Post-Traumatic Stress DisorderNCT00245232
Cognitive Processing Therapy Versus Its Individual Components in the Treatment of Post-Traumatic Stress Disorder and Depression in Women Who Have Been Sexually Abused
A study testing Cognitive Therapy, Cognitive Processing Therapy and Written Exposure in people with Post-Traumatic Stress Disorder, run by University of Missouri, St. Louis at 1 site in United States.
Trial summary
This study will evaluate the effectiveness of cognitive processing therapy versus its individual components in treating women with post-traumatic stress disorder (PTSD) and depression brought on by sexual assault. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Cognitive Therapy, Cognitive Processing Therapy and Written Exposure
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2000to Apr 2005
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of a discrete episode of assault in childhood or adulthood
- Meets criteria for post-traumatic stress disorder
Who cannot join
- Experienced a traumatic event that was in the form of chronic ongoing abuse and not a discrete incidence
- Psychosis
- Mental retardation
- Suicidal or parasuicidal
- Currently addicted to drugs
- Illiterate
- Currently in an abusive relationship
- Currently being stalked
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Trauma and Recovery, University of Missouri - St. Louis
St Louis, Missouri, 63121-4499
About this study
Official title: Cognitive Processes in PTSD: Treatment
This study will evaluate the effectiveness of cognitive processing therapy versus its individual components in treating women with post-traumatic stress disorder (PTSD) and depression brought on by sexual assault.
Read the detailed description
PTSD is a psychiatric disorder that can occur following exposure to a traumatic event in which grave physical harm occurred or was threatened. PTSD is marked by clear biological changes as well as psychological symptoms. Many people with PTSD repeatedly relive the trauma in the form of flashback episodes, memories, nightmares, or frightening thoughts. This study will evaluate the effectiveness of cognitive processing therapy versus its individual components in treating women with post-traumatic stress disorder and depression brought on by sexual assault.
Participants in this single-blind study will be randomly assigned to receive one of three treatments: cognitive processing therapy (CPT); cognitive therapy (CT); or written exposure (WE). Participants assigned to receive either CPT or CT will attend therapy sessions twice weekly for 6 weeks. CPT will focus on helping each individual to process accurate memories of the traumatic event and to work through any memories that cannot be completely ignored, nor completely integrated back into their thinking. Also included in CPT will be a WE component, in which participants will be encouraged to recall the traumatic event and experience any emotions connected to it. CT will be similar to CPT, but will not include the WE component. Participants assigned to receive only WE will attend one 2-hour session each week. Symptoms of PTSD and depression will be measured at baseline, post-treatment, and at a 6-month follow-up visit.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Cognitive Therapy, Cognitive Processing Therapy, Written Exposure
- Keywords
- PTSD, Cognitive therapy, 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.
Cognitive TherapyBehavioural
Cognitive Processing TherapyBehavioural
Written ExposureBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression symptoms; measured immediately post-treatment and 6 months post-treatment
Post-traumatic stress disorder symptoms; measured immediately post-treatment and 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2005 (estimated)
- Study startAug 2000
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post-Traumatic Stress DisorderStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 228 participants
Sponsor and investigators
- Lead sponsor
- University of Missouri, St. Louis
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Investigators
- Patricia A. Resick, PhD, Principal investigator, National Center for PTSD, Women's Health Sciences Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245232
- Sponsor's protocol ID
- R01MH051509-06
- Other IDs
- R01MH051509-06, DSIR AT-AS
- Status last verified
- Mar 2015
- First submitted
- 25 Oct 2005
- Last updated
- 31 Mar 2015
- Results posted
- No
Publications
Resick PA, Nishith P, Weaver TL, Astin MC, Feuer CA. A comparison of cognitive-processing therapy with prolonged exposure and a waiting condition for the treatment of chronic posttraumatic stress disorder in female rape victims. J Consult Clin Psychol. 2002 Aug;70(4):867-79. doi: 10.1037//0022-006x.70.4.867.
PubMed 12182270O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.
PubMed 37795783Fitzpatrick SS, Liebman RE, Monson CM, Resick PA. Latent emotion profiles of PTSD and specific emotions predicting differential therapy outcomes in a dismantling study of cognitive processing therapy. J Anxiety Disord. 2023 Apr;95:102681. doi: 10.1016/j.janxdis.2023.102681. Epub 2023 Feb 17.
