Skip to main content
OpenTrials
Completed

NCT Number: NCT04073004

RRT for PTSD Symptoms in Survivors of Sexual Violence

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

PTSD Mental Disorders Rape Sexual Assault Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado at Denver counseling center

Denver, Colorado, 80210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Rapid Resolution Therapy

Behavioral

psychotherapy that includes trance states

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

Rapid Resolution Therapy (RRT) for Post-traumatic Stress Disorder (PTSD) Symptoms in Survivors of Sexual Violence

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Aug 28, 2019
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.