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

NCT ID: NCT00909194

Last Updated: 2018-01-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2008-12-31

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.

Conditions

Juvenile Primary Fibromyalgia Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Psychoeducational Seminar and Relaxation Technique

Intervention Type: BEHAVIORAL

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

Control

Control Arm consisted of an educational seminar on skin care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Psychoeducational Seminar and Relaxation Technique

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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Joel Thompson

OTHER

Sponsor Role: lead

Responsible Party

Joel Thompson

Clinical trial compliance administrator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Karen M Lommel, DO, MHA

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Countries

United States

Other Identifiers

FIBRO1

Identifier Type: -

Identifier Source: org_study_id