Stress Disorders, Post-Traumatic Clinical Trial
— THRIVEVerified date | March 2018 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Brief Summary: The specific aims of this study are:
1. To test, in a two-arm randomized controlled trial, the efficacy of cognitive processing
therapy for sexual risk and posttraumatic symptom severity reduction (CPT-SR) in
HIV-uninfected men who have sex with men (MSM) who have histories of childhood sexual
abuse (CSA). The primary outcome is reduction in unprotected anal/vaginal intercourse
(number and proportion) with serodiscordant partners. The investigators will also
examine the intervention effect on CSA-related trauma symptom severity and cognitions
and behaviors.
2. To examine the degree to which intervention-related reductions in sexual risk behavior
are mediated by reductions in CSA-related symptom severity, cognitions, and behaviors.
3. To examine the degree to which the intervention reduces incident sexually transmitted
infections (STIs) during the study period, as well as to explore additional potential
moderators and mediators of intervention efficacy.
Study hypotheses:
1. For the primary outcome, the investigators hypothesize that those who receive the
intervention will have reduced transmission-risk behavior.
2. For the secondary outcome, the investigators hypothesize that those who receive the
intervention will have reduced trauma symptom severity (cognitions and behaviors).
Status | Completed |
Enrollment | 232 |
Est. completion date | May 2017 |
Est. primary completion date | May 2017 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Eligibility Criteria: Inclusion Criteria: - Identifies as MSM. - Reports history of CSA (sexual contact before the age of 13 with an adult or person 5 years older or sexual contact with the threat of force or harm between the ages of 13 and 16 inclusive or with a person 10 years older). - Reports >1 episode of unprotected anal or vaginal intercourse within the past three months. - Reports HIV-negative status confirmed by rapid HIV test. - Is capable of completing and fully understanding the informed consent process and the study procedures. Exclusion Criteria: - All episodes of unprotected anal or vaginal intercourse occurred with only a single, primary HIV-negative partner. - Significant mental health diagnosis requiring immediate treatment (e.g. bipolar disorder; any psychotic disorder). - Inability to complete informed consent process (e.g. substantial cognitive impairment, inadequate English language skills). - Has received CPT for PTSD within the past 12 months. |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | The Fenway Institute | Boston | Massachusetts |
United States | University of Miami | Coral Gables | Florida |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Fenway Community Health, University of Miami |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes from Baseline in Sexual Risk Behavior for HIV Acquisition | Number of unprotected (no condom was used) insertive or receptive anal or vaginal intercourse acts reported in the past 3 months with casual partners or with partners with unknown or positive HIV status. | Baseline, (2 weeks post-baseline pre-randomization), 3,6, 9, and 12 month follow ups | |
Secondary | Changes from Baseline in Trauma Symptom Severity | Davidson Trauma Scale which has been correlated with measures of Post-Traumatic Stress Disorder (PTSD) severity, depression, and general anxiety, and discriminated well between traumatized individuals with and without PTSD. | Baseline assessment, 3, 6, and 9-month follow-up assessments |
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