Post-Traumatic Stress DisorderPhase 3NCT01199107
Maximizing Treatment Outcome and Examining Sleep in Post-traumatic Stress Disorder (PTSD)
A Phase 3 study testing Prolonged Exposure, Exercise and Wellness Intervention in people with Post-Traumatic Stress Disorder, run by Southern Methodist University at 1 site in United States.
Trial summary
The purpose of this study is to examine the efficacy of exercise in comparison to wellness education to determine if they can improve the effects of prolonged exposure therapy (PE) in reducing symptoms of anxiety associated with Post-traumatic Stress Disorder (PTSD). Read more about this study
- Who is it for?
- Ages 18 to 54 years
- Conditions the study is for
- Post-Traumatic Stress Disorder
- What is being tested?
- Prolonged Exposure, Exercise and Wellness Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Aug 2013
- Phase
- Phase 3
- 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 54 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- You have PTSD
- You are between the age of 18 and 54 if female or between ages 18 and 44 if male.
- You have written physician approval/medical clearance to participate in an exercise protocol.
- Are currently taking no psychotropic medications or are able and willing to discontinue these medications prior to the first PE session.
Who cannot join
- You are currently participating in a structured exercise program
- You have severe depression
- You have any history of bipolar disorder, psychotic disorder, or obsessive compulsive disorder;
- You have a diagnosis of eating disorder, or substance abuse or dependence (excluding nicotine) within the past six months
- You have any history of a suicide attempt, or are at significant risk of self-harm or harm to others
- You have ever been diagnosed with organic brain syndrome, mental retardation, or other cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine the efficacy of exercise in comparison to wellness education to determine if they can improve the effects of prolonged exposure therapy (PE) in reducing symptoms of anxiety associated with Post-traumatic Stress Disorder (PTSD). In addition, the two strategies (i.e., exercise and wellness education) will be compared in terms of improvements in sleep as well as levels of brain-derived neurotrophic factor (BDNF). BDNF is a protein that helps to support the survival of existing neurons and stimulate the growth new neurons and synapses. BDNF is important to learning and memory in general and therefore may be associated with the learning and memory as it relates to PE and corresponding symptom PTSD improvement.
- Conditions
- Post-Traumatic Stress Disorder
- Being tested
- Prolonged Exposure, Exercise, Wellness Intervention
- Keywords
- PTSD, Anxiety, Behavior Therapy, Prolonged Exposure, Exercise, Wellness, Posttraumatic, Stress
- Medical subject headings
- Stress Disorders, Post-Traumatic, Anxiety Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged ExposureBehavioural
75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders
ExerciseBehavioural
30 minutes of moderate-intensity treadmill exercise prior to the Prolonged Exposure
Wellness InterventionBehavioural
30 minutes of wellness education prior to Prolonged Exposure
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Exposure + Exercise | Experimental | Not described Receives: Behavioral: Prolonged Exposure; Behavioral: Exercise |
| Prolonged Exposure + Wellness Intervention | Active comparator | Not described Receives: Behavioral: Prolonged Exposure; Behavioral: Wellness Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD Symptoms
Self-report measure that assesses PTSD Symptoms. Will be assessed at each visit throughout the 3 month protocol.
Measured: 3 months
Secondary outcomes (3)
Sleep Quality
Sleep measure that will be assessed twice (at the beginning and end of the 3 month protocol).
Measured: 3 months
BDNF (by blood sample)
Small blood sample taken twice (at the beginning and end of the 3 month protocol).
Measured: 3 months
General Mood and Anxiety Symptoms
Self-report measure that assesses mood and anxiety. Will be assessed at each visit throughout the 3 month protocol.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Southern Methodist University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasper Smits, Ph.D., Southern Methodist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199107
- Sponsor's protocol ID
- KS10-106
- Status last verified
- Dec 2014
- First submitted
- 8 Sep 2010
- Last updated
- 10 Dec 2014
- Results posted
- No
Publications
Powers MB, Medina JL, Burns S, Kauffman BY, Monfils M, Asmundson GJ, Diamond A, McIntyre C, Smits JA. Exercise Augmentation of Exposure Therapy for PTSD: Rationale and Pilot Efficacy Data. Cogn Behav Ther. 2015;44(4):314-27. doi: 10.1080/16506073.2015.1012740. Epub 2015 Feb 23.
