Schnurr 2007.
Methods |
Design: parallel group RCT Dates of study: August 2002 ‐ October 2005 Number of study centers and locations: nine VA medical centers, two VA re‐adjustment counseling centers, and one military hospital Recruitment: clinician referrals Study duration: six months |
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Participants |
Participants: 277 Age: mean (CI) 44.6 (43.1 to 46.2) for the PE group, 44.9 (43.4 to 46.5) for the PCT group Sex: 0% male Baseline CAPS score: mean (CI) 77.6 (74.8 to 80.4) for the PE group, 77.9 (75.1 to 80.6) for the PCT group Trauma type: sexual trauma (68.3%), physical assault (15.8%), and war‐zone exposure (5.6%) Duration of time since trauma: average of 23.0 years in PE group, 22.8 years in PCT group Comorbid conditions: in the PE group, 75.2% had any current comorbid psychiatric disorder, 61.7% had a current comorbid mood disorder, 48.9% had a current comorbid anxiety disorder, and 2.1% had current comorbid substance abuse. In the PCT group, 80.4% had any current comorbid psychiatric disorder, 65.7% had a current comorbid mood disorder, 46.9% had a current comorbid anxiety disorder, and 2.1% had current comorbid substance abuse. Diagnostic criteria: overall CAPS score of 45 or higher, and symptoms occurred at least monthly with moderate intensity Inclusion criteria:
Exclusion criteria:
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Interventions |
Group I: prolonged exposure therapy (PE) Description: "...included education about common reactions to trauma; breathing retraining; prolonged (repeated) recounting (imaginal exposure) of trauma memories during sessions; homework (listening to a recording of the recounting made during the therapy session and repeated in vivo exposure to safe situations the patient avoids because of trauma‐related fear); and discussion of thoughts and feelings related to exposure exercises. Sessions 1 and 2 were introductory and included provision of the treatment rationale and education about PTSD. Imaginal exposure occurred in sessions 3 through 10." Delivered by: 52 female therapists who were master’s‐ or doctoral‐level clinicians experienced in treating women with PTSD Number of sessions: 10 weekly 90‐minute sessions Format: individual Group II: PCT Manual/Model: CSP 494 version Delivered by: 52 female therapists who were master’s‐ or doctoral‐level clinicians experienced in treating women with PTSD Number of sessions: 10 weekly 90‐minute sessions Format: individual |
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Outcomes |
PTSD:
Depression:
Anxiety:
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Notes | 21 lost to follow‐up out of 141 in PE group, 17 lost to follow‐up out of 142 in PCT group | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization was done using permuted blocks with random block sizes of 4 or 6. |
Allocation concealment (selection bias) | Low risk | Study staff called a computerized voice information system at the study coordinating center to obtain the treatment assignment for participants. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not feasible in psychotherapy trials |
Blinding of outcome assessment (detection bias) Patient reported symptoms | High risk | Blinding of participants to treatment allocation not feasible |
Blinding of outcome assessment (detection bias) Observer rated symptoms | Low risk | Assessors blinded to treatment assignment performed assessments before and after treatment and at 3‐ and 6‐month follow‐up appointments. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Intention‐to‐treat analysis for all outcomes. Higher dropout rates in the TF‐CBT arm relative to PCT |
Selective reporting (reporting bias) | Low risk | No published protocol, but all outcomes specified in design paper were reported in study publications. |
Other bias | Unclear risk | Potential concerns of bias due to investigator allegiance; study team member (Foa) is a developer of treatment under investigation (PE). |