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 |
| Secondary identifying numbers | Th 899/2-1, Th 899/2-2 |
- 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
Not provided at time of registration
Contact information
Dr Kati Thieme
Scientific
Scientific
1959 NE Pacific Street
Box 356540
Seattle
Washington
98195-6540
United States of America
| Phone | +1 206 685 2082 |
|---|---|
| thiemek@u.washington.edu |
Study information
| Study design | Randomized, placebo-controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | CBTOBTFMS |
| Study hypothesis | 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 |
| Condition | 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 | 1. Pain 2. Physical impairment 3. Affective distress |
| Secondary outcome measures | 1. Coping 2. Catastrophizing 3. Pain behaviour 4. Number of physician visits 5. Spouse behavior |
| Overall study start date | 01/04/2000 |
| Overall study end date | 01/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 180 |
| Participant 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 |
| Participant exclusion criteria | 1. Inflammatory rheumatic diseases 2. Acute episode of carcinoma 3. Psychotic episode 4. Opioid abuse |
| Recruitment start date | 01/04/2000 |
| Recruitment end date | 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
98195-6540
United States of America
Sponsor information
German Research Council (Deutsche Forschungsgemeinschaft) (DFG)
Research organisation
Research organisation
DFG
Kennedyallee 40
Bonn
53170
Germany
| Phone | +49 (0)22 8885 2626 |
|---|---|
| Anne.Brueggemann@dfg.de | |
| Website | http://www.dfg.de |
"ROR" |
https://ror.org/018mejw64 |
Funders
Funder type
Charity
German Research Council (Deutsche Forschungsgemeinschaft) (DFG)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
