Chronic Posttraumatic Stress DisorderPhase 2NCT01574118
Enhancing Exposure Therapy for Post-traumatic Stress Disorder
A Phase 2 study testing Revisiting the Trauma memories, Processing the trauma memories and Psychoeducation in people with Chronic Posttraumatic Stress Disorder, run by University of Texas at Austin at 1 site in United States.
Trial summary
This study is investigating a new brief psychotherapy for post-traumatic stress disorder (PTSD) which, modifies an already proven psychotherapy for PTSD by adding two new components and modifying several others. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Posttraumatic Stress Disorder
- What is being tested?
- Revisiting the Trauma memories, Processing the trauma memories and Psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2012to Mar 2020
- Phase
- Phase 2
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current primary PTSD diagnosis based on DSM-IV criteria, with a minimum duration of 12 weeks since the traumatic event.
- Between the age of 18 and 65.
- Medication status stable for at least 6 weeks
Who cannot join
- Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-IV.
- Current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan).
- Current diagnosis of alcohol or substance dependence within the 3 previous months.
- Unwilling or unable to discontinue current trauma-focused psychotherapy.
- Ongoing intimate relationship with the perpetrator (in assault-related PTSD cases).
- Other severe acute or chronic medical or psychiatric condition that, in the judgment of the Medical Director, would make the participant inappropriate for entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
Laboratory for the Study of Anxiety Disorders, University of Texas at Austin
Austin, Texas, 78712
About this study
Official title: Enhancing Exposure Therapy for PTSD: An Investigation of Non-Pharmacological Augmentation Strategies
This study is investigating a new brief psychotherapy for post-traumatic stress disorder (PTSD) which, modifies an already proven psychotherapy for PTSD by adding two new components and modifying several others. The goal of the study is to determine whether this experimental treatment outperforms the well-established standard treatment.
Read the detailed description
This study is investigating a new brief psychotherapy for post-traumatic stress disorder (PTSD) which, modifies an already proven psychotherapy for PTSD by adding two new components and modifying several others. The goal of the study is to determine whether this experimental treatment outperforms the well-established standard treatment. Individuals between the ages of 18-65 with chronic PTSD are randomly assigned to one of three psychotherapy conditions: (a) brief enhanced exposure therapy; (b) standard prolonged exposure therapy; and (c) delayed standard exposure therapy. All study participants undergo a phone and face-to-face screening assessment to determine study eligibility and baseline (pretreatment-Week 0) symptom severity. Upon completing treatment, participants undergo three additional assessment visits (Week 6, Week 10, and Week 22). During each of these outcome assessment visits, participants complete a structured clinical interview and a battery of computer-administered questionnaires.
- Conditions
- Chronic Posttraumatic Stress Disorder
- Being tested
- Revisiting the Trauma memories, Processing the trauma memories, Psychoeducation, Trauma Memory Retrieval Trial, Exposure to video clips related to the patient's trauma
- Keywords
- PTSD, Posttraumatic Stress Disorder, Exposure Therapy, Prolonged Exposure, Fear Memory Retrieval, Compound extinction, Deepened extinction, Psychotherapy
- 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.
Revisiting the Trauma memoriesBehavioural
Also called Trauma Revisiting
Patient engages in repeated revisiting of their trauma memory under the guidance of the therapist for about 40 minutes. During each revisiting trial the patient closes their eyes and verbally describes the trauma and the feeling and thoughts experienced during the trauma.
Processing the trauma memoriesBehavioural
Also called Trauma Processing
The patient and therapist discuss the patient's experience during the trauma revisiting with the goal of helping the patient gain alternative perspectives of the trauma.
PsychoeducationBehavioural
Through patient handouts and didactic instruction, the patient learns about the common reactions to trauma and the rationale for exposure therapy.
Trauma Memory Retrieval TrialBehavioural
Also called Fear Retrieval
Prior to the start of Imaginal Exposure, the patient is asked to recall a threatening element of their trauma memory for 1 minute. This is followed by a 30-minute rest-period prior to beginning imaginal exposure.
Exposure to video clips related to the patient's traumaBehavioural
Also called Exposure to trauma clips
Patient is seated in front of a computer monitor and instructed to view a 30-min looped video clip that thematically resembles the patient's trauma.
Breathing retrainingBehavioural
Also called Relaxed breathing
Patient is seated comfortably in a chair and instructed to breathe slowly and deeply in a relaxed manner.
Exposure HomeworkBehavioural
Also called In vivo exposure outside of session
Therapist assists the patient in identifying trauma-related situations/activities that the patient is avoiding and encourages the patient to begin to confront these situations between sessions.
