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

Not Applicable

Terminated

• Conditions: Panic Disorder
• Interventions: Behavioral: Muscle Relaxation; Behavioral: Biofeedback

• Registration Number: NCT01671033
• Lead Sponsor: Chimei Medical Center

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.

Detailed Description

All participants had access to a computer with an internet connection and received the treatment via internet.

Study Timeline

• Study Start: 2010-02
• Status Verified: 2010-04
• Primary Completion: 2010-12
• Study Completion: 2011-01
• Study First Submitted: 2012-08-20
• Study First Submitted QC: 2012-08-22
• Last Update Submitted: 2012-08-22
• Study First Posted: 2012-08-23
• Last Update Posted: 2012-08-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. The participant must fulfill DSM-IV criteria for panic disorder.
2. The participant must be between 20 and 60 years of age.
3. The participant must have the Panic Disorder Severity Scale(PDSS) score ≧8.
4. 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.
5. If the participant was already in therapy, the contact must have lasted at least 3 months and not be based on cognitive behavior therapy.
6. All participants have access to a computer with an Internet connection.

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Muscle Relaxation	Muscle Relaxation	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.
Muscle Relaxation with Biofeedback	Biofeedback	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.
Muscle Relaxation with Biofeedback	Muscle Relaxation	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.

Primary Outcome Measures

Name	Time	Method
Score Change of The Panic Disorder Severity Scale(PDSS)	Baseline / Week 4/ Week 8/ Week12/ Week 16

Secondary Outcome Measures

Name	Time	Method
Score Change of relaxation-rating	Baseline / Week 4/ Week 8/ Week 12/ Week 16

Trial Locations

Locations (1)

Chimei Medical Center; 🇨🇳 Tainan, Taiwan