Treatment of Panic Disorder Via Internet With a Wireless Temperature Biofeedback Ring

NCT01671033 | Terminated DMC

• 1 other identifier: IRB 09902-006
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

From the scarce literature it showed that computer/internet-aided cognitive behavior therapy (CBT) was superior to waitlist and placebo assignment across outcome measures, and the effects of computer/internet-aided CBT were equal to therapist-delivered treatment across anxiety disorders. The aim of this study is to evidence the effectiveness of internet-based relaxation with biofeedback treatment for panic disorder.

Conditions

Panic Disorder

Keywords

Panic disorder; cognitive behavior therapy; Internet

Outcome Measures

Primary Outcomes (1)

• Score Change of The Panic Disorder Severity Scale(PDSS)

  Baseline / Week 4/ Week 8/ Week12/ Week 16

Secondary Outcomes (1)

• Score Change of relaxation-rating

  Baseline / Week 4/ Week 8/ Week 12/ Week 16

Study Arms (3)

Muscle Relaxation

EXPERIMENTAL

The patients of this arm practice on-line muscle relaxation every day.They complete the Brief Symptom Rating Scale(BSRS), Family APGAR(APGAR), the Chinese-version of the Medical Outcomes Study 36-Item Short Form Health Survey(SF-36), and the panic diary via internet browser. The Panic Disorder Severity Scale(PDSS)and Clinical Global Impression (CGI) were performed by well-trained clinicians.

Behavioral: Muscle Relaxation

Muscle Relaxation with Biofeedback

EXPERIMENTAL

The patients of this arm practice on-line muscle relaxation with finger temperature biofeedback every day. They complete the Brief Symptom Rating Scale(BSRS), Family APGAR(APGAR), the Chinese-version of the Medical Outcomes Study 36-Item Short Form Health Survey(SF-36), and the panic diary via internet browser. The Panic Disorder Severity Scale(PDSS)and Clinical Global Impression (CGI) were performed by well-trained clinicians.

Behavioral: Biofeedback; Behavioral: Muscle Relaxation

Waiting-List

NO INTERVENTION

The patients of this arm waited for four weeks. They complete the Brief Symptom Rating Scale(BSRS), Family APGAR (APGAR), the Chinese-version of the Medical Outcomes Study 36-Item Short Form Health Survey(SF-36), and the panic diary via internet browser. The Panic Disorder Severity Scale(PDSS)and Impressions-Improvement(CGI) were performed by well-trained clinicians.

Interventions

Biofeedback BEHAVIORAL

Patients with panic disorder practice muscle relaxation with temperature biofeedback monitor, and send the temperature data to server via internet every day. Therapist gives comments and suggestions on line. Patients also have to complete some self-rating scales on browser every day or every week.

Also known as: finger temperature biofeedback

Muscle Relaxation with Biofeedback

Muscle Relaxation BEHAVIORAL

Patients with panic disorder practice muscle relaxation via internet every day. Therapist gives comments and suggestions on line. Patients also have to complete some self-rating scales on browser every day or every week.

Muscle Relaxation; Muscle Relaxation with Biofeedback

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The participant must fulfill DSM-IV criteria for panic disorder.
• The participant must be between 20 and 60 years of age.
• The participant must have the Panic Disorder Severity Scale(PDSS) score ≧8.
• If the participant is taking prescribed drugs for panic disorder, a) the dosage have to be constant for 6 weeks before starting treatment, and b) the participant have to agree to keep the dosage constant for 2 months after starting treatment.
• If the participant was already in therapy, the contact must have lasted at least 3 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.
• The participant has alcoholism or substance dependence.

Sponsors & Collaborators

• Chimei Medical Center: lead
• National Cheng Kung University: collaborator

Study Sites (1)

Chimei Medical Center

Tainan, 70246, Taiwan

Location

MeSH Terms

Conditions

Panic Disorder

Interventions

Biofeedback, Psychology; Muscle Relaxation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological; Muscle Contraction; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

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: M.D.

Study Record Dates

• First Submitted: August 20, 2012
• First Posted: August 23, 2012
• Study Start: February 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: January 1, 2011
• Last Updated: August 23, 2012

Record last verified: 2010-04

Locations

TW (1)