NCT00607815

A Comparison of Cognitive Processing Therapy (CPT) Versus Present Centered Therapy (PCT) for Veterans

Completed NA Results posted Last updated 26 June 2018

What this trial tests

NA trial testing Cognitive Processing Therapy in PTSD in 79 participants. Completed in 27 December 2015.

Timeline

15 June 2009

Primary endpoint
1 February 2015

27 December 2015

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	79
Start date	15 June 2009
Primary completion	1 February 2015
Estimated completion	27 December 2015
Sites	1 location across United States

Drugs / interventions tested

• Cognitive Processing Therapy
• Present Centered Therapy

Conditions studied

• PTSD — all drugs for PTSD →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Adults 18 to 75, male only, with PTSD. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Clinician Administered PTSD Scale Primary · Post-treatment, at 3 months and 1 year

Clinician-rated PTSD symptom severity; higher is worse; range at post-treatment is 0 to 80; scale scores are summed.

post

Group	Value	95% CI
Cognitive Processing Therapy	31.56	± 21.24
Present Centered Therapy	42.62	± 23.76

3-month

Group	Value	95% CI
Cognitive Processing Therapy	31.65	± 21.77
Present Centered Therapy	38.73	± 18.38

12-month

Group	Value	95% CI
Cognitive Processing Therapy	26.78	± 19.26
Present Centered Therapy	32.12	± 22.48

PTSD Checklist (PCL) Primary · post-treatment, at 3 months and 1 year

17-item patient self-reported PTSD severity; higher is worse; range at post-treatment is 17-73; scale scores are summed

post

Group	Value	95% CI
Cognitive Processing Therapy	33.48	± 15.75
Present Centered Therapy	42.88	± 23.76

3-month

Group	Value	95% CI
Cognitive Processing Therapy	35.55	± 14.17
Present Centered Therapy	41.84	± 14.66

12-month

Group	Value	95% CI
Cognitive Processing Therapy	33.72	± 13.69
Present Centered Therapy	34.88	± 12.32

Beck Depression Inventory - II (BDI-II) Secondary · post-treatment, at 3 months and 1 year

Gold-standard, self-reported depression severity measure; higher is worse; post-treatment range is 2-45. scale scores are summed.

post

Group	Value	95% CI
Cognitive Processing Therapy	16.32	± 11.42
Present Centered Therapy	20.73	± 10.53

3-month

Group	Value	95% CI
Cognitive Processing Therapy	17.10	± 10.48
Present Centered Therapy	18.95	± 9.67

12-month

Group	Value	95% CI
Cognitive Processing Therapy	15.56	± 12.41
Present Centered Therapy	18.47	± 11.96

State-Trait Anger Scale (STAXI) Secondary · post-treatment, at 3 months and 1 year

Self-reported trait anger; subscale score is summed; higher is worse; range at post-treatment is 10-37.

post

Group	Value	95% CI
Cognitive Processing Therapy	21.75	± 5.58
Present Centered Therapy	23.81	± 6.69

3-month

Group	Value	95% CI
Cognitive Processing Therapy	21.26	± 6.49
Present Centered Therapy	23.09	± 5.04

12-month

Group	Value	95% CI
Cognitive Processing Therapy	21.64	± 7.09
Present Centered Therapy	22.41	± 3.95

State-Trait Anxiety Scale Secondary · post-treatment, at 3 months and 1 year

Self-reported state anxiety; higher is worse; scale score is summed; range at post-treatment is 20-73.

post

Group	Value	95% CI
Cognitive Processing Therapy	43.20	± 13.71
Present Centered Therapy	48.34	± 11.42

3-month

Group	Value	95% CI
Cognitive Processing Therapy	44.98	± 12.92
Present Centered Therapy	47.21	± 13.20

12-month

Group	Value	95% CI
Cognitive Processing Therapy	43.27	± 13.39
Present Centered Therapy	45.71	± 12.29

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cognitive Processing Therapy

Serious: 1/43 (2%)

Deaths: —

Present Centered Therapy

Serious: 0/36 (0%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	Cognitive Processing Therapy	Present Centered Therapy
Self Harm	Psychiatric disorders	—	—

Most-reported serious reactions: Self Harm.

Data from ClinicalTrials.gov NCT00607815 adverse events section.

Sponsor's own description

The purpose of this study is to compare the effectiveness of Cognitive Processing Therapy (CPT) versus Present Centered Therapy (PCT) for male OEF/OIF Veterans with combat related PTSD.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Present-centered therapy (PCT) for post-traumatic stress disorder (PTSD) in adults.
   Belsher BE, Beech E, Evatt D, Smolenski DJ, et al · · 2019 · cited 34× · PMID 31742672 · DOI 10.1002/14651858.cd012898.pub2