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

Not Applicable

Completed

• Conditions: Juvenile Primary Fibromyalgia Syndrome
• Interventions: Behavioral: Psychoeducational Seminar and Relaxation Technique

• Registration Number: NCT00909194
• Lead Sponsor: Joel Thompson

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.

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2008-06
• Study Completion: 2008-12
• Study First Submitted: 2009-05-26
• Study First Submitted QC: 2009-05-26
• Study First Posted: 2009-05-27
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-19
• Last Update Posted: 2018-01-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 132

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Psychoeducational Seminar and Relaxation Technique	Educational Seminar on Juvenile Primary Fibromyalgia Syndrome and CD-guided total body relaxation technique

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
To determine the efficacy of an intervention on functioning and well-being (short-term and long-term)	Immediately after intervention and 8 weeks after discharge

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States