- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01803802
Effects of Early Abuse on Adult Intimate Relationships
December 1, 2014 updated by: Tierney Kyle Ahrold Lorenz, University of Texas at Austin
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
148
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78712
- University of Texas at Austin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Time management
Writing prompts oriented towards objective recounting of previous day
|
Five sessions of 30 minutes of expressive writing
|
Experimental: Sexual schema writing
Expressive writing prompts oriented towards beliefs about sexuality
|
Five sessions of 30 minutes of expressive writing
|
Active Comparator: Trauma writing
Expressive writing prompts oriented towards processing traumatic experiences
|
Five sessions of 30 minutes of expressive writing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sexual Dysfunction Interview
Time Frame: 6 months
|
Clinical classification of Female Sexual Dysfunctions including Hypoactive Sexual Desire Disorder, Female Sexual Arousal Disorder, and/or Female Orgasm Disorder
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression
Time Frame: 6 months
|
As measured by clinical interview and validated questionnaires
|
6 months
|
Post-Traumatic Stress
Time Frame: 6 months
|
As measured by clinical interview and validated questionnaires
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (Actual)
August 1, 2011
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
February 25, 2013
First Submitted That Met QC Criteria
February 28, 2013
First Posted (Estimate)
March 4, 2013
Study Record Updates
Last Update Posted (Estimate)
December 2, 2014
Last Update Submitted That Met QC Criteria
December 1, 2014
Last Verified
December 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R01HD051676 (U.S. NIH Grant/Contract)
- R01HD051676 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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