Compound extinctionBehavioural
Also called Deepened Extinction
The patient repeatedly confronts the truama-related media clip while simultaneously listening to their own trauma script through headphones.
| Study group | Role | What they receive |
|---|---|---|
| Brief Enhanaced Exposure Therapy | Experimental | The following interventions are included in this arm:
1. Psycho-education addressing common reactions to trauma
2. Revisiting the Trauma memories
3. Processing the trauma memories
4. In vivo Exposure homework
5. *Use of a brief pre-exposure trauma memory retrieval trial
6. Exposure to video clips related to the patient's trauma
7. Compound extinction - simultaneously exposing patient to trauma video clips while they listen to their trauma script Receives: Behavioral: Revisiting the Trauma memories; Behavioral: Processing the trauma memories; Behavioral: Psychoeducation; Behavioral: Trauma Memory Retrieval Trial; Behavioral: Exposure to video clips related to the patient's trauma; Behavioral: Exposure Homework; Behavioral: Compound extinction |
| Standard Prolonged Exposure Therapy | Active comparator | The following interventions are included in this arm:
1. Psycho-education addressing common reactions to trauma
2. Revisiting of the Trauma memories
3. Processing the trauma memories
4. Breathing retraining
5. In vivo Exposure homework Receives: Behavioral: Revisiting the Trauma memories; Behavioral: Processing the trauma memories; Behavioral: Psychoeducation; Behavioral: Breathing retraining; Behavioral: Exposure Homework |
| Delayed Treatment Control | No intervention | Patients assigned to this arm receive assessment only (Week 0, 3, and 6) prior to receiving standard prolonged exposure therapy using the Foa et al treatment manual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in PTSD symptom severity
PTSD Symptom Scale - Interview Version
Measured: Weeks 6, 10, 22
Secondary outcomes (4)
Change from baseline in depression symptom severity
Quick Inventory of Depressive Symptomatology - Self-Report
Measured: Weeks 6, 10, 22.
Change from baseline in trauma-related cognitions
Post-Traumatic Cognitions Inventory - Self-Report
Measured: Weeks 6, 10, 22.
Change from baseline in general physical and psychological health
Medical Outcomes Study Short Form 36, Version 2 - Self-report
Measured: Weeks 6, 10, 22
Change from baseline in work, social/leisure activities, and family/home life functioning
Sheehan Disability Scale - Self-report
Measured: Weeks 6, 10, 22.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionMar 2020
- Study completionMar 2020
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania
- Responsible party
- Principal investigator, Michael J. Telch, University of Texas at Austin
- Investigators
- Michael J Telch, Ph.D., Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01574118
- Sponsor's protocol ID
- 2012-02-0100
- Status last verified
- Aug 2022
- First submitted
- 3 Apr 2012
- Last updated
- 29 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Exposure Therapy for PTSD: An Investigation of Non-Pharmacological Augmentation Strategies
- ClinicalTrials.gov ID
- NCT01574118
- Acronym / sponsor ID
- 2012-02-0100
- Conditions
- Chronic Posttraumatic Stress Disorder
- Keywords
- PTSD, Posttraumatic Stress Disorder, Exposure Therapy, Prolonged Exposure, Fear Memory Retrieval, Compound extinction, Deepened extinction, Psychotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- University of Pennsylvania
- Study start
- Apr 2012
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 10 Apr 2012 (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 is investigating a new brief psychotherapy for post-traumatic stress disorder (PTSD) which, modifies an already proven psychotherapy for PTSD by adding two new components and modifying several others. The goal of the study is to determine whether this experimental treatment outperforms the well-established standard treatment.
Detailed description
This study is investigating a new brief psychotherapy for post-traumatic stress disorder (PTSD) which, modifies an already proven psychotherapy for PTSD by adding two new components and modifying several others. The goal of the study is to determine whether this experimental treatment outperforms the well-established standard treatment. Individuals between the ages of 18-65 with chronic PTSD are randomly assigned to one of three psychotherapy conditions: (a) brief enhanced exposure therapy; (b) standard prolonged exposure therapy; and (c) delayed standard exposure therapy. All study participants undergo a phone and face-to-face screening assessment to determine study eligibility and baseline (pretreatment-Week 0) symptom severity. Upon completing treatment, participants undergo three additional assessment visits (Week 6, Week 10, and Week 22). During each of these outcome assessment visits, participants complete a structured clinical interview and a battery of computer-administered questionnaires.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brief Enhanaced Exposure Therapy | Experimental | Behavioral: Revisiting the Trauma memories, Behavioral: Processing the trauma memories, Behavioral: Psychoeducation, Behavioral: Trauma Memory Retrieval Trial, Behavioral: Exposure to video clips related to the patient's trauma, Behavioral: Exposure Homework, Behavioral: Compound extinctionThe following interventions are included in this arm: 1. Psycho-education addressing common reactions to trauma 2. Revisiting the Trauma memories 3. Processing the trauma memories 4. In vivo Exposure homework 5. *Use of a brief pre-exposure trauma memory retrieval trial 6. Exposure to video clips related to the patient's trauma 7. Compound extinction - simultaneously exposing patient to trauma video clips while they listen to their trauma script |
| Standard Prolonged Exposure Therapy | Active comparator | Behavioral: Revisiting the Trauma memories, Behavioral: Processing the trauma memories, Behavioral: Psychoeducation, Behavioral: Breathing retraining, Behavioral: Exposure HomeworkThe following interventions are included in this arm: 1. Psycho-education addressing common reactions to trauma 2. Revisiting of the Trauma memories 3. Processing the trauma memories 4. Breathing retraining 5. In vivo Exposure homework |
| Delayed Treatment Control | No intervention | –Patients assigned to this arm receive assessment only (Week 0, 3, and 6) prior to receiving standard prolonged exposure therapy using the Foa et al treatment manual. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Current primary PTSD diagnosis based on DSM-IV criteria, with a minimum duration of 12 weeks since the traumatic event.
