An interventional study of Cognitive Behavioral Therapy and Supportive Counseling in Stress Disorders, Post-Traumatic, Mood Disorders and Sleep Disorders, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-08-24.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Prevention
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.
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).
788 studies on the registry are indexed under Sleep Wake Disorders; 186 are open to participants now.
This study's enrollment of 60 is close to the median of 62 across 548 interventional studies indexed under Sleep Wake Disorders.
Browse Sleep Wake Disorders studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Behavioral: Cognitive Behavioral Therapy
Behavioral: Supportive Counseling
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
Supportive counseling (4 sessions): common factors among effective psychotherapies (e.g., empathy, positive regard)
Also known as: Usual Care
Structured Clinical Interview for DSM IV: Mood and PTSD modules
Time frame: 1 week, 1 month and 6 months post-treatment
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
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Johns Hopkins University