Clinical trial NCT04073004: RRT for PTSD Symptoms in Survivors of Sexual Violence
Official title: Rapid Resolution Therapy (RRT) for Post-traumatic Stress Disorder (PTSD) Symptoms in Survivors of Sexual Violence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PTSD
Rape Sexual Assault
Keywords: PTSD
Psychotherapy
Rape
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: all participants will receive the same treatment. The investigators will compare their results to data reported by Rothbaum et al (2005) which includes 2 treatment groups and a control group.
Primary purpose: TREATMENT

Brief summary: Study to provide evidence of efficacy for Rapid Resolution Therapy in symptoms of PTSD, Anxiety, and Depression in survivors of sexual violence.

Detailed description: The investigators will recruit 24 participants to complete pre-test measures, participate in a 3 hour therapy session of Rapid Resolution Therapy (RRT), and then re-test one week post treatment and 6 months follow up.

If participants do not report a "good result" following the 3 hour session, the investigators will offer a 1.5 hour follow up session Participants will receive free therapy for their participation, but will not be paid.

Participants will be men and women over the age of 18 who do not have a diagnosis of psychosis and are not actively suicidal and have experienced a single rape at least 3 months before enrolling in the study.

Sessions will be audio recorded and transcribed for construct validity (of RRT). Identifying in formation will be removed by the study coordinator before transcripts are coded for validity.

This study proposes to use the same methods as Rothbaum et al (2005) published in Journal of Traumatic Stress that compares Prolonged Exposure to Eye Movement and Desensitization and Reprocessing (EMDR) for PTSD Rape Victims. The investigators will compare our results to theirs. Both of their treatments were 8 sessions, and this study's treatment is one. They also include data for a control group.

Eligibility criteria: Inclusion Criteria:

* 18-70 years old
* self report experiencing a rape any time before 3 months prior to treatment
* on PCL-C (Positive for PTSD)

  * score 3-5 on at least one item 1-5
  * score 3-5 on at least 3 items 6-12
  * score 3-5 on at least 2 items 13-17

Exclusion Criteria:

* history of schizophrenia or psychosis current
* suicidal risk
* in an ongoing threatening situation (i.e. domestic violence)
* participants who are pregnant or become pregnant during the study (if someone becomes pregnant during the study, we will complete treatment if she desires, but will not include data)

Primary outcomes:
measure: Change in The Clinician-Administered PTSD Scale (CAPS-5: Weathers et al, 2015)
timeFrame: pre-intervention (one month version), one week post intervention (past week version) , 6 months post intervention (one month version)
measure: Change in PTSD Symptom Scale Self-Report- Civilian Version (PSS-SR: Foa et al, 1993)
timeFrame: screening, one week post-treatment, 6 month follow up
measure: Change in Beck Depression Inventory (BDI): beck et al, 1988)
timeFrame: pre-intervention, one week post intervention, 6 month follow up
measure: Change in The State Trait Anxiety Inventory (STAI: Spielberger et al, 1970)
timeFrame: Pre-intervention, one week follow up, 6 month follow up
Secondary outcomes:
measure: Session Rating Scale (Miller et al 2002)
timeFrame: one week post intervention
measure: Outcome Rating Scale (ORS: Miller and Duncan, 2000)
timeFrame: One week post intervention
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado at Denver counseling center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Heather Aberle, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rothbaum BO, Astin MC, Marsteller F. Prolonged Exposure versus Eye Movement Desensitization and Reprocessing (EMDR) for PTSD rape victims. J Trauma Stress. 2005 Dec;18(6):607-16. doi: 10.1002/jts.20069.