NCT00988104

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2007

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 30, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 1, 2009

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

August 24, 2018

Status Verified

August 1, 2018

Enrollment Period

8 years

First QC Date

September 30, 2009

Last Update Submit

August 22, 2018

Conditions

Stress Disorders, Post-TraumaticMood DisordersSleep Disorders

Keywords

Behavior TherapyRandomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

  • Structured Clinical Interview for DSM IV: Mood and PTSD modules

    1 week, 1 month and 6 months post-treatment

Secondary Outcomes (5)

  • Davidson Trauma Scale

    1 week, 1 month and 6 months post-treatment

  • Patient Health Questionnaire - 9 (depression)

    1 week, 1 month and 6 months post-treatment

  • Insomnia Severity Index

    1 week, 1 month and 6 months post-treatment

  • Post Traumatic Growth Inventory

    1 week, 1 month and 6 months post-treatment

  • McGill pain Questionnaire

    1 week, 1 month and 6 months post-treatment

Study Arms (2)

Cognitive Behavioral Therapy

ACTIVE COMPARATOR
Behavioral: Cognitive Behavioral Therapy

Supportive Counseling

ACTIVE COMPARATOR
Behavioral: Supportive Counseling

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

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.

Also known as: SMART
Cognitive Behavioral Therapy
Supportive CounselingBEHAVIORAL

Supportive counseling (4 sessions): common factors among effective psychotherapies (e.g., empathy, positive regard)

Also known as: Usual Care
Supportive Counseling

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Burn Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (10)

  • 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.

    PMID: 18182894BACKGROUND

  • Fauerbach 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.

    PMID: 17585064BACKGROUND

  • Smith 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.

    PMID: 18362052BACKGROUND

  • Edwards 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.

    PMID: 18036980BACKGROUND

  • Edwards 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.

    PMID: 18020941BACKGROUND

  • Esselman 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.

    PMID: 16554686BACKGROUND

  • Fauerbach 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.

    PMID: 15640730BACKGROUND

  • Lawrence 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.

    PMID: 12543997BACKGROUND

  • Fauerbach 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.

    PMID: 12142577BACKGROUND

  • Fauerbach 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.

    PMID: 19170120BACKGROUND

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticMood DisordersSleep Wake Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • James A Fauerbach, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

  • Una D McCann, MD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2009

First Posted

October 1, 2009

Study Start

October 16, 2007

Primary Completion

October 15, 2015

Study Completion

December 1, 2015

Last Updated

August 24, 2018

Record last verified: 2018-08

Locations

US(1)