Trial Outcomes & Findings for Post Traumatic Stress Disorder (PTSD) Hyperarousal Symptoms Treated With Physiological Stress Management (NCT NCT00855816)

Results Overview

Change in total score for all criterion D items on the Clinician-Administered PTSD Scale for DSM-IV, from baseline to post-treatment. Total Criterion D subscore = sum of all frequency (0-4) and intensity (0-4) ratings of 5 PTSD hyperarousal symptoms. Range: 0 to 40, with higher scores indicating more severe (frequent and/or intense) symptoms. Change score calculated as: CAPS D score time 2 - CAPS D score time 1. Greater negative change scores indicate greater reduction in symptom severity (aka symptom improvement).

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

80 participants

Primary outcome timeframe

Baseline and 8 weeks

Results posted on

2014-10-20

Participant Flow

Participant milestones

Participant milestones
Measure	Breathing Training relaxation training	Treatment as Usual No intervention - treatment as usual
Overall Study STARTED	47	33
Overall Study COMPLETED	21	12
Overall Study NOT COMPLETED	26	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Breathing Training relaxation training	Treatment as Usual No intervention - treatment as usual
Overall Study Withdrawal by Subject	22	15
Overall Study Lost to Follow-up	3	5
Overall Study Death	1	0
Overall Study Became ineligible	0	1

Baseline Characteristics

Post Traumatic Stress Disorder (PTSD) Hyperarousal Symptoms Treated With Physiological Stress Management

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Breathing Training n=47 Participants relaxation training	Treatment as Usual n=33 Participants No intervention: Treatment as usual	Total n=80 Participants Total of all reporting groups
Age, Continuous	53.09 years STANDARD_DEVIATION 11.04 • n=5 Participants	53.21 years STANDARD_DEVIATION 10.62 • n=7 Participants	53.14 years STANDARD_DEVIATION 10.8 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants	30 Participants n=7 Participants	70 Participants n=5 Participants
Region of Enrollment United States	47 participants n=5 Participants	33 participants n=7 Participants	80 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 8 weeks

Change in total score for all criterion D items on the Clinician-Administered PTSD Scale for DSM-IV, from baseline to post-treatment. Total Criterion D subscore = sum of all frequency (0-4) and intensity (0-4) ratings of 5 PTSD hyperarousal symptoms. Range: 0 to 40, with higher scores indicating more severe (frequent and/or intense) symptoms. Change score calculated as: CAPS D score time 2 - CAPS D score time 1. Greater negative change scores indicate greater reduction in symptom severity (aka symptom improvement).

Outcome measures

Outcome measures
Measure	Breathing Training n=47 Participants relaxation training	Treatment as Usual n=33 Participants No intervention: treatment as usual
Change Scores for Criteria D Items on the CAPS Structured Clinical Interview	-1.20 units on a scale Standard Deviation 4.41	-6.27 units on a scale Standard Deviation 6.22

Adverse Events

Breathing Training

Serious events: 3 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment as Usual

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Breathing Training n=47 participants at risk relaxation training	Treatment as Usual n=33 participants at risk No intervention: Treatment as usual
Musculoskeletal and connective tissue disorders Hospitalization	4.3% 2/47 • Number of events 2	0.00% 0/33
Blood and lymphatic system disorders Death	2.1% 1/47 • Number of events 1	0.00% 0/33
Psychiatric disorders Hospitalization	0.00% 0/47	3.0% 1/33 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Walton T. Roth, M.D.

VA Palo Alto Health Care System / Stanford University School of Medicine

Phone: 650-493-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place