NCT00183521

Brief Summary

This study will compare two different breathing regulation techniques to determine which is more effective in reducing the rate of panic attacks in people with panic disorder.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 16, 2005

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

December 2, 2011

Status Verified

November 1, 2011

Enrollment Period

3.7 years

First QC Date

September 13, 2005

Last Update Submit

November 30, 2011

Conditions

Panic Disorder

Keywords

HyperventilationBreathing ExercisesCarbon DioxidePanic Attack

Outcome Measures

Primary Outcomes (1)

  • Breathing regulation

    Measured at Month 6 after completion of therapy

Study Arms (3)

1

EXPERIMENTAL

Participants will receive raise-CO2 breathing regulation training

Behavioral: Raise-CO2 breathing regulation training

2

EXPERIMENTAL

Participants will receive lower-CO2 breathing regulation training

Behavioral: Lower-CO2 breathing regulation training

3

ACTIVE COMPARATOR

Participants will receive no breathing regulation training

Behavioral: Control

Interventions

Raise-CO2 breathing regulation trainingBEHAVIORAL

Reverse hyperventilation (defined by low arterial CO2) is often characteristic of individuals with panic disorder. Participants will be randomly assigned to one of three groups: raise-CO2 breathing, lower-CO2 breathing, or a control group. Participants in the raise-CO2 group will be taught techniques to recover from hyperventilation faster.

1
Lower-CO2 breathing regulation trainingBEHAVIORAL

According to the false suffocation alarm theory, anxiety is experienced when an overly sensitive hypothalamic mechanism is triggered by rising pCO2. Participants in the lower-CO2 group will be taught techniques to reach hyperventilation levels, then switch to breathing techniques that reduce hyperventilation symptoms.

2
ControlBEHAVIORAL

Participants in the control group will not be taught any breathing techniques but will be included in all assessments.

3

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Diagnosis of PD
  • History of panic attacks that are at least moderately severe in frequency and severity
  • Able and willing to comply with all study requirements

You may not qualify if:

  • History of chest pain, heart attack, congestive heart failure, or clinically significant irregular heartbeat
  • History of blood circulation problems or cerebrovascular accidents
  • Diabetes mellitus
  • Asthma or chronic obstructive pulmonary disease (COPD)
  • History of schizophrenia, bipolar disorder, or dementia
  • Drugs which would affect breathing
  • Alcohol or other substance abuse within 1 year prior to study entry
  • Current use of any recreational drugs or consumption of more than 15 alcoholic drinks per week
  • History of anxiety disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University & VA Health Care System

Palo Alto, California, 94304, United States

Location

Related Publications (1)

  • Kim S, Wollburg E, Roth WT. Opposing breathing therapies for panic disorder: a randomized controlled trial of lowering vs raising end-tidal P(CO(2)). J Clin Psychiatry. 2012 Jul;73(7):931-9. doi: 10.4088/JCP.11m07068.

    PMID: 22901344DERIVED

MeSH Terms

Conditions

Panic DisorderHyperventilation

Condition Hierarchy (Ancestors)

Anxiety DisordersMental DisordersRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Walton T. Roth, MD

    Stanford University and VA Health Care System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 16, 2005

Study Start

March 1, 2005

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

December 2, 2011

Record last verified: 2011-11

Locations

US(1)