NCT00607815.
Methods |
Design: parallel group RCT Dates of study: June 15, 2009 ‐ December 27, 2015 Number of study centers and locations: one VA medical center (Cincinnati, Ohio) Recruitment: not reported Study duration: 1 year |
|
Participants |
Participants: 79 Age: mean (SD) 30.9 (7.6) overall, 29.5 (7.1) for the CPT group, 32.1 (7.9) for the PCT group Sex: 100% male Baseline CAPS score: mean (SD) 61.8 (13.1) overall, 60.1 (11.6) for the CPT group, 62.4 (14.8) for the PCT group Trauma type: not reported Duration of time since trauma: not reported Comorbid conditions: not reported Diagnostic criteria: SCID and CAPS Inclusion criteria:
Exclusion criteria:
|
|
Interventions |
Group I: cognitive processing therapy (CPT) Description: clients learn the skills of recognizing and challenging dysfunctional cognitions related to post‐traumatic beliefs. Delivered by: not reported Number of sessions: 12 weekly sessions Format: individual Group II: PCT Manual/Model: CSP 494 version Delivered by: not reported Number of sessions: not reported Format: individual |
|
Outcomes |
PTSD:
Depression:
Anxiety:
|
|
Notes | Unpublished trial. Data was obtained from clinicaltrials.gov and author contact. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Study statistician used a random number generator program (information received via email correspondence with the lead investigator). |
Allocation concealment (selection bias) | Low risk | Treatment allocation was not known prior to randomization (information received via email correspondence with the lead investigator). |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not feasible in psychotherapy trial |
Blinding of outcome assessment (detection bias) Patient reported symptoms | High risk | Blinding of participants to treatment allocation was not feasible. |
Blinding of outcome assessment (detection bias) Observer rated symptoms | Low risk | Protocol stated that outcomes assessors would be blind to treatment allocation. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Data have not been published and study authors did not respond to requests to confirm numbers given in clinicaltrials.gov. Higher dropout rates in the TF‐CBT arm relative to PCT |
Selective reporting (reporting bias) | Low risk | All outcome measures listed in the study's clinicaltrials.gov trial registration were reported in the publication. |
Other bias | Unclear risk | Potential concerns of bias due to investigator allegiance; principal investigator is a developer of treatment under investigation (CPT). |