Trial Outcomes & Findings for Exposure Therapy for Chronic PTSD: Efficacy and Mechanisms (NCT NCT00475241)

Results Overview

Clinician Administered PTSD Scale (CAPS) assesses PTSD symptom severity. Scores range from 0 to 136 and higher scores represent more severe symptoms.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

36 participants

Primary outcome timeframe

PostTreatment (Week 12)

Results posted on

2019-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	Prolonged Exposure Prolonged exposure therapy for PTSD Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD	Present Centered Therapy Present centered therapy for PTSD Present centered therapy for PTSD: present focused coping and problem solving for PTSD
Overall Study STARTED	18	18
Overall Study COMPLETED	11	15
Overall Study NOT COMPLETED	7	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Exposure Therapy for Chronic PTSD: Efficacy and Mechanisms

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prolonged Exposure n=11 Participants Prolonged exposure therapy for PTSD Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD	Present Centered Therapy n=15 Participants Present centered therapy for PTSD Present centered therapy for PTSD: present focused coping and problem solving for PTSD	Total n=26 Participants Total of all reporting groups
Age, Continuous	29.8 years STANDARD_DEVIATION 6.5 • n=5 Participants	32.9 years STANDARD_DEVIATION 7.2 • n=7 Participants	31.6 years STANDARD_DEVIATION 7.0 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	15 Participants n=7 Participants	24 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants	15 Participants n=7 Participants	26 Participants n=5 Participants
CAPS	79.2 units on a scale STANDARD_DEVIATION 12.1 • n=5 Participants	77.4 units on a scale STANDARD_DEVIATION 12.1 • n=7 Participants	78.2 units on a scale STANDARD_DEVIATION 11.9 • n=5 Participants

PRIMARY outcome

Timeframe: PostTreatment (Week 12)

Population: Treatment Completers

Clinician Administered PTSD Scale (CAPS) assesses PTSD symptom severity. Scores range from 0 to 136 and higher scores represent more severe symptoms.

Outcome measures

Outcome measures
Measure	Prolonged Exposure n=11 Participants Prolonged exposure therapy for PTSD Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD	Present Centered Therapy n=15 Participants Present centered therapy for PTSD Present centered therapy for PTSD: present focused coping and problem solving for PTSD
Clinician Administered PTSD Scale (Pre & Posttreatment)	30.0 units on a scale Standard Deviation 18.4	53.6 units on a scale Standard Deviation 28.7

SECONDARY outcome

Timeframe: PostTreatment (Week 12)

Population: data was not available due to recording errors for some patients

Psychophysiological reactivity will be assessed using electromyography collected using a Biopac MP-100 physiology. The potentiation is recorded using a difference score (trauma probe response minus non-trauma probe response). The unit of measure is µV. Higher is more response to trauma cue compared to non-trauma cue.

Outcome measures

Outcome measures
Measure	Prolonged Exposure n=7 Participants Prolonged exposure therapy for PTSD Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD	Present Centered Therapy n=10 Participants Present centered therapy for PTSD Present centered therapy for PTSD: present focused coping and problem solving for PTSD
Trauma Potentiated Startle	4.8 µV Standard Deviation 16.2	19.5 µV Standard Deviation 30.3

SECONDARY outcome

Timeframe: PostTreatment (Week 12)

Population: Patient assay quality not adequate for some patients

Area under the curve for awakening, 30 min, and 45 minute salivary cortisol assays. Higher means more cortisol response to awakening detected.

Outcome measures

Outcome measures
Measure	Prolonged Exposure n=7 Participants Prolonged exposure therapy for PTSD Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD	Present Centered Therapy n=10 Participants Present centered therapy for PTSD Present centered therapy for PTSD: present focused coping and problem solving for PTSD
Cortisol Response to Awakening	1.2 min*mg/mL Standard Deviation .4	.5 min*mg/mL Standard Deviation .4

SECONDARY outcome

Timeframe: PostTreatment (Week 12)

Population: patients with missing data not included

Self-report measure of trauma-related cognitions. Range is 21-147. Higher is more problematic trauma-related cognitions.

Outcome measures

Outcome measures
Measure	Prolonged Exposure n=11 Participants Prolonged exposure therapy for PTSD Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD	Present Centered Therapy n=14 Participants Present centered therapy for PTSD Present centered therapy for PTSD: present focused coping and problem solving for PTSD
Posttraumatic Cognitions Inventory	91.3 units on a scale Standard Deviation 41.9	97.1 units on a scale Standard Deviation 45.6

Adverse Events

Prolonged Exposure

Serious events: 0 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

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sheila A.M. Rauch

VA Ann Arbor Healthcare System

Phone: 734-845-3545

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place