PubMed 36848714
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Processes in PTSD: Treatment
- ClinicalTrials.gov ID
- NCT00245232
- Acronym / sponsor ID
- R01MH051509-06
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- PTSD, Cognitive therapy, Rape
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants
- Lead sponsor
- University of Missouri, St. LouisUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2000
- Study completion
- Apr 2005
- First posted
- 27 Oct 2005 (estimated)
- 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.
This study will evaluate the effectiveness of cognitive processing therapy versus its individual components in treating women with post-traumatic stress disorder (PTSD) and depression brought on by sexual assault.
Detailed description
PTSD is a psychiatric disorder that can occur following exposure to a traumatic event in which grave physical harm occurred or was threatened. PTSD is marked by clear biological changes as well as psychological symptoms. Many people with PTSD repeatedly relive the trauma in the form of flashback episodes, memories, nightmares, or frightening thoughts. This study will evaluate the effectiveness of cognitive processing therapy versus its individual components in treating women with post-traumatic stress disorder and depression brought on by sexual assault.
Participants in this single-blind study will be randomly assigned to receive one of three treatments: cognitive processing therapy (CPT); cognitive therapy (CT); or written exposure (WE). Participants assigned to receive either CPT or CT will attend therapy sessions twice weekly for 6 weeks. CPT will focus on helping each individual to process accurate memories of the traumatic event and to work through any memories that cannot be completely ignored, nor completely integrated back into their thinking. Also included in CPT will be a WE component, in which participants will be encouraged to recall the traumatic event and experience any emotions connected to it. CT will be similar to CPT, but will not include the WE component. Participants assigned to receive only WE will attend one 2-hour session each week. Symptoms of PTSD and depression will be measured at baseline, post-treatment, and at a 6-month follow-up visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- History of a discrete episode of assault in childhood or adulthood
- Meets criteria for post-traumatic stress disorder
Key exclusion criteria (8 listed)
- Experienced a traumatic event that was in the form of chronic ongoing abuse and not a discrete incidence
- Psychosis
- Mental retardation
- Suicidal or parasuicidal
- Currently addicted to drugs
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 |
|---|---|---|
| Cognitive Therapy | Behavioural | – |
| Cognitive Processing Therapy | Behavioural | – |
| Written Exposure | Behavioural | – |
Primary outcome
Depression symptoms; measured immediately post-treatment and 6 months post-treatment
Post-traumatic stress disorder symptoms; measured immediately post-treatment and 6 months post-treatment
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 31 Mar 2015.
- Results publication: PubMed 12182270Resick PA, Nishith P, Weaver TL, Astin MC, Feuer CA. A comparison of cognitive-processing therapy with prolonged exposure and a waiting condition for the treatment of chronic posttraumatic stress disorder in female rape victims. J Consult Clin Psychol. 2002 Aug;70(4):867-79. doi: 10.1037//0022-006x.70.4.867.
- Derived from this study: PubMed 37795783O'Doherty L, Whelan M, Carter GJ, Brown K, Tarzia L, Hegarty K, Feder G, Brown SJ. Psychosocial interventions for survivors of rape and sexual assault experienced during adulthood. Cochrane Database Syst Rev. 2023 Oct 5;10(10):CD013456. doi: 10.1002/14651858.CD013456.pub2.
- Derived from this study: PubMed 36848714Fitzpatrick SS, Liebman RE, Monson CM, Resick PA. Latent emotion profiles of PTSD and specific emotions predicting differential therapy outcomes in a dismantling study of cognitive processing therapy. J Anxiety Disord. 2023 Apr;95:102681. doi: 10.1016/j.janxdis.2023.102681. Epub 2023 Feb 17.
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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.
Patricia A. Resick, PhD principal investigator
National Center for PTSD, Women's Health Sciences Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Therapy, Cognitive Processing Therapy and Written Exposure in people with Post-Traumatic Stress Disorder, run by University of Missouri, St. Louis 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 2 inclusion and 8 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 31 Mar 2015. 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?
Depression symptoms; measured immediately post-treatment and 6 months post-treatment. The study lists 2 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 NCT00245232, which also lists 3 linked publications.
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 31 Mar 2015.