PTSDNCT04549493
Effectiveness of Trauma Management Therapy and Prolonged Exposure Therapy
A study testing Exposure Therapy in people with PTSD, run by University of Central Florida at 1 site in United States.
Trial summary
The purpose of this requirement is to identify an effective exposure psychotherapy paradigm for the treatment of Post-Traumatic Stress Disorder (PTSD) in active duty service members and veterans by comparing different exposure psychotherapy modalities. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 134 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2020to 1 May 2024
- 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 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Active duty military personnel with a diagnoses of PTSD
- Traumatic event must have occurred during military service
- Military sexual trauma limited to attempted or completed sexual assault.
Who cannot join
- Acute cardiac difficulties
- Severe comorbid substance use disorders.
- Diagnosis of schizophrenia or other psychotic disorders
- Diagnosis of antisocial personality disorder
- Moderate or severe traumatic brain injury (TBI)
- Use of benzodiazepines
Trial locations and contacts
1 site in 1 country.
United States1 site
UCF RESTORES, University of Central Florida
Orlando, Florida, 32816
About this study
Official title: Effectiveness of Trauma Management Therapy and Prolonged Exposure Therapy for the Treatment of Post-Traumatic Stress Disorder in an Active Duty Sample: A Comparison Study
The purpose of this requirement is to identify an effective exposure psychotherapy paradigm for the treatment of Post-Traumatic Stress Disorder (PTSD) in active duty service members and veterans by comparing different exposure psychotherapy modalities. The long-term goal of exposure psychotherapy is to improve the mental health of U.S. service members and veterans with military-related PTSD. Recovery from PTSD will reduce the economic burden not only for those persons experiencing PTSD, but also for the health care system and society as a whole (Galovski \& Lyons, 2004).
Read the detailed description
This study will provide an evaluation of performance and suitability of the compressed versions of exposure psychotherapy to support the capability gap for the treatment of active duty service members and veterans with PTSD by comparing different exposure psychotherapy modalities. The overall objective of this study is to determine if compressed psychotherapy can be used as an effective alternative treatment for PTSD and to compare the impact of TMT and PE on social, familial, and occupational impairment. The primary objectives will be to compare 1) 3 week TMT with 12 week PE and 2) 3 week TMT with 2 week PE for the effectiveness of reducing PTSD symptoms in a gated approach or some other method to control for multiplicity. Outcomes will be determined based upon self-report, clinician ratings, as well as other aspects of psychopathology, and social/emotional functioning. The addition of the TMT group component will be assessed in particular to determine its impact on social, familial, and occupational impairment. Blood samples should be collected from participants at baseline and at the end of the treatment period in order to identify PTSD biomarkers, e.g. predictors of response, biological subtypes of PTSD, and therapeutic markers. Collection, storage, and transfer of the blood samples to DoD should be performed according to standardized protocols provided by the DoD. One or more site visits may occur in order to assess adherence to standardized protocols.
- Conditions
- PTSD
- Being tested
- Exposure Therapy
- Keywords
- Trauma Management Therapy, Exposure Therapy, Group Therapy, PTSD, Military
- 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.
