Juvenile Primary Fibromyalgia SyndromeNCT00909194
Juvenile Primary Fibromyalgia Syndrome (JPFS) in an Adolescent Psychiatric Population
A study testing Psychoeducational Seminar and Relaxation Technique in people with Juvenile Primary Fibromyalgia Syndrome, run by Joel Thompson at 1 site in United States.
Trial summary
The purpose of this study was to identify clinical characteristics and estimate the prevalence of Juvenile Primary Fibromyalgia in a female inpatient psychiatric population. The secondary purpose of this study was to determine the efficacy of an intervention (psychoeducational seminar and relaxation technique) on… Read more about this study
- Who is it for?
- Ages 12 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Juvenile Primary Fibromyalgia Syndrome
- What is being tested?
- Psychoeducational Seminar and Relaxation Technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2008
- 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 12 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Admitted to inpatient child psychiatric facility
- Between 12-18 years of age
- in parental or family (relative as guardian) custody
Who cannot join
- In state custody
- low intellectual functioning (i.e. IQ less than or equal to 70)
- active psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Juvenile Primary Fibromyalgia in a Female Adolescent Psychiatric Population
The purpose of this study was to identify clinical characteristics and estimate the prevalence of Juvenile Primary Fibromyalgia in a female inpatient psychiatric population. The secondary purpose of this study was to determine the efficacy of an intervention (psychoeducational seminar and relaxation technique) on reducing the symptoms of Juvenile Primary Fibromyalgia Syndrome. We looked at the short-term and long-term effects of this intervention in comparison to the control (skin care seminar).
Read the detailed description
The specific aims of phase one of this study were to estimate the prevalence of Juvenile Primary Fibromyalgia Syndrome (JPFS) in an inpatient female psychiatric population and to identify characteristics associated with JPFS in this population. We chose to explore two primary hypotheses. Because of the common link between adult fibromyalgia and anxiety and depression, we hypothesize that those with JPFS will score higher on measures of these symptoms. Given the adult literature on the suspected link between physical and or sexual abuse and adult fibromyalgia, we also hypothesized that adolescents who meet criteria for JPFS will have higher rates of sexual and physical abuse.
The other specific aim of this study was to determine the short- and long-term impact of an intervention on reduction of JPFS symptoms. The intervention was a psychoeducational seminar on JPFS (pain management, diet, exercise and sleep hygiene) followed by a relaxation technique (audio-guided CD). The control group was involved in an educational seminar on skin care (WITHOUT relaxation technique). Study measures were obtained immediately before and after the intervention/control seminars (short-term) and 8 weeks after discharge (long-term). Each group was discharged with a CD player and CD with relaxation technique or skin care seminar. Participants recorded the use of the CD's and completed follow up questionnaires 8 weeks after discharge from the hospital.
- Conditions
- Juvenile Primary Fibromyalgia Syndrome
- Being tested
- Psychoeducational Seminar and Relaxation Technique
- Keywords
- Juvenile Primary Fibromyalgia, Adolescents, Psychiatry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducational Seminar and Relaxation TechniqueBehavioural
Psychoeducational seminar on Juvenile Primary Fibromyalgia (pain management, diet, exercise and sleep hygiene) followed by a total body relaxation technique
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Educational Seminar on Juvenile Primary Fibromyalgia Syndrome and CD-guided total body relaxation technique Receives: Behavioral: Psychoeducational Seminar and Relaxation Technique |
| Control | No intervention | Control Arm consisted of an educational seminar on skin care |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize adolescents who are admitted to an inpatient psychiatric unit and meet criteria for JPFS
Secondary outcomes (1)
To determine the efficacy of an intervention on functioning and well-being (short-term and long-term)
Measured: Immediately after intervention and 8 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2009 (estimated)
- Study startJul 2007
- Primary completionJun 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Primary Fibromyalgia SyndromeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joel Thompson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joel Thompson, University of Kentucky
- Investigators
- Karen M Lommel, DO, MHA, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00909194
- Sponsor's protocol ID
- FIBRO1
- Status last verified
- Jan 2018
- First submitted
- 26 May 2009
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Juvenile Primary Fibromyalgia in a Female Adolescent Psychiatric Population
- ClinicalTrials.gov ID
- NCT00909194
- Acronym / sponsor ID
- FIBRO1
- Conditions
- Juvenile Primary Fibromyalgia Syndrome
- Keywords
- Juvenile Primary Fibromyalgia, Adolescents, Psychiatry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Joel ThompsonUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 27 May 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.
The purpose of this study was to identify clinical characteristics and estimate the prevalence of Juvenile Primary Fibromyalgia in a female inpatient psychiatric population. The secondary purpose of this study was to determine the efficacy of an intervention (psychoeducational seminar and relaxation technique) on reducing the symptoms of Juvenile Primary Fibromyalgia Syndrome. We looked at the short-term and long-term effects of this intervention in comparison to the control (skin care seminar).
Detailed description
The specific aims of phase one of this study were to estimate the prevalence of Juvenile Primary Fibromyalgia Syndrome (JPFS) in an inpatient female psychiatric population and to identify characteristics associated with JPFS in this population. We chose to explore two primary hypotheses. Because of the common link between adult fibromyalgia and anxiety and depression, we hypothesize that those with JPFS will score higher on measures of these symptoms. Given the adult literature on the suspected link between physical and or sexual abuse and adult fibromyalgia, we also hypothesized that adolescents who meet criteria for JPFS will have higher rates of sexual and physical abuse.
The other specific aim of this study was to determine the short- and long-term impact of an intervention on reduction of JPFS symptoms. The intervention was a psychoeducational seminar on JPFS (pain management, diet, exercise and sleep hygiene) followed by a relaxation technique (audio-guided CD). The control group was involved in an educational seminar on skin care (WITHOUT relaxation technique). Study measures were obtained immediately before and after the intervention/control seminars (short-term) and 8 weeks after discharge (long-term). Each group was discharged with a CD player and CD with relaxation technique or skin care seminar. Participants recorded the use of the CD's and completed follow up questionnaires 8 weeks after discharge from the hospital.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Psychoeducational Seminar and Relaxation TechniqueEducational Seminar on Juvenile Primary Fibromyalgia Syndrome and CD-guided total body relaxation technique |
| Control | No intervention | –Control Arm consisted of an educational seminar on skin care |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Admitted to inpatient child psychiatric facility
- Between 12-18 years of age
- in parental or family (relative as guardian) custody
Key exclusion criteria (3 listed)
- In state custody
- low intellectual functioning (i.e. IQ less than or equal to 70)
- active psychosis
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 |
|---|---|---|
| Psychoeducational Seminar and Relaxation TechniquePsychoeducational seminar on Juvenile Primary Fibromyalgia (pain management, diet, exercise and sleep hygiene) followed by a total body relaxation technique | Behavioural | Intervention |
Primary outcome
To characterize adolescents who are admitted to an inpatient psychiatric unit and meet criteria for JPFS
1 secondary outcome
To determine the efficacy of an intervention on functioning and well-being (short-term and long-term)
Time frame: Immediately after intervention and 8 weeks after discharge
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 23 Jan 2018.
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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.
Karen M Lommel, DO, MHA principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducational Seminar and Relaxation Technique in people with Juvenile Primary Fibromyalgia Syndrome, run by Joel Thompson at 1 site in United States.
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 3 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: finished, as of the sponsor's last update on 23 Jan 2018. 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 United States. 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?
To characterize adolescents who are admitted to an inpatient psychiatric unit and meet criteria for JPFS. 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 Jan 2018.