PTSDNCT04073004
RRT for PTSD Symptoms in Survivors of Sexual Violence
A study testing Rapid Resolution Therapy in people with PTSD and Rape Sexual Assault, run by University of Colorado, Denver at 1 site in United States.
Trial summary
Study to provide evidence of efficacy for Rapid Resolution Therapy in symptoms of PTSD, Anxiety, and Depression in survivors of sexual violence. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD, Rape Sexual Assault
- What is being tested?
- Rapid Resolution Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2020to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado at Denver counseling center
Denver, Colorado, 80210
About this study
Official title: Rapid Resolution Therapy (RRT) for Post-traumatic Stress Disorder (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.
Read the 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.
- Conditions
- PTSD, Rape Sexual Assault
- Being tested
- Rapid Resolution Therapy
- Keywords
- PTSD, Psychotherapy, Rape
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rapid Resolution TherapyBehavioural
psychotherapy that includes trance states
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Rapid Resolution Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Pre-intervention, one week follow up, 6 month follow up
Secondary outcomes (2)
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
Measured: one week post intervention
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
Measured: One week post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start15 Nov 2020
- Primary completion30 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Aberle, MA, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04073004
- Sponsor's protocol ID
- 19-1453
- Status last verified
- Mar 2025
- First submitted
- 19 Aug 2019
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 16382428
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Resolution Therapy (RRT) for Post-traumatic Stress Disorder (PTSD) Symptoms in Survivors of Sexual Violence
- ClinicalTrials.gov ID
- NCT04073004
- Acronym / sponsor ID
- 19-1453
- Conditions
- PTSD, Rape Sexual Assault
- Keywords
- PTSD, Psychotherapy, Rape
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 15 Nov 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Rapid Resolution Therapy | Experimental | Behavioral: Rapid Resolution TherapyRRT 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-70 years old
- self report experiencing a rape any time before 3 months prior to treatment
- on PCL-C (Positive for PTSD)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rapid Resolution Therapypsychotherapy that includes trance states | Behavioural | Rapid Resolution Therapy |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Session Rating Scale (Miller et al 2002)
Time frame: one week post intervention
Outcome Rating Scale (ORS: Miller and Duncan, 2000)
Time frame: One week post intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Background: PubMed 16382428Rothbaum 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.
- cite describing RRT and link to membersLink provided by the sponsor.
- site describing PCL-C and updated versionLink provided by the sponsor.
- Site describing CAPS-5Link provided by the sponsor.
- Pearson Assessments site describing psychometric properties of the BDI-IILink provided by the sponsor.
- Publisher's description and psychometric properties of the State Trait Anxiety InventoryLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather Aberle, MA principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rapid Resolution Therapy in people with PTSD and Rape Sexual Assault, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04073004, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.