Mental HealthNCT04958902
RESTORE in Patients Who Had COVID-19 and Close Others
A study testing RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health in people with Mental Health and PTSD, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
There is considerable need for psychological intervention targeting stressor-related mental health symptoms related to COVID-19. The investigators have developed an online self-directed transdiagnostic intervention to address this need called RESTORE: Recovering from Extreme Stressors Through Online Resources and… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health, PTSD, Anxiety
- What is being tested?
- RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 22 Oct 2021to 1 Nov 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
- Experienced a traumatic or extremely stressful experience related to being COVID-19+ or having a close other who was COVID-19+
- Participants who were COVID+ will be eligible once they are no longer exhibiting COVID-19 symptoms and those who were hospitalized will be eligible post-discharge
- Close others will be eligible once their close other with COVID-19 has recovered or if their loved one is deceased
- ≥ 18 years of age
- Scores at above clinical threshold on at least one of: Patient Health Questionnaire-9 ([PHQ-9] score ≥ 10), Generalized Anxiety Disorder Scale-7 ([GAD-7] score ≥ 10), and/or Posttraumatic Stress Disorder Scale-5 ([PCL-5] score ≥ 33)
- Access to a computer or a tablet with high speed internet access, be able to clearly see the screen of a computer or tablet, and be fluent in English
- Ability to provide consent
Who cannot join
- Elevated risk of suicide
- Currently enrolled in another intervention or treatment (e.g., cognitive behavioural therapy) for stress responses related to the COVID-19 pandemic
Trial locations and contacts
1 site in 1 country.
Candice Monson, PhD contact
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario
About this study
Official title: RESTORE: An Online Self-directed Mental Health Intervention for Individuals Who Had COVID-19 and Close Others
There is considerable need for psychological intervention targeting stressor-related mental health symptoms related to COVID-19. The investigators have developed an online self-directed transdiagnostic intervention to address this need called RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health. The specific aims of this project are to refine and investigate the initial safety, efficacy, and desirability of RESTORE for addressing mental-health symptoms in individuals who have recovered from severe COVID-19 and close others.
Read the detailed description
This uncontrolled pilot interventional study will examine the feasibility and preliminary efficacy of RESTORE. RESTORE is a guided self-directed online intervention to improve anxiety, depression, and posttraumatic stress disorder (PTSD) in individuals exposed to COVID-19 related traumatic or extreme stressors. RESTORE is based on evidence-based psychotherapies and has been designed to overcome many of the barriers associated with accessing evidence-based psychotherapies. The intervention will be iteratively refined over the course of the study. The guidance methods will also be refined over the course of the study
The primary hypotheses are that RESTORE will be safe, feasible, and desirable to participants, and will lead to improvements in mental health symptom severity from baseline to post-intervention. Secondary hypotheses are that RESTORE will lead to significant improvements in perceived health, quality of life, and functioning that will be maintained at one-month follow-up. Participants will be assessed at baseline, pre-intervention, during the intervention (after module 4), immediately after the intervention, and 1 month after completion of the intervention.
- Conditions
- Mental Health, PTSD, Anxiety, Depressive Symptoms
- Being tested
- RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health
- Medical subject headings
- Psychological Well-Being, Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RESTORE: Recovering from Extreme Stressors Through Online Resources and E-healthBehavioural
RESTORE (www.restoreonline.ca) includes eight e-modules anticipated to be approximately 30-40 minutes each in length and intended to be completed over 4-8 weeks. The modules address cognitive and behavioural factors posited to cause and maintain psychological distress related to the COVID-19 pandemic. These include cognitions about the cause and meaning of stressors related to the pandemic, including self-blame, other blame and hindsight bias, as well as problematic beliefs related to safety, trust, and control. The modules also address the importance of: (1) expressing emotions that are natural to the events of the pandemic (e.g., sadness in the face of loss), (2) working through, rather than avoiding, thoughts, feelings and grief related to the pandemic, and (3) utilizing social supports. The modules consist of written materials, brief videos, and practice assignments delivered through the platform. RESTORE includes guidance via direct messaging and/or brief telephone calls.
| Study group | Role | What they receive |
|---|---|---|
| RESTORE intervention | Experimental | Participants who screen eligible and consent will receive RESTORE with guidance. Receives: Behavioral: RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported Post Traumatic Stress Disorder (PTSD) symptoms
The PTSD Checklist-5 (PCL-5); Weathers, Litz, Keane, Palemeri, Marx, \& Schnurr, 2013) weekly version will provide a measure of change in self-reported PTSD symptoms over the course of intervention. Items are rated from 0 (not at all) to 4 (extremely). Items are summed to create a total score ranging from 0 to 80. A cutoff score of ≥ 33 can be used for screening for PTSD diagnosis (Weathers et al, 2013).
