- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04073004
RRT for PTSD Symptoms in Survivors of Sexual Violence
Rapid Resolution Therapy (RRT) for Post-traumatic Stress Disorder (PTSD) Symptoms in Survivors of Sexual Violence
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
Denver, Colorado, United States, 80210
- University of Colorado at Denver counseling center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Rapid Resolution Therapy
RRT is a talk therapy that uses Neurolinguistic Programming Language and trance states to cause a shift in how the mind is processing incoming data. The understanding is that the part of the mind that is causing the disturbing emotion, thought or sensation is causing them to cause the person to take an action to ensure the organisms survival. RRT therapists employ psycho-therapeutic techniques taht are designed to cause the mind to process information differently so that the disturbing content and distorted meaning shift. |
psychotherapy that includes trance states
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in The Clinician-Administered PTSD Scale (CAPS-5: Weathers et al, 2015)
Time Frame: pre-intervention (one month version), one week post intervention (past week version) , 6 months post intervention (one month version)
|
The CAPS-5 is a 30-item structured interview that can be used to make current (past month) diagnosis of PTSD, make lifetime diagnosis of PTSD and assess PTSD symptoms over the past week In addition to assessing the 20 Diagnostic and Statistics Manual- 5th Edition (DSM-5) PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization). The scale measures 1) severity of PTSD symptoms 2) severity of PTSD clusters and 3) PTSD Diagnostic status. |
pre-intervention (one month version), one week post intervention (past week version) , 6 months post intervention (one month version)
|
|
Change in PTSD Symptom Scale Self-Report- Civilian Version (PSS-SR: Foa et al, 1993)
Time Frame: screening, one week post-treatment, 6 month follow up
|
A 17 item self-report measure that corresponds to the 17 DSM-IV PTSD symptoms. Items are rated 0 (not present) to 3 (very much). Responses create three subscales, including re-experiencing, avoidance, and arousal, as well as a total score that ranges from 0 to 51. Score above 13 indicate a presence of PTSD. we expect to see scores decrease post-treatment and to stay lower than baseline at 6 month follow up. |
screening, one week post-treatment, 6 month follow up
|
|
Change in Beck Depression Inventory (BDI): beck et al, 1988)
Time Frame: pre-intervention, one week post intervention, 6 month follow up
|
The BDI is a 21 item self-report questionnaire widely used in research on depression to evaluate cognitive and vegetative symptoms of depression. The inventory includes 21 items rated from 0 to 3, with 0 being absence of symptoms and 3 being extreme symptoms. A score between 1 and 16 indicates a low level of mood disturbance, 17-30 indicates Moderate depression, and 31 and up indicates severe or extreme depression. We are looking for a decrease in scores with treatment, and lower than baseline score at 6 month follow up. |
pre-intervention, one week post intervention, 6 month follow up
|
|
Change in The State Trait Anxiety Inventory (STAI: Spielberger et al, 1970)
Time Frame: Pre-intervention, one week follow up, 6 month follow up
|
STAI is a 40-item self-report measure with two scales designed to assess state anxiety and trait anxiety. Items are score on a 4-point Likert scale, with 4 being most severe. 20 items measure state anxiety and 20 measure state anxiety. Scores on each scale range from 20-80, with lower scores indicating more mild anxiety and higher scores indicating clinical anxiety. We are looking for scores to go down with treatment and remain lower than baseline at 6 month follow up. |
Pre-intervention, one week follow up, 6 month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Session Rating Scale (Miller et al 2002)
Time Frame: one week post intervention
|
A 4-item continual scale measure that asks the client to report on his or her experience of the session: relationship, goals and topics, approach or method and overall from negative to positive.
The rater uses a ruler to divide the scale into 10 intervals and gives the score that matches the position on a line between positive and negative
|
one week post intervention
|
|
Outcome Rating Scale (ORS: Miller and Duncan, 2000)
Time Frame: One week post intervention
|
A 4-item continual scale measure that asks the client to report on his or her subjective experience of how s/he is feeling individually, interpersonally, socially, and overall.
The rater uses a ruler to divide the scale into 10 intervals and gives the score that matches the position on a line between positive and negative
|
One week post intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Heather Aberle, MA, University of Colorado, Denver
Publications and helpful links
Helpful Links
- cite describing RRT and link to members
- site describing PCL-C and updated version
- Site describing CAPS-5
- Pearson Assessments site describing psychometric properties of the BDI-II
- Journal report from Journal of Brief Therapy for reliability and validity of the ORS
- Publisher's description and psychometric properties of the State Trait Anxiety Inventory
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-1453
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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