NCT06808828

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
4mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress80%
Feb 2025Sep 2026

First Submitted

Initial submission to the registry

January 25, 2025

Completed
9 days until next milestone

Study Start

First participant enrolled

February 3, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

July 25, 2025

Status Verified

July 1, 2025

Enrollment Period

1.6 years

First QC Date

January 25, 2025

Last Update Submit

July 23, 2025

Conditions

Keywords

domestic violenceintimate partner violenceoccupational therapy

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    Change between the baseline assessment and post-test at study completion, up to 9 weeks post-enrollment.

Study Arms (1)

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.

Behavioral: Health and coping skills

Interventions

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.

Health and coping skills

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or Female 18 years of age or older receiving services from a domestic violence organization

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University Health

Loma Linda, California, 92350, United States

RECRUITING

MeSH Terms

Interventions

HealthCoping Skills

Intervention Hierarchy (Ancestors)

Population CharacteristicsBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Heather Javaherian, OTD

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heather Javaherian, OTD

CONTACT

Leticia Guerrero, BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2025

First Posted

February 5, 2025

Study Start

February 3, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

July 25, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations