StressCoronaStressNCT04394403
Pilot Internet-based Self-Help Program for Managing Corona (COVID-19) Stress
A study testing Internet-based guided self-help based on CBT principles in people with Stress and Stress, Psychological, run by Hebrew University of Jerusalem at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Stress, Psychological
- What is being tested?
- Internet-based guided self-help based on CBT principles
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- 14 May 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Read/Write English,
- feels stress due to Corona/COVID-19
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hebrew University of Jerusalem
Jerusalem, 9190501
Jonathan Huppert, PhD, +97225883376, coronastress@mail.huji.ac.il
Jonathan D Huppert, PhD
About this study
Official title: Pilot Internet-based Self-Help Program for Managing Corona Stress vs. Waitlist Control
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.
Read the 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/
- Conditions
- Stress, Stress, Psychological
- Being tested
- Internet-based guided self-help based on CBT principles
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based guided self-help based on CBT principlesBehavioural
Also called ICBT for CoronaStress
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
| Study group | Role | What they receive |
|---|---|---|
| immediate guided self-help | Experimental | In this condition, individuals will be given access to material and exercises based on CBT to reduce their stress Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: change from Pre to 1 year Follow-up
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: change from pre to 1 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start14 May 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized trial to either immediate or delayed access to the internet guided self-help program
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebrew University of Jerusalem
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan D. Huppert, Hebrew University of Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04394403
- Sponsor's protocol ID
- coronastress
- Acronym
- CoronaStress
- Status last verified
- Feb 2021
- First submitted
- 13 May 2020
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Internet-based Self-Help Program for Managing Corona Stress vs. Waitlist Control
- ClinicalTrials.gov ID
- NCT04394403
- Acronym / sponsor ID
- CoronaStress / coronastress
- Conditions
- Stress, Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hebrew University of JerusalemUniversity, hospital or other
- Study start
- 14 May 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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/
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized trial to either immediate or delayed access to the internet guided self-help program
| Arm | Type | Receives |
|---|---|---|
| immediate guided self-help | Experimental | Behavioral: Internet-based guided self-help based on CBT principlesIn this condition, individuals will be given access to material and exercises based on CBT to reduce their stress |
| waitlist | No intervention | –Individuals in this condition will wait 6 weeks before they are provided access to the guided self-help program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Read/Write English,
- feels stress due to Corona/COVID-19
Key exclusion criteria (8 listed)
- current psychological or psychiatric treatment,
- current psychiatric illness,
- suicidality,
- psychosis,
- bipolar,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-based guided self-help based on CBT principlesAlso: ICBT for CoronaStressIndividuals are provided basic rationale of CBT to deal with stress, worry, anxiety, dysphoria, sleep difficulties, emotion dysregulation, and memories all related to COVID-19 | Behavioural | immediate guided self-help |
Primary outcome
The CoRonavIruS Health Impact Survey (CRISIS)
Time frame: change from Pre to post treatment (6 weeks),
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)
Time frame: change from Pre to 6 months Follow-up
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)
Time frame: change from Pre to 1 year Follow-up
change in a self-report measure of stress during the COVID-19 pandemic that ranges from 0-128. Higher means more symptomatic.
3 secondary outcomes
Depression, Anxiety, and Stress Scale- 21 item version: DASS-21
Time frame: Weekly change during treatment and at pre and post (6 week) treatment evaluations
Depression, Anxiety, and Stress Scale- 21 item version: DASS-21
Time frame: change from pre to 6 month follow up
Depression, Anxiety, and Stress Scale- 21 item version: DASS-21
Time frame: change from pre to 1 year follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- site website for guided self-help programLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-based guided self-help based on CBT principles in people with Stress and Stress, Psychological, run by Hebrew University of Jerusalem at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jonathan Huppert, PhD (+97225883376, jonathan.huppert@mail.huji.ac.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The CoRonavIruS Health Impact Survey (CRISIS) (time frame: change from Pre to post treatment (6 weeks),). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.