Trial Outcomes & Findings for A Comparison of Cognitive Processing Therapy (CPT) Versus Present Centered Therapy (PCT) for Veterans (NCT NCT00607815)

NCT ID: NCT00607815

Last Updated: 2018-06-26

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 79 participants
• Primary outcome timeframe: Post-treatment, at 3 months and 1 year
• Results posted on: 2018-06-26

Participant Flow

Participant milestones

Measure	Cognitive Processing Therapy Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.	Present Centered Therapy Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called "present centered therapy" to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors
Overall Study STARTED	43	36
Overall Study COMPLETED	20	25
Overall Study NOT COMPLETED	23	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Cognitive Processing Therapy n=43 Participants Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.	Present Centered Therapy n=36 Participants Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called "present centered therapy" to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors	Total n=79 Participants Total of all reporting groups
Age, Continuous	29.5 years STANDARD_DEVIATION 7.11 • n=5 Participants	32.11 years STANDARD_DEVIATION 7.85 • n=7 Participants	30.92 years STANDARD_DEVIATION 7.59 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	43 Participants n=5 Participants	36 Participants n=7 Participants	79 Participants n=5 Participants
Clinician Administered PTSD Scale	60.14 units on a scale STANDARD_DEVIATION 11.61 • n=5 Participants	62.42 units on a scale STANDARD_DEVIATION 14.84 • n=7 Participants	61.77 units on a scale STANDARD_DEVIATION 13.14 • n=5 Participants
PTSD Checklist	53.83 units on a scale STANDARD_DEVIATION 9.87 • n=5 Participants	53.49 units on a scale STANDARD_DEVIATION 9.33 • n=7 Participants	53.65 units on a scale STANDARD_DEVIATION 9.52 • n=5 Participants
Beck Depression Inventory	27.70 units on a scale STANDARD_DEVIATION 9.68 • n=5 Participants	28.22 units on a scale STANDARD_DEVIATION 10.21 • n=7 Participants	27.94 units on a scale STANDARD_DEVIATION 9.86 • n=5 Participants
State Trait Anxiety	43.19 units on a scale STANDARD_DEVIATION 5.60 • n=5 Participants	43.14 units on a scale STANDARD_DEVIATION 4.18 • n=7 Participants	43.17 units on a scale STANDARD_DEVIATION 4.84 • n=5 Participants
State Trait Anger Expression Inventory	28.14 units on a scale STANDARD_DEVIATION 5.52 • n=5 Participants	26.35 units on a scale STANDARD_DEVIATION 6.07 • n=7 Participants	27.16 units on a scale STANDARD_DEVIATION 5.86 • n=5 Participants

PRIMARY outcome

Timeframe: Post-treatment, at 3 months and 1 year

Population: Generalized estimating equations (GEE) were used to test study hypotheses.

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

Outcome measures

Measure	Cognitive Processing Therapy n=43 Participants Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.	Present Centered Therapy n=36 Participants Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called "present centered therapy" to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors
Clinician Administered PTSD Scale post	31.56 units on a scale Standard Deviation 21.24	42.62 units on a scale Standard Deviation 23.76
Clinician Administered PTSD Scale 3-month	31.65 units on a scale Standard Deviation 21.77	38.73 units on a scale Standard Deviation 18.38
Clinician Administered PTSD Scale 12-month	26.78 units on a scale Standard Deviation 19.26	32.12 units on a scale Standard Deviation 22.48

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Cognitive Processing Therapy n=43 Participants Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.	Present Centered Therapy n=36 Participants Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called "present centered therapy" to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors
PTSD Checklist (PCL) post	33.48 units on a scale Standard Deviation 15.75	42.88 units on a scale Standard Deviation 23.76
PTSD Checklist (PCL) 3-month	35.55 units on a scale Standard Deviation 14.17	41.84 units on a scale Standard Deviation 14.66
PTSD Checklist (PCL) 12-month	33.72 units on a scale Standard Deviation 13.69	34.88 units on a scale Standard Deviation 12.32

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Cognitive Processing Therapy n=43 Participants Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.	Present Centered Therapy n=36 Participants Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called "present centered therapy" to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors
Beck Depression Inventory - II (BDI-II) post	16.32 units on a scale Standard Deviation 11.42	20.73 units on a scale Standard Deviation 10.53
Beck Depression Inventory - II (BDI-II) 3-month	17.10 units on a scale Standard Deviation 10.48	18.95 units on a scale Standard Deviation 9.67
Beck Depression Inventory - II (BDI-II) 12-month	15.56 units on a scale Standard Deviation 12.41	18.47 units on a scale Standard Deviation 11.96

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Cognitive Processing Therapy n=43 Participants Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.	Present Centered Therapy n=36 Participants Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called "present centered therapy" to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors
State-Trait Anger Scale (STAXI) post	21.75 units on a scale Standard Deviation 5.58	23.81 units on a scale Standard Deviation 6.69
State-Trait Anger Scale (STAXI) 3-month	21.26 units on a scale Standard Deviation 6.49	23.09 units on a scale Standard Deviation 5.04
State-Trait Anger Scale (STAXI) 12-month	21.64 units on a scale Standard Deviation 7.09	22.41 units on a scale Standard Deviation 3.95

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Cognitive Processing Therapy n=43 Participants Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.	Present Centered Therapy n=36 Participants Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called "present centered therapy" to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors
State-Trait Anxiety Scale post	43.20 units on a scale Standard Deviation 13.71	48.34 units on a scale Standard Deviation 11.42
State-Trait Anxiety Scale 3-month	44.98 units on a scale Standard Deviation 12.92	47.21 units on a scale Standard Deviation 13.20
State-Trait Anxiety Scale 12-month	43.27 units on a scale Standard Deviation 13.39	45.71 units on a scale Standard Deviation 12.29

Adverse Events

Cognitive Processing Therapy

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Present Centered Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cognitive Processing Therapy n=43 participants at risk Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.	Present Centered Therapy n=36 participants at risk Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called "present centered therapy" to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors
Psychiatric disorders Self Harm	2.3% 1/43 • Number of events 1	0.00% 0/36

Other adverse events

Adverse event data not reported

Additional Information

Dr. Kathleen M. Chard

Cincinnati VA Medical Center

Phone: 859-572-6741

Email: Kathleen.Chard@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place