Hypoactive Sexual Desire DisorderNCT01803802
Effects of Early Abuse on Adult Intimate Relationships
A study testing Expressive writing in people with Hypoactive Sexual Desire Disorder and Female Sexual Arousal Disorder, run by University of Texas at Austin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoactive Sexual Desire Disorder, Female Sexual Arousal Disorder, Female Orgasmic Disorder
- What is being tested?
- Expressive writing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 148 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Aug 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Hypoactive Sexual Desire Disorder, Female Sexual Arousal Disorder, Female Orgasmic Disorder, Major Depressive Disorder, Post-traumatic Stress Disorder
- Being tested
- Expressive writing
- Keywords
- childhood sexual abuse, depression, PTSD, sexual function, women
- Medical subject headings
- Sexual Dysfunctions, Psychological, Depressive Disorder, Major, Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive writingBehavioural
Five sessions of 30 minutes of expressive writing
| Study group | Role | What they receive |
|---|---|---|
| Time management | Placebo comparator | Writing prompts oriented towards objective recounting of previous day Receives: Behavioral: Expressive writing |
| Sexual schema writing | Experimental | Expressive writing prompts oriented towards beliefs about sexuality Receives: Behavioral: Expressive writing |
| Trauma writing | Active comparator | Expressive writing prompts oriented towards processing traumatic experiences Receives: Behavioral: Expressive writing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sexual Dysfunction Interview
Clinical classification of Female Sexual Dysfunctions including Hypoactive Sexual Desire Disorder, Female Sexual Arousal Disorder, and/or Female Orgasm Disorder
Measured: 6 months
Secondary outcomes (2)
Depression
As measured by clinical interview and validated questionnaires
Measured: 6 months
Post-Traumatic Stress
As measured by clinical interview and validated questionnaires
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startApr 2005
- Primary completionAug 2011
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypoactive Sexual Desire DisorderStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Tierney Kyle Ahrold Lorenz, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803802
- Sponsor's protocol ID
- 1R01HD051676
- Other IDs
- R01HD051676
- Status last verified
- Dec 2014
- First submitted
- 25 Feb 2013
- Last updated
- 2 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23875721
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Early Abuse on Adult Intimate Relationships
- ClinicalTrials.gov ID
- NCT01803802
- Acronym / sponsor ID
- 1R01HD051676
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- Apr 2005
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 4 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Time management | Placebo comparator | Behavioral: Expressive writingWriting prompts oriented towards objective recounting of previous day |
| Sexual schema writing | Experimental | Behavioral: Expressive writingExpressive writing prompts oriented towards beliefs about sexuality |
| Trauma writing | Active comparator | Behavioral: Expressive writingExpressive writing prompts oriented towards processing traumatic experiences |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expressive writingFive sessions of 30 minutes of expressive writing | Behavioural | Sexual schema writing, Time management, Trauma writing |
Primary outcome
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
2 secondary outcomes
Depression
Time frame: 6 months
Post-Traumatic Stress
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2014.
- Derived from this study: PubMed 23875721Meston 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.
- Link to laboratory websiteLink provided by the sponsor.
Related trials for Hypoactive Sexual Desire Disorder
Not yet recruitingPhase 1/2
BRE-06: Study to Increase Tolerance to Aromatase Inhibitors for Patients With Early-Stage Hormone Receptor Positive Breast Cancer Who Developed Hypoactive Sexual Desire Disorder
Early-stage Breast Cancer, Hypoactive Sexual Desire Disorder
Not yet recruitingPhase 2
An Open-Label Study of 50 Mg Oral Testosterone Undecanoate (Kyztrex) in Menopausal Women with Low Testosterone and HSDD
Hypoactive Sexual Desire Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Expressive writing in people with Hypoactive Sexual Desire Disorder and Female Sexual Arousal Disorder, run by University of Texas at Austin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sexual Dysfunction Interview (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01803802, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2014.