Panic DisorderNCT02826096
A Brief Version of Biofeedback Therapy for Panic Disorder
A study testing Biofeedback therapy in people with Panic Disorder and Feedback, Psychological, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The study is to examine the therapeutic effect of a brief version of biofeedback therapy (developed bu the research team) on panic disorder. It is a randomized controlled design. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Panic Disorder, Feedback, Psychological
- What is being tested?
- Biofeedback therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 Dec 2015to 18 Apr 2021
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- The age is younger than 20 or older than 70 years.
- With psychotic symptoms or cognitive dysfunction.
- A major physical illness (physical illness with fatal risks, such as cancer, myocardial infarction)
- Unable to read or understand the questionnaire
Trial locations and contacts
1 site in 1 country.
About this study
The study is to examine the therapeutic effect of a brief version of biofeedback therapy (developed bu the research team) on panic disorder. It is a randomized controlled design. The severity of panic symptoms of two groups of panic patients (reveiving biofeedback therapy or not) were measured before and after the six week duration. Besides, the severity of anxiety, depressive, somatic symptoms, and physiological indexes were recorded.
Read the detailed description
The purpose of this study is trying to find out whether our newly developed brief version of biofeedback is an effective treatment approach for panic disorder. At the same time, the investigators want to clarify the change of bio- and psycho- indices present through the process. Patient recently experienced panic attacks are recruited in this study. The diagnosis of "Panic Disorder" is made by psychiatrists according to The Diagnostic and Statistical Manual of Mental Disorders(DSM-5) criteria. Subjects are randomly assigned to medication group or biofeedback therapy. The biofeedback therapy is conducted by psychologists following the structure way. Every subject will be measured both the bio and psycho indices on week 0, 3, and 6 under 6-week observation. In the end of the study, the investigators hope to analyze and clarify the treatment effects of our design, and also to exam the meanings of these indices, in order to find out an effective treatment approach.
- Conditions
- Panic Disorder, Feedback, Psychological
- Being tested
- Biofeedback therapy
- Keywords
- Psychiatry, psychological, psychotherapy, randomize, Biofeedback
- Medical subject headings
- Panic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback therapyBehavioural
The brief version of biofeedback therapy is conducted by psychologists following the structure way. Biofeedback therapy is six session treatment once a week.
| Study group | Role | What they receive |
|---|---|---|
| biofeedback group | Experimental | biofeedback therapy Receives: Behavioral: Biofeedback therapy |
| medication group | No intervention | only medication treament |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline Panic Disorder Severity Scale (PDSS)
PDSS is a scale rating the severity of panic disorder. It is a 5-point Likert scale with 7 items. The scores range from 0 (lowest level of panic disorder) to 28 (highest level of panic disorder).
Measured: week 0, week 3, week 6
Secondary outcomes (8)
Scores of Patient Health Questionnaire-15 (PHQ-15)
PHQ-15 is a scale rating the severity of somatic distress. It is a 3-point Likert scale with 15 items. The scores range from 0 (lowest level of somatic distress) to 30 (highest level of somatic distress).
Measured: week 0, week 3, week 6
Scores of Health Anxiety Questionnaire (HAQ)
HAQ is a scale rating the severity of health anxiety. It is a 4-point Likert scale with 21 items. The scores range from 0 (lowest level of health anxiety) to 63 (highest level of health anxiety).
Measured: week 0, week 3, week 6
Penn State Worry Questionnaire (PSWQ)
PSWQ is a scale rating the severity of worry. It is 5-point Likert scale with 16 items. The scores range from 1 (lowest level of worry) to 80 (highest level of worry).
Measured: week 0, week 3, week 6
Scores of WHOQOL-BREF
It is a self-report questionnaire measuring health-related quality of life. It is a 4-point Likert scale with 28 items, which belong to 5 domains (the overall, physical, psychological, social and environmental domains). The scores of each domain are usually normalized with 0-20 or 0-100.
Measured: week 0, week 3, week 6
Sheehan Function Inventory
It is a scale rating the function in various dimensions of work, social life, leisure activities, family life and family responsibilities.
Measured: week 0, week 3, week 6
Scores of Beck Depression Inventory-II (BDI-II)
BDI- II is a scale rating the severity of depression. It is a 4-point Likert scale with 21 items. The scores range from 0 (lowest level of depression) to 63 (highest level of depression).
Measured: week 0, week 3, week 6
Scores of Beck Anxiety Inventory (BAI)
BAI is a scale rating the severity of anxiety. It is a 4-point Likert scale with 21 items. The scores range from 0 (lowest level of anxiety) to 63 (highest level of anxiety).
