Williams 2010.
Methods |
Study setting: North America (USA). Single university research centre, outpatient based, referral by primary or specialist care physician Study design: Parallel Duration therapy: 6 months Follow‐up: None Analysis: Comparisons between groups (baseline): t‐tests and Chi‐quadrat, intention‐to‐treat approach, ANCOVA, responder analysis to anyone who reported 30% improvement in pain, an 0.50 SD in physical function via Fisher's exact test |
|
Participants |
Patients: Treatment Group: 59 patients, 95% female, 98% white, mean age 50 years; duration FM 9.5 (6.9) years Control Group: 59 patients, 95% female, 97% white, mean age 51 years; duration FM 9.3 (6.1) years Inclusion: ACR 1990 criteria for FM, age > 18 years, under standard medical care of a physician the last 3 months prior to assessment, possess basic computer literacy and access Exclusion: Severe physical impairment, co‐morbid medical illnesses capable of causing a worsening of physical functional status independent of FM, any present psychiatric disorder involving psychosis, suicide attempts or current risk, substance abuse, prior CBT for pain management, pending status associated with disability compensation or receipt of disability compensation in the last 2 years |
|
Interventions |
Treatment Group: Self management education program: Web‐enhanced Behavioral Self‐Management: website included 13 modules segregated into: educational lectures, education, behavioral and cognitive skills to help with symptom management, behavioral and cognitive skills to facilitate adaptive life style changes for managing FM. Each module featured a video lecture. Total hours: NA, but mean number of skills used every month and in total Control Group: TAU Co‐medication allowed: Yes Other Co‐therapies: Not reported |
|
Outcomes |
Primary Outcomes Self reported pain: Pain Severity scale of the Brief Pain Inventory (BPI) 0‐10 Self reported negative mood: CED‐S 0‐60 Self reported disability: SF‐36 Physical Functioning Scale 50‐0 Acceptability: Total dropout rate Secondary Outcomes Self reported self efficacy pain: Not assessed Self reported fatigue: Multidimensional Fatigue Inventory (MFI) 4‐20 Self reported sleep problems: MOS Sleep Scale 50‐0 Self reported disease‐specific health‐related quality of life: Not assessed |
|
Notes | 1. Reasons for dropout: ‐ Treatment Group: 1xmedical complications, 3xpersonal choice ‐ Control Group: 1x medical complications, 6x personal choice 1x relocation 2. Attendance rate: 89‐94% of the patients in the self management education group used at least 1 skill by month 3. Responder analysis: 29% of the patients in the self management education group and 8% of the patients in the TAU group reported a ≥30% pain reduction at final treatment. 31% of the patients in the self management education group and 6% of the patients in the TAU group reported a ≥0.5 SD improvement of the subscale physical functioning of the SF‐36 at end of treatment 4. Funding sources and declaration of interest of the primary researchers: Supported in part by Grant numbers R01‐AR050044 (NIAMS/ NIH), and DAMD 17‐00‐2‐0018 (Department of Defense). |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computerised randomisation program |
Allocation concealment (selection bias) | Low risk | Allocation sequence was done by computerised randomisation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | BOCF was used in ITT analysis for missing endpoint values |
Selective reporting (reporting bias) | Low risk | All outcomes reported |
Blinding of outcome assessor | Low risk | Study personnel were blinded |