## Protocol Section
### Identification Module
**NCT ID:** NCT01380379

**Brief Title:** Self-Defense Training in Women With Trauma

**Official Title:** A Pilot Study of Self-Defense Training in Women With Trauma

#### Organization Study ID Info
**ID:** SU-04152011-7701
#### Organization
**Class:** OTHER
**Full Name:** Stanford University
#### Secondary ID Infos
**ID:** 20776
### Status Module
#### Completion Date
**Date:** 2015-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-02-01

**Type:** ESTIMATED

**Last Update Submit Date:** 2016-12-07

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-08

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2017-02-01

**Type:** ESTIMATED

**Results First Submit Date:** 2016-10-11

**Results First Submit QC Date:** 2016-12-07

#### Start Date
**Date:** 2011-04

**Status Verified Date:** 2016-12

#### Study First Post Date
**Date:** 2011-06-27
**Type:** ESTIMATED
**Study First Submit Date:** 2011-05-18
**Study First Submit QC Date:** 2011-06-22
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Stanford University

#### Responsible Party

**Investigator Affiliation:** Stanford University

**Investigator Full Name:** Jennifer Keller

**Investigator Title:** Senior Research Scholar

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Depression

- Anxiety

- Stress Disorders, Post-Traumatic

**Keywords:**

- physical violence

- sexual violence

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 9

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Women will participate in a therapeutic group which covers education, skills, and empowerment activities.

**Intervention Names:**

- Behavioral: Life skills and self-defense training

**Label:** Life skills and self-defense training

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Life skills and self-defense training

**Description:** 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.

**Name:** Life skills and self-defense training

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

**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.

**Measure:** Change in Self-efficacy From Baseline to Post-treatment

**Time Frame:** Change in GSE from baseline to 8 weeks

#### Secondary Outcomes

**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.

**Measure:** Change in Assertiveness Between Baseline and Post-intervention

**Time Frame:** Change in assertiveness from baseline to post-class (8 weeks)

### Eligibility Module

**Eligibility Criteria:** 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.

**Maximum Age:** 65 Years

**Minimum Age:** 21 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Stanford

**Country:** United States

**Facility:** Stanford University School of Medicine

**State:** California

**Zip:** 94305

#### Overall Officials

**Official 1:**

**Affiliation:** Stanford University

**Name:** Jennifer Keller

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000040921

- Term: Stress Disorders, Traumatic

- ID: D000068099

- Term: Trauma and Stressor Related Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M16103

- Name: Stress Disorders, Post-Traumatic

- Relevance: HIGH

- As Found: Stress Disorders, Post-Traumatic

- ID: M7058

- Name: Depression

- Relevance: LOW

- As Found: Unknown

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M24916

- Name: Stress Disorders, Traumatic

- Relevance: LOW

- As Found: Unknown

- ID: M222

- Name: Trauma and Stressor Related Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000013313

- Term: Stress Disorders, Post-Traumatic

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Life Skills and Self-defense Training

**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.

**ID:** EG000

**Other Num Affected:** 1

**Other Num at Risk:** 8

**Serious Number At Risk:** 8

**Title:** Life Skills and Self-defense Training

**Frequency Threshold:** 0

#### Other Events

**Term:** Dissociation during class

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** Psychiatric disorders

**Source Vocabulary:** 

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 9

**Units:** Participants

### Group

**ID:** BG000

**Title:** Life Skills and Self-defense Training

**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.

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 9.6

**Value:** 46.38

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 9

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** American Indian or Alaska Native

#### Measurement

**Group ID:** BG000

**Value:** 4

**Category Title:** Asian

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Native Hawaiian or Other Pacific Islander

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Black or African American

#### Measurement

**Group ID:** BG000

**Value:** 5

**Category Title:** White

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** More than one race

#### Measurement

**Group ID:** BG000

**Value:** 0

**Category Title:** Unknown or Not Reported

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 9

**Class Title:** United States

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Gender
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Race (NIH/OMB)
**Unit of Measure:** Participants
### Measure 4
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Region of Enrollment
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
### Point of Contact
**Email:** jkeller@stanford.edu
**Organization:** Stanford University
**Phone:** 650-724-0070
**Title:** Dr. Jennifer Keller
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <.01
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** Single group comparison pre-post change score, compared to a value of 0 (no change)
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** False
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** 
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <.04
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** t-test, 2 sided
**Tested Non-Inferiority:** False
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 5.8
- **Upper Limit:** 
- **Value:** 23.38
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 3.0
- **Upper Limit:** 
- **Value:** 29.63
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 34.6
- **Upper Limit:** 
- **Value:** -24.88
**Title:** 
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 33.85
- **Upper Limit:** 
- **Value:** -15.88
**Title:** 
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**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
**Reporting Status:** POSTED
**Time Frame:** Change in GSE from baseline to 8 weeks
**Title:** Change in Self-efficacy From Baseline to Post-treatment
**Type:** PRIMARY
**Unit of Measure:** units on a scale
##### 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.
**ID:** OG000
**Title:** Life Skills and Self-defense Training
#### Outcome Measure 2
**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.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Reporting Status:** POSTED
**Time Frame:** Change in assertiveness from baseline to post-class (8 weeks)
**Title:** Change in Assertiveness Between Baseline and Post-intervention
**Type:** SECONDARY
**Unit of Measure:** units on a scale
##### 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.
**ID:** OG000
**Title:** Life Skills and Self-defense Training
### Participant Flow Module
#### 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.
**ID:** FG000
**Title:** Life Skills and Self-defense Training
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Pregnancy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 9
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 8
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 1
**Has Results:** True