Efficacy of operant- and cognitive-behavioral treatments in fibromyalgia syndrome: analysis of psychophysiological reactivity (Th 899/2-1) and analysis of psychophysiological reactivity in fibromyalgia-syndrome after operant- or cognitive-behavioral pain therapy in fibromyalgia-syndrome (Th 899/2-2)

ISRCTN	ISRCTN83953414
DOI	https://doi.org/10.1186/ISRCTN83953414
Protocol serial number	Th 899/2-1, Th 899/2-2
Sponsor	German Research Council (Deutsche Forschungsgemeinschaft) (DFG)
Funder	German Research Council (Deutsche Forschungsgemeinschaft) (DFG)

Submission date: 17/02/2006
Registration date: 20/02/2006
Last edited: 28/10/2008

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kati Thieme
Scientific

1959 NE Pacific Street
Box 356540
Seattle
Washington
98195-6540
United States of America

Phone	+1 206 685 2082
Email	thiemek@u.washington.edu

Study information

Primary study design	Interventional
Study design	Randomized, placebo-controlled clinical trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	CBTOBTFMS
Study objectives	1. Cognitive-Behavioral Therapy (CBT) and Operant-Behavioral Therapy (OBT) will produce significant improvements in pain, physical functioning, and emotional distress in Fibromyalgia Syndrome (FMS) patients 2. CBT and OBT will produce significantly greater improvements in pain, physical functioning, and emotional distress than the Attention Placebo (AP) treatment 3. CBT will produce significantly greater effects than the OBT and AP groups on coping and catastrophizing responses. Since the OBT indirectly focuses on inappropriate beliefs, it will produce significantly greater improvements on coping and catastrophizing than the AP group. 4. OBT will produce significantly greater reductions in pain, behaviors, physical therapy, and medication than CBT or AP treatments. Since CBT indirectly focuses on maladaptive behaviors, it will produce significantly greater improvements in pain behaviors than the AP group.
Ethics approval(s)	Approved by Charite, Humboldt-University, Berlin, Germany on 01/02/2000, reference number 1270/2000
Health condition(s) or problem(s) studied	Fibromyalgia syndrome
Intervention	The operant- and cognitive-behavioral pain therapy were compared to an attention placebo group (a social discussion group), a physiotherapy and a wait-list control group
Intervention type	Other
Primary outcome measure(s)	1. Pain 2. Physical impairment 3. Affective distress
Key secondary outcome measure(s)	1. Coping 2. Catastrophizing 3. Pain behaviour 4. Number of physician visits 5. Spouse behavior
Completion date	01/04/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	180
Key inclusion criteria	1. Participants must suffer from FMS as validated by a rheumatologist 2. They must meet the American College of Rheumatology (ACR) criteria for FMS 3. Pain for a period of at least six months 4. Married, and must show willingness of the spouse to be involved 5. Ability to complete the questionnaires and understand the treatment components
Key exclusion criteria	1. Inflammatory rheumatic diseases 2. Acute episode of carcinoma 3. Psychotic episode 4. Opioid abuse
Date of first enrolment	01/04/2000
Date of final enrolment	01/04/2005

Locations

Countries of recruitment

Germany
United States of America

Study participating centre

1959 NE Pacific Street

Washington
98195-6540
United States of America

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/12/2006		Yes	No