Pilot Internet-based Self-Help Program for Managing Corona (COVID-19) Stress (CoronaStress)
Primary Purpose
Stress, Stress, Psychological
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Internet-based guided self-help based on CBT principles
Sponsored by
About this trial
This is an interventional treatment trial for Stress
Eligibility Criteria
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.
Sites / Locations
- Hebrew University of JerusalemRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
immediate guided self-help
waitlist
Arm Description
In this condition, individuals will be given access to material and exercises based on CBT to reduce their stress
Individuals in this condition will wait 6 weeks before they are provided access to the guided self-help program
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04394403
First Posted
May 13, 2020
Last Updated
February 8, 2021
Sponsor
Hebrew University of Jerusalem
1. Study Identification
Unique Protocol Identification Number
NCT04394403
Brief Title
Pilot Internet-based Self-Help Program for Managing Corona (COVID-19) Stress
Acronym
CoronaStress
Official Title
Pilot Internet-based Self-Help Program for Managing Corona Stress vs. Waitlist Control
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 14, 2020 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hebrew University of Jerusalem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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/
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Stress, Psychological
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a randomized trial to either immediate or delayed access to the internet guided self-help program
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
immediate guided self-help
Arm Type
Experimental
Arm Description
In this condition, individuals will be given access to material and exercises based on CBT to reduce their stress
Arm Title
waitlist
Arm Type
No Intervention
Arm Description
Individuals in this condition will wait 6 weeks before they are provided access to the guided self-help program
Intervention Type
Behavioral
Intervention Name(s)
Internet-based guided self-help based on CBT principles
Other Intervention Name(s)
ICBT for CoronaStress
Intervention Description
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
Primary Outcome Measure Information:
Title
The CoRonavIruS Health Impact Survey (CRISIS)
Description
change in a self-report measure of stress during the COVID-19 pandemic that ranges from 0-128. Higher means more symptomatic.
Time Frame
change from Pre to post treatment (6 weeks),
Title
The CoRonavIruS Health Impact Survey (CRISIS)
Description
change in a self-report measure of stress during the COVID-19 pandemic that ranges from 0-128. Higher means more symptomatic.
Time Frame
change from Pre to 6 months Follow-up
Title
The CoRonavIruS Health Impact Survey (CRISIS)
Description
change in a self-report measure of stress during the COVID-19 pandemic that ranges from 0-128. Higher means more symptomatic.
Time Frame
change from Pre to 1 year Follow-up
Secondary Outcome Measure Information:
Title
Depression, Anxiety, and Stress Scale- 21 item version: DASS-21
Description
a self-report measure of depression, anxiety and stress, with each subscale ranging from 0-28. Higher means more symptomatic.
Time Frame
Weekly change during treatment and at pre and post (6 week) treatment evaluations
Title
Depression, Anxiety, and Stress Scale- 21 item version: DASS-21
Description
a self-report measure of depression, anxiety and stress, with each subscale ranging from 0-28. Higher means more symptomatic.
Time Frame
change from pre to 6 month follow up
Title
Depression, Anxiety, and Stress Scale- 21 item version: DASS-21
Description
a self-report measure of depression, anxiety and stress, with each subscale ranging from 0-28. Higher means more symptomatic.
Time Frame
change from pre to 1 year follow-up
Other Pre-specified Outcome Measures:
Title
completion rate of modules
Description
how many modules each individual completes, with less than 2 being considered dropout
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Huppert, PhD
Phone
+97225883376
Email
jonathan.huppert@mail.huji.ac.il
Facility Information:
Facility Name
Hebrew University of Jerusalem
City
Jerusalem
ZIP/Postal Code
9190501
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Huppert, PhD
Phone
+97225883376
Email
coronastress@mail.huji.ac.il
First Name & Middle Initial & Last Name & Degree
Jonathan D Huppert, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.iterapi.se/sites/coronastress/
Description
site website for guided self-help program
Learn more about this trial
Pilot Internet-based Self-Help Program for Managing Corona (COVID-19) Stress
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