Clinical trial NCT04394403: Pilot Internet-based Self-Help Program for Managing Corona (COVID-19) Stress
Official title: Pilot Internet-based Self-Help Program for Managing Corona Stress vs. Waitlist Control
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stress
Stress, Psychological
Lead sponsor: Hebrew University of Jerusalem
Sponsor class: OTHER
First posted: 2020-05-19
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a randomized trial to either immediate or delayed access to the internet guided self-help program
Primary purpose: TREATMENT

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/

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.

Primary outcomes:
measure: The CoRonavIruS Health Impact Survey (CRISIS)
timeFrame: change from Pre to post treatment (6 weeks),
measure: The CoRonavIruS Health Impact Survey (CRISIS)
timeFrame: change from Pre to 6 months Follow-up
measure: The CoRonavIruS Health Impact Survey (CRISIS)
timeFrame: change from Pre to 1 year Follow-up
Secondary outcomes:
measure: Depression, Anxiety, and Stress Scale- 21 item version: DASS-21
timeFrame: Weekly change during treatment and at pre and post (6 week) treatment evaluations
measure: Depression, Anxiety, and Stress Scale- 21 item version: DASS-21
timeFrame: change from pre to 6 month follow up
measure: Depression, Anxiety, and Stress Scale- 21 item version: DASS-21
timeFrame: change from pre to 1 year follow-up
Other outcomes:
measure: completion rate of modules
timeFrame: 6 weeks
Locations:
city: Jerusalem
country: Israel
facility: Hebrew University of Jerusalem
Study officials:
References: