NCT00825136

Brief Summary

Internet plays a more and more important role in many applications of healthcare. Many researches on the integrations of internet and mental health care have been proposed in recent years. This project aims at the development of an online treatment system which combines the biofeedback therapy and the web technologies to treat the patients suffering from panic disorder with partial response to medications. This project also evaluates the efficacy of a new- designed wireless temperature biofeedback ring.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2008

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 15, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 19, 2009

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

August 21, 2012

Status Verified

August 1, 2012

Enrollment Period

7 months

First QC Date

January 15, 2009

Last Update Submit

August 19, 2012

Conditions

Panic Disorder

Keywords

Panic DisorderTemperature BiofeedbackInternet

Outcome Measures

Primary Outcomes (1)

  • score change of The Panic Disorder Severity Scale(PDSS)

    day 1 / 4 weeks/ 8 weeks

Secondary Outcomes (1)

  • score change of MOS 36-Item Short-Form Health Survey (SF-36)

    day 1 / 4 weeks/ 8 weeks

Study Arms (2)

relaxation

ACTIVE COMPARATOR

The patients of this arm practice on-line muscle relaxation for 8 weeks.

Behavioral: relaxation

relaxation & biofeedback

EXPERIMENTAL

The patients of this arm practice on-line muscle relaxation plus finger temperature biofeedback for 8 weeks.

Behavioral: relaxationBehavioral: biofeedback (finger temperature biofeedback)

Interventions

relaxationBEHAVIORAL

Participants were asked to log in the system to keep the muscle relaxation program every day and complete some self-rating scales on browser every week.

relaxationrelaxation & biofeedback
biofeedback (finger temperature biofeedback)BEHAVIORAL

Participants were asked to log in the system to keep the muscle relaxation program plus finger temperature biofeedback every day and complete some self-rating scales on browser every week.

relaxation & biofeedback

Eligibility Criteria

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

You may qualify if:

  • The participant must fulfill DSM-IV criteria for panic disorder.
  • The participant must be between 18 and 60 years of age.
  • The participant must have panic disorder as the primary problem.
  • If the participant is taking prescribed drugs for panic disorder, a) the dosage have to be constant for 2 months before starting treatment, and b) the participant have to agree to keep the dosage constant for 1 month after starting treatment.
  • If the participant was already in therapy, the contact must have lasted at least 6 months and not be based on cognitive behavior therapy.
  • All participants have access to a computer with an Internet connection.

You may not qualify if:

  • The participant suffers from any other psychiatric disorder in immediate need of treatment.
  • The participant fulfills DSM-IV criteria for major depression.
  • The participant has epilepsy, kidney problems, strokes, organic brain syndrome, emphysema, heart disorders, or chronic hypertension. 4. The participant has alcoholism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Psychiatry Department, Chimei Medical Center

Tainan, 700, Taiwan

Location

MeSH Terms

Conditions

Panic Disorder

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsBehavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesFeedback, Psychological

Study Officials

  • Fong-Lin Jang, M.D.

    Chimei Medical Center

    STUDY DIRECTOR

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
Department of Psychiatry

Study Record Dates

First Submitted

January 15, 2009

First Posted

January 19, 2009

Study Start

July 1, 2008

Primary Completion

February 1, 2009

Study Completion

May 1, 2009

Last Updated

August 21, 2012

Record last verified: 2012-08

Locations

TW(1)