PubMed 25706090
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximizing Treatment Outcome and Examining Sleep in Post-traumatic Stress Disorder (PTSD)
- ClinicalTrials.gov ID
- NCT01199107
- Acronym / sponsor ID
- KS10-106
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- PTSD, Anxiety, Behavior Therapy, Prolonged Exposure, Exercise, Wellness, Posttraumatic, Stress
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Southern Methodist UniversityUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 10 Sep 2010 (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.
The purpose of this study is to examine the efficacy of exercise in comparison to wellness education to determine if they can improve the effects of prolonged exposure therapy (PE) in reducing symptoms of anxiety associated with Post-traumatic Stress Disorder (PTSD). In addition, the two strategies (i.e., exercise and wellness education) will be compared in terms of improvements in sleep as well as levels of brain-derived neurotrophic factor (BDNF). BDNF is a protein that helps to support the survival of existing neurons and stimulate the growth new neurons and synapses. BDNF is important to learning and memory in general and therefore may be associated with the learning and memory as it relates to PE and corresponding symptom PTSD improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged Exposure + Exercise | Experimental | Behavioral: Prolonged Exposure, Behavioral: Exercise |
| Prolonged Exposure + Wellness Intervention | Active comparator | Behavioral: Prolonged Exposure, Behavioral: Wellness Intervention |
Who may qualify
- Ages
- 18 to 54 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- You have PTSD
- You are between the age of 18 and 54 if female or between ages 18 and 44 if male.
- You have written physician approval/medical clearance to participate in an exercise protocol.
- Are currently taking no psychotropic medications or are able and willing to discontinue these medications prior to the first PE session.
Key exclusion criteria (6 listed)
- You are currently participating in a structured exercise program
- You have severe depression
- You have any history of bipolar disorder, psychotic disorder, or obsessive compulsive disorder;
- You have a diagnosis of eating disorder, or substance abuse or dependence (excluding nicotine) within the past six months
- You have any history of a suicide attempt, or are at significant risk of self-harm or harm to others
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 |
|---|---|---|
| Prolonged Exposure75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders | Behavioural | Prolonged Exposure + Exercise, Prolonged Exposure + Wellness Intervention |
| Exercise30 minutes of moderate-intensity treadmill exercise prior to the Prolonged Exposure | Behavioural | Prolonged Exposure + Exercise |
| Wellness Intervention30 minutes of wellness education prior to Prolonged Exposure | Behavioural | Prolonged Exposure + Wellness Intervention |
Primary outcome
PTSD Symptoms
Time frame: 3 months
Self-report measure that assesses PTSD Symptoms. Will be assessed at each visit throughout the 3 month protocol.
3 secondary outcomes
Sleep Quality
Time frame: 3 months
BDNF (by blood sample)
Time frame: 3 months
General Mood and Anxiety Symptoms
Time frame: 3 months
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 Dec 2014.
- Derived from this study: PubMed 25706090Powers MB, Medina JL, Burns S, Kauffman BY, Monfils M, Asmundson GJ, Diamond A, McIntyre C, Smits JA. Exercise Augmentation of Exposure Therapy for PTSD: Rationale and Pilot Efficacy Data. Cogn Behav Ther. 2015;44(4):314-27. doi: 10.1080/16506073.2015.1012740. Epub 2015 Feb 23.
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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 Phase 3 study testing Prolonged Exposure, Exercise and Wellness Intervention in people with Post-Traumatic Stress Disorder, run by Southern Methodist University 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 4 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 Dec 2014. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 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?
PTSD Symptoms (time frame: 3 months). 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 NCT01199107, which also lists 1 linked publication.
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 Dec 2014.