- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06808828
Occupational Therapy for Adults Who Have Experienced Intimate Partner Violence (IPV) (IPV)
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:
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Heather Javaherian, OTD
- Phone Number: 9095584628
- Email: hjavaherian@llu.edu
Study Contact Backup
- Name: Leticia Guerrero, BA
- Phone Number: 909-558-4628
- Email: letguerrero@llu.edu
Study Locations
-
-
California
-
Loma Linda, California, United States, 92350
- Recruiting
- Loma Linda University Health
-
Contact:
- Heather Javaherian, PhD
- Phone Number: 909-558-4628
- Email: hjavaherian@llu.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Male or Female 18 years of age or older receiving services from a domestic violence organization
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Health and coping skills
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Change between baseline assessment at initial enrollment and completion of Session 8 at 8 weeks post-enrollment.
|
|
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.
|
Change between the baseline assessment and post-test at study completion, up to 9 weeks post-enrollment
|
|
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.
|
Change between the baseline assessment and post-test at study completion, up to 9 weeks post-enrollment.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Heather Javaherian, OTD, Loma Linda University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 5240501
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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