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Mental HealthRESTORENCT04873622

Further Development and Initial Testing of RESTORE in Frontline Workers

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteCanada
Study dates
23 Mar 2021to 5 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

  • Canadian healthcare worker, first responder, or military member
  • Experienced a traumatic or extremely stressful situation in the course of work related to COVID-19
  • ≥ 18 years of age
  • Scores at above clinical threshold, as defined by the investigators, 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.

Canada1 site

  • UHN - Toronto General Hospital

    Toronto, Ontario, M5G2C4

Other trials in Canada

About this study

Official title: Addressing Stress Responses on the Frontline-Further Development of RESTORE (Recovering From Extreme Stressors Through Online Resources and E-health)

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 feasibility, initial safety, and efficacy of RESTORE for addressing mental health symptoms in first responders, health care workers (HCW), and Canadian Armed Forces members exposed to COVID-19-related traumatic or extreme stressors.

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 and manualized 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 from baseline to post-intervention. 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.

Being tested
RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health
Keywords
eHealth intervention, COVID-19, mental health
Medical subject headings
Psychological Well-Being, Stress Disorders, Post-Traumatic, Anxiety Disorders, Depression, COVID-19

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 groups in NCT04873622
Study groupRoleWhat they receive
RESTORE interventionExperimentalParticipants 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.

  1. 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

  2. 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

  3. 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 (6)

  1. 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

  2. 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

  3. 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

  4. 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

  5. Change in Adapted Expressions of Moral Injury Scale

    The Adapted Expressions of Moral Injury Scale is an investigator-adapted version of the Expressions of Moral Injury Scale (EMES). The EMES is a brief measure assessing emotions, beliefs, and behaviours associated with moral injury (Koenig, Mantri, Wang, \& Lawson, 2020). Each of the 11 items is rated on a 5-point scale, 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

  6. 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.

  1. First posted5 May 2021
  2. Study start23 Mar 2021
  3. Primary completion8 Sep 2021
  4. Study completion5 Nov 2021

Resources

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
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04873622
Sponsor's protocol ID
REB# 20-5546-1
Acronym
RESTORE
Status last verified
Nov 2021
First submitted
22 Apr 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 29355346

  • Jacobson 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 2002127

  • Kroenke 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 11556941

  • Kubany, 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 22184363

  • Mantri S, Lawson JM, Wang Z, Koenig HG. Identifying Moral Injury in Healthcare Professionals: The Moral Injury Symptom Scale-HP. J Relig Health. 2020 Oct;59(5):2323-2340. doi: 10.1007/s10943-020-01065-w.

    PubMed 32681398

  • Shear 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 16968758

  • Spitzer 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 16717171

  • Stappenbeck 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 25437266

  • The 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 9672396

  • Weathers, 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

  • Trottier K, Monson CM, Kaysen D, Wagner AC, Liebman RE, Abbey SE. Initial findings on RESTORE for healthcare workers: an internet-delivered intervention for COVID-19-related mental health symptoms. Transl Psychiatry. 2022 Jun 1;12(1):222. doi: 10.1038/s41398-022-01965-3.

    PubMed 35650179

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 6 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 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?

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 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 NCT04873622, which also lists 13 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; AzTrials last refreshed its copy on 31 Oct 2026.

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