverse ethnicity and considered eligible for participation in the study if they indicated in a pre-screening form that they had experienced traumatic event. These subjects will be invited to participate in the study through advertisement on notice board of each center. A written informed consent will be obtained from each study subject after providing detailed information regarding objectives of the study and its duration.
Interventions
The experimental intervention (GDP):
It includes three writing sessions of 20 minutes where the participants will be made to recall the facts regarding the traumatic event first and then the emotions triggered related to the revealed facts will be channelized. The information related to the immediate priority changes due to the revival of the traumatic history and its reflection on current feelings will be collected. Moreover, the learned coping mechanisms will also be inquired and how the traumatic event altered their vision and their personalities and how it helps in coping with future difficulties.
The original instructions will be translated into local language and altered according to the specific traumatic experience.
In the following, a fusion of the tasks concerning each of the three writing sessions is shown.
- Participants will be required to describe memories associated with traumatic event in a sequential order, with an objective and detached attitude
- They will be asked to describe
- Their opinion regarding the traumatic event and emotions perceived during the experience
- Its impact on their daily lives, and how it has altered their attitudes toward life.
- The actual situation will be focused, while reviving the whole traumatic event experience which aids in exploring the following aspects:
- Present thoughts and feelings regarding the traumatic experience, and also clarify the differences between the ones felt at the time of traumatic event in comparison to the current feelings.
- How much they understand and appreciate themselves for successfully dealing with the traumatic event
- To what extent the traumatic event has modified their vision, attitude, knowledge, and skills, and how it can help in their future;
- What will be their future reactions to other similar events. For the writing session it is mandatory to maintain standard experimental environment with maximum silence so that the subject can write peacefully without getting disturbed. Two weeks after the initial assessment, the first writing session will be performed followed by two sessions once every 2 weeks.
The control intervention:
In control intervention the subjects will be required to take three 20-minute writing sessions, in which they will be asked to write about their daily events of the past week, the writing must focus on the facts and highlight an objective and detached attitude. It has shown potential improvements after the guided disclosure protocol (GDP). Works through the placebo effect. Same protocol will be followed for these subjects as the one used for GDP.
A day prior to each writing session, in both conditions either experimental or control the researcher will communicate with each study subject via telephone in order to give them a reminder to perform the writing task and to check their understanding regarding the instructions given in the booklet. Details regarding the inability to contact the subject will also be recorded in the patient form.
- Conditions
- Traumatic Stress, Post-Traumatic Growth
- Being tested
- GDP
- Keywords
- Guided disclosure protocol, Post-traumatic growth, psycho-physiological alterations, Trauma Symptom Checklist, Sadaf Stress Scale
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDPBehavioural
Guided Disclosure Protocol
| Study group | Role | What they receive |
|---|---|---|
| The experimental intervention (GDP): It includes three writing | Experimental | 1. Participants will be required to describe memories associated with traumatic event in a sequential order, with an objective and detached attitude
2. They will be asked to describe
1. Their opinion regarding the traumatic event and emotions perceived during the experience
2. Its impact on their daily lives, and how it has altered their attitudes toward life.
3. The actual situation will be focused, while reviving the whole traumatic event experience which aids in exploring the following aspects:
* Present thoughts and feelings regarding the traumatic experience, and also clarify the differences between the ones felt at the time of traumatic event in comparison to the current feelings.
* How much they understand and appreciate themselves for successfully dealing with the traumatic event
* To what extent the traumatic event has modified their vision, attitude, knowledge, and skills, and how it can help in their future;
* What will be their future reactions to other similar events. Receives: Behavioral: GDP |
| The control intervention: | No intervention | A day prior to each writing session, the researcher will communicate with each study subject via telephone in order to give them a reminder to perform the writing task and to check their understanding regarding the instructions given in the booklet. Details regarding the inability to contact the subject will also be recorded in the patient form. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-Traumatic Growth (PTG)
Change in the Post-traumatic Growth Inventory (PTGI) will be observed among the subjects enrolled in the GDP group as compared to the control group.
Measured: 3 Months
Secondary outcomes (8)
C- Reactive Protein (CRP)
Change in the CRP level will be observed among the subjects enrolled in the GDP group as compared to the control group.
Measured: 3 Months
Brain-derived neurotrophic factor (BDNF)
Change in the BDNF level will be observed among the subjects enrolled in the GDP group as compared to the control group.
Measured: 3 Months
Interleukin-6 (IL-6)
Change in the IL-6 level will be observed among the subjects enrolled in the GDP group as compared to the control group.
Measured: 3 Months
Glutamate
Change in the Glutamate level will be observed among the subjects enrolled in the GDP group as compared to the control group.
