Inclusion and exclusion criteria in randomized controlled trials of psychotherapy for PTSD. 2014

Julia M Ronconi, and Brian Shiner, and Bradley V Watts
RONCONI: White River Junction Veterans Affairs Medical Center, White River Junction, VT; SHINER: White River Junction Veterans Affairs Medical Center and Geisel School of Medicine at Dartmouth, Hanover, NH; WATTS: Geisel School of Medicine at Dartmouth and VA National Center for Patient Safety, White River Junction, VT.

OBJECTIVE Posttraumatic stress disorder (PTSD) is a prevalent and often disabling condition. Fortunately, effective psychological treatments for PTSD are available. However, research indicates that these treatments may be underutilized in clinical practice. One reason for this underutilization may be clinicians' unwarranted exclusion of patients from these treatments based on their understanding of exclusion criteria used in clinical trials of psychological treatments for PTSD. There is no comprehensive and up-to-date review of inclusion and exclusion criteria used in randomized clinical trials (RCTs) of psychological treatments for PTSD. Therefore, our objective was to better understand how patients were excluded from such RCTs in order to provide guidance to clinicians regarding clinical populations likely to benefit from these treatments. METHODS We conducted a comprehensive literature review of RCTs of psychological treatments for PTSD from January 1, 1980 through April 1, 2012. We categorized these clinical trials according to the types of psychotherapy discussed in the major guidelines for treatment of PTSD and reviewed all treatments that were studied in at least two RCTs (N=64 published studies with 75 intervention arms since some studies compared two or more interventions). We abstracted and tabulated information concerning exclusion criteria for each type of psychotherapy for PTSD. RESULTS We identified multiple RCTs of cognitive behavioral therapy (n=56), eye movement desensitization and reprocessing (n=11), and group psychotherapy (n=8) for PTSD. The most common exclusions were psychosis, substance abuse and dependence, bipolar disorder, and suicidal ideation. Clinical trials varied in how stringently these criteria were applied. It is important to note that no exclusion criterion was used in all studies and there was at least one study of each type of therapy that included patients from each of the commonly excluded groups. A paucity of evidence exists concerning the treatment of patients with PTSD and four comorbidities: alcohol and substance abuse or dependence with current use, current psychosis, current mania, and suicidal ideation with current intent. CONCLUSIONS Psychological treatments for PTSD have been studied in broad and representative clinical populations. It appears that more liberal use of these treatments regardless of comorbidities is warranted.

UI MeSH Term Description Entries
D011613 Psychotherapy A generic term for the treatment of mental illness or emotional disturbances primarily by verbal or nonverbal communication. Psychotherapies
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D013313 Stress Disorders, Post-Traumatic A class of traumatic stress disorders with symptoms that last more than one month. Moral Injury,Neuroses, Post-Traumatic,PTSD,Post Traumatic Stress Disorder,Post-Traumatic Stress Disorders,Acute Post-Traumatic Stress Disorder,Chronic Post-Traumatic Stress Disorder,Delayed Onset Post-Traumatic Stress Disorder,Neuroses, Posttraumatic,Posttraumatic Stress Disorders,Stress Disorder, Post Traumatic,Stress Disorders, Posttraumatic,Acute Post Traumatic Stress Disorder,Chronic Post Traumatic Stress Disorder,Delayed Onset Post Traumatic Stress Disorder,Injury, Moral,Moral Injuries,Neuroses, Post Traumatic,Post Traumatic Stress Disorders,Post-Traumatic Neuroses,Post-Traumatic Stress Disorder,Posttraumatic Neuroses,Posttraumatic Stress Disorder,Stress Disorder, Post-Traumatic,Stress Disorder, Posttraumatic
D016032 Randomized Controlled Trials as Topic Works about clinical trials that involve at least one test treatment and one control treatment, concurrent enrollment and follow-up of the test- and control-treated groups, and in which the treatments to be administered are selected by a random process, such as the use of a random-numbers table. Clinical Trials, Randomized,Controlled Clinical Trials, Randomized,Trials, Randomized Clinical
D018579 Patient Selection Criteria and standards used for the determination of the appropriateness of the inclusion of patients with specific conditions in proposed treatment plans and the criteria used for the inclusion of subjects in various clinical trials and other research protocols. Patient Recruitment,Research Subject Recruitment,Selection Criteria,Research Subject Selection,Selection for Treatment,Selection of Research Volunteers,Selection of Subjects,Criteria, Selection,Recruitment, Patient,Recruitment, Research Subject,Recruitments, Research Subject,Research Subject Recruitments,Research Subject Selections,Research Volunteers Selection,Research Volunteers Selections,Selection for Treatments,Selection, Patient,Selection, Research Subject,Selections, Research Subject,Subject Recruitment, Research,Subject Recruitments, Research,Subject Selection, Research,Subject Selections, Research,Subjects Selection,Subjects Selections,Treatment, Selection for,Treatments, Selection for,Volunteers Selection, Research

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