Exposure TherapyBehavioural
Exposure Therapy is used to reduce the symptoms of PTSD
| Study group | Role | What they receive |
|---|---|---|
| Trauma Management Therapy | Active comparator | 1. Trauma Management Therapy (TMT; Turner, Beidel, \& Frueh, 2005): TMT is a multicomponent behavioral treatment program designed to target various aspects of chronic PTSD - reducing emotional and physiological reactivity to traumatic cues, reducing intrusive symptoms and avoidance behavior, improving interpersonal skills and emotion modulation (e.g., anger control), and increasing the range of enjoyable social activities. In this investigation and in line with our previous publications, TMT will include virtual-reality augmented exposure (i.e. olfactory stimulation, heart rate, and skin conductance); group therapy to address sleep, anger, depression, and social isolation; homework assignments; and programmed practice. In the 3-week treatment program, each participant receives virtual-reality assisted exposure in the morning followed by in vivo exposure and group therapy (SER) each afternoon for a total of 29 sessions. Receives: Behavioral: Exposure Therapy |
| Prolonged Exposure | Active comparator | 2. Standard Prolonged Exposure (PE; Foa, Hembree, \& Rothbaum, 2007) consists of psychoeducation, imaginal exposure to trauma memories, in vivo exposure to situations that are avoided due to their association with the trauma, and emotional processing. The standard protocol consists of 12 imaginal exposure sessions, along with in vivo exposure/homework assignments and listening to a recording of the imaginal sessions at home during the evening. Receives: Behavioral: Exposure Therapy |
| Compressed Prolonged Exposure | Active comparator | 3. Compressed PE consists of 10 standard PE sessions delivered on consecutive work days. The imaginal exposure sessions take place in the morning, with in vivo exposures assigned (not therapist accompanied) for the afternoons. Patients are instructed to listen to the recordings of the imaginal exposure each night. Being most concerned with having enough time for in vivo practice, Session 1 does not start on a Monday, allowing for two full weekends in order to maximize in vivo exposures. Both versions of PE average 36 total treatment hours. Receives: Behavioral: Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5
PTSD symptoms rating scale (severity and frequency) administered by blinded clinician
Measured: 1 week posttreatment
Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5
PTSD symptoms rating scale (severity and frequency) administered by blinded clinician
Measured: 3 months posttreatment
Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5
PTSD symptoms rating scale (severity and frequency) administered by blinded clinician
Measured: 6 months posttreatment
Secondary outcomes (48)
Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Patient Self Report of PTSD symptoms
Measured: 1 week posttreatment
Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Patient Self Report of PTSD symptoms
Measured: 3 months posttreatment
Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Patient Self Report of PTSD symptoms
Measured: 6 months posttreatment
Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ)
self-report measure assessing lifetime history of 22 traumatic events
Measured: 1 week posttreatment
Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ)
self-report measure assessing lifetime history of 22 traumatic events
Measured: 3 months posttreatment
Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ)
self-report measure assessing lifetime history of 22 traumatic events
Measured: 6 months posttreatment
Change from Baseline on the Trauma-Related Guilt Inventory (TRGI)
32-item measure rating 3 domains of trauma-related guilt cognitions (Global Guilt, Distress, and Guilt Cognitions)
Measured: 1 week posttreatment
Change from Baseline on the Trauma-Related Guilt Inventory (TRGI)
32-item measure rating 3 domains of trauma-related guilt cognitions (Global Guilt, Distress, and Guilt Cognitions)
Measured: 3 months posttreatment
Change from Baseline on the Trauma-Related Guilt Inventory (TRGI)
32-item measure rating 3 domains of trauma-related guilt cognitions (Global Guilt, Distress, and Guilt Cognitions)
Measured: 6 months posttreatment
Change from Baseline on the Posttraumatic Cognitions Inventory (PTCI)
36-item measure assessing 3 domains of trauma-related cognitions (Negative Cognitions about Self, Negative Cognitions about the World, and Self-Blame)
Measured: 1 week posttreatment
Change from Baseline on the Posttraumatic Cognitions Inventory (PTCI)
36-item measure assessing 3 domains of trauma-related cognitions (Negative Cognitions about Self, Negative Cognitions about the World, and Self-Blame)
Measured: 3 months posttreatment
Change from Baseline on the Posttraumatic Cognitions Inventory (PTCI)
36-item measure assessing 3 domains of trauma-related cognitions (Negative Cognitions about Self, Negative Cognitions about the World, and Self-Blame)
Measured: 6 months posttreatment
Change from Baseline on the Moral Injury Event Scale (MIES)
patient-report measure assessing psychological distress associated with violations of moral standards.
Measured: 1 week posttreatment
Change from Baseline on the Moral Injury Event Scale (MIES)
patient-report measure assessing psychological distress associated with violations of moral standards.
Measured: 3 months posttreatment
Change from Baseline on the Moral Injury Event Scale (MIES)
patient-report measure assessing psychological distress associated with violations of moral standards.
