Pilot Internet-based Self-Help Program for Managing Corona (COVID-19) Stress (CoronaStress)

Pilot Internet-based Self-Help Program for Managing Corona Stress vs. Waitlist Control

The current study examines an adapted guided self-help stress reduction program, focusing on reducing stress in the time of COVID-19. Two studies are planned: 1) an international study in English in which individuals proficient in English throughout the world will participate and 2) a follow-up study in Hebrew.

Study Overview

• Status: Unknown
• Conditions: Stress; Stress, Psychological
• Intervention / Treatment: Behavioral: Internet-based guided self-help based on CBT principles

Detailed Description

The current study examines an adapted guided self-help stress reduction program, focusing on reducing stress in the time of COVID-19. Two studies are proposed: 1) an international study in English in which individuals proficient in English throughout the world will participate and 2) a study in Hebrew. The first study will publicize via social media and participants will be randomized to either immediate participation or a 6 week waitlist period. Assessments will be conducted pre, (again after waitlist for the control group), posttx (after completion/cessation of the program), 6 month and 1 year followup. Two forms of assessment will be conducted: pre-post-follow-up (with the CRISIS measure) and weekly during the program (via the DASS-21). For the full program see: https://www.iterapi.se/sites/coronastress/

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel, 9190501
    • Recruiting
    • Hebrew University of Jerusalem
    • Principal Investigator: Jonathan D Huppert, PhD
    • Contact: Jonathan Huppert, PhD; Phone Number: +97225883376; Email: coronastress@mail.huji.ac.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Read/Write English,
• feels stress due to Corona/COVID-19

Exclusion Criteria:

• current psychological or psychiatric treatment,
• current psychiatric illness,
• suicidality,
• psychosis,
• bipolar,
• severe dissociative symptoms,
• in a currently severe traumatic situation,
• having a serious medical illness.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: immediate guided self-help; In this condition, individuals will be given access to material and exercises based on CBT to reduce their stress	Behavioral: Internet-based guided self-help based on CBT principles; Individuals are provided basic rationale of CBT to deal with stress, worry, anxiety, dysphoria, sleep difficulties, emotion dysregulation, and memories all related to COVID-19; Other Names: ICBT for CoronaStress
No Intervention: waitlist; Individuals in this condition will wait 6 weeks before they are provided access to the guided self-help program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The CoRonavIruS Health Impact Survey (CRISIS)	change in a self-report measure of stress during the COVID-19 pandemic that ranges from 0-128. Higher means more symptomatic.	change from Pre to post treatment (6 weeks),
The CoRonavIruS Health Impact Survey (CRISIS)	change in a self-report measure of stress during the COVID-19 pandemic that ranges from 0-128. Higher means more symptomatic.	change from Pre to 6 months Follow-up
The CoRonavIruS Health Impact Survey (CRISIS)	change in a self-report measure of stress during the COVID-19 pandemic that ranges from 0-128. Higher means more symptomatic.	change from Pre to 1 year Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression, Anxiety, and Stress Scale- 21 item version: DASS-21	a self-report measure of depression, anxiety and stress, with each subscale ranging from 0-28. Higher means more symptomatic.	Weekly change during treatment and at pre and post (6 week) treatment evaluations
Depression, Anxiety, and Stress Scale- 21 item version: DASS-21	a self-report measure of depression, anxiety and stress, with each subscale ranging from 0-28. Higher means more symptomatic.	change from pre to 6 month follow up
Depression, Anxiety, and Stress Scale- 21 item version: DASS-21	a self-report measure of depression, anxiety and stress, with each subscale ranging from 0-28. Higher means more symptomatic.	change from pre to 1 year follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
completion rate of modules	how many modules each individual completes, with less than 2 being considered dropout	6 weeks

Collaborators and Investigators

• Sponsor: Hebrew University of Jerusalem

Publications and helpful links

Helpful Links

• site website for guided self-help program

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2020
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): February 9, 2021
• Last Update Submitted That Met QC Criteria: February 8, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological
• Other Study ID Numbers: coronastress

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No