Domestic ViolenceIPVNCT06808828
Occupational Therapy for Adults Who Have Experienced Intimate Partner Violence (IPV)
A study testing Health and coping skills in people with Domestic Violence, run by Loma Linda University at 1 site in United States.
Trial summary
The purpose of this graduate student research study is to understand the effectiveness of an occupational therapy program in a domestic violence shelter. It is expected that participation will last about 6 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Domestic Violence
- What is being tested?
- Health and coping skills
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Feb 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female 18 years of age or older receiving services from a domestic violence organization
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Loma Linda University Health
Loma Linda, California, 92350
Heather Javaherian, PhD, 909-558-4628, hjavaherian@llu.edu
About this study
Official title: Occupational Therapy for Adults Who Have Experienced Intimate Partner Violence
The purpose of this graduate student research study is to understand the effectiveness of an occupational therapy program in a domestic violence shelter. It is expected that participation will last about 6 weeks. Subjects will complete pretests involving lifestyle assessments and a coping scale and then participate in 8 occupational therapy sessions during the 4 weeks of program implementation. The occupational therapy sessions will last approximately 90 minutes. After the program is completed, subjects will complete the posttests.
Procedures and Activities. You will be asked to:
Read more
Complete a series of questionnaires about your health, well-being, and daily activities.
Participate in 8 OT sessions that may include activities such as journaling, positive self-talk, coping skills methods, and grounding exercises.
Complete the posttests.
- Conditions
- Domestic Violence
- Being tested
- Health and coping skills
- Keywords
- domestic violence, intimate partner violence, occupational therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health and coping skillsBehavioural
An occupational therapist and occupational therapy graduate capstone student will lead in-person sessions. Subjects will participate in an occupational therapy program that meets 2x/week x 4 weeks for eight sessions. Topics will include sleep hygiene, physical activity, healthy cooking, self-management, coping skills, self-esteem, mindfulness, and goal setting. Subjects will receive education as well as actively engage in activities related to the topic. Subjects will be provided with a personal journal to complete homework involving reflections on the topics discussed in the sessions.
| Study group | Role | What they receive |
|---|---|---|
| Health and coping skills | Experimental | Subjects will complete an 8-item occupational therapy lifestyle medicine checklist at each session. The subjects will participate in eight sessions receiving education on health topics of sleep hygiene, physical activity, healthy cooking, self-management, coping skills, self-esteem, mindfulness, and goal setting. Receives: Behavioral: Health and coping skills |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Healthy Lifestyle
This is a composite measurement, utilizing the Occupational Therapy Lifestyle Medicine Checklist (OTLM) to assess improvement in the following categories: Healthy eating; Physical Activity; Stress Management; Social Connections; Sleep; Work/School (that's too vague to measure), Leisure and Hobbies; Avoiding Risky Substances. Participants will complete this checklist at baseline, prior to the first intervention and after the final eight intervention is completed. Each category will have a range (1-10), which will indicate how the participant has responded overall to the intervention. An overall increase of >15 points in the combined categories will indicate significant improvement. An overall decrease of any number of points will indicate non-significant improvement.
Measured: Change between baseline assessment at initial enrollment and completion of Session 8 at 8 weeks post-enrollment.
Improvement in Quality of Life
This is a compositive measure utilizing the 36-Item Short Form Health Survey Questionnaire. Quality of life involves several areas. The 36-item Short Form is a self-reported measure that consists of thirty-six questions covering eight domains of health. Categories include (1) limitations in physical activities, (2) limitations in social activities, (3) limitations in usual role activities because of physical health problems, (4) bodily pain, (5) general mental health, (6) limitations in usual role activities because of emotional problems, (7) vitality, and (8) general health perceptions. Subjects may receive a score ranging from 0-100. Higher scores indicate more favorable health.
Measured: Change between the baseline assessment and post-test at study completion, up to 9 weeks post-enrollment
Improvement in Coping Skills
This is a composite measure that will utilize the Coping Scale Questionnaire. This 13-item questionnaire gathers information on how the subject copes. Categories include anger management, endurance, well-being, and posttraumatic growth. Higher scores indicate higher levels of coping.