Measured: 6 months posttreatment
Change from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
patient report of impairment in six domains: cognition, mobility, self-care, getting along with people, life activities (at home and work), and participation in society
Measured: 1 week posttreatment
Change from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
patient report of impairment in six domains: cognition, mobility, self-care, getting along with people, life activities (at home and work), and participation in society
Measured: 3 months posttreatment
Change from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
patient report of impairment in six domains: cognition, mobility, self-care, getting along with people, life activities (at home and work), and participation in society
Measured: 6 months posttreatment
Change from baseline on the Quality of Life Scale (QOLS)
Patient report of 6 domains of life: independence, recreation, personal development and fulfillment, material and physical well-being, relationships with others, and community and civic involvement
Measured: 1 week posttreatment
Change from baseline on the Quality of Life Scale (QOLS)
Patient report of 6 domains of life: independence, recreation, personal development and fulfillment, material and physical well-being, relationships with others, and community and civic involvement
Measured: 3 months posttreatment
Change from baseline on the Quality of Life Scale (QOLS)
Patient report of 6 domains of life: independence, recreation, personal development and fulfillment, material and physical well-being, relationships with others, and community and civic involvement
Measured: 6 months posttreatment
Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC)
Patient report of coping ability
Measured: 1 week posttreatment
Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC)
Patient report of coping ability
Measured: 3 months posttreatment
Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC)
Patient report of coping ability
Measured: 6 months posttreatment
Change from baseline on the Patient Health Questionnaire-9 (PHQ-9)
Patient report measure of depression symptoms
Measured: 1 week posttreatment
Change from baseline on the Patient Health Questionnaire-9 (PHQ-9)
Patient report measure of depression symptoms
Measured: 3 months posttreatment
Change from baseline on the Patient Health Questionnaire-9 (PHQ-9)
Patient report measure of depression symptoms
Measured: 6 months posttreatment
Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7)
Patient report measure of general anxiety symptoms
Measured: 1 week posttreatment
Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7)
Patient report measure of general anxiety symptoms
Measured: 3 months posttreatment
Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7)
Patient report measure of general anxiety symptoms
Measured: 6 months posttreatment
Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5)
Patient report measure of anger
Measured: 1 week posttreatment
Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5)
Patient report measure of anger
Measured: 3 months posttreatment
Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5)
Patient report measure of anger
Measured: 6 months posttreatment
Change from baseline on the Clinical Global Impressions Scales (CGI)
Clinician rated scales to evaluate the severity of pretreatment psychopathology and treatment change
Measured: 1 week posttreatment
Change from baseline on the Clinical Global Impressions Scales (CGI)
Clinician rated scales to evaluate the severity of pretreatment psychopathology and treatment change
Measured: 3 months posttreatment
Change from baseline on the Clinical Global Impressions Scales (CGI)
Clinician rated scales to evaluate the severity of pretreatment psychopathology and treatment change
Measured: 6 months posttreatment
Sleep actigraphy - change from baseline in total sleep time
Objective assessment of sleep
Measured: 1 week posttreatment
Sleep actigraphy - change from baseline in total sleep time
Objective assessment of sleep
Measured: 3 months posttreatment
Sleep actigraphy - change from baseline in total sleep time
Objective assessment of sleep
Measured: 6 months posttreatment
Sleep actigraphy - change from baseline in sleep onset latency
Objective assessment of sleep (# of minutes to sleep onset after getting into bed)
Measured: 1 week posttreatment
Sleep actigraphy - change from baseline in sleep onset latency
Objective assessment of sleep (# of minutes to sleep onset after getting into bed)
Measured: 3 months posttreatment
Sleep actigraphy - change from baseline in sleep onset latency
Objective assessment of sleep (# of minutes to sleep onset after getting into bed)
Measured: 6 months posttreatment
Sleep actigraphy - change from baseline in sleep efficiency
Objective assessment of sleep (% of time in bed spent sleeping)
Measured: 1 week posttreatment
Sleep actigraphy - change from baseline in sleep efficiency
Objective assessment of sleep (% of time in bed spent sleeping)
Measured: 3 months posttreatment
Sleep actigraphy - change from baseline in sleep efficiency
Objective assessment of sleep (% of time in bed spent sleeping)
Measured: 6 months posttreatment
Sleep actigraphy - change from baseline in wake minutes after sleep onset
Objective assessment of sleep (# of minutes awake after falling asleep)
Measured: 1 week posttreatment
Sleep actigraphy - change from baseline in wake minutes after sleep onset
Objective assessment of sleep (# of minutes awake after falling asleep)
Measured: 3 months posttreatment
Sleep actigraphy - change from baseline in wake minutes after sleep onset
Objective assessment of sleep (# of minutes awake after falling asleep)
Measured: 6 months posttreatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start12 Feb 2020
- Primary completion20 Dec 2023
- Study completion1 May 2024
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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Deborah Beidel, Ph.D., Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549493
- Sponsor's protocol ID
- W81XWH18C0331
- Status last verified
- Dec 2023
- First submitted
- 22 May 2020
- Last updated
- 10 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Trauma Management Therapy and Prolonged Exposure Therapy for the Treatment of Post-Traumatic Stress Disorder in an Active Duty Sample: A Comparison Study
- ClinicalTrials.gov ID
- NCT04549493
- Acronym / sponsor ID
- W81XWH18C0331
- Conditions
- PTSD
- Keywords
- Trauma Management Therapy, Exposure Therapy, Group Therapy, PTSD, Military
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 20 Dec 2023 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 16 Sep 2020 (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 purpose of this requirement is to identify an effective exposure psychotherapy paradigm for the treatment of Post-Traumatic Stress Disorder (PTSD) in active duty service members and veterans by comparing different exposure psychotherapy modalities. The long-term goal of exposure psychotherapy is to improve the mental health of U.S. service members and veterans with military-related PTSD. Recovery from PTSD will reduce the economic burden not only for those persons experiencing PTSD, but also for the health care system and society as a whole (Galovski \& Lyons, 2004).
