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Completed

NCT Number: NCT00909194

Juvenile Primary Fibromyalgia Syndrome (JPFS) in an 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).

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Key information

Age range

12 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky

Lexington, Kentucky, 40536, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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)

    Time frame: Immediately after intervention and 8 weeks after discharge

Sponsors and collaborators

Lead sponsor

Joel Thompson

Other

Registry information

Official study title

Juvenile Primary Fibromyalgia in a Female Adolescent Psychiatric Population

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 27, 2009
Registry last updated
Jan 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.