Panic DisorderNCT01671033
Treatment of Panic Disorder Via Internet With a Wireless Temperature Biofeedback Ring
A study testing Biofeedback and Muscle Relaxation in people with Panic Disorder, run by Chimei Medical Center at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- Biofeedback and Muscle Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2010to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Muscle Relaxation With Biofeedback Via Internet for Panic disorder-a Randomized Pilot Study
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.
Read the detailed description
All participants had access to a computer with an internet connection and received the treatment via internet.
- Conditions
- Panic Disorder
- Being tested
- Biofeedback, Muscle Relaxation
- Keywords
- Panic disorder, cognitive behavior therapy, Internet
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiofeedbackBehavioural
Also called finger temperature biofeedback
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.
Muscle RelaxationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score Change of The Panic Disorder Severity Scale(PDSS)
Measured: Baseline / Week 4/ Week 8/ Week12/ Week 16
Secondary outcomes (1)
Score Change of relaxation-rating
Measured: Baseline / Week 4/ Week 8/ Week 12/ Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startFeb 2010
- Primary completionDec 2010
- Study completionJan 2011
Why it stopped: The drop-out rate was too high.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Panic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chimei Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cheng Kung University
- Responsible party
- Principal investigator, Fong-Lin Jang, Chimei Medical Center
- Investigators
- Fong-Lin Jang, M.D., Study director, Chimei Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671033
- Sponsor's protocol ID
- IRB 09902-006
- Status last verified
- Apr 2010
- First submitted
- 20 Aug 2012
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle Relaxation With Biofeedback Via Internet for Panic disorder-a Randomized Pilot Study
- ClinicalTrials.gov ID
- NCT01671033
- Acronym / sponsor ID
- IRB 09902-006
- Conditions
- Panic Disorder
- Keywords
- Panic disorder, cognitive behavior therapy, Internet
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The drop-out rate was too high.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Chimei Medical CenterUniversity, hospital or other
- Collaborators
- National Cheng Kung University
- Study start
- Feb 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 23 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Muscle Relaxation | Experimental | Behavioral: Muscle RelaxationThe 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 | Experimental | Behavioral: Biofeedback, Behavioral: Muscle RelaxationThe 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. |
| 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BiofeedbackAlso: finger temperature biofeedbackPatients 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. | Behavioural | Muscle Relaxation with Biofeedback |
| Muscle RelaxationPatients 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. | Behavioural | Muscle Relaxation, Muscle Relaxation with Biofeedback |
Primary outcome
Score Change of The Panic Disorder Severity Scale(PDSS)
Time frame: Baseline / Week 4/ Week 8/ Week12/ Week 16
1 secondary outcome
Score Change of relaxation-rating
Time frame: Baseline / Week 4/ Week 8/ Week 12/ Week 16
Results and safety
The study was stopped early (reason given: The drop-out rate was too high.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fong-Lin Jang, M.D. study director
Chimei Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback and Muscle Relaxation in people with Panic Disorder, run by Chimei Medical Center at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The drop-out rate was too high.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score Change of The Panic Disorder Severity Scale(PDSS) (time frame: Baseline / Week 4/ Week 8/ Week12/ Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2012.