Mental Health WellnessNCT04257773
International REACH Forgiveness Intervention
A study testing REACH Forgiveness Workbook Intervention in people with Mental Health Wellness, run by City University of Hong Kong at 5 sites in 4 countries.
Trial summary
Six sites spanning five regions (Hong Kong, Colombia, Indonesia, Ukraine, South Africa) will administer a forgiveness workbook intervention in a randomized design with a stepped, waitlist intervention deployment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Wellness
- What is being tested?
- REACH Forgiveness Workbook Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,598 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 11 Feb 2020to 25 Oct 2021
- 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
- Must be able to read and comprehend the materials in the workbook
- Must be 18 years old or above
- Have someone in mind they want to forgive
Who cannot join
- No
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
Ukraine2 sites
Realis Center for Education and Research
Kyiv
Ukrainian Institute of Arts and Sciences
Kyiv
South Africa1 site
The South African and Africa Chapter of the International Association of Assessing Officers
Pretoria
About this study
Six sites spanning five regions (Hong Kong, Colombia, Indonesia, Ukraine, South Africa) will administer a forgiveness workbook intervention in a randomized design with a stepped, waitlist intervention deployment.
Read the detailed description
Intervention deployment:
ODO1 X O2 O3 (immediate-treatment [IT ] group) ODO1 O2 X O3 (delayed-treatment [DT ] group)
where OD denotes measurement of baseline demographic and personality measures, X denotes deployment of the intervention, and O1, O2, and O3 denote measurements of outcomes.
- Conditions
- Mental Health Wellness
- Being tested
- REACH Forgiveness Workbook Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REACH Forgiveness Workbook InterventionBehavioural
Participants will be asked to complete the REACH Forgiveness Workbook
| Study group | Role | What they receive |
|---|---|---|
| Immediate Treatment | Experimental | Participants in this group will receive treatment/intervention immediately. Receives: Behavioral: REACH Forgiveness Workbook Intervention |
| Delayed Treatment | Experimental | Participant in this group will receive treatment/intervention 2-week later. Receives: Behavioral: REACH Forgiveness Workbook Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression (BSI)
Brief Symptom Index, minimum value = 0, maximum value = 4. Higher scores indicates a higher psychological distress.
Measured: 4 months
Anxiety (BSI)
Brief Symptom Index. minimum value = 0, maximum value = 4. Higher scores indicates a higher psychological distress.
Measured: 4 months
Forgiveness (TRIM)
Transgression-Related Interpersonal Motivations, minimum value = 1, maximum value = 5. The higher the score, the more unforgiving the person is.
Measured: 4 months
Secondary outcomes (4)
Trait Forgiveness (TSF)
Trait Forgiveness Scale, minimum value = 1, maximum value = 5. The higher the whole score, the more forgiveness the person is.
Measured: 4 months
Forbearance (FS)
Forbearance Scale, minimum value = 1, maximum value = 6. The higher the score, the higher forbearing the person is.
Measured: 4 months
Decision to Forgive (DTSF)
Decision to Forgive Scale, minimum value = 1, maximum value = 5. The higher the score, the higher decisional forgiveness of the subject.
Measured: 4 months
Flourishing
Flourishing Index, minimum value = 1, maximum value = 10. The higher the score, the higher flourishing of the subject.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start11 Feb 2020
- Primary completion25 Oct 2021
- Study completion25 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health WellnessStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 4,598 participants (actual)
Sponsor and investigators
- Lead sponsor
- City University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, Stanford University
- Responsible party
- Principal investigator, Dr. HO Man Yee, City University of Hong Kong
- Investigators
- Man Yee Ho, PhD, Principal investigator, City University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257773
- Sponsor's protocol ID
- CityUHK
- Status last verified
- Jan 2024
- First submitted
- 4 Feb 2020
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data, which will be used for meta-analysis, reproducibility, and replication purposes, will be disclosed after the embargo period (30 April, 2024).
