PTSDNCT05265039
Exploring Mechanisms of Massed Cognitive Processing Therapy
A study testing Cognitive Processing Therapy and Relaxation Training in people with PTSD, run by Rush University Medical Center at 1 site in United States.
Trial summary
The overall goal of this randomized controlled trial with partial crossover is to compare the effectiveness of 1-week virtual massed Cognitive Processing Therapy (CPT) to 5-day virtual relaxation training (RT) with regard to their ability to reduce posttraumatic stress disorder (PTSD) symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- Cognitive Processing Therapy and Relaxation Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Apr 2022to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Are fluent in English
- Have experienced a Criterion A traumatic event during their lifetime
- Have a PTSD diagnosis verified via the Clinician Administered PTSD Scale for DSM
- Are interested in receiving evidence-based treatment (CPT) for PTSD and able to attend either 10 therapy sessions over the course of one week (5 days) or are interested and able to complete 5 relaxation training sessions over the course of one week (5 days)
- Are willing and able to complete self-report measures and clinician-rated assessments at multiple time points over the course of the study
- Reside in the state of Illinois during the course of treatment
Who cannot join
- The traumatic event occurred in the past month
- They are currently suicidal or homicidal (i.e., plan and intent)
- They have unmanaged psychosis or mania
- They have not been on a stable dose of psychotropic medication for at least one month by the time of the baseline assessment
- They have completed an evidence-based cognitive behavioral PTSD treatment (e.g., Cognitive Processing Therapy or Prolonged Exposure) in the past 3 months or are currently receiving an evidence-based PTSD treatment
- They have an intellectual disability or significant cognitive impairment that would prevent them from engaging in CPT
Show all 11Show fewer
- They have a serious or unstable medical illness or instability for which hospitalization may be likely within the next year
- They have an active substance use disorder (within the past 3 months) that would require immediate medical observation if substance use was discontinued (i.e., potential lethality)
- They are involved with current legal actions related to the traumatic event that is anticipated to be targeted during treatment
- They have a visual or auditory impairment that would prevent them from fully participating in study activities
- Subjects who, at the time of consent, appear to have extenuating life circumstances (e.g., unstable housing, no internet access, etc.) which, in the judgement of the Principal Investigator, could affect the ability to deliver the intervention with fidelity
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Denter
Chicago, Illinois, 60612
About this study
Official title: Exploring Mechanisms of Massed Cognitive Processing Therapy: A Randomized Controlled Trial
The overall goal of this randomized controlled trial with partial crossover is to compare the effectiveness of 1-week virtual massed Cognitive Processing Therapy (CPT) to 5-day virtual relaxation training (RT) with regard to their ability to reduce posttraumatic stress disorder (PTSD) symptoms. Specifically, this study is designed to 1) examine changes in PTSD symptoms during and following the respective intervention, and 2) explore possible psychological treatment mechanisms, including cognitive control, inhibition, self-efficacy, and memory, and 3) examine possible moderators of treatment success (e.g. neuropsychological factors).
- Conditions
- PTSD
- Being tested
- Cognitive Processing Therapy, Relaxation Training
- 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 Processing TherapyBehavioural
An evidence-based treatment for posttraumatic stress disorder (PTSD)
Relaxation TrainingBehavioural
Guided relaxation
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Processing Therapy (CPT) | Experimental | Not described Receives: Behavioral: Cognitive Processing Therapy |
| Relaxation Training (RT) | Active comparator | Not described Receives: Behavioral: Relaxation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician-Administered PTSD Scale for DSM
Clinician-Administered Assessment of PTSD
Measured: Through study completion, an average of 8 months
PTSD Checklist for DSM-5 Criteria
Self Report Measure for PTSD
Measured: Through study completion, an average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start26 Apr 2022
- Primary completion30 Sep 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Held, Rush University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05265039
- Sponsor's protocol ID
- 21082701
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2022
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Mechanisms of Massed Cognitive Processing Therapy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05265039
- Acronym / sponsor ID
- 21082701
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Mar 2022 (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.
The overall goal of this randomized controlled trial with partial crossover is to compare the effectiveness of 1-week virtual massed Cognitive Processing Therapy (CPT) to 5-day virtual relaxation training (RT) with regard to their ability to reduce posttraumatic stress disorder (PTSD) symptoms. Specifically, this study is designed to 1) examine changes in PTSD symptoms during and following the respective intervention, and 2) explore possible psychological treatment mechanisms, including cognitive control, inhibition, self-efficacy, and memory, and 3) examine possible moderators of treatment success (e.g. neuropsychological factors).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Processing Therapy (CPT) | Experimental | Behavioral: Cognitive Processing Therapy |
| Relaxation Training (RT) | Active comparator | Behavioral: Relaxation Training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Are fluent in English
- Have experienced a Criterion A traumatic event during their lifetime
- Have a PTSD diagnosis verified via the Clinician Administered PTSD Scale for DSM
- Are interested in receiving evidence-based treatment (CPT) for PTSD and able to attend either 10 therapy sessions over the course of one week (5 days) or are interested and able to complete 5 relaxation training sessions over the course of one week (5 days)
- Are willing and able to complete self-report measures and clinician-rated assessments at multiple time points over the course of the study
Key exclusion criteria (11 listed)
- The traumatic event occurred in the past month
- They are currently suicidal or homicidal (i.e., plan and intent)
- They have unmanaged psychosis or mania
- They have not been on a stable dose of psychotropic medication for at least one month by the time of the baseline assessment
- They have completed an evidence-based cognitive behavioral PTSD treatment (e.g., Cognitive Processing Therapy or Prolonged Exposure) in the past 3 months or are currently receiving an evidence-based PTSD treatment
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 TherapyAn evidence-based treatment for posttraumatic stress disorder (PTSD) | Behavioural | Cognitive Processing Therapy (CPT) |
| Relaxation TrainingGuided relaxation | Behavioural | Relaxation Training (RT) |
Primary outcome
Clinician-Administered PTSD Scale for DSM
Time frame: Through study completion, an average of 8 months
Clinician-Administered Assessment of PTSD
PTSD Checklist for DSM-5 Criteria
Time frame: Through study completion, an average of 8 months
Self Report Measure for PTSD
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Relaxation Training in people with PTSD, run by Rush University Medical Center 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 11 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: under way, not looking for participants, as of the sponsor's last update on 27 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinician-Administered PTSD Scale for DSM (time frame: Through study completion, an average of 8 months). 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?
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 27 Feb 2026.