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

NCT00909194 | Completed

• 1 other identifier: FIBRO1
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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).

Conditions

Juvenile Primary Fibromyalgia Syndrome

Keywords

Juvenile Primary Fibromyalgia; Adolescents; Psychiatry

Outcome Measures

Primary Outcomes (1)

• 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)

  Immediately after intervention and 8 weeks after discharge

Study Arms (2)

Intervention

EXPERIMENTAL

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

Behavioral: Psychoeducational Seminar and Relaxation Technique

Control

NO INTERVENTION

Control Arm consisted of an educational seminar on skin care

Interventions

Psychoeducational Seminar and Relaxation Technique BEHAVIORAL

Psychoeducational seminar on Juvenile Primary Fibromyalgia (pain management, diet, exercise and sleep hygiene) followed by a total body relaxation technique

Intervention

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Joel Thompson: lead

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Interventions

Relaxation Therapy

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Karen M Lommel, DO, MHA

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical trial compliance administrator

Study Record Dates

• First Submitted: May 26, 2009
• First Posted: May 27, 2009
• Study Start: July 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: December 1, 2008
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

US (1)