Sexual Dysfunction Clinical Trial
— AWAREOfficial title:
Reducing Alcohol Use and Sexual Dysfunction in Survivors of Sexual Trauma
The goal of this clinical trial is to develop and evaluate the preliminary efficacy of an intervention to address alcohol use, sexual distress, and sexual assault risk among college women with a history of sexual victimization. The main questions it aims to answer are: 1) what is the feasibility of the recruitment method, research design, interventionist training methods, and delivery of the intervention; 2) does the intervention, relatively to control, the 2- and 6-month follow-up produces reductions in the quantity/frequency of alcohol use and heavy drinking, sexual distress, and sex-related drinking motives, and sexual revictimization. Participants will engage in both individual and group based intervention for alcohol use, sexual distress, and sexual assault risk. Follow-up assessments are completed at 2- and 6-months following program completion. The intervention will be compared to a general health promotion control group.
Status | Recruiting |
Enrollment | 90 |
Est. completion date | April 30, 2026 |
Est. primary completion date | April 30, 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 24 Years |
Eligibility | Inclusion Criteria: 1. be between the ages of 18 and 24; 2. speak and comprehend English; 3. report a history of attempted or completed penetrative acts of sexual victimization (i.e., oral, vaginal, anal) since age 14 via incapacitation or force; 4. report exceeding the national recommended limits for daily drinking (4 or more for women) on two or more occasions in the past month; 5. report past month sexual activity; 6. exceed the clinical cut point on the Female Sexual Functioning Index. Exclusion Criteria: 1. suicide risk on the Beck Depression Inventory; 2. screen positive on the Alcohol Use Withdrawal Checklist. |
Country | Name | City | State |
---|---|---|---|
United States | Rhode Island Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Lifespan |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alcohol Use | The number of past month drinking days (Minmum = 0, Maximum = 30), average drinks per drinking day (Minmum = 0, Maximum = unspecificed), number of heavy drinking days (Minimum = 0, Maximum = 30), assessed via the Time Line Follow Back, with greater scores meaning worse outcomes. | Change from baseline alcohol use at 6 months. | |
Primary | Sexual Distress | Assessed via the Female Sexual Dysfunction Index, Minumum = 2, Maximum = 36 with higher scores meaning worse outcomes. | Change from overall levels of sexual dysfunction at 6 months. | |
Primary | Sexual Victimization | Assessed via the Sexual Experiences Survey. Scored based on frequency and severity, Minumum = 0, Maximum = 63, higher scores means worse outcomes. | Reductions in severity and frequency of victimization in comparison to control at 6 months. | |
Secondary | Sex-Related Drinking Motives | Assessed via 2 subscales of the Drinking Motives Questionnaire, Minimum = 8, Maximum | Change in sexual related drinking motives at 6 months. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05039775 -
Clitoral Therapy Device in Alleviating Sexual Dysfunction After Genital Mutilation.
|
N/A | |
Recruiting |
NCT05380856 -
Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction
|
N/A | |
Not yet recruiting |
NCT05918770 -
Side Effects Screening and Early Intervention to Impact in Quality of Life of Gynaecological Cancer Patients
|
N/A | |
Completed |
NCT02096783 -
Scripted Sexual Health Informational Intervention in Improving Sexual Function in Patients With Gynecologic Cancer
|
N/A | |
Completed |
NCT02430987 -
Low Sexual Desire and Metabolic Syndrome
|
N/A | |
Completed |
NCT02837796 -
Effects of Trans-Obturator Tape outside-in Versus Inside-out Procedure for Stres Urinary Incontinence
|
N/A | |
Completed |
NCT01660152 -
Vacuum Erection Device in Improving Recovery of Erectile Function in Patients With Prostate Cancer Undergoing Surgery
|
N/A | |
Completed |
NCT01434290 -
Radiation Therapy in Treating Patients With Prostate Cancer
|
Phase 2 | |
Active, not recruiting |
NCT00981305 -
Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors
|
Phase 3 | |
Completed |
NCT04964895 -
Sexual Quality of Patients After Bladder Cancer Cystectomy
|
N/A | |
Enrolling by invitation |
NCT05832268 -
Pelvic Floor Function After Obstetric Injury to the Anal Sphincter
|
||
Completed |
NCT04066218 -
Sexual Function Screening in Childhood Cancer Survivors
|
||
Not yet recruiting |
NCT05530681 -
Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth
|
N/A | |
Recruiting |
NCT05826691 -
Benign Prostate Surgery and QOL and Sexual Function
|
||
Completed |
NCT04560283 -
HYDEAL-D® Application for Promoting the Restoration of Sexual Function in the Postpartum Period
|
Phase 4 | |
Completed |
NCT03232801 -
A Mindfulness-based Intervention for Older Women With Low Sexual Desire
|
N/A | |
Suspended |
NCT04544735 -
Improving Women's Function After Pelvic Radiation
|
N/A | |
Completed |
NCT05732844 -
Efficacy of the Use of Vaginal Balls for the Improvement of Urinary Incontinence and Sexual Function in Women.
|
N/A | |
Recruiting |
NCT05097469 -
Carbon Dioxide Acupulse Laser Treatment Versus Sham Treatment and Sexual Dysfunction.
|
N/A | |
Withdrawn |
NCT01635543 -
Investigation of Sexual Function in Crohn's Disease Patients With Perianal Fistulas
|
N/A |