Trial Outcomes & Findings for Respiratory Dysregulation and Breathing Training in Anxious Outpatients (NCT NCT00108277)

Results Overview

Episodic Anxiety Scale (EAS) is a modification of the Panic Disorder Severity Scale (Shear et al., 1997) that includes 2 additional questions regarding acute anxiety episodes that may not meet full criteria for a panic attack. The EAS consists of 9 questions, each ranging from 0 (none) to 4 (worst possible). The EAS total score is the sum of all 9 items, such that the minimum total score = 0 (no anxiety symptoms) and maximum total score = 36 (worst possible anxiety symptoms).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

92 participants

Primary outcome timeframe

1 month

Results posted on

2015-01-19

Participant Flow

Participants were recruited from October 2005 to September 2008 from the local VA medical center and surrounding community. Participants were primarily recruited via posted flyers and other public advertisements (e.g., ads in local newspapers).

Participant milestones

Participant milestones
Measure	Raise CO2 Raise CO2 Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2	Lower CO2 Lower CO2 Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2	Waitlist Waitlist Treatment as Usual
Overall Study STARTED	29	28	35
Overall Study COMPLETED	19	16	19
Overall Study NOT COMPLETED	10	12	16

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Respiratory Dysregulation and Breathing Training in Anxious Outpatients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Raise CO2 n=29 Participants Raise CO2 Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2	Lower CO2 n=28 Participants Lower CO2 Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2	Waitlist n=35 Participants Waitlist Treatment as usual	Total n=92 Participants Total of all reporting groups
Age, Continuous	47.3 years STANDARD_DEVIATION 13.2 • n=5 Participants	40.6 years STANDARD_DEVIATION 12.2 • n=7 Participants	49.9 years STANDARD_DEVIATION 10.9 • n=5 Participants	45.9 years STANDARD_DEVIATION 12.1 • n=4 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	20 Participants n=7 Participants	25 Participants n=5 Participants	61 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	8 Participants n=7 Participants	10 Participants n=5 Participants	31 Participants n=4 Participants
Race/Ethnicity, Customized White	15 participants n=5 Participants	16 participants n=7 Participants	17 participants n=5 Participants	48 participants n=4 Participants
Race/Ethnicity, Customized Other	14 participants n=5 Participants	12 participants n=7 Participants	18 participants n=5 Participants	44 participants n=4 Participants
Episodic Anxiety Scale	15.5 units on a scale STANDARD_DEVIATION 3.44 • n=5 Participants	15.7 units on a scale STANDARD_DEVIATION 4.53 • n=7 Participants	16.1 units on a scale STANDARD_DEVIATION 3.23 • n=5 Participants	15.8 units on a scale STANDARD_DEVIATION 3.73 • n=4 Participants

PRIMARY outcome

Timeframe: 1 month

Episodic Anxiety Scale (EAS) is a modification of the Panic Disorder Severity Scale (Shear et al., 1997) that includes 2 additional questions regarding acute anxiety episodes that may not meet full criteria for a panic attack. The EAS consists of 9 questions, each ranging from 0 (none) to 4 (worst possible). The EAS total score is the sum of all 9 items, such that the minimum total score = 0 (no anxiety symptoms) and maximum total score = 36 (worst possible anxiety symptoms).

Outcome measures

Outcome measures
Measure	Raise CO2 n=19 Participants Raise CO2 Breathing Training-Raise CO2: while breathing 9 breaths per minute, patients are instructed to raise CO2	Lower CO2 n=16 Participants Lower CO2 Breathing Training- Lower CO2: while breathing 9 breaths per minute, patients are instructed to lower CO2	Waitlist n=19 Participants Waitlist Treatment as usual
Episodic Anxiety Scale	8.1 units on a scale Standard Deviation 2.73	9.0 units on a scale Standard Deviation 3.89	14.3 units on a scale Standard Deviation 3.67

Adverse Events

Raise CO2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Lower CO2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Waitlist

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

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