Measured: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
Change in Generalized Anxiety Disorder-7 (GAD-7)
A brief clinical measure to assess anxiety severity. Each item is rated on a 4-point scale from 0 (not at all) to 3 (nearly every day). A symptom severity score is calculated based on the sum of the 7 items, with scores ranging from 0 to 21. GAD-7 scores of 10 and 15 are the cut-off points for moderate and severe anxiety, respectively (Spitzer et., 2006).
Measured: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
Change in Patient Health Questionnaire-9 (PHQ-9)
A self-report measure of depression symptoms. Each of the 9 items is rated on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day). Items are summed to produce a total severity score ranging from 0 to 27, with higher scores indicating greater symptom severity. PHQ-9 scores ≥ 10 are considered indicative of moderate levels of depression (Manea et al., 2011).
Measured: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
Secondary outcomes (5)
Change in Perceived Health, Functioning, and Quality of Life (QOL)
Single items will be used to measure perceived health, work functioning, and quality of life over the past month. Each item is rated on a 5-point scale, ranging from 1 (not at all satisfied/poor) to 5 (extremely satisfied/excellent).
Measured: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
Change in Trauma-Related Guilt Inventory (TRGI)
The TRGI is a 32-item self-report questionnaire designed to measure guilt experienced as a result of surviving a traumatic event. The inventory includes three scales: guilt cognitions, distress, and global guilt scales.
Measured: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
Change in Adapted Brief Grief Questionnaire
The Adapted Brief Grief Questionnaire is a 5-item self-report measure for screening for complicated grief (Shear et al., 2006). The items deal with difficulty accepting the death, interference in current life, troubling thoughts related to the death, avoidance of reminders of the loss, and feeling distant from others. Each item is scored from 0 to 2 (0 = not at all, 1 = somewhat, 2 = a lot).
Measured: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
Change in Perceived emotional social support
Perceived Emotional Social Support is a single item measure of emotional of social support received in the past week from family and friends (Stappenbeck et al., 2015). The item is rated on a 5-point Likert scale, with responses ranging from 1 (strongly disagree) to 5 (strongly agree).
Measured: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
Change in Mental Health Seeking Attitudes/Intention Scale
The Mental Health Seeking Attitudes/Intention Scale is an adapted 3-item measure to assess attitudes toward seeking help from a mental health professional (Hammer, Parent, \& Spiker, 2018). Each of the items is rated on a 7-point scale, ranging from 1 (definitely false) to 7 (definitely true).
Measured: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2021
- Study start22 Oct 2021
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Toronto Metropolitan University
- Responsible party
- Principal investigator, Kathryn Trottier, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04958902
- Sponsor's protocol ID
- REB# 21-5394-0
- Status last verified
- Nov 2021
- First submitted
- 8 Jul 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hammer JH, Parent MC, Spiker DA. Mental Help Seeking Attitudes Scale (MHSAS): Development, reliability, validity, and comparison with the ATSPPH-SF and IASMHS-PO. J Couns Psychol. 2018 Jan;65(1):74-85. doi: 10.1037/cou0000248.
PubMed 29355346Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991 Feb;59(1):12-9. doi: 10.1037//0022-006x.59.1.12.
PubMed 2002127Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941Kubany, E. S., Haynes, S. N., Abueg, F., Manke, F. P., Brennan, J. M., Stahura, C. (1996). Development and Validation of the Trauma-Related Guilt Inventory (TRGI). Psychological Assessment, 8, 428-444. https://doi.org/10.1037/1040-3590.8.4.428
Manea L, Gilbody S, McMillan D. Optimal cut-off score for diagnosing depression with the Patient Health Questionnaire (PHQ-9): a meta-analysis. CMAJ. 2012 Feb 21;184(3):E191-6. doi: 10.1503/cmaj.110829. Epub 2011 Dec 19.
PubMed 22184363Shear KM, Jackson CT, Essock SM, Donahue SA, Felton CJ. Screening for complicated grief among Project Liberty service recipients 18 months after September 11, 2001. Psychiatr Serv. 2006 Sep;57(9):1291-7. doi: 10.1176/ps.2006.57.9.1291.