Detailed description
This study will provide an evaluation of performance and suitability of the compressed versions of exposure psychotherapy to support the capability gap for the treatment of active duty service members and veterans with PTSD by comparing different exposure psychotherapy modalities. The overall objective of this study is to determine if compressed psychotherapy can be used as an effective alternative treatment for PTSD and to compare the impact of TMT and PE on social, familial, and occupational impairment. The primary objectives will be to compare 1) 3 week TMT with 12 week PE and 2) 3 week TMT with 2 week PE for the effectiveness of reducing PTSD symptoms in a gated approach or some other method to control for multiplicity. Outcomes will be determined based upon self-report, clinician ratings, as well as other aspects of psychopathology, and social/emotional functioning. The addition of the TMT group component will be assessed in particular to determine its impact on social, familial, and occupational impairment. Blood samples should be collected from participants at baseline and at the end of the treatment period in order to identify PTSD biomarkers, e.g. predictors of response, biological subtypes of PTSD, and therapeutic markers. Collection, storage, and transfer of the blood samples to DoD should be performed according to standardized protocols provided by the DoD. One or more site visits may occur in order to assess adherence to standardized protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Trauma Management Therapy | Active comparator | Behavioral: Exposure Therapy1. Trauma Management Therapy (TMT; Turner, Beidel, \& Frueh, 2005): TMT is a multicomponent behavioral treatment program designed to target various aspects of chronic PTSD - reducing emotional and physiological reactivity to traumatic cues, reducing intrusive symptoms and avoidance behavior, improving interpersonal skills and emotion modulation (e.g., anger control), and increasing the range of enjoyable social activities. In this investigation and in line with our previous publications, TMT will include virtual-reality augmented exposure (i.e. olfactory stimulation, heart rate, and skin conductance); group therapy to address sleep, anger, depression, and social isolation; homework assignments; and programmed practice. In the 3-week treatment program, each participant receives virtual-reality assisted exposure in the morning followed by in vivo exposure and group therapy (SER) each afternoon for a total of 29 sessions. |
| Prolonged Exposure | Active comparator | Behavioral: Exposure Therapy2. Standard Prolonged Exposure (PE; Foa, Hembree, \& Rothbaum, 2007) consists of psychoeducation, imaginal exposure to trauma memories, in vivo exposure to situations that are avoided due to their association with the trauma, and emotional processing. The standard protocol consists of 12 imaginal exposure sessions, along with in vivo exposure/homework assignments and listening to a recording of the imaginal sessions at home during the evening. |
| Compressed Prolonged Exposure | Active comparator | Behavioral: Exposure Therapy3. Compressed PE consists of 10 standard PE sessions delivered on consecutive work days. The imaginal exposure sessions take place in the morning, with in vivo exposures assigned (not therapist accompanied) for the afternoons. Patients are instructed to listen to the recordings of the imaginal exposure each night. Being most concerned with having enough time for in vivo practice, Session 1 does not start on a Monday, allowing for two full weekends in order to maximize in vivo exposures. Both versions of PE average 36 total treatment hours. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Active duty military personnel with a diagnoses of PTSD
- Traumatic event must have occurred during military service
- Military sexual trauma limited to attempted or completed sexual assault.
Key exclusion criteria (6 listed)
- Acute cardiac difficulties
- Severe comorbid substance use disorders.
