RESTORE in Patients Who Had COVID-19 and Close Others

NCT04958902 | Unknown

• 1 other identifier: REB# 21-5394-0
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Mental Health; PTSD; Anxiety; Depressive Symptoms

Outcome Measures

Primary Outcomes (3)

• 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).

  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).

  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).

  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)

  Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up

• Change in Trauma-Related Guilt Inventory (TRGI)

  Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up

• Change in Adapted Brief Grief Questionnaire

  Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up

• Change in Perceived emotional social support

  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

  Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up

Other Outcomes (5)

• Qualitative interviews

  Immediately after the intervention

• Eligibility and enrolment rates

  From screening through to study enrolment.

• Intervention adherence

  Immediately after the intervention

Study Arms (1)

RESTORE intervention

EXPERIMENTAL

Participants who screen eligible and consent will receive RESTORE with guidance.

Behavioral: RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health

Interventions

RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health BEHAVIORAL

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.

RESTORE intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Toronto Metropolitan University: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, Canada

RECRUITING

Related Publications (11)

• 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.

  PMID: 29355346 BACKGROUND

• 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.

  PMID: 2002127 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 22184363 BACKGROUND

• 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.

  PMID: 16968758 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 25437266 BACKGROUND

• 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.

  PMID: 9672396 BACKGROUND

• 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/

  BACKGROUND

• 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.

  PMID: 10259963 BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being; Stress Disorders, Post-Traumatic; Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms

Central Study Contacts

Kathryn Trottier, PhD

CONTACT

4163404800; kathryn.trottier@uhn.ca

Candice Monson, PhD

CONTACT

candice.monson@ryerson.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist and Clinical Program Lead

Study Record Dates

• First Submitted: July 8, 2021
• First Posted: July 12, 2021
• Study Start: October 22, 2021
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: November 5, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)