NCT04073004

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 19, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

November 15, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

2.6 years

First QC Date

August 19, 2019

Last Update Submit

March 27, 2025

Conditions

Keywords

PTSDPsychotherapyRape

Outcome Measures

Primary Outcomes (4)

  • 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.

    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)

    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)

    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)

    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 Outcomes (2)

  • Session Rating Scale (Miller et al 2002)

    one week post intervention

  • Outcome Rating Scale (ORS: Miller and Duncan, 2000)

    One week post intervention

Study Arms (1)

Rapid Resolution Therapy

EXPERIMENTAL

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.

Behavioral: Rapid Resolution Therapy

Interventions

psychotherapy that includes trance states

Rapid Resolution Therapy

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado at Denver counseling center

Denver, Colorado, 80210, United States

Location

Related Publications (1)

  • 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.

    PMID: 16382428BACKGROUND

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Heather Aberle, MA

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2019

First Posted

August 28, 2019

Study Start

November 15, 2020

Primary Completion

June 30, 2023

Study Completion

June 30, 2023

Last Updated

April 2, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations