Back to resultsEffects of Early Abuse on Adult Intimate Relationships
Primary Purpose
Hypoactive Sexual Desire Disorder, Female Sexual Arousal Disorder, Female Orgasmic Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Expressive writing
Sponsored by
About this trial
This is an interventional treatment trial for Hypoactive Sexual Desire Disorder focused on measuring childhood sexual abuse, depression, PTSD, sexual function, women
Eligibility Criteria
Inclusion Criteria:
- at least one involuntary sexual experience, defined as "unwanted oral, anal, or vaginal intercourse, penetration of the vagina or anus using objects or digits, or genital touching or fondling," before age 16 and no less than 2 years prior to enrollment.
- currently sexually active or cohabiting in a potentially sexual relationship.
- current sexual dysfunction, distress, or low sexual satisfaction
Exclusion Criteria:
- traumatic event in the previous three months
- sexual abuse in the past two years
- diagnosis of a psychotic disorder in the previous six months
- significant suicidal or homicidal intent
- currently receiving psychotherapy for sexual or abuse-related concerns
- use of illicit drugs
- in a currently abusive relationship
Sites / Locations
- University of Texas at Austin
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Active Comparator
Arm Label
Time management
Sexual schema writing
Trauma writing
Arm Description
Writing prompts oriented towards objective recounting of previous day
Expressive writing prompts oriented towards beliefs about sexuality
Expressive writing prompts oriented towards processing traumatic experiences
Outcomes
Primary Outcome Measures
Sexual Dysfunction Interview
Clinical classification of Female Sexual Dysfunctions including Hypoactive Sexual Desire Disorder, Female Sexual Arousal Disorder, and/or Female Orgasm Disorder
Secondary Outcome Measures
Depression
As measured by clinical interview and validated questionnaires
Post-Traumatic Stress
As measured by clinical interview and validated questionnaires
Full Information
NCT ID
NCT01803802
First Posted
February 25, 2013
Last Updated
December 1, 2014
Sponsor
University of Texas at Austin
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1. Study Identification
Unique Protocol Identification Number
NCT01803802
Brief Title
Effects of Early Abuse on Adult Intimate Relationships
Official Title
Effects of Early Abuse on Adult Intimate Relationships
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas at Austin
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is designed to help us better understand the factors that affect the sexual lives of women who have been sexually mistreated during childhood. With this study we hope to learn about factors that may be promising targets for future treatments of sexual problems related to past sexual experiences. The investigators hypothesize that women who have experienced early sexual abuse are more likely to have sexual problems in adulthood than women who were not abuse in childhood.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoactive Sexual Desire Disorder, Female Sexual Arousal Disorder, Female Orgasmic Disorder, Major Depressive Disorder, Post-traumatic Stress Disorder
Keywords
childhood sexual abuse, depression, PTSD, sexual function, women
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Time management
Arm Type
Placebo Comparator
Arm Description
Writing prompts oriented towards objective recounting of previous day
Arm Title
Sexual schema writing
Arm Type
Experimental
Arm Description
Expressive writing prompts oriented towards beliefs about sexuality
Arm Title
Trauma writing
Arm Type
Active Comparator
Arm Description
Expressive writing prompts oriented towards processing traumatic experiences
Intervention Type
Behavioral
Intervention Name(s)
Expressive writing
Intervention Description
Five sessions of 30 minutes of expressive writing
Primary Outcome Measure Information:
Title
Sexual Dysfunction Interview
Description
Clinical classification of Female Sexual Dysfunctions including Hypoactive Sexual Desire Disorder, Female Sexual Arousal Disorder, and/or Female Orgasm Disorder
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Depression
Description
As measured by clinical interview and validated questionnaires
Time Frame
6 months
Title
Post-Traumatic Stress
Description
As measured by clinical interview and validated questionnaires
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
at least one involuntary sexual experience, defined as "unwanted oral, anal, or vaginal intercourse, penetration of the vagina or anus using objects or digits, or genital touching or fondling," before age 16 and no less than 2 years prior to enrollment.
currently sexually active or cohabiting in a potentially sexual relationship.
current sexual dysfunction, distress, or low sexual satisfaction
Exclusion Criteria:
traumatic event in the previous three months
sexual abuse in the past two years
diagnosis of a psychotic disorder in the previous six months
significant suicidal or homicidal intent
currently receiving psychotherapy for sexual or abuse-related concerns
use of illicit drugs
in a currently abusive relationship
Facility Information:
Facility Name
University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23875721
Citation
Meston CM, Lorenz TA, Stephenson KR. Effects of expressive writing on sexual dysfunction, depression, and PTSD in women with a history of childhood sexual abuse: results from a randomized clinical trial. J Sex Med. 2013 Sep;10(9):2177-89. doi: 10.1111/jsm.12247. Epub 2013 Jul 22.
Results Reference
derived
Links:
URL
http://mestonlab.com
Description
Link to laboratory website
Learn more about this trial
Effects of Early Abuse on Adult Intimate Relationships
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