Self-Defense Training in Women With Trauma

• 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: Stanford University
• Information provided by (Responsible Party): Jennifer Keller, Stanford University

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Depression; Anxiety; Stress Disorders, Post-Traumatic
• Intervention: Behavioral: Life skills and self-defense training
• Enrollment: 9

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Life Skills and Self-defense Training
Arm/Group Description	Women will participate in a therapeutic group which covers education, skills, and empowerment activities. 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.
Period Title: Overall Study
Started	9
Completed	8
Not Completed	1
Reason Not Completed
Pregnancy	1

Baseline Characteristics

Arm/Group Title		Life Skills and Self-defense Training
Arm/Group Description		Women will participate in a therapeutic group which covers education, skills, and empowerment activities. 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.
Overall Number of Baseline Participants		9
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	9 participants
		46.38 (9.6)
Gender; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	9 participants
	Female	9 100.0%
	Male	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	9 participants
	American Indian or Alaska Native	0 0.0%
	Asian	4 44.4%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	0 0.0%
	White	5 55.6%
	More than one race	0 0.0%
	Unknown or Not Reported	0 0.0%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
United States	Number Analyzed	9 participants
		9 100.0%

Outcome Measures

1. Primary Outcome

Title	Change in Self-efficacy From Baseline to Post-treatment
Description	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.
Time Frame	Change in GSE from baseline to 8 weeks

Outcome Measure Data

Analysis Population Description

The data is the change in general self efficacy from baseline to post-class, with higher scores indicating a greater increase in self-efficacy

Arm/Group Title	Life Skills and Self-defense Training
Arm/Group Description:	Women will participate in a therapeutic group which covers education, skills, and empowerment activities. 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.
Overall Number of Participants Analyzed	8
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline General Self efficacy	23.38 (5.8)
Week 8 (post-class) GSE	29.63 (3.0)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Life Skills and Self-defense Training
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.01
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	Single group comparison pre-post change score, compared to a value of 0 (no change)

2. Secondary Outcome

Title	Change in Assertiveness Between Baseline and Post-intervention
Description	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.
Time Frame	Change in assertiveness from baseline to post-class (8 weeks)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Life Skills and Self-defense Training
Arm/Group Description:	Women will participate in a therapeutic group which covers education, skills, and empowerment activities. 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.
Overall Number of Participants Analyzed	8
Mean (Standard Deviation); Unit of Measure: units on a scale
Baseline Assertiveness Total	-24.88 (34.6)
Week 8 (post-class) Assertiveness Total	-15.88 (33.85)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Life Skills and Self-defense Training
	Comments	[Not Specified]
	Type of Statistical Test	Superiority or Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	<.04
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

Adverse Events

Time Frame	[Not Specified]
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Life Skills and Self-defense Training
Arm/Group Description	Women will participate in a therapeutic group which covers education, skills, and empowerment activities. 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.
All-Cause Mortality
	Life Skills and Self-defense Training
	Affected / at Risk (%)
Total	--/--
Serious Adverse Events
	Life Skills and Self-defense Training
	Affected / at Risk (%)	# Events
Total	0/8 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Life Skills and Self-defense Training
	Affected / at Risk (%)	# Events
Total	1/8 (12.50%)
Psychiatric disorders
Dissociation during class *	1/8 (12.50%)	8
* Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Jennifer Keller
• Organization: Stanford University
• Phone: 650-724-0070
• EMail: jkeller@stanford.edu

• Responsible Party: Jennifer Keller, Stanford University
• ClinicalTrials.gov Identifier: NCT01380379
• Other Study ID Numbers: SU-04152011-7701; 20776
• First Submitted: May 18, 2011
• First Posted: June 27, 2011
• Results First Submitted: October 11, 2016
• Results First Posted: February 1, 2017
• Last Update Posted: February 1, 2017