Measured: 3 Months
Cortisol
Change in the Cortisol level will be observed among the subjects enrolled in the GDP group as compared to the control group.
Measured: 3 Months
Alpha waves
Change in the Brain waves (Alpha waves) will be observed among the subjects enrolled in the GDP group as compared to the control group.
Measured: 3 Months
Heart Rate Variability
Change in the Heart Rate Variability will be observed among the subjects enrolled in the GDP group as compared to the control group.
Measured: 3 Months
Beta waves
Change in the Brain waves (Beta waves) will be observed among the subjects enrolled in the GDP group as compared to the control group.
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2020
- Study start2 Dec 2019
- Primary completion10 Aug 2021
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Traumatic Stress, Post-Traumatic GrowthStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Karachi
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Education & Research Center
- Responsible party
- Principal investigator, Shamoon Noushad, University of Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217863
- Sponsor's protocol ID
- KU-Psychophysiology-5
- Status last verified
- Aug 2021
- First submitted
- 24 Dec 2019
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gandubert C, Scali J, Ancelin ML, Carriere I, Dupuy AM, Bagnolini G, Ritchie K, Sebanne M, Martrille L, Baccino E, Hermes A, Attal J, Chaudieu I. Biological and psychological predictors of posttraumatic stress disorder onset and chronicity. A one-year prospective study. Neurobiol Stress. 2016 Feb 4;3:61-67. doi: 10.1016/j.ynstr.2016.02.002. eCollection 2016 Jun.
PubMed 27981178Kalisch R, Muller MB, Tuscher O. A conceptual framework for the neurobiological study of resilience. Behav Brain Sci. 2015;38:e92. doi: 10.1017/S0140525X1400082X. Epub 2014 Aug 27.
PubMed 25158686Cai WP, Pan Y, Zhang SM, Wei C, Dong W, Deng GH. Relationship between cognitive emotion regulation, social support, resilience and acute stress responses in Chinese soldiers: Exploring multiple mediation model. Psychiatry Res. 2017 Oct;256:71-78. doi: 10.1016/j.psychres.2017.06.018. Epub 2017 Jun 8.
PubMed 28624675Liu AN, Wang LL, Li HP, Gong J, Liu XH. Correlation Between Posttraumatic Growth and Posttraumatic Stress Disorder Symptoms Based on Pearson Correlation Coefficient: A Meta-Analysis. J Nerv Ment Dis. 2017 May;205(5):380-389. doi: 10.1097/NMD.0000000000000605.
PubMed 27875386Linz R, Puhlmann LMC, Apostolakou F, Mantzou E, Papassotiriou I, Chrousos GP, Engert V, Singer T. Acute psychosocial stress increases serum BDNF levels: an antagonistic relation to cortisol but no group differences after mental training. Neuropsychopharmacology. 2019 Sep;44(10):1797-1804. doi: 10.1038/s41386-019-0391-y. Epub 2019 Apr 16.
PubMed 30991416Alper B, Erdogan B, Erdogan MO, Bozan K, Can M. Associations of Trauma Severity with Mean Platelet Volume and Levels of Systemic Inflammatory Markers (IL1beta, IL6, TNFalpha, and CRP). Mediators Inflamm. 2016;2016:9894716. doi: 10.1155/2016/9894716. Epub 2016 Apr 5.
PubMed 27127347Smith HE, Jones CJ, Hankins M, Field A, Theadom A, Bowskill R, Horne R, Frew AJ. The effects of expressive writing on lung function, quality of life, medication use, and symptoms in adults with asthma: a randomized controlled trial. Psychosom Med. 2015 May;77(4):429-37. doi: 10.1097/PSY.0000000000000166.
PubMed 25939030Gidron Y, Duncan E, Lazar A, Biderman A, Tandeter H, Shvartzman P. Effects of guided written disclosure of stressful experiences on clinic visits and symptoms in frequent clinic attenders. Fam Pract. 2002 Apr;19(2):161-6. doi: 10.1093/fampra/19.2.161.
PubMed 11906981
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of the Guided Disclosure Protocol on Post-Traumatic Growth: A Randomized Control Trial Designed to Observe Psychophysiological Alterations in Traumatic Stress Subjects
- ClinicalTrials.gov ID
- NCT04217863
- Acronym / sponsor ID
- KU-Psychophysiology-5
- Conditions
- Traumatic Stress, Post-Traumatic Growth
- Keywords
- Guided disclosure protocol, Post-traumatic growth, psycho-physiological alterations, Trauma Symptom Checklist, Sadaf Stress Scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- University of KarachiUniversity, hospital or other
- Collaborators
- Advanced Education & Research Center
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 6 Jan 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.
This Multicenter study is planned to investigate the effectiveness of the guided disclosure protocol for the promotion of post-traumatic growth (PTG), in the traumatic stress subjects and to determine whether PTG is associated with psychophysiological alterations i.e. (C-Reactive Protein, Brain Derived Neurotropic Factor, Interlukin-6, Cortisol, Heart Rate Variability and brain waves). Study subjects meeting eligibility criteria will be randomized into two groups. Guided disclosure protocol (GDP) will be used as intervention vs the control. Blinded treatment will be provided and the subjects will be made to complete study questionnaires (Screening, Traumatic Stress Scale SSS, Trauma Symptom Checklist, Post-traumatic growth Inventory) at baseline and at post-intervention (3-months later).
Detailed description
Study design:
The study will be conducted as multicenter randomized controlled trial. On the basis of eligibility criteria subjects providing consent to participate in the study will be randomized into two groups, experimental group including those who receive the intervention and a control group receiving control intervention. The study outcomes will be monitored in subjects of both groups at different intervals i.e. at baseline and at 3-month follow-up (post-interventional).
Participants Subjects for the present study will be recruited from 5 centers (based in Karachi, Pakistan). The targeted population includes subjects from diverse ethnicity and considered eligible for participation in the study if they indicated in a pre-screening form that they had experienced traumatic event. These subjects will be invited to participate in the study through advertisement on notice board of each center. A written informed consent will be obtained from each study subject after providing detailed information regarding objectives of the study and its duration.
Interventions
The experimental intervention (GDP):
It includes three writing sessions of 20 minutes where the participants will be made to recall the facts regarding the traumatic event first and then the emotions triggered related to the revealed facts will be channelized. The information related to the immediate priority changes due to the revival of the traumatic history and its reflection on current feelings will be collected. Moreover, the learned coping mechanisms will also be inquired and how the traumatic event altered their vision and their personalities and how it helps in coping with future difficulties.
The original instructions will be translated into local language and altered according to the specific traumatic experience.
In the following, a fusion of the tasks concerning each of the three writing sessions is shown.
- Participants will be required to describe memories associated with traumatic event in a sequential order, with an objective and detached attitude
- They will be asked to describe
- Their opinion regarding the traumatic event and emotions perceived during the experience
- Its impact on their daily lives, and how it has altered their attitudes toward life.
- The actual situation will be focused, while reviving the whole traumatic event experience which aids in exploring the following aspects:
- Present thoughts and feelings regarding the traumatic experience, and also clarify the differences between the ones felt at the time of traumatic event in comparison to the current feelings.
- How much they understand and appreciate themselves for successfully dealing with the traumatic event
- To what extent the traumatic event has modified their vision, attitude, knowledge, and skills, and how it can help in their future;
- What will be their future reactions to other similar events. For the writing session it is mandatory to maintain standard experimental environment with maximum silence so that the subject can write peacefully without getting disturbed. Two weeks after the initial assessment, the first writing session will be performed followed by two sessions once every 2 weeks.
The control intervention:
In control intervention the subjects will be required to take three 20-minute writing sessions, in which they will be asked to write about their daily events of the past week, the writing must focus on the facts and highlight an objective and detached attitude. It has shown potential improvements after the guided disclosure protocol (GDP). Works through the placebo effect. Same protocol will be followed for these subjects as the one used for GDP.
A day prior to each writing session, in both conditions either experimental or control the researcher will communicate with each study subject via telephone in order to give them a reminder to perform the writing task and to check their understanding regarding the instructions given in the booklet. Details regarding the inability to contact the subject will also be recorded in the patient form.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The experimental intervention (GDP): It includes three writing | Experimental | Behavioral: GDP1. Participants will be required to describe memories associated with traumatic event in a sequential order, with an objective and detached attitude 2. They will be asked to describe 1. Their opinion regarding the traumatic event and emotions perceived during the experience 2. Its impact on their daily lives, and how it has altered their attitudes toward life. 3. The actual situation will be focused, while reviving the whole traumatic event experience which aids in exploring the following aspects: * Present thoughts and feelings regarding the traumatic experience, and also clarify the differences between the ones felt at the time of traumatic event in comparison to the current feelings. * How much they understand and appreciate themselves for successfully dealing with the traumatic event * To what extent the traumatic event has modified their vision, attitude, knowledge, and skills, and how it can help in their future; * What will be their future reactions to other similar events. |
| The control intervention: | No intervention | –A day prior to each writing session, the researcher will communicate with each study subject via telephone in order to give them a reminder to perform the writing task and to check their understanding regarding the instructions given in the booklet. Details regarding the inability to contact the subject will also be recorded in the patient form. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Must be disease free, there must be no evidence of any metastatic disease
- Property of written and spoken the English language.
