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Juvenile Primary Fibromyalgia Syndrome (JPFS) in an Adolescent Psychiatric Population

Primary Purpose

Juvenile Primary Fibromyalgia Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Psychoeducational Seminar and Relaxation Technique
Sponsored by
Joel Thompson
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Juvenile Primary Fibromyalgia Syndrome focused on measuring Juvenile Primary Fibromyalgia, Adolescents, Psychiatry

Eligibility Criteria

12 Years - 18 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Admitted to inpatient child psychiatric facility
  • Between 12-18 years of age
  • in parental or family (relative as guardian) custody

Exclusion Criteria:

  • In state custody
  • low intellectual functioning (i.e. IQ less than or equal to 70)
  • active psychosis

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Educational Seminar on Juvenile Primary Fibromyalgia Syndrome and CD-guided total body relaxation technique

Control Arm consisted of an educational seminar on skin care

Outcomes

Primary Outcome Measures

To characterize adolescents who are admitted to an inpatient psychiatric unit and meet criteria for JPFS

Secondary Outcome Measures

To determine the efficacy of an intervention on functioning and well-being (short-term and long-term)

Full Information

First Posted
May 26, 2009
Last Updated
January 19, 2018
Sponsor
Joel Thompson
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1. Study Identification

Unique Protocol Identification Number
NCT00909194
Brief Title
Juvenile Primary Fibromyalgia Syndrome (JPFS) in an Adolescent Psychiatric Population
Official Title
Juvenile Primary Fibromyalgia in a Female Adolescent Psychiatric Population
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Joel Thompson

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Primary Fibromyalgia Syndrome
Keywords
Juvenile Primary Fibromyalgia, Adolescents, Psychiatry

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
132 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Educational Seminar on Juvenile Primary Fibromyalgia Syndrome and CD-guided total body relaxation technique
Arm Title
Control
Arm Type
No Intervention
Arm Description
Control Arm consisted of an educational seminar on skin care
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducational Seminar and Relaxation Technique
Intervention Description
Psychoeducational seminar on Juvenile Primary Fibromyalgia (pain management, diet, exercise and sleep hygiene) followed by a total body relaxation technique
Primary Outcome Measure Information:
Title
To characterize adolescents who are admitted to an inpatient psychiatric unit and meet criteria for JPFS
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Admitted to inpatient child psychiatric facility Between 12-18 years of age in parental or family (relative as guardian) custody Exclusion Criteria: In state custody low intellectual functioning (i.e. IQ less than or equal to 70) active psychosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen M Lommel, DO, MHA
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States

12. IPD Sharing Statement

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Juvenile Primary Fibromyalgia Syndrome (JPFS) in an Adolescent Psychiatric Population

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