Stress Disorders, Post-TraumaticSMARTNCT00988104
Preventing Long Term Psychiatric Disability Among Those With Major Burn Injuries
A study testing Cognitive Behavioral Therapy and Supportive Counseling in people with Stress Disorders, Post-Traumatic and Mood Disorders, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether a newly developed, brief cognitive behavioral intervention, relative to supportive counseling, is effective in reducing acute stress disorder (ASD) and preventing post traumatic stress disorder (PTSD) and depression. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Stress Disorders, Post-Traumatic, Mood Disorders, Sleep Disorders
- What is being tested?
- Cognitive Behavioral Therapy and Supportive Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Oct 2007to Dec 2015
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 to 70 years old
- acute burn injury
- exceeding criteria on screening instrument at baseline (in-hospital prior to treatment): Acute Stress Disorder Scale (ASDS score ≥ 37: acute posttrauma distress).
Who cannot join
- Age less than 18 or greater than 70 years
- Presence of a significant cognitive / neurological or psychiatric condition precluding informed consent (e.g., psychosis, acute suicidality)
- Inability to communicate in English
- intubated or sedated
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Burn Center
Baltimore, Maryland, 21224
About this study
Official title: Preventing Long Term Psychiatric Disability Among Those With Major Burn Injuries: the Safety, Meaning, Activation and Resilience Trial (SMART)
The purpose of this study is to determine whether a newly developed, brief cognitive behavioral intervention, relative to supportive counseling, is effective in reducing acute stress disorder (ASD) and preventing post traumatic stress disorder (PTSD) and depression.
Read the detailed description
Importance: Burns are painful, life threatening and disfiguring. Severe psychological distress, pain and sleep disturbance are among the most common, enduring and disabling of secondary complications, however, no evidence based treatments exists for these complex problems in the acute burn care setting.
Design: Randomized, controlled effectiveness trial, group assignment blinded to baseline status, groups stratified by history of pre-existing psychiatric disorder.
Objectives. To develop the Safety, Meaning, Activation and Resilience Training (SMART) protocol; To evaluate its short and long-term effectiveness, relative to viable placebo, Supportive Counseling (SC), in improving key dependent measures (e.g., ASD, PTSD), mediators, and, enhancing health and function outcomes.
Setting: A leading edge, State-dedicated, regional burn center in a major, metropolitan teaching hospital serving diverse residents from large urban settings, small towns and remote rural areas.
Interventions: SMART (focused cognitive-behavioral therapy with training in anxiety management, and treatment with prolonged exposure and cognitive restructuring) will be contrasted with SC (non-directive empathy, warmth, positive regard).
Primary Outcome Measures: Health (psychological distress, sleep, pain), function (physical, psychological, social), costs (direct and indirect).
- Being tested
- Cognitive Behavioral Therapy, Supportive Counseling
- Keywords
- Behavior Therapy, Randomized Controlled Trial
- Medical subject headings
- Stress Disorders, Post-Traumatic, Mood Disorders, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Also called SMART
CBT (4 sessions): 1) Cognitive therapy targeting key appraisals. 2) Prolonged exposure targeting trauma memories and reminders. 3) Active coping/Anxiety Management training mindfulness-based techniques.
Supportive CounselingBehavioural
Also called Usual Care
Supportive counseling (4 sessions): common factors among effective psychotherapies (e.g., empathy, positive regard)
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy | Active comparator | Not described Receives: Behavioral: Cognitive Behavioral Therapy |
| Supportive Counseling | Active comparator | Not described Receives: Behavioral: Supportive Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structured Clinical Interview for DSM IV: Mood and PTSD modules
Measured: 1 week, 1 month and 6 months post-treatment
Secondary outcomes (5)
Davidson Trauma Scale
Measured: 1 week, 1 month and 6 months post-treatment
Patient Health Questionnaire - 9 (depression)
Measured: 1 week, 1 month and 6 months post-treatment
Insomnia Severity Index
Measured: 1 week, 1 month and 6 months post-treatment
Post Traumatic Growth Inventory
Measured: 1 week, 1 month and 6 months post-treatment
McGill pain Questionnaire
Measured: 1 week, 1 month and 6 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2009 (estimated)
- Study start16 Oct 2007
- Primary completion15 Oct 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Stress Disorders, Post-TraumaticStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Department of Education
- Responsible party
- Sponsor
- Investigators
- James A Fauerbach, PhD, Principal investigator, Johns Hopkins UniversityUna D McCann, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00988104
- Sponsor's protocol ID
- NA_00002545
- Other IDs
- NIDRR H133A070045, H133A070045
- Acronym
- SMART
- Status last verified
- Aug 2018
- First submitted
- 30 Sep 2009
- Last updated
- 24 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
McKibben JB, Bresnick MG, Wiechman Askay SA, Fauerbach JA. Acute stress disorder and posttraumatic stress disorder: a prospective study of prevalence, course, and predictors in a sample with major burn injuries. J Burn Care Res. 2008 Jan-Feb;29(1):22-35. doi: 10.1097/BCR.0b013e31815f59c4.
