RESTORE in Patients Who Had COVID-19 and Close Others

Anxiety Clinical Trial

Official title:

RESTORE: An Online Self-directed Mental Health Intervention for Individuals Who Had COVID-19 and Close Others

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04958902
• Other study ID #: REB# 21-5394-0
• Status: Recruiting
• Phase: N/A
• Start date: October 22, 2021
• Est. completion date: November 1, 2021

Study information

• Verified date: November 2021
• Source: University Health Network, Toronto
• Contact: Kathryn Trottier, PhD
• Phone: 4163404800
• Email: kathryn.trottier[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 1, 2021
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Symptoms
• Mental Health
• PTSD

Intervention

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

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Ryerson University

Country where clinical trial is conducted

Canada, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. — View Citation

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. — View Citation

The World Health Organization Quality of Life Assessment (WHOQOL): development and general psychometric properties. Soc Sci Med. 1998 Jun;46(12):1569-85. — View Citation

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/

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Qualitative interviews	Qualitative interviews will be conducted post-intervention to further assess acceptability and to improve RESTORE content and presentation.	Immediately after the intervention
Other	Eligibility and enrolment rates	Feasibility of recruitment measured by percentage of screened individuals who are eligible and percentage of those who screen eligible who are subsequently enrolled.	From screening through to study enrolment.
Other	Intervention adherence	Adherence to the intervention measured by mean number of completed modules and drop out rate.	Immediately after the intervention
Other	Intervention engagement	Engagement will be measured by mean number of platform log-ins, mean number of module entries and mean number of practice assignment entries.	Immediately after the intervention
Other	Client Satisfaction Questionnaire	At the end of the intervention, participants will complete the Client Satisfaction Questionnaire (Attkisson & Zwick, 1982), which measures client satisfaction with the intervention they received. This short questionnaire consists of 6 items, and each item is rated on a 4-point scale with varying response alternatives (1=poor/no, definitely not/quite dissatisfied to 4=excellent/yes, definitely/very satisfied).	Immediately after the intervention
Primary	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
Primary	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
Primary	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	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).	Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
Secondary	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.	Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
Secondary	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).	Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
Secondary	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).	Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up
Secondary	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).	Baseline, pre-intervention; during the intervention (after module 4); immediately after the intervention; 1-month follow-up

External Links

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