Effects of Early Abuse on Adult Intimate Relationships

Sponsor

University of Texas at Austin (Other)

Overall Status

Completed

CT.gov ID

NCT01803802

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

148

Enrollment

Location

Arms

112

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypoactive Sexual Desire Disorder Female Sexual Arousal Disorder Female Orgasmic Disorder Major Depressive Disorder Post-traumatic Stress Disorder	Behavioral: Expressive writing	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

148 participants

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effects of Early Abuse on Adult Intimate Relationships

Study Start Date :

Apr 1, 2005

Actual Primary Completion Date :

Aug 1, 2011

Actual Study Completion Date :

Aug 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Sexual Dysfunction Interview [6 months]
Clinical classification of Female Sexual Dysfunctions including Hypoactive Sexual Desire Disorder, Female Sexual Arousal Disorder, and/or Female Orgasm Disorder

Secondary Outcome Measures

Depression [6 months]
As measured by clinical interview and validated questionnaires
Post-Traumatic Stress [6 months]
As measured by clinical interview and validated questionnaires

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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