Publications
Ho MY, Worthington EL, Cowden RG, Bechara AO, Chen ZJ, Gunatirin EY, Joynt S, Khalanskyi VV, Korzhov H, Kurniati NMT, Rodriguez N, Anastasiya Salnykova A, Shtanko L, Tymchenko S, Voytenko VL, Zulkaida A, Mathur MB, VanderWeele TJ. International REACH forgiveness intervention: a multisite randomised controlled trial. BMJ Public Health. 2024 Mar 13;2(1):e000072. doi: 10.1136/bmjph-2023-000072. eCollection 2024 Jun.
PubMed 40018096
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International REACH Forgiveness Intervention
- ClinicalTrials.gov ID
- NCT04257773
- Acronym / sponsor ID
- CityUHK
- Conditions
- Mental Health Wellness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,598 participants (actual)
- Lead sponsor
- City University of Hong KongUniversity, hospital or other
- Collaborators
- Harvard University, Stanford University
- Study start
- 11 Feb 2020 (actual)
- Primary completion
- 25 Oct 2021 (actual)
- Study completion
- 25 Oct 2021 (actual)
- First posted
- 6 Feb 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.
Six sites spanning five regions (Hong Kong, Colombia, Indonesia, Ukraine, South Africa) will administer a forgiveness workbook intervention in a randomized design with a stepped, waitlist intervention deployment.
Detailed description
Intervention deployment:
ODO1 X O2 O3 (immediate-treatment [IT ] group) ODO1 O2 X O3 (delayed-treatment [DT ] group)
where OD denotes measurement of baseline demographic and personality measures, X denotes deployment of the intervention, and O1, O2, and O3 denote measurements of outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate Treatment | Experimental | Behavioral: REACH Forgiveness Workbook InterventionParticipants in this group will receive treatment/intervention immediately. |
| Delayed Treatment | Experimental | Behavioral: REACH Forgiveness Workbook InterventionParticipant in this group will receive treatment/intervention 2-week later. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be able to read and comprehend the materials in the workbook
- Must be 18 years old or above
- Have someone in mind they want to forgive
Key exclusion criteria (1 listed)
- No
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 |
|---|---|---|
| REACH Forgiveness Workbook InterventionParticipants will be asked to complete the REACH Forgiveness Workbook | Behavioural | Delayed Treatment, Immediate Treatment |
Primary outcome
Depression (BSI)
Time frame: 4 months
Brief Symptom Index, minimum value = 0, maximum value = 4. Higher scores indicates a higher psychological distress.
Anxiety (BSI)
Time frame: 4 months
Brief Symptom Index. minimum value = 0, maximum value = 4. Higher scores indicates a higher psychological distress.
Forgiveness (TRIM)
Time frame: 4 months
Transgression-Related Interpersonal Motivations, minimum value = 1, maximum value = 5. The higher the score, the more unforgiving the person is.
4 secondary outcomes
Trait Forgiveness (TSF)
Time frame: 4 months
Forbearance (FS)
Time frame: 4 months
Decision to Forgive (DTSF)
Time frame: 4 months
Flourishing
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Derived from this study: PubMed 40018096Ho MY, Worthington EL, Cowden RG, Bechara AO, Chen ZJ, Gunatirin EY, Joynt S, Khalanskyi VV, Korzhov H, Kurniati NMT, Rodriguez N, Anastasiya Salnykova A, Shtanko L, Tymchenko S, Voytenko VL, Zulkaida A, Mathur MB, VanderWeele TJ. International REACH forgiveness intervention: a multisite randomised controlled trial. BMJ Public Health. 2024 Mar 13;2(1):e000072. doi: 10.1136/bmjph-2023-000072. eCollection 2024 Jun.
- Individual participant dataSharing planned: Yes. Data, which will be used for meta-analysis, reproducibility, and replication purposes, will be disclosed after the embargo period (30 April, 2024).
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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.
Man Yee Ho, PhD principal investigator
City University of Hong Kong
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REACH Forgiveness Workbook Intervention in people with Mental Health Wellness, run by City University of Hong Kong at 5 sites in 4 countries.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Ukraine, Colombia, Indonesia, South Africa. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression (BSI) (time frame: 4 months). 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?
On the ClinicalTrials.gov record for NCT04257773, which also lists 1 linked publication.
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 5 Jan 2024.