Posttraumatic Stress DisorderCPTNCT02684994
Client-directed Cognitive Processing Therapy
A study testing Cognitive Processing Therapy in people with Posttraumatic Stress Disorder, run by University of Indianapolis at 1 site in United States.
Trial summary
This study will take place over approximately 6 months and includes 3 assessment appointments (where information will be gathered, but no direct treatment provided) and 12 treatment sessions of cognitive processing therapy if eligible. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Cognitive Processing Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to 1 Aug 2018
- 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
- Female, 18 years of age or over, experienced one or more interpersonal violence events, traumatic event happened over a month ago, no traumatic events in the last 3 months, must be proficient in English
Who cannot join
- Current psychosis, mania, active suicidal ideation; Substance use disorder in the last 6 months; in a relationship with perpetrator of violence
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Indianapolis
Indianapolis, Indiana, 46202
About this study
This study will take place over approximately 6 months and includes 3 assessment appointments (where information will be gathered, but no direct treatment provided) and 12 treatment sessions of cognitive processing therapy if eligible.
Read the detailed description
The purpose of this research study is to examine the effectiveness of a client-directed version of a well-supported psychological therapy, cognitive processing therapy (CPT), for the treatment of psychological effects of traumatic experiences. Participants in this study are expected to be women who have experienced one or more interpersonal violence experiences (i.e. physical or sexual assault).
During the first assessment, participants will be interviewed by a qualified investigator/interviewer. The investigator/interviewer will ask participants about life experiences and reactions, including traumatic experiences and symptoms participants might be experiencing. This portion of the study will take approximately 2-3 hours. If participant's assessment reveals that participant is eligible for the study participant will begin the treatment portion of the study. If eligible, participant will also be given a packet of questionnaires to complete before participant's first treatment session. If participant is not eligible for the study, investigator/interviewer will provide participant with a list of referrals from which participant could seek treatment with other agencies.
If participant begins the treatment portion of the study, participant will participate in a client-directed version of cognitive processing therapy (CPT). CPT is a treatment designed to help participant understand the ways participant's traumatic experience has affected various aspects of participant's life (feelings, beliefs, behaviors, etc.). The treatment will consist of four main components: education about trauma responses, experiencing emotions related to the assault, development of skills for examining the truth of thoughts, and examination of beliefs in areas commonly influenced by traumatic experiences. During this treatment, participant will be exploring the ways in which the assault has affected participant's beliefs, such as participant's beliefs about participant's own safety, trust, and ability to have relationships. In the sessions, participant will explore these areas to discover and change the ways participant believes, since the assault has led to feelings of distress, fear, anxiety, and depression. Participant will be asked to do activities in between sessions each week, which will ask participant to think and write about participant's traumatic experiences. The treatment includes 12 sessions, each for one hour. Sessions will be held once or twice a week. The current version of CPT will include all the components of the regular CPT treatment, but may vary in order of sessions. The regular treatment protocol provides sessions in a set order, but the current study will allow participant some choices in when participant complete certain activities.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Cognitive Processing Therapy
- Keywords
- Trauma, Sexual assault, Sexual abuse, Physical assault, Physical abuse, PTSD, Interpersonal Violence, Women
- Medical subject headings
- Stress Disorders, Post-Traumatic, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Processing TherapyBehavioural
Also called CPT, Client-directed CPT
Cognitive-processing therapy is a well-supported treatment for reactions following traumatic events. It includes 12 individual psychotherapy sessions and consists of 4 components: education about trauma responses, experiencing emotions related to the assault, development of skills for examining the truth of thoughts, and examination of beliefs in areas commonly influenced by the trauma.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Processing Therapy | Other | Cognitive Processing Therapy Receives: Behavioral: Cognitive Processing Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in PTSD symptoms
Clinician administered clinical interview (Clinician Administered PTSD Scale) assessing PTSD symptoms
Measured: pre-treatment, post-treatment, 3 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2016 (estimated)
- Study startOct 2014
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Indianapolis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lisa S Elwood, Ph.D., Principal investigator, University of Indianapolis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02684994
- Sponsor's protocol ID
- 0619
- Acronym
- CPT
- Status last verified
- Oct 2018
- First submitted
- 12 Feb 2016
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Client-directed Cognitive Processing Therapy
- ClinicalTrials.gov ID
- NCT02684994
- Acronym / sponsor ID
- CPT / 0619
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Trauma, Sexual assault, Sexual abuse, Physical assault, Physical abuse, PTSD, Interpersonal Violence, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- University of IndianapolisUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 18 Feb 2016 (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 take place over approximately 6 months and includes 3 assessment appointments (where information will be gathered, but no direct treatment provided) and 12 treatment sessions of cognitive processing therapy if eligible.