Measured: week 0, week 3, week 6
Degree of Change in Physiological Parameters
ProComp5 Infiniti (SA7525) Biofeedback System would be used. Heart rate variability, skin conductance, body temperature and respiratory rate would be measured.
Measured: week 0, week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start21 Dec 2015
- Primary completion18 Apr 2021
- Study completion18 Apr 2021
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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taiwan University Hospital, Yun-Lin Branch
- Responsible party
- Sponsor
- Investigators
- Kuan-Fu Lin, MD, Principal investigator, National Taiwan University Hospital, Yun-Lin Branch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826096
- Sponsor's protocol ID
- 201511031RIND
- Status last verified
- Apr 2021
- First submitted
- 5 Jul 2016
- Last updated
- 21 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Brief Version of Biofeedback Therapy for Panic Disorder
- ClinicalTrials.gov ID
- NCT02826096
- Acronym / sponsor ID
- 201511031RIND
- Conditions
- Panic Disorder, Feedback, Psychological
- Keywords
- Psychiatry, psychological, psychotherapy, randomize, Biofeedback
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Taiwan University Hospital, Yun-Lin Branch
- Study start
- 21 Dec 2015 (actual)
- Primary completion
- 18 Apr 2021 (actual)
- Study completion
- 18 Apr 2021 (actual)
- First posted
- 7 Jul 2016 (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.
The study is to examine the therapeutic effect of a brief version of biofeedback therapy (developed bu the research team) on panic disorder. It is a randomized controlled design. The severity of panic symptoms of two groups of panic patients (reveiving biofeedback therapy or not) were measured before and after the six week duration. Besides, the severity of anxiety, depressive, somatic symptoms, and physiological indexes were recorded.
Detailed description
The purpose of this study is trying to find out whether our newly developed brief version of biofeedback is an effective treatment approach for panic disorder. At the same time, the investigators want to clarify the change of bio- and psycho- indices present through the process. Patient recently experienced panic attacks are recruited in this study. The diagnosis of "Panic Disorder" is made by psychiatrists according to The Diagnostic and Statistical Manual of Mental Disorders(DSM-5) criteria. Subjects are randomly assigned to medication group or biofeedback therapy. The biofeedback therapy is conducted by psychologists following the structure way. Every subject will be measured both the bio and psycho indices on week 0, 3, and 6 under 6-week observation. In the end of the study, the investigators hope to analyze and clarify the treatment effects of our design, and also to exam the meanings of these indices, in order to find out an effective treatment approach.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| biofeedback group | Experimental | Behavioral: Biofeedback therapybiofeedback therapy |
| medication group | No intervention | –only medication treament |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- The age is younger than 20 or older than 70 years.
- With psychotic symptoms or cognitive dysfunction.
- A major physical illness (physical illness with fatal risks, such as cancer, myocardial infarction)
- Unable to read or understand the questionnaire
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 |
|---|---|---|
| Biofeedback therapyThe brief version of biofeedback therapy is conducted by psychologists following the structure way. Biofeedback therapy is six session treatment once a week. | Behavioural | biofeedback group |
Primary outcome
Changes from baseline Panic Disorder Severity Scale (PDSS)
Time frame: week 0, week 3, week 6
PDSS is a scale rating the severity of panic disorder. It is a 5-point Likert scale with 7 items. The scores range from 0 (lowest level of panic disorder) to 28 (highest level of panic disorder).
8 secondary outcomes
Scores of Patient Health Questionnaire-15 (PHQ-15)
Time frame: week 0, week 3, week 6
Scores of Health Anxiety Questionnaire (HAQ)
Time frame: week 0, week 3, week 6
Penn State Worry Questionnaire (PSWQ)
Time frame: week 0, week 3, week 6
Scores of WHOQOL-BREF
Time frame: week 0, week 3, week 6
Sheehan Function Inventory
Time frame: week 0, week 3, week 6
Scores of Beck Depression Inventory-II (BDI-II)
Time frame: week 0, week 3, week 6
Scores of Beck Anxiety Inventory (BAI)
Time frame: week 0, week 3, week 6
Degree of Change in Physiological Parameters
Time frame: week 0, week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Kuan-Fu Lin, MD principal investigator
National Taiwan University Hospital, Yun-Lin Branch
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 therapy in people with Panic Disorder and Feedback, Psychological, run by National Taiwan University Hospital 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 0 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: finished, as of the sponsor's last update on 21 Apr 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes from baseline Panic Disorder Severity Scale (PDSS) (time frame: week 0, week 3, week 6). 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 Apr 2021.