Therapeutic intervention for intimate partner violence survivors with PTSD

Not Applicable

Recruiting

• Conditions: Brain Injury in Intimate Partner Survivors; PTSD; Neurological - Other neurological disorders; Mental Health - Studies of normal psychology, cognitive function and behaviour; Injuries and Accidents - Other injuries and accidents

• Registration Number: ACTRN12624000893505
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-22
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Female participants aged between 18-70 years providing informed consent
Self-report history of IPV (> 3 months)
Probable post-traumatic stress disorder as measured by Post traumatic Stress Disorder Checklist PCL-5
Have daily access to a smartphone and internet
Eligible for Medicare

Exclusion Criteria

Subjects who are not willing or able to exercise due to health or personal reasons (e.g. orthopaedic injury, cervical spine injury, diabetes, known heart disease or musculoskeletal injuries which could make exercise difficult or painful) via Physical Activity Readiness questionnaire used (PAR-Q).

Increased cardiac risk indicated by two or more of the following:
a) Prior diagnosis of, or currently taking medication for cardiovascular (e.g., beta-blockers), metabolic or pulmonary conditions;
b) Family history of myocardial infarction, coronary revascularisation or sudden death before 55 years;
c) Diagnosis of hypertension;
d) Diagnosis of hyperlipidemia;
e) Subjects with peripheral circulatory disorders.

History of prior head injury as defined by:
a) Any head injury within the last 30 days
b) Moderate or severe TBI, defined as a brain injury with an associated Glasgow Coma Scale score of 12 or less

Diagnosis of a neurological (e.g., stroke, multiple sclerosis, epilepsy, brain tumour/cancer, encephalitis, dementia, movement disorder, or spontaneous nystagmus)

History of drug or alcohol dependency or abuse within a year before screening by self-report

Limited English proficiency precluding completion of measures

Significant psychiatric history (e.g. psychiatric hospitalisation, schizophrenia, history of legal trouble for violence)

IPV history < 3 month

No PTSD symptomology at the initial visit (i.e., asymptomatic).

Sustaining another head injury during the research period

New (< 1 month) or non-stable or pharmacological regimen prior to intervention (regiment must be maintained for the duration of intervention)

Exercise-tolerant individuals with a current activity level equal to or greater than the proposed intervention

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Post traumatic Stress Disorder Symptom Burden[The Post traumatic Stress Disorder Checklist (PCL-5) <br><br>The Post Traumatic Stress Disorder (PTSD) Checklist for DSM-5 (PCL-5) is a 20-item self-report measure of the twenty DSM-5 symptoms of PTSD in adult populations (ages 18+). It is designed for use with people who have experienced traumatic events. Baseline, weeks 1, 2, 3 and 4 (primary timepoint) post-randomisation.<br>Optional: weeks 5, 6, 7 and 8 post-randomisation.];Quality of life [WORLD HEALTH ORGANISATION- QUALITY OF LIFE (WHOQOL- BREF)<br><br>The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centres, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally. Baseline, weeks 1, 2, 3 and 4 (primary timepoint) post-randomisation.<br>Optional: weeks 5, 6, 7 and 8 post-randomisation.]