Panic DisorderNCT00825136
Treatment of Panic Disorder Via Internet With a Wireless Temperature Biofeedback Ring
A study testing relaxation and biofeedback (finger temperature biofeedback) in people with Panic Disorder, run by Chimei Medical Center at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Panic Disorder
- What is being tested?
- relaxation and biofeedback (finger temperature biofeedback)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2008to May 2009
- 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 18 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 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.
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. 4. The participant has alcoholism.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study on Mental Health Care by Using Specific Vital Signs
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.
Read the detailed description
The participants should be chronic panic patients. They login an web-based server and practice muscle relaxation on-line every day. There will be two two parallel groups: one group practicing muscle relaxation only and the other practicing muscle relaxation with finger surface temperature monitor through a wireless biofeedback ring.
- Conditions
- Panic Disorder
- Being tested
- relaxation, biofeedback (finger temperature biofeedback)
- Keywords
- Panic Disorder, Temperature Biofeedback, 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.
relaxationBehavioural
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.
biofeedback (finger temperature biofeedback)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| relaxation | Active comparator | The patients of this arm practice on-line muscle relaxation for 8 weeks. Receives: Behavioral: relaxation |
| relaxation & biofeedback | Experimental | The patients of this arm practice on-line muscle relaxation plus finger temperature biofeedback for 8 weeks. Receives: Behavioral: relaxation; Behavioral: biofeedback (finger temperature biofeedback) |
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: day 1 / 4 weeks/ 8 weeks
Secondary outcomes (1)
score change of MOS 36-Item Short-Form Health Survey (SF-36)
Measured: day 1 / 4 weeks/ 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startJul 2008
- Primary completionFeb 2009
- Study completionMay 2009
Why it stopped: The main limitations were the small sample size and low completion rate.
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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chimei Medical Center
- Sponsor type
- University, hospital or other
- 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
- NCT00825136
- Sponsor's protocol ID
- IRB 09707-001
- Status last verified
- Aug 2012
- First submitted
- 15 Jan 2009
- Last updated
- 21 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Mental Health Care by Using Specific Vital Signs
- ClinicalTrials.gov ID
- NCT00825136
- Acronym / sponsor ID
- IRB 09707-001
- Conditions
- Panic Disorder
- Keywords
- Panic Disorder, Temperature Biofeedback, Internet
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The main limitations were the small sample size and low completion rate.
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Chimei Medical CenterUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 19 Jan 2009 (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.
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.
Detailed description
The participants should be chronic panic patients. They login an web-based server and practice muscle relaxation on-line every day. There will be two two parallel groups: one group practicing muscle relaxation only and the other practicing muscle relaxation with finger surface temperature monitor through a wireless biofeedback ring.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| relaxation | Active comparator | Behavioral: relaxationThe patients of this arm practice on-line muscle relaxation for 8 weeks. |
| relaxation & biofeedback | Experimental | Behavioral: relaxation, Behavioral: biofeedback (finger temperature biofeedback)The patients of this arm practice on-line muscle relaxation plus finger temperature biofeedback for 8 weeks. |
Who may qualify
- Ages
- 18 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 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.
Key exclusion criteria (3 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. 4. The participant has alcoholism.
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 |
|---|---|---|
| relaxationParticipants 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. | Behavioural | relaxation, relaxation & biofeedback |
| biofeedback (finger temperature biofeedback)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. | Behavioural | relaxation & biofeedback |
Primary outcome
score change of The Panic Disorder Severity Scale(PDSS)
Time frame: day 1 / 4 weeks/ 8 weeks
1 secondary outcome
score change of MOS 36-Item Short-Form Health Survey (SF-36)
Time frame: day 1 / 4 weeks/ 8 weeks
Results and safety
The study was stopped early (reason given: The main limitations were the small sample size and low completion rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 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 relaxation and biofeedback (finger temperature biofeedback) 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 3 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 21 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 main limitations were the small sample size and low completion rate.). 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: day 1 / 4 weeks/ 8 weeks). 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 21 Aug 2012.