PubMed 18182894Fauerbach JA, McKibben J, Bienvenu OJ, Magyar-Russell G, Smith MT, Holavanahalli R, Patterson DR, Wiechman SA, Blakeney P, Lezotte D. Psychological distress after major burn injury. Psychosom Med. 2007 Jun;69(5):473-82. doi: 10.1097/psy.0b013e31806bf393.
PubMed 17585064Smith MT, Klick B, Kozachik S, Edwards RE, Holavanahalli R, Wiechman S, Blakeney P, Lezotte D, Fauerbach JA. Sleep onset insomnia symptoms during hospitalization for major burn injury predict chronic pain. Pain. 2008 Sep 15;138(3):497-506. doi: 10.1016/j.pain.2008.01.028. Epub 2008 Mar 24.
PubMed 18362052Edwards RR, Magyar-Russell G, Thombs B, Smith MT, Holavanahalli RK, Patterson DR, Blakeney P, Lezotte DC, Haythornthwaite JA, Fauerbach JA. Acute pain at discharge from hospitalization is a prospective predictor of long-term suicidal ideation after burn injury. Arch Phys Med Rehabil. 2007 Dec;88(12 Suppl 2):S36-42. doi: 10.1016/j.apmr.2007.05.031.
PubMed 18036980Edwards RR, Smith MT, Klick B, Magyar-Russell G, Haythornthwaite JA, Holavanahalli R, Patterson DR, Blakeney P, Lezotte D, McKibben J, Fauerbach JA. Symptoms of depression and anxiety as unique predictors of pain-related outcomes following burn injury. Ann Behav Med. 2007 Nov-Dec;34(3):313-22. doi: 10.1007/BF02874556.
PubMed 18020941Esselman PC, Thombs BD, Magyar-Russell G, Fauerbach JA. Burn rehabilitation: state of the science. Am J Phys Med Rehabil. 2006 Apr;85(4):383-413. doi: 10.1097/01.phm.0000202095.51037.a3. No abstract available.
PubMed 16554686Fauerbach JA, Lezotte D, Hills RA, Cromes GF, Kowalske K, de Lateur BJ, Goodwin CW, Blakeney P, Herndon DN, Wiechman SA, Engrav LH, Patterson DR. Burden of burn: a norm-based inquiry into the influence of burn size and distress on recovery of physical and psychosocial function. J Burn Care Rehabil. 2005 Jan-Feb;26(1):21-32. doi: 10.1097/01.bcr.0000150216.87940.ac.
PubMed 15640730Lawrence JW, Fauerbach JA. Personality, coping, chronic stress, social support and PTSD symptoms among adult burn survivors: a path analysis. J Burn Care Rehabil. 2003 Jan-Feb;24(1):63-72; discussion 62. doi: 10.1097/00004630-200301000-00016.
PubMed 12543997Fauerbach JA, Richter L, Lawrence JW. Regulating acute posttrauma distress. J Burn Care Rehabil. 2002 Jul-Aug;23(4):249-57. doi: 10.1097/00004630-200207000-00005.
PubMed 12142577Fauerbach JA, Lawrence JW, Fogel J, Richter L, Magyar-Russell G, McKibben JB, McCann U. Approach-avoidance coping conflict in a sample of burn patients at risk for posttraumatic stress disorder. Depress Anxiety. 2009;26(9):838-50. doi: 10.1002/da.20439.
