Self-Defense Training in Women With Trauma

Depression Clinical Trial

Official title:

A Pilot Study of Self-Defense Training in Women With Trauma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01380379
• Other study ID #: SU-04152011-7701
• Secondary ID: 20776
• Status: Completed
• Phase: N/A
• First received: May 18, 2011
• Last updated: November 18, 2015
• Start date: April 2011
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Previous research has shown that self-defense training can lead to gains in women's assertiveness, self-esteem, self-efficacy, and physical competence, and decreases in anxiety, helplessness, fear, and avoidant behaviors. However, most of this research has been conducted with healthy women who had not previously experienced physical or sexual violence. The investigators believe that women with such trauma histories require additional care because of potential triggering symptoms. As such, the investigators are mindful of the potential for triggering trauma symptoms and will work with the women so that they feel safe and comfortable in their participation. This pilot study aims to examine whether similar psychological gains from self-defense training are made in women who have previous experiences of physical and/or sexual violence.

Description:

There is a high rate of violence against women in the United States. For example, at least 1 in 6 women will experience an attempted or completed rape in their lifetime (Tjaden & Thoenees, 2000). The high physical, emotional, economic and social costs of such violence are staggering. In particular, there can be a serious impact on mental health, with both immediate and long-term consequences (e.g., Coker et al., 2000). The aim of this project is to examine the psychological benefits of a class, which incorporates psychological and physical self-defense skills, for women who have been the victim of sexual or physical violence.

A small literature suggests that women who take self-defense classes have increases in general self-efficacy and self-esteem (e.g.,Ozer and Bandura, 1990). This project is focusing on women who already have a history of physical or sexual violence. The investigators hypothesize that women who already have such a history of violence will benefit from a self-defense class that incorporates psychoeducation and brief psychology treatments in order to successfully participate in such a class and that ultimately it will improve their psychological well-being.

Potential participants will first do a short phone screening to see whether they may be eligible for the study. If so, they will be brought into the clinic for a full eligibility assessment.

Eligibility Procedures: Before entering the study, participants will participate in an eligibility interview. This will consist of a psychiatric interview (e.g., portions of the SCID and psychiatric rating scales), trauma history (e.g. CAPS), and physical health assessment. Participants will either need approval from their primary care physician to participate in the physical self-defense portion of the study or have a brief physical exam will a physician on the research team.

If the participant is eligible for the study, they will be added to the list of participants. Once 16-20 participants have been screened and determine eligible for the study, all will be randomly assigned to either the first self-defense class or a wait-list group. Those in the first class will actively participate in the class for the first 8 weeks of the study. Those in the wait-list group will receive no specific treatment during the first 8 weeks. After completion of the first course, participants on the wait-list group will then be offered the same 8-week course. All woman will participate in the class - either in the 1st or 2nd 8-week class session.

During the initial 8 weeks, all participants, regardless of group assigned, will be asked to fill out a series of questionnaires prior to the course, and after 4 and 8 weeks. Each set of questionnaires should take less than 1 hour to complete. In addition, the investigators will conduct a 6-month post-class, follow up assessment, which will also be on-line.

Self-defense class: The self-defense program is an eight week curriculum that meets once per week for 2.5 hours per session. The course which involves three components. The first component is a psycho-educational component which provides current basic information about physical and sexual assaults and also skill building, such as assertiveness, communication skills, and boundary setting. The second component of each class is physical resistance techniques which offers ample training. This includes information about basic targets, punches, and kicks, as well as breaking out of holds and other resistance skills. The third component of each class includes a supportive psychotherapy debriefing session. Following participation in the self-defense class all participants will be required to come for an in-person, debriefing interview.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 2015
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Women ages 21-65 years

2. History of physical and/or sexual violence, with subsequent interpersonal or psychological distress (e.g., depression or anxiety) related to this history.

Exclusion Criteria:

1. Substance abuse in the past 6 months

2. Significant medical conditions that would preclude safe participation in the study

3. High levels of depression with significant suicide risk

4. Pregnant women

5. Active symptoms of psychosis or psychiatric instability

6. History of assaultive behavior or is judged to be at potential risk to assault others.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety
• Depression
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Life skills and self-defense training
8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in self-efficacy from baseline to post-treatment and maintenance at 6 and 12-months post intervention	Several measures of self-efficacy will be assessed. General self-efficacy (Schwartz and Jerusalem, 1993) will assess overall self-efficacy. More specific aspects of self efficacy will include one's physical self-efficacy (Rychman et al., 1982) and coping self-efficacy (Chesney et al., 2006)	8 weeks, 6 and 12- months post-treatment	No
Secondary	Change in assertiveness between baseline and post-intervention and maintenance at 6 anad 12 months	Measured by the Rathus Assertiveness Schedule (Rathus, 1973)	post class and 6 and 12 months post-class	No
Secondary	Change in self-esteem between baseline and post-intervention and maintenance at 6 anad 12 months	Measured by the Rosenberg Self-esteem inventory (Rosengerb, 1955)	post class and 6 and 12 months post-class	No
Secondary	Change in trauma symptoms and depression between baseline and post-intervention and maintenance at 6 and 12 months	Measured by the Trauma Symptom Inventory-2 (Briere, 2010)	post class and 6 and 12 months post-class	No
Secondary	Change in Risk perception between baseline and post-intervention and maintenance at 6 and 12 months	Measured by the Risk Perception Survey (Messman-Moore & Brown, 2006)	post class and 6 and 12 months post-class	No
Secondary	Relationship of shame to type and severity of trauma history	Measured by the TOSCA-3 (Tangney et al.,1989) and ETI-SR.	baseline	No