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

NCT04394403 | Unknown

• 1 other identifier: coronastress
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Stress, Psychological

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Depression, Anxiety, and Stress Scale- 21 item version: DASS-21

  Weekly change during treatment and at pre and post (6 week) treatment evaluations

• Depression, Anxiety, and Stress Scale- 21 item version: DASS-21

  change from pre to 6 month follow up

• Depression, Anxiety, and Stress Scale- 21 item version: DASS-21

  change from pre to 1 year follow-up

Other Outcomes (1)

• completion rate of modules

  6 weeks

Study Arms (2)

immediate guided self-help

EXPERIMENTAL

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

waitlist

NO INTERVENTION

Individuals in this condition will wait 6 weeks before they are provided access to the guided self-help program

Interventions

Internet-based guided self-help based on CBT principles BEHAVIORAL

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

Also known as: ICBT for CoronaStress

immediate guided self-help

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebrew University of Jerusalem: lead

Study Sites (1)

Hebrew University of Jerusalem

Jerusalem, 9190501, Israel

RECRUITING

Related Links

• site website for guided self-help program

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Jonathan Huppert, PhD

CONTACT

+97225883376; jonathan.huppert@mail.huji.ac.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This is a randomized trial to either immediate or delayed access to the internet guided self-help program

Study Record Dates

• First Submitted: May 13, 2020
• First Posted: May 19, 2020
• Study Start: May 14, 2020
• Primary Completion: December 31, 2021
• Study Completion: June 30, 2022
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)