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. 2019 Nov 18;2019(11):CD012898. doi: 10.1002/14651858.CD012898.pub2

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:
  • male combat veteran between 18 and 75

  • diagnosis of PTSD

  • memory of the trauma

  • able to read/write

  • stable on medication for 3 months


Exclusion criteria:
  • psychosis

  • suicidal/homicidal intent

  • alcohol/substance dependence

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:
  • self‐assessment by PCL

  • clinician‐rated assessment by CAPS


Depression:
  • self‐assessment by BDI


Anxiety:
  • self‐assessment by STAI

Notes Unpublished trial.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).