PubMed 16968758Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
PubMed 16717171Stappenbeck CA, Hassija CM, Zimmerman L, Kaysen D. Sexual assault related distress and drinking: the influence of daily reports of social support and coping control. Addict Behav. 2015 Mar;42:108-13. doi: 10.1016/j.addbeh.2014.11.013. Epub 2014 Nov 20.
PubMed 25437266The World Health Organization Quality of Life Assessment (WHOQOL): development and general psychometric properties. Soc Sci Med. 1998 Jun;46(12):1569-85. doi: 10.1016/s0277-9536(98)00009-4.
PubMed 9672396Weathers, F.W., Litz, B.T., Keane, T.M., et al. (2013). The PTSD Checklist for DSM-5 (PCL-5). Retrieved from http://www.ptsd.va.gov/professional/assessment/adult-sr/
Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
PubMed 10259963
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RESTORE: An Online Self-directed Mental Health Intervention for Individuals Who Had COVID-19 and Close Others
- ClinicalTrials.gov ID
- NCT04958902
- Acronym / sponsor ID
- REB# 21-5394-0
- Conditions
- Mental Health, PTSD, Anxiety, Depressive Symptoms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Toronto Metropolitan University
- Study start
- 22 Oct 2021 (actual)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 12 Jul 2021 (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.
There is considerable need for psychological intervention targeting stressor-related mental health symptoms related to COVID-19. The investigators have developed an online self-directed transdiagnostic intervention to address this need called RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health. The specific aims of this project are to refine and investigate the initial safety, efficacy, and desirability of RESTORE for addressing mental-health symptoms in individuals who have recovered from severe COVID-19 and close others.
Detailed description
This uncontrolled pilot interventional study will examine the feasibility and preliminary efficacy of RESTORE. RESTORE is a guided self-directed online intervention to improve anxiety, depression, and posttraumatic stress disorder (PTSD) in individuals exposed to COVID-19 related traumatic or extreme stressors. RESTORE is based on evidence-based psychotherapies and has been designed to overcome many of the barriers associated with accessing evidence-based psychotherapies. The intervention will be iteratively refined over the course of the study. The guidance methods will also be refined over the course of the study
The primary hypotheses are that RESTORE will be safe, feasible, and desirable to participants, and will lead to improvements in mental health symptom severity from baseline to post-intervention. Secondary hypotheses are that RESTORE will lead to significant improvements in perceived health, quality of life, and functioning that will be maintained at one-month follow-up. Participants will be assessed at baseline, pre-intervention, during the intervention (after module 4), immediately after the intervention, and 1 month after completion of the intervention.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RESTORE intervention | Experimental | Behavioral: RESTORE: Recovering from Extreme Stressors Through Online Resources and E-healthParticipants who screen eligible and consent will receive RESTORE with guidance. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Experienced a traumatic or extremely stressful experience related to being COVID-19+ or having a close other who was COVID-19+
- Participants who were COVID+ will be eligible once they are no longer exhibiting COVID-19 symptoms and those who were hospitalized will be eligible post-discharge
- Close others will be eligible once their close other with COVID-19 has recovered or if their loved one is deceased
- ≥ 18 years of age
- Scores at above clinical threshold on at least one of: Patient Health Questionnaire-9 ([PHQ-9] score ≥ 10), Generalized Anxiety Disorder Scale-7 ([GAD-7] score ≥ 10), and/or Posttraumatic Stress Disorder Scale-5 ([PCL-5] score ≥ 33)
Key exclusion criteria (2 listed)
- Elevated risk of suicide
- Currently enrolled in another intervention or treatment (e.g., cognitive behavioural therapy) for stress responses related to the COVID-19 pandemic
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 |
|---|---|---|
| RESTORE: Recovering from Extreme Stressors Through Online Resources and E-healthRESTORE (www.restoreonline.ca) includes eight e-modules anticipated to be approximately 30-40 minutes each in length and intended to be completed over 4-8 weeks. The modules address cognitive and behavioural factors posited to cause and maintain psychological distress related to the COVID-19 pandemic. These include cognitions about the cause and meaning of stressors related to the pandemic, including self-blame, other blame and hindsight bias, as well as problematic beliefs related to safety, trust, and control. The modules also address the importance of: (1) expressing emotions that are natural to the events of the pandemic (e.g., sadness in the face of loss), (2) working through, rather than avoiding, thoughts, feelings and grief related to the pandemic, and (3) utilizing social supports. The modules consist of written materials, brief videos, and practice assignments delivered through the platform. RESTORE includes guidance via direct messaging and/or brief telephone calls. | Behavioural | RESTORE intervention |
Primary outcome
Change in self-reported Post Traumatic Stress Disorder (PTSD) symptoms
Time frame: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
The PTSD Checklist-5 (PCL-5); Weathers, Litz, Keane, Palemeri, Marx, \& Schnurr, 2013) weekly version will provide a measure of change in self-reported PTSD symptoms over the course of intervention. Items are rated from 0 (not at all) to 4 (extremely). Items are summed to create a total score ranging from 0 to 80. A cutoff score of ≥ 33 can be used for screening for PTSD diagnosis (Weathers et al, 2013).
