Sexual Health on Antidepressants Through Physical Exercise (SHAPE)

Preliminary findings from a trial in the investigators laboratory suggest that acute exercise may ameliorate deficits in sexual arousal associated with use of antidepressants. The goal of this project is to evaluate the real-world effectiveness of an exercise-based intervention for these side effects in a community-based sample. The investigators hypothesize that general exercise will help improve sexual functioning in women taking antidepressants, and that exercise immediately before sexual activity - that is, acute exercise - will have an additional beneficial effect above and beyond that of general exercise.

Study Overview

• Status: Completed
• Conditions: Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological
• Intervention / Treatment: Behavioral: Physical activity

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78712
      • University of Texas at Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• female
• age 18 or older
• currently receiving a consistent dosage of escitalopram, citalopram, sertraline, desvenlafaxine, venlafaxine, or duloxetine
• currently sexually active
• willing and able to exercise
• experiencing regular menstrual cycles
• not currently pregnant and not intending to become pregnant during trial

Exclusion Criteria:

• currently taking more than one psychoactive medication
• factors indicating risk of cardiovascular activity, including acute or chronic cardiovascular illness, including clinically significant hypertension (defined as self-reported hypertension or "blood pressure greater than 140/90" or receiving medications designed to treat hypertension); recent chest pain; frequent or recurrent faint or dizzy spells; severe or untreated exercise-related asthma; or musculoskeletal illness or injury that would be expected to worsen with physical exercise. Additionally, women will be excluded if they are found to have any of the following as measured during the fitness assessment of the first session: a BMI over 40, waist circumference over 40 inches, waist-to-hip ratio of greater than 0.9, systolic blood pressure greater than 150 or diastolic pressure over 95, or resting heart rate over 90.
• factors associated with significant genital nerve damage, including: previous major pelvic surgery that may have caused nerve damage, including hysterectomy, vulvectomy, circumcision, colostomy, cystostomy, or serious bladder, rectal, or abdominal surgery; or neurological impairment due to diabetes, stroke, pelvic nerve damage secondary to trauma, cancer treatments, myasthenia gravis, multiple sclerosis or spinal cord damage.
• factors associated with non-normative endocrine function, including: perimenopausal or menopausal status, or >1 missed menstrual period in the previous 6 months; or currently pregnant, breastfeeding, or having breastfed within the past 3 months; or reporting clinically significant untreated renal or endocrine disease
• untreated serious mental health conditions
• sexual aversion or distress due to history of unwanted sexual contact

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Baseline; Assessment only baseline
Experimental: Acute exercise; Exercise immediately before sexual activity, three times per week.	Behavioral: Physical activity; 30 minutes of moderate to intense physical activity including strength training and cardiovascular activity.
Active Comparator: General exercise; Exercise not immediately before sexual activity, three times per week.	Behavioral: Physical activity; 30 minutes of moderate to intense physical activity including strength training and cardiovascular activity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual Functioning	Sexual functioning as measured by the Female Sexual Functioning Index	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual satisfaction	Sexual satisfaction as measured by self-report measure completed weekly throughout the trial	Baseline (0 weeks), 1 week, 2 weeks, 3 weeks, 4 weeks, 5 weeks, 6 weeks, 7 weeks, 8 weeks, 9 weeks
Sexual Functioning	Sexual functioning as measured by the Female Sexual Functioning Index will be measured in between each arm of the trial.	3 weeks, 6 weeks, 9 weeks

Collaborators and Investigators

• Sponsor: University of Texas at Austin
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Tierney K Lorenz, M.A., University of Texas at Austin

Publications and helpful links

Helpful Links

• Laboratory webpage

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: August 20, 2010
• First Submitted That Met QC Criteria: August 24, 2010
• First Posted (Estimate): August 25, 2010

Study Record Updates

• Last Update Posted (Estimate): May 27, 2015
• Last Update Submitted That Met QC Criteria: May 26, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological
• Other Study ID Numbers: 2010-07-0043; F31MH085416 (U.S. NIH Grant/Contract)