RRT for PTSD Symptoms in Survivors of Sexual Violence

PTSD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04073004
• Other study ID #: 19-1453
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2020
• Est. completion date: December 2022

Study information

• Verified date: April 2022
• Source: University of Colorado, Denver
• Contact: Susan Hughes, RN
• Phone: 7197611466
• Email: susanhughes.rrt[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• PTSD
• Rape Sexual Assault
• Stress Disorders, Post-Traumatic

Intervention

Behavioral:
• Rapid Resolution Therapy
psychotherapy that includes trance states

Locations

Country	Name	City	State
United States	University of Colorado at Denver counseling center	Denver	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
University of Colorado, Denver

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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
Primary	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	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	one week post intervention
Secondary	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	One week post intervention

External Links

•   cite describing RRT and link to members
•   Journal report from Journal of Brief Therapy for reliability and validity of the ORS
•   Pearson Assessments site describing psychometric properties of the BDI-II
•   Publisher's description and psychometric properties of the State Trait Anxiety Inventory
•   Site describing CAPS-5
•   site describing PCL-C and updated version