Change in Generalized Anxiety Disorder-7 (GAD-7)
Time frame: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
A brief clinical measure to assess anxiety severity. Each item is rated on a 4-point scale from 0 (not at all) to 3 (nearly every day). A symptom severity score is calculated based on the sum of the 7 items, with scores ranging from 0 to 21. GAD-7 scores of 10 and 15 are the cut-off points for moderate and severe anxiety, respectively (Spitzer et., 2006).
Change in Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
A self-report measure of depression symptoms. Each of the 9 items is rated on a 4-point scale, ranging from 0 (not at all) to 3 (nearly every day). Items are summed to produce a total severity score ranging from 0 to 27, with higher scores indicating greater symptom severity. PHQ-9 scores ≥ 10 are considered indicative of moderate levels of depression (Manea et al., 2011).
5 secondary outcomes
Change in Perceived Health, Functioning, and Quality of Life (QOL)
Time frame: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
Change in Trauma-Related Guilt Inventory (TRGI)
Time frame: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
Change in Adapted Brief Grief Questionnaire
Time frame: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
Change in Perceived emotional social support
Time frame: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
Change in Mental Health Seeking Attitudes/Intention Scale
Time frame: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Background: PubMed 29355346Hammer JH, Parent MC, Spiker DA. Mental Help Seeking Attitudes Scale (MHSAS): Development, reliability, validity, and comparison with the ATSPPH-SF and IASMHS-PO. J Couns Psychol. 2018 Jan;65(1):74-85. doi: 10.1037/cou0000248.
- Background: PubMed 2002127Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991 Feb;59(1):12-9. doi: 10.1037//0022-006x.59.1.12.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- BackgroundKubany, E. S., Haynes, S. N., Abueg, F., Manke, F. P., Brennan, J. M., Stahura, C. (1996). Development and Validation of the Trauma-Related Guilt Inventory (TRGI). Psychological Assessment, 8, 428-444. https://doi.org/10.1037/1040-3590.8.4.428
- Background: PubMed 22184363Manea L, Gilbody S, McMillan D. Optimal cut-off score for diagnosing depression with the Patient Health Questionnaire (PHQ-9): a meta-analysis. CMAJ. 2012 Feb 21;184(3):E191-6. doi: 10.1503/cmaj.110829. Epub 2011 Dec 19.
- Background: PubMed 16968758Shear KM, Jackson CT, Essock SM, Donahue SA, Felton CJ. Screening for complicated grief among Project Liberty service recipients 18 months after September 11, 2001. Psychiatr Serv. 2006 Sep;57(9):1291-7. doi: 10.1176/ps.2006.57.9.1291.
- Background: PubMed 16717171Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Background: PubMed 25437266Stappenbeck CA, Hassija CM, Zimmerman L, Kaysen D. Sexual assault related distress and drinking: the influence of daily reports of social support and coping control. Addict Behav. 2015 Mar;42:108-13. doi: 10.1016/j.addbeh.2014.11.013. Epub 2014 Nov 20.
- Background: PubMed 9672396The World Health Organization Quality of Life Assessment (WHOQOL): development and general psychometric properties. Soc Sci Med. 1998 Jun;46(12):1569-85. doi: 10.1016/s0277-9536(98)00009-4.
- BackgroundWeathers, F.W., Litz, B.T., Keane, T.M., et al. (2013). The PTSD Checklist for DSM-5 (PCL-5). Retrieved from http://www.ptsd.va.gov/professional/assessment/adult-sr/
- Background: PubMed 10259963Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
- Intervention HomepageLink provided by the sponsor.
- 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.
Candice Monson, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health in people with Mental Health and PTSD, run by University Health Network, Toronto at 1 site in Canada.
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 7 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: status not confirmed, as of the sponsor's last update on 5 Nov 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kathryn Trottier, PhD (4163404800 ext. 4067, kathryn.trottier@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported Post Traumatic Stress Disorder (PTSD) symptoms (time frame: Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up). The study lists 3 primary outcomes in all. 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 NCT04958902, which also lists 11 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 5 Nov 2021.