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RRT for PTSD Symptoms in Survivors of Sexual Violence

Primary Purpose

PTSD, Rape Sexual Assault

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Rapid Resolution Therapy
Sponsored by
University of Colorado, Denver
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PTSD focused on measuring PTSD, Psychotherapy, Rape

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Colorado at Denver counseling centerRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Rapid Resolution Therapy

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in The Clinician-Administered PTSD Scale (CAPS-5: Weathers et al, 2015)
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.
Change in PTSD Symptom Scale Self-Report- Civilian Version (PSS-SR: Foa et al, 1993)
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.
Change in Beck Depression Inventory (BDI): beck et al, 1988)
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.
Change in The State Trait Anxiety Inventory (STAI: Spielberger et al, 1970)
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.

Secondary Outcome Measures

Session Rating Scale (Miller et al 2002)
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
Outcome Rating Scale (ORS: Miller and Duncan, 2000)
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

Full Information

First Posted
August 19, 2019
Last Updated
April 21, 2022
Sponsor
University of Colorado, Denver
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1. Study Identification

Unique Protocol Identification Number
NCT04073004
Brief Title
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2020 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PTSD, Rape Sexual Assault
Keywords
PTSD, Psychotherapy, Rape

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rapid Resolution Therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Rapid Resolution Therapy
Intervention Description
psychotherapy that includes trance states
Primary Outcome Measure Information:
Title
Change in The Clinician-Administered PTSD Scale (CAPS-5: Weathers et al, 2015)
Description
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.
Time Frame
pre-intervention (one month version), one week post intervention (past week version) , 6 months post intervention (one month version)
Title
Change in PTSD Symptom Scale Self-Report- Civilian Version (PSS-SR: Foa et al, 1993)
Description
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.
Time Frame
screening, one week post-treatment, 6 month follow up
Title
Change in Beck Depression Inventory (BDI): beck et al, 1988)
Description
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.
Time Frame
pre-intervention, one week post intervention, 6 month follow up
Title
Change in The State Trait Anxiety Inventory (STAI: Spielberger et al, 1970)
Description
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.
Time Frame
Pre-intervention, one week follow up, 6 month follow up
Secondary Outcome Measure Information:
Title
Session Rating Scale (Miller et al 2002)
Description
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
Time Frame
one week post intervention
Title
Outcome Rating Scale (ORS: Miller and Duncan, 2000)
Description
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
Time Frame
One week post intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Hughes, RN
Phone
7197611466
Email
susanhughes.rrt@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sonja Hellman, PhD
Phone
7204701094
Email
sonja.hellman@ucdenver.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather Aberle, MA
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado at Denver counseling center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather Aberle, MA
Phone
303-315-7270
Email
heather.aberle@ucdenver.edu
First Name & Middle Initial & Last Name & Degree
Sonja Hellman, PhD
First Name & Middle Initial & Last Name & Degree
Suzanne Simon, MA
First Name & Middle Initial & Last Name & Degree
Elaina Swanson, MA

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
16382428
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.
Results Reference
background
Links:
URL
http://rapidresolutiontherapy.com
Description
cite describing RRT and link to members
URL
http://www.ptsd.va.gov/professional/assessment/adult-sr/ptsd-checklist.asp
Description
site describing PCL-C and updated version
URL
http://www.ptsd.va.gov/professional/assessment/adult-int/caps.asp
Description
Site describing CAPS-5
URL
http://pearsonclinical.in/solutions/beck-depression-inventory-ii-bdi-ii/
Description
Pearson Assessments site describing psychometric properties of the BDI-II
URL
http://www.scottdmiller.com/wp-content/uploads/documents/OutcomeRatingScale-JBTv2n2.pdf
Description
Journal report from Journal of Brief Therapy for reliability and validity of the ORS
URL
http://www.mindgarden.com/145-state-trait-anxiety-inventory-for-adults
Description
Publisher's description and psychometric properties of the State Trait Anxiety Inventory

Learn more about this trial

RRT for PTSD Symptoms in Survivors of Sexual Violence

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