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

Stress Clinical Trial

— CoronaStress  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04394403
• Other study ID #: coronastress
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2021
• Source: Hebrew University of Jerusalem
• Contact: Jonathan Huppert, PhD
• Phone: +97225883376
• Email: jonathan.huppert[@]mail.huji.ac.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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/

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Stress
• Stress, Psychological

Intervention

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

Locations

Country	Name	City	State
Israel	Hebrew University of Jerusalem	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hebrew University of Jerusalem

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	completion rate of modules	how many modules each individual completes, with less than 2 being considered dropout	6 weeks
Primary	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),
Primary	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
Primary	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	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
Secondary	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
Secondary	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

External Links

•   site website for guided self-help program