NCT01380379

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Apr 2011

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2011

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

February 1, 2017

Completed
Last Updated

February 1, 2017

Status Verified

December 1, 2016

Enrollment Period

2.3 years

First QC Date

May 18, 2011

Results QC Date

October 11, 2016

Last Update Submit

December 7, 2016

Conditions

Keywords

physical violencesexual violence

Outcome Measures

Primary Outcomes (1)

  • Change in Self-efficacy From Baseline to Post-treatment

    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.

    Change in GSE from baseline to 8 weeks

Secondary Outcomes (1)

  • Change in Assertiveness Between Baseline and Post-intervention

    Change in assertiveness from baseline to post-class (8 weeks)

Study Arms (1)

Life skills and self-defense training

EXPERIMENTAL

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

Behavioral: Life skills and self-defense training

Interventions

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.

Life skills and self-defense training

Eligibility Criteria

Age21 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women ages 21-65 years
  • History of physical and/or sexual violence, with subsequent interpersonal or psychological distress (e.g., depression or anxiety) related to this history.

You may not qualify if:

  • Substance abuse in the past 6 months
  • Significant medical conditions that would preclude safe participation in the study
  • High levels of depression with significant suicide risk
  • Pregnant women
  • Active symptoms of psychosis or psychiatric instability
  • History of assaultive behavior or is judged to be at potential risk to assault others.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersStress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersStress Disorders, TraumaticTrauma and Stressor Related Disorders

Results Point of Contact

Title
Dr. Jennifer Keller
Organization
Stanford University

Study Officials

  • Jennifer Keller

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scholar

Study Record Dates

First Submitted

May 18, 2011

First Posted

June 27, 2011

Study Start

April 1, 2011

Primary Completion

August 1, 2013

Study Completion

November 1, 2015

Last Updated

February 1, 2017

Results First Posted

February 1, 2017

Record last verified: 2016-12

Locations