Effects of Early Abuse on Adult Intimate Relationships

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Tierney Kyle Ahrold Lorenz, University of Texas at Austin
ClinicalTrials.gov Identifier:
NCT01803802
First received: February 25, 2013
Last updated: February 28, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Hypoactive Sexual Desire Disorder
Female Sexual Arousal Disorder
Female Orgasmic Disorder
Major Depressive Disorder
Post-traumatic Stress Disorder
Behavioral: Expressive writing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Early Abuse on Adult Intimate Relationships

Further study details as provided by University of Texas at Austin:

Primary Outcome Measures:
  • Sexual Dysfunction Interview [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Clinical classification of Female Sexual Dysfunctions including Hypoactive Sexual Desire Disorder, Female Sexual Arousal Disorder, and/or Female Orgasm Disorder


Secondary Outcome Measures:
  • Depression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    As measured by clinical interview and validated questionnaires

  • Post-Traumatic Stress [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    As measured by clinical interview and validated questionnaires


Estimated Enrollment: 300
Study Start Date: April 2005
Estimated Study Completion Date: August 2015
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Time management
Writing prompts oriented towards objective recounting of previous day
Behavioral: Expressive writing
Five sessions of 30 minutes of expressive writing
Experimental: Sexual schema writing
Expressive writing prompts oriented towards beliefs about sexuality
Behavioral: Expressive writing
Five sessions of 30 minutes of expressive writing
Active Comparator: Trauma writing
Expressive writing prompts oriented towards processing traumatic experiences
Behavioral: Expressive writing
Five sessions of 30 minutes of expressive writing

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803802

Locations
United States, Texas
University of Texas at Austin
Austin, Texas, United States, 78712
Sponsors and Collaborators
University of Texas at Austin
  More Information

Additional Information:
No publications provided by University of Texas at Austin

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tierney Kyle Ahrold Lorenz, Study Coordinator, University of Texas at Austin
ClinicalTrials.gov Identifier: NCT01803802     History of Changes
Other Study ID Numbers: 1 RO1 HD051676, R01HD051676
Study First Received: February 25, 2013
Last Updated: February 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Texas at Austin:
childhood sexual abuse
depression
PTSD
sexual function
women

Additional relevant MeSH terms:
Disease
Depressive Disorder
Depression
Stress Disorders, Traumatic
Depressive Disorder, Major
Stress Disorders, Post-Traumatic
Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Anxiety Disorders
Sexual and Gender Disorders
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 18, 2014