NCT01803802

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2005

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2013

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

December 2, 2014

Status Verified

December 1, 2014

Enrollment Period

6.3 years

First QC Date

February 25, 2013

Last Update Submit

December 1, 2014

Conditions

Hypoactive Sexual Desire DisorderFemale Sexual Arousal DisorderFemale Orgasmic DisorderMajor Depressive DisorderPost-traumatic Stress Disorder

Keywords

childhood sexual abusedepressionPTSDsexual functionwomen

Outcome Measures

Primary Outcomes (1)

  • Sexual Dysfunction Interview

    Clinical classification of Female Sexual Dysfunctions including Hypoactive Sexual Desire Disorder, Female Sexual Arousal Disorder, and/or Female Orgasm Disorder

    6 months

Secondary Outcomes (2)

  • Depression

    6 months

  • Post-Traumatic Stress

    6 months

Study Arms (3)

Time management

PLACEBO COMPARATOR

Writing prompts oriented towards objective recounting of previous day

Behavioral: Expressive writing

Sexual schema writing

EXPERIMENTAL

Expressive writing prompts oriented towards beliefs about sexuality

Behavioral: Expressive writing

Trauma writing

ACTIVE COMPARATOR

Expressive writing prompts oriented towards processing traumatic experiences

Behavioral: Expressive writing

Interventions

Expressive writingBEHAVIORAL

Five sessions of 30 minutes of expressive writing

Sexual schema writingTime managementTrauma writing

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (1)

  • 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.

    PMID: 23875721DERIVED

Related Links

MeSH Terms

Conditions

Sexual Dysfunctions, PsychologicalDepressive Disorder, MajorStress Disorders, Post-TraumaticDepression

Condition Hierarchy (Ancestors)

Mental DisordersDepressive DisorderMood DisordersStress Disorders, TraumaticTrauma and Stressor Related DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Coordinator

Study Record Dates

First Submitted

February 25, 2013

First Posted

March 4, 2013

Study Start

April 1, 2005

Primary Completion

August 1, 2011

Study Completion

August 1, 2014

Last Updated

December 2, 2014

Record last verified: 2014-12

Locations

US(1)