PubMed 19170120
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Long Term Psychiatric Disability Among Those With Major Burn Injuries: the Safety, Meaning, Activation and Resilience Trial (SMART)
- ClinicalTrials.gov ID
- NCT00988104
- Acronym / sponsor ID
- SMART / NA_00002545
- Keywords
- Behavior Therapy, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- U.S. Department of Education
- Study start
- 16 Oct 2007 (actual)
- Primary completion
- 15 Oct 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Oct 2009 (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 determine whether a newly developed, brief cognitive behavioral intervention, relative to supportive counseling, is effective in reducing acute stress disorder (ASD) and preventing post traumatic stress disorder (PTSD) and depression.
Detailed description
Importance: Burns are painful, life threatening and disfiguring. Severe psychological distress, pain and sleep disturbance are among the most common, enduring and disabling of secondary complications, however, no evidence based treatments exists for these complex problems in the acute burn care setting.
Design: Randomized, controlled effectiveness trial, group assignment blinded to baseline status, groups stratified by history of pre-existing psychiatric disorder.
Objectives. To develop the Safety, Meaning, Activation and Resilience Training (SMART) protocol; To evaluate its short and long-term effectiveness, relative to viable placebo, Supportive Counseling (SC), in improving key dependent measures (e.g., ASD, PTSD), mediators, and, enhancing health and function outcomes.
Setting: A leading edge, State-dedicated, regional burn center in a major, metropolitan teaching hospital serving diverse residents from large urban settings, small towns and remote rural areas.
Interventions: SMART (focused cognitive-behavioral therapy with training in anxiety management, and treatment with prolonged exposure and cognitive restructuring) will be contrasted with SC (non-directive empathy, warmth, positive regard).
Primary Outcome Measures: Health (psychological distress, sleep, pain), function (physical, psychological, social), costs (direct and indirect).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Active comparator | Behavioral: Cognitive Behavioral Therapy |
| Supportive Counseling | Active comparator | Behavioral: Supportive Counseling |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 to 70 years old
- acute burn injury
- exceeding criteria on screening instrument at baseline (in-hospital prior to treatment): Acute Stress Disorder Scale (ASDS score ≥ 37: acute posttrauma distress).
Key exclusion criteria (4 listed)
- Age less than 18 or greater than 70 years
- Presence of a significant cognitive / neurological or psychiatric condition precluding informed consent (e.g., psychosis, acute suicidality)
- Inability to communicate in English
- intubated or sedated
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 Behavioral TherapyAlso: SMARTCBT (4 sessions): 1) Cognitive therapy targeting key appraisals. 2) Prolonged exposure targeting trauma memories and reminders. 3) Active coping/Anxiety Management training mindfulness-based techniques. | Behavioural | Cognitive Behavioral Therapy |
| Supportive CounselingAlso: Usual CareSupportive counseling (4 sessions): common factors among effective psychotherapies (e.g., empathy, positive regard) | Behavioural | Supportive Counseling |
Primary outcome
Structured Clinical Interview for DSM IV: Mood and PTSD modules
Time frame: 1 week, 1 month and 6 months post-treatment
5 secondary outcomes
Davidson Trauma Scale
Time frame: 1 week, 1 month and 6 months post-treatment
Patient Health Questionnaire - 9 (depression)
Time frame: 1 week, 1 month and 6 months post-treatment
Insomnia Severity Index
Time frame: 1 week, 1 month and 6 months post-treatment
Post Traumatic Growth Inventory
Time frame: 1 week, 1 month and 6 months post-treatment
McGill pain Questionnaire
Time frame: 1 week, 1 month and 6 months post-treatment
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 24 Aug 2018.
- Background: PubMed 18182894McKibben JB, Bresnick MG, Wiechman Askay SA, Fauerbach JA. Acute stress disorder and posttraumatic stress disorder: a prospective study of prevalence, course, and predictors in a sample with major burn injuries. J Burn Care Res. 2008 Jan-Feb;29(1):22-35. doi: 10.1097/BCR.0b013e31815f59c4.