Measured: Change between the baseline assessment and post-test at study completion, up to 9 weeks post-enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2025
- Study start3 Feb 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Domestic ViolenceStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will attend a 90-minute session twice a week sessions per week for four weeks. During the session, participants will receive education on resilience and developing healthy lifestyles. Participants will be assessed at baseline with a pre-test and post-intervention with a post-test. In addition, participants will complete the occupational therapy lifestyle medicine check-in at each session.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Javaherian, OTD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06808828
- Sponsor's protocol ID
- 5240501
- Acronym
- IPV
- Status last verified
- Jul 2026
- First submitted
- 25 Jan 2025
- Last updated
- 4 Aug 2026
- 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 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Therapy for Adults Who Have Experienced Intimate Partner Violence
- ClinicalTrials.gov ID
- NCT06808828
- Acronym / sponsor ID
- IPV / 5240501
- Conditions
- Domestic Violence
- Keywords
- domestic violence, intimate partner violence, occupational therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 5 Feb 2025 (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 purpose of this graduate student research study is to understand the effectiveness of an occupational therapy program in a domestic violence shelter. It is expected that participation will last about 6 weeks. Subjects will complete pretests involving lifestyle assessments and a coping scale and then participate in 8 occupational therapy sessions during the 4 weeks of program implementation. The occupational therapy sessions will last approximately 90 minutes. After the program is completed, subjects will complete the posttests.
Procedures and Activities. You will be asked to:
Complete a series of questionnaires about your health, well-being, and daily activities.
Participate in 8 OT sessions that may include activities such as journaling, positive self-talk, coping skills methods, and grounding exercises.
Complete the posttests.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will attend a 90-minute session twice a week sessions per week for four weeks. During the session, participants will receive education on resilience and developing healthy lifestyles. Participants will be assessed at baseline with a pre-test and post-intervention with a post-test. In addition, participants will complete the occupational therapy lifestyle medicine check-in at each session.
| Arm | Type | Receives |
|---|---|---|
| Health and coping skills | Experimental | Behavioral: Health and coping skillsSubjects will complete an 8-item occupational therapy lifestyle medicine checklist at each session. The subjects will participate in eight sessions receiving education on health topics of sleep hygiene, physical activity, healthy cooking, self-management, coping skills, self-esteem, mindfulness, and goal setting. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or Female 18 years of age or older receiving services from a domestic violence organization
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Health and coping skillsAn occupational therapist and occupational therapy graduate capstone student will lead in-person sessions. Subjects will participate in an occupational therapy program that meets 2x/week x 4 weeks for eight sessions. Topics will include sleep hygiene, physical activity, healthy cooking, self-management, coping skills, self-esteem, mindfulness, and goal setting. Subjects will receive education as well as actively engage in activities related to the topic. Subjects will be provided with a personal journal to complete homework involving reflections on the topics discussed in the sessions. | Behavioural | Health and coping skills |
Primary outcome
Improvement in Healthy Lifestyle
Time frame: Change between baseline assessment at initial enrollment and completion of Session 8 at 8 weeks post-enrollment.
This is a composite measurement, utilizing the Occupational Therapy Lifestyle Medicine Checklist (OTLM) to assess improvement in the following categories: Healthy eating; Physical Activity; Stress Management; Social Connections; Sleep; Work/School (that's too vague to measure), Leisure and Hobbies; Avoiding Risky Substances. Participants will complete this checklist at baseline, prior to the first intervention and after the final eight intervention is completed. Each category will have a range (1-10), which will indicate how the participant has responded overall to the intervention. An overall increase of >15 points in the combined categories will indicate significant improvement. An overall decrease of any number of points will indicate non-significant improvement.
Improvement in Quality of Life
Time frame: Change between the baseline assessment and post-test at study completion, up to 9 weeks post-enrollment
This is a compositive measure utilizing the 36-Item Short Form Health Survey Questionnaire. Quality of life involves several areas. The 36-item Short Form is a self-reported measure that consists of thirty-six questions covering eight domains of health. Categories include (1) limitations in physical activities, (2) limitations in social activities, (3) limitations in usual role activities because of physical health problems, (4) bodily pain, (5) general mental health, (6) limitations in usual role activities because of emotional problems, (7) vitality, and (8) general health perceptions. Subjects may receive a score ranging from 0-100. Higher scores indicate more favorable health.
Improvement in Coping Skills
Time frame: Change between the baseline assessment and post-test at study completion, up to 9 weeks post-enrollment.
This is a composite measure that will utilize the Coping Scale Questionnaire. This 13-item questionnaire gathers information on how the subject copes. Categories include anger management, endurance, well-being, and posttraumatic growth. Higher scores indicate higher levels of coping.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- 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.
Heather Javaherian, OTD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health and coping skills in people with Domestic Violence, run by Loma Linda University at 1 site in United States.
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 1 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: looking for participants now, as of the sponsor's last update on 4 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Javaherian, OTD (9095584628, hjavaherian@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Healthy Lifestyle (time frame: Change between baseline assessment at initial enrollment and completion of Session 8 at 8 weeks post-enrollment.). 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 4 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.