Detailed description
The purpose of this research study is to examine the effectiveness of a client-directed version of a well-supported psychological therapy, cognitive processing therapy (CPT), for the treatment of psychological effects of traumatic experiences. Participants in this study are expected to be women who have experienced one or more interpersonal violence experiences (i.e. physical or sexual assault).
During the first assessment, participants will be interviewed by a qualified investigator/interviewer. The investigator/interviewer will ask participants about life experiences and reactions, including traumatic experiences and symptoms participants might be experiencing. This portion of the study will take approximately 2-3 hours. If participant's assessment reveals that participant is eligible for the study participant will begin the treatment portion of the study. If eligible, participant will also be given a packet of questionnaires to complete before participant's first treatment session. If participant is not eligible for the study, investigator/interviewer will provide participant with a list of referrals from which participant could seek treatment with other agencies.
If participant begins the treatment portion of the study, participant will participate in a client-directed version of cognitive processing therapy (CPT). CPT is a treatment designed to help participant understand the ways participant's traumatic experience has affected various aspects of participant's life (feelings, beliefs, behaviors, etc.). The treatment will consist of four main components: education about trauma responses, experiencing emotions related to the assault, development of skills for examining the truth of thoughts, and examination of beliefs in areas commonly influenced by traumatic experiences. During this treatment, participant will be exploring the ways in which the assault has affected participant's beliefs, such as participant's beliefs about participant's own safety, trust, and ability to have relationships. In the sessions, participant will explore these areas to discover and change the ways participant believes, since the assault has led to feelings of distress, fear, anxiety, and depression. Participant will be asked to do activities in between sessions each week, which will ask participant to think and write about participant's traumatic experiences. The treatment includes 12 sessions, each for one hour. Sessions will be held once or twice a week. The current version of CPT will include all the components of the regular CPT treatment, but may vary in order of sessions. The regular treatment protocol provides sessions in a set order, but the current study will allow participant some choices in when participant complete certain activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Processing Therapy | Other | Behavioral: Cognitive Processing TherapyCognitive Processing Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Female, 18 years of age or over, experienced one or more interpersonal violence events, traumatic event happened over a month ago, no traumatic events in the last 3 months, must be proficient in English
Key exclusion criteria (1 listed)
- Current psychosis, mania, active suicidal ideation; Substance use disorder in the last 6 months; in a relationship with perpetrator of violence
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 Processing TherapyAlso: CPT, Client-directed CPTCognitive-processing therapy is a well-supported treatment for reactions following traumatic events. It includes 12 individual psychotherapy sessions and consists of 4 components: education about trauma responses, experiencing emotions related to the assault, development of skills for examining the truth of thoughts, and examination of beliefs in areas commonly influenced by the trauma. | Behavioural | Cognitive Processing Therapy |
Primary outcome
change in PTSD symptoms
Time frame: pre-treatment, post-treatment, 3 month follow-up
Clinician administered clinical interview (Clinician Administered PTSD Scale) assessing PTSD symptoms
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 17 Oct 2018.
- 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.
Lisa S Elwood, Ph.D. principal investigator
University of Indianapolis
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 Processing Therapy in people with Posttraumatic Stress Disorder, run by University of Indianapolis 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 1 inclusion and 1 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 17 Oct 2018. 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 PTSD symptoms (time frame: pre-treatment, post-treatment, 3 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Oct 2018.