- Experienced any traumatic event in the last 12 Months
Key exclusion criteria (2 listed)
- Subjects who received a structured psychological intervention for at least 6 months during the last 3 years performed by a psychologist or psychiatrist will be excluded.
- Those with a codified psychiatric disorder (according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) who received Psychopharmacological treatment during the last 3 years will also be excluded from the study sample.
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 |
|---|---|---|
| GDPGuided Disclosure Protocol | Behavioural | The experimental intervention (GDP): It includes three writing |
Primary outcome
Post-Traumatic Growth (PTG)
Time frame: 3 Months
Change in the Post-traumatic Growth Inventory (PTGI) will be observed among the subjects enrolled in the GDP group as compared to the control group.
8 secondary outcomes
C- Reactive Protein (CRP)
Time frame: 3 Months
Brain-derived neurotrophic factor (BDNF)
Time frame: 3 Months
Interleukin-6 (IL-6)
Time frame: 3 Months
Glutamate
Time frame: 3 Months
Cortisol
Time frame: 3 Months
Alpha waves
Time frame: 3 Months
Heart Rate Variability
Time frame: 3 Months
Beta waves
Time frame: 3 Months
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 11 Aug 2021.
- Background: PubMed 27981178Gandubert C, Scali J, Ancelin ML, Carriere I, Dupuy AM, Bagnolini G, Ritchie K, Sebanne M, Martrille L, Baccino E, Hermes A, Attal J, Chaudieu I. Biological and psychological predictors of posttraumatic stress disorder onset and chronicity. A one-year prospective study. Neurobiol Stress. 2016 Feb 4;3:61-67. doi: 10.1016/j.ynstr.2016.02.002. eCollection 2016 Jun.
- Background: PubMed 25158686Kalisch R, Muller MB, Tuscher O. A conceptual framework for the neurobiological study of resilience. Behav Brain Sci. 2015;38:e92. doi: 10.1017/S0140525X1400082X. Epub 2014 Aug 27.
- Background: PubMed 28624675Cai WP, Pan Y, Zhang SM, Wei C, Dong W, Deng GH. Relationship between cognitive emotion regulation, social support, resilience and acute stress responses in Chinese soldiers: Exploring multiple mediation model. Psychiatry Res. 2017 Oct;256:71-78. doi: 10.1016/j.psychres.2017.06.018. Epub 2017 Jun 8.
- Background: PubMed 27875386Liu AN, Wang LL, Li HP, Gong J, Liu XH. Correlation Between Posttraumatic Growth and Posttraumatic Stress Disorder Symptoms Based on Pearson Correlation Coefficient: A Meta-Analysis. J Nerv Ment Dis. 2017 May;205(5):380-389. doi: 10.1097/NMD.0000000000000605.
- Background: PubMed 30991416Linz R, Puhlmann LMC, Apostolakou F, Mantzou E, Papassotiriou I, Chrousos GP, Engert V, Singer T. Acute psychosocial stress increases serum BDNF levels: an antagonistic relation to cortisol but no group differences after mental training. Neuropsychopharmacology. 2019 Sep;44(10):1797-1804. doi: 10.1038/s41386-019-0391-y. Epub 2019 Apr 16.
- Background: PubMed 27127347Alper B, Erdogan B, Erdogan MO, Bozan K, Can M. Associations of Trauma Severity with Mean Platelet Volume and Levels of Systemic Inflammatory Markers (IL1beta, IL6, TNFalpha, and CRP). Mediators Inflamm. 2016;2016:9894716. doi: 10.1155/2016/9894716. Epub 2016 Apr 5.
- Background: PubMed 25939030Smith HE, Jones CJ, Hankins M, Field A, Theadom A, Bowskill R, Horne R, Frew AJ. The effects of expressive writing on lung function, quality of life, medication use, and symptoms in adults with asthma: a randomized controlled trial. Psychosom Med. 2015 May;77(4):429-37. doi: 10.1097/PSY.0000000000000166.
- Background: PubMed 11906981Gidron Y, Duncan E, Lazar A, Biderman A, Tandeter H, Shvartzman P. Effects of guided written disclosure of stressful experiences on clinic visits and symptoms in frequent clinic attenders. Fam Pract. 2002 Apr;19(2):161-6. doi: 10.1093/fampra/19.2.161.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GDP in people with Traumatic Stress, Post-Traumatic Growth, run by University of Karachi at 1 site in Pakistan.
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 3 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 11 Aug 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 Pakistan. 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?
Post-Traumatic Growth (PTG) (time frame: 3 Months). 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 NCT04217863, which also lists 8 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 11 Aug 2021.