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Completed

NCT Number: NCT00268606

Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk

The present study is a new approach of examining tailored cognitive-behavioral interventions for fibromyalgia patients at risk. For this purpose, fibromyalgia patients are screened with respect to cognitive-behavioral risk factors and these patients are offered tailored cognitive-behavioral treatment options. It is expected that this approach will result in increased magnitude and maintenance of effects.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jeroen Bosch Ziekenhuis, department of Medical Psychology, 's-Hertogenbosch, Netherlands

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About this study

The fibromyalgia syndrome is a chronic condition with widespread pain that poses a great challenge for patients, rheumatologists and society because of the lack of optimal treatment options. There is extensive evidence that, in comparison with patients with rheumatoid arthritis, fibromyalgia patients report higher levels of functional disability, pain, fatigue, and lower levels of quality of life. Although effectiveness of pharmacological agents and other interventions is generally limited, most promising effects have been found for non-pharmacological treatments, particularly those with a primary focus on cognitive-behavioral treatment components. However, also these treatment outcomes are characterized by large individual variation. Particularly patients with less impairments in daily life seem to benefit less from these treatments. In line with the international literature, previous findings of the research group suggest that effectiveness might be increased when tailored cognitive-behavioural treatments are solely offered to patients at risk.

In the present project the effects of tailored interventions based on cognitive-behavioral factors for patients at risk are studied. In a randomized, controlled trial, fibromyalgia patients are screened for risk profiles. Patients at risk will be assigned to tailored cognitive or behavioral treatment conditions, depending on their risk profile with respect to cognitive-behavioral factors. Half of the patients are subsequently randomly assigned to a waiting list control condition. It is expected that this tailored treatment approach will increase magnitude and maintenance of treatment effects for pain, disability, fatigue and increased quality of life, which means an important step forward for patients, involved professionals and society.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • fibromyalgia according to the criteria of the American College of Rheumatology (ACR)

Exclusion criteria

  • physical or psychological comorbidity that interferes with cognitive-behavioral treatment
  • participation in other clinical trials
  • other psychological treatments
  • pregnancy
  • illiteracy
  • difficulties with understanding Dutch language

Treatment and study plan

Cognitive-Behavioral Therapy

Behavioral

Primary outcomes

  1. pain

  2. disability

  3. fatigue

  4. psychological distress at post treatment and 6 month follow-up

Secondary outcomes

  1. passive coping

  2. illness cognitions

  3. social support at post treatment and 6 month follow-up

Sponsors and collaborators

Lead sponsor

ZonMw: The Netherlands Organisation for Health Research and Development

Other

Collaborators

  • Radboud University Medical Center
  • Reumafonds
  • Sint Maartenskliniek

Registry information

Official study title

Tailored Cognitive-Behavioral Therapy for Fibromyalgia Patients at Risk: A Randomized, Controlled Trial

Important dates

Study start
2003
Study completion
2007
First posted
Dec 22, 2005
Registry last updated
May 21, 2008

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.

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