- Background: PubMed 17585064Fauerbach JA, McKibben J, Bienvenu OJ, Magyar-Russell G, Smith MT, Holavanahalli R, Patterson DR, Wiechman SA, Blakeney P, Lezotte D. Psychological distress after major burn injury. Psychosom Med. 2007 Jun;69(5):473-82. doi: 10.1097/psy.0b013e31806bf393.
- Background: PubMed 18362052Smith MT, Klick B, Kozachik S, Edwards RE, Holavanahalli R, Wiechman S, Blakeney P, Lezotte D, Fauerbach JA. Sleep onset insomnia symptoms during hospitalization for major burn injury predict chronic pain. Pain. 2008 Sep 15;138(3):497-506. doi: 10.1016/j.pain.2008.01.028. Epub 2008 Mar 24.
- Background: PubMed 18036980Edwards RR, Magyar-Russell G, Thombs B, Smith MT, Holavanahalli RK, Patterson DR, Blakeney P, Lezotte DC, Haythornthwaite JA, Fauerbach JA. Acute pain at discharge from hospitalization is a prospective predictor of long-term suicidal ideation after burn injury. Arch Phys Med Rehabil. 2007 Dec;88(12 Suppl 2):S36-42. doi: 10.1016/j.apmr.2007.05.031.
- Background: PubMed 18020941Edwards RR, Smith MT, Klick B, Magyar-Russell G, Haythornthwaite JA, Holavanahalli R, Patterson DR, Blakeney P, Lezotte D, McKibben J, Fauerbach JA. Symptoms of depression and anxiety as unique predictors of pain-related outcomes following burn injury. Ann Behav Med. 2007 Nov-Dec;34(3):313-22. doi: 10.1007/BF02874556.
- Background: PubMed 16554686Esselman PC, Thombs BD, Magyar-Russell G, Fauerbach JA. Burn rehabilitation: state of the science. Am J Phys Med Rehabil. 2006 Apr;85(4):383-413. doi: 10.1097/01.phm.0000202095.51037.a3. No abstract available.
- Background: PubMed 15640730Fauerbach JA, Lezotte D, Hills RA, Cromes GF, Kowalske K, de Lateur BJ, Goodwin CW, Blakeney P, Herndon DN, Wiechman SA, Engrav LH, Patterson DR. Burden of burn: a norm-based inquiry into the influence of burn size and distress on recovery of physical and psychosocial function. J Burn Care Rehabil. 2005 Jan-Feb;26(1):21-32. doi: 10.1097/01.bcr.0000150216.87940.ac.
- Background: PubMed 12543997Lawrence JW, Fauerbach JA. Personality, coping, chronic stress, social support and PTSD symptoms among adult burn survivors: a path analysis. J Burn Care Rehabil. 2003 Jan-Feb;24(1):63-72; discussion 62. doi: 10.1097/00004630-200301000-00016.
- Background: PubMed 12142577Fauerbach JA, Richter L, Lawrence JW. Regulating acute posttrauma distress. J Burn Care Rehabil. 2002 Jul-Aug;23(4):249-57. doi: 10.1097/00004630-200207000-00005.
- Background: PubMed 19170120Fauerbach JA, Lawrence JW, Fogel J, Richter L, Magyar-Russell G, McKibben JB, McCann U. Approach-avoidance coping conflict in a sample of burn patients at risk for posttraumatic stress disorder. Depress Anxiety. 2009;26(9):838-50. doi: 10.1002/da.20439.
- Johns Hopkins Burn CenterLink provided by the sponsor.
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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.
James A Fauerbach, PhD principal investigator
Johns Hopkins University
Una D McCann, MD principal investigator
Johns Hopkins University
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 Behavioral Therapy and Supportive Counseling in people with Stress Disorders, Post-Traumatic and Mood Disorders, run by Johns Hopkins 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 3 inclusion and 4 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 24 Aug 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?
Structured Clinical Interview for DSM IV: Mood and PTSD modules (time frame: 1 week, 1 month and 6 months post-treatment). 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 NCT00988104, which also lists 10 linked publications.
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 24 Aug 2018.