Effects of Physical Exercise Versus Group Therapy on Self-esteem Among Domestic Violence Victims

Study Overview
=================
Brief Summary
-----------------
The current study is a randomized controlled trial comparing the effects of 6 weeks of physical exercise training versus group therapy on self-esteem as well as on the various subdomains of physical self-esteem among women who have experienced domestic violence within the last two months at the time of data collection

Detailed Description
-----------------
The present study design includes three arms (two intervention arms): Physical Exercise (Group A), Counseling/Support Group (Group B), and No Intervention (Control, Group C). Random allocation to each group was done in a 1:1:1 ratio at the end of an initial telephone interview by one of the authors. A permutated block design with a block size of three was used. For each participant in Groups A and B, the assigned intervention was started the week following the initial interview, and lasted 6 weeks.

Official Title
-----------------
Physical Exercise and Self-esteem: a Randomized Controlled Trial in Domestic Violence Victims

Conditions
-----------------
Domestic Violence

Intervention / Treatment
-----------------
* Behavioral: Counseling/support group therapy
* Behavioral: Physical Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having experienced domestic violence at some time in the past 2 months Exclusion Criteria: not being physically active on a regular basis (less than 20 min of moderate-vigorous physical activity per day during the last year) absence of medical contraindication to exercise

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three independant groups including two intervention groups (Physical Exercise vs. Group Therapy) and one control group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical Exercise<br> | Behavioral: Physical Exercise<br>* 6 weeks of physical exercise training; 2 sessions of 30 min each week, with an instructor<br>|
| Active Comparator: Counseling/support group therapy<br> | Behavioral: Counseling/support group therapy<br>* 6 weeks of counseling group therapy; 2 sessions of 30 min each week, with a psychologist and two former victims<br>|
| No Intervention: Control<br>no intervention | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change score for each of the physical and global self esteem subscales from the Inventaire du Soi Physique (ISP-25). This instrument has 25 items each with a 6-point Likert response scale. Higher scores indicate greater self-esteem (physical or global) | magnitude of change in global and physical self-esteem from pre- to post-study. Minimum = -150; Maximum = +150 | baseline (pre-): the day before intervention implementation; post-study: the day following cessation of intervention, 6 weeks from baseline |