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

Study Overview
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Brief Summary
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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
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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/

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

Conditions
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Stress, Stress, Psychological

Intervention / Treatment
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* Behavioral: Internet-based guided self-help based on CBT principles


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a randomized trial to either immediate or delayed access to the internet guided self-help program
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: immediate guided self-help<br>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<br>* 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<br>* Other names: ICBT for CoronaStress;|
| No Intervention: waitlist<br>Individuals in this condition will wait 6 weeks before they are provided access to the guided self-help program | |

What is the study measuring?
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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 |