- Between the age of 18 and 65.
- Medication status stable for at least 6 weeks
Key exclusion criteria (6 listed)
- Current diagnosis of schizophrenia, delusional disorder, or organic mental disorder as defined by the DSM-IV.
- Current diagnosis of bipolar disorder, depression with psychotic features, or depression severe enough to require immediate psychiatric treatment (i.e., serious suicide risk with intent and plan).
- Current diagnosis of alcohol or substance dependence within the 3 previous months.
- Unwilling or unable to discontinue current trauma-focused psychotherapy.
- Ongoing intimate relationship with the perpetrator (in assault-related PTSD cases).
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 |
|---|---|---|
| Revisiting the Trauma memoriesAlso: Trauma RevisitingPatient engages in repeated revisiting of their trauma memory under the guidance of the therapist for about 40 minutes. During each revisiting trial the patient closes their eyes and verbally describes the trauma and the feeling and thoughts experienced during the trauma. | Behavioural | Brief Enhanaced Exposure Therapy, Standard Prolonged Exposure Therapy |
| Processing the trauma memoriesAlso: Trauma ProcessingThe patient and therapist discuss the patient's experience during the trauma revisiting with the goal of helping the patient gain alternative perspectives of the trauma. | Behavioural | Brief Enhanaced Exposure Therapy, Standard Prolonged Exposure Therapy |
| PsychoeducationThrough patient handouts and didactic instruction, the patient learns about the common reactions to trauma and the rationale for exposure therapy. | Behavioural | Brief Enhanaced Exposure Therapy, Standard Prolonged Exposure Therapy |
| Trauma Memory Retrieval TrialAlso: Fear RetrievalPrior to the start of Imaginal Exposure, the patient is asked to recall a threatening element of their trauma memory for 1 minute. This is followed by a 30-minute rest-period prior to beginning imaginal exposure. | Behavioural | Brief Enhanaced Exposure Therapy |
| Exposure to video clips related to the patient's traumaAlso: Exposure to trauma clipsPatient is seated in front of a computer monitor and instructed to view a 30-min looped video clip that thematically resembles the patient's trauma. | Behavioural | Brief Enhanaced Exposure Therapy |
| Breathing retrainingAlso: Relaxed breathingPatient is seated comfortably in a chair and instructed to breathe slowly and deeply in a relaxed manner. | Behavioural | Standard Prolonged Exposure Therapy |
| Exposure HomeworkAlso: In vivo exposure outside of sessionTherapist assists the patient in identifying trauma-related situations/activities that the patient is avoiding and encourages the patient to begin to confront these situations between sessions. | Behavioural | Brief Enhanaced Exposure Therapy, Standard Prolonged Exposure Therapy |
| Compound extinctionAlso: Deepened ExtinctionThe patient repeatedly confronts the truama-related media clip while simultaneously listening to their own trauma script through headphones. | Behavioural | Brief Enhanaced Exposure Therapy |
Primary outcome
Change from baseline in PTSD symptom severity
Time frame: Weeks 6, 10, 22
PTSD Symptom Scale - Interview Version
4 secondary outcomes
Change from baseline in depression symptom severity
Time frame: Weeks 6, 10, 22.
Change from baseline in trauma-related cognitions
Time frame: Weeks 6, 10, 22.
Change from baseline in general physical and psychological health
Time frame: Weeks 6, 10, 22
Change from baseline in work, social/leisure activities, and family/home life functioning
Time frame: Weeks 6, 10, 22.
Results and safety
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2022.
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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.
Michael J Telch, Ph.D. principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Revisiting the Trauma memories, Processing the trauma memories and Psychoeducation in people with Chronic Posttraumatic Stress Disorder, run by University of Texas at Austin 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 29 Aug 2022. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: COVID-19). Results are not available in the source record.
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 from baseline in PTSD symptom severity (time frame: Weeks 6, 10, 22). 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 29 Aug 2022.