- Diagnosis of schizophrenia or other psychotic disorders
- Diagnosis of antisocial personality disorder
- Moderate or severe traumatic brain injury (TBI)
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 |
|---|---|---|
| Exposure TherapyExposure Therapy is used to reduce the symptoms of PTSD | Behavioural | Compressed Prolonged Exposure, Prolonged Exposure, Trauma Management Therapy |
Primary outcome
Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5
Time frame: 1 week posttreatment
PTSD symptoms rating scale (severity and frequency) administered by blinded clinician
Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5
Time frame: 3 months posttreatment
PTSD symptoms rating scale (severity and frequency) administered by blinded clinician
Change from Baseline on the Clinician-Administered PTSD Scale for DSM-5
Time frame: 6 months posttreatment
PTSD symptoms rating scale (severity and frequency) administered by blinded clinician
48 secondary outcomes
Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time frame: 1 week posttreatment
Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time frame: 3 months posttreatment
Change from Baseline on the Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5)
Time frame: 6 months posttreatment
Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ)
Time frame: 1 week posttreatment
Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ)
Time frame: 3 months posttreatment
Change from Baseline on the Traumatic Life Events Questionnaire (TLEQ)
Time frame: 6 months posttreatment
Change from Baseline on the Trauma-Related Guilt Inventory (TRGI)
Time frame: 1 week posttreatment
Change from Baseline on the Trauma-Related Guilt Inventory (TRGI)
Time frame: 3 months posttreatment
Change from Baseline on the Trauma-Related Guilt Inventory (TRGI)
Time frame: 6 months posttreatment
Change from Baseline on the Posttraumatic Cognitions Inventory (PTCI)
Time frame: 1 week posttreatment
Change from Baseline on the Posttraumatic Cognitions Inventory (PTCI)
Time frame: 3 months posttreatment
Change from Baseline on the Posttraumatic Cognitions Inventory (PTCI)
Time frame: 6 months posttreatment
Change from Baseline on the Moral Injury Event Scale (MIES)
Time frame: 1 week posttreatment
Change from Baseline on the Moral Injury Event Scale (MIES)
Time frame: 3 months posttreatment
Change from Baseline on the Moral Injury Event Scale (MIES)
Time frame: 6 months posttreatment
Change from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: 1 week posttreatment
Change from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: 3 months posttreatment
Change from baseline on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
Time frame: 6 months posttreatment
Change from baseline on the Quality of Life Scale (QOLS)
Time frame: 1 week posttreatment
Change from baseline on the Quality of Life Scale (QOLS)
Time frame: 3 months posttreatment
Change from baseline on the Quality of Life Scale (QOLS)
Time frame: 6 months posttreatment
Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC)
Time frame: 1 week posttreatment
Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC)
Time frame: 3 months posttreatment
Change from baseline on the Connor-Davidson Resilience Scale (CD-RISC)
Time frame: 6 months posttreatment
Change from baseline on the Patient Health Questionnaire-9 (PHQ-9)
Time frame: 1 week posttreatment
Change from baseline on the Patient Health Questionnaire-9 (PHQ-9)
Time frame: 3 months posttreatment
Change from baseline on the Patient Health Questionnaire-9 (PHQ-9)
Time frame: 6 months posttreatment
Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 1 week posttreatment
Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 3 months posttreatment
Change from baseline on the Generalized Anxiety Disorder-7 (GAD-7)
Time frame: 6 months posttreatment
Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5)
Time frame: 1 week posttreatment
Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5)
Time frame: 3 months posttreatment
Change from baseline on the Dimensions of Anger Reactions-5 (DAR-5)
Time frame: 6 months posttreatment
Change from baseline on the Clinical Global Impressions Scales (CGI)
Time frame: 1 week posttreatment
Change from baseline on the Clinical Global Impressions Scales (CGI)
Time frame: 3 months posttreatment
Change from baseline on the Clinical Global Impressions Scales (CGI)
Time frame: 6 months posttreatment
Sleep actigraphy - change from baseline in total sleep time
Time frame: 1 week posttreatment
Sleep actigraphy - change from baseline in total sleep time
Time frame: 3 months posttreatment
Sleep actigraphy - change from baseline in total sleep time
Time frame: 6 months posttreatment
Sleep actigraphy - change from baseline in sleep onset latency
Time frame: 1 week posttreatment
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 10 May 2024.
- 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.
Deborah Beidel, Ph.D. principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exposure Therapy in people with PTSD, run by University of Central Florida 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: finished, as of the sponsor's last update on 10 May 2024. 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 from Baseline on the Clinician-Administered PTSD Scale for DSM-5 (time frame: 1 week posttreatment). The study lists 3 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 10 May 2024.