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Self-Defense Training in Women With Trauma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01380379
Recruitment Status : Completed
First Posted : June 27, 2011
Results First Posted : February 1, 2017
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Jennifer Keller, Stanford University

Tracking Information
First Submitted Date  ICMJE May 18, 2011
First Posted Date  ICMJE June 27, 2011
Results First Submitted Date  ICMJE October 11, 2016
Results First Posted Date  ICMJE February 1, 2017
Last Update Posted Date February 1, 2017
Study Start Date  ICMJE April 2011
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
Change in Self-efficacy From Baseline to Post-treatment [ Time Frame: Change in GSE from baseline to 8 weeks ]
General self-efficacy (Schwartz and Jerusalem, 1993) is a measure of one's perceived self-competence. Scores are summed across 10 items, and range between 10-40, where higher scores reflect a stronger sense of personal competence.
Original Primary Outcome Measures  ICMJE
 (submitted: June 22, 2011)
Change in self-efficacy from baseline to post-treatment and maintenance at 6 and 12-months post intervention [ Time Frame: 8 weeks, 6 and 12- months post-treatment ]
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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2016)
Change in Assertiveness Between Baseline and Post-intervention [ Time Frame: Change in assertiveness from baseline to post-class (8 weeks) ]
Measured by the Rathus Assertiveness Schedule (Rathus, 1973). Rathus Assertiveness Scale is a 30-item scale assessing assertive behavior in a variety of situations. Each item is rated on a 6-point Likert scale from +3 (very characteristic of me) to -3 (very uncharacteristic of me). Total scores range from +90, which is equivalent of very assertive behavior to -90, which is equivalent to very unassertive behavior. The positive change indicates an increase in assertive behavior.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2011)
  • Change in assertiveness between baseline and post-intervention and maintenance at 6 anad 12 months [ Time Frame: post class and 6 and 12 months post-class ]
    Measured by the Rathus Assertiveness Schedule (Rathus, 1973)
  • Change in self-esteem between baseline and post-intervention and maintenance at 6 anad 12 months [ Time Frame: post class and 6 and 12 months post-class ]
    Measured by the Rosenberg Self-esteem inventory (Rosengerb, 1955)
  • Change in trauma symptoms and depression between baseline and post-intervention and maintenance at 6 and 12 months [ Time Frame: post class and 6 and 12 months post-class ]
    Measured by the Trauma Symptom Inventory-2 (Briere, 2010)
  • Change in Risk perception between baseline and post-intervention and maintenance at 6 and 12 months [ Time Frame: post class and 6 and 12 months post-class ]
    Measured by the Risk Perception Survey (Messman-Moore & Brown, 2006)
  • Relationship of shame to type and severity of trauma history [ Time Frame: baseline ]
    Measured by the TOSCA-3 (Tangney et al.,1989) and ETI-SR.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Self-Defense Training in Women With Trauma
Official Title  ICMJE A Pilot Study of Self-Defense Training in Women With Trauma
Brief 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.
Detailed 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 an adequate number of participants have been screened and determine eligible for the study, they will participate in the group for 8 weeks.

Participants will fill out a series of questionnaires pre- and post- the course. Each set of questionnaires should take less than 1 hour to complete. In addition, the investigators conducted a 6-month post-class, follow up assessment.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Depression
  • Anxiety
  • Stress Disorders, Post-Traumatic
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Life skills and self-defense training
Women will participate in a therapeutic group which covers education, skills, and empowerment activities.
Intervention: Behavioral: Life skills and self-defense training
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 7, 2016)
9
Original Estimated Enrollment  ICMJE
 (submitted: June 22, 2011)
20
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01380379
Other Study ID Numbers  ICMJE SU-04152011-7701
20776
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jennifer Keller, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jennifer Keller Stanford University
PRS Account Stanford University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP