Individualized cognitive-behavioral therapy improves anxiety, depression, sleep quality, hopelessness, and disease severity in fibromyalgia syndrome: a single-blind randomized controlled trial

Burhan Fatih Koçyiğit, Gülşah Yaşa Öztürk, Mehmet Macit Sönmez, Saltanat K. Yerkebayeva, Meirgul I. Assylbek

2026

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DOI 10.1007/s00296-026-06146-9
Data confidence 70 medium
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Abstract

The current study evaluates the effects of individualized cognitive-behavioral therapy (CBT), administered alongside routine treatment, on anxiety, depression, sleep quality, hopelessness, and disease severity in patients with fibromyalgia syndrome (FMS). This is a randomized, controlled, single-blind clinical trial was conducted in a tertiary physical therapy and rehabilitation clinic. Seventy patients who met the 2016 American College of Rheumatology diagnostic criteria were randomized in a 1:1 ratio into an intervention group (n = 35) and a control group (n = 35). The intervention group received a 10-week individualized CBT program administered by a psychologist in addition to routine treatment, while the control group received only routine treatment. Outcomes were assessed using the hospital anxiety and depression Scale (HADS), comprising the anxiety subscale (HADS-A) and the depression subscale (HADS-D), Jenkins sleep scale (JSS), fibromyalgia impact questionnaire (FIQ), and Beck hopelessness scale (BHS) before and after the intervention. A total of 57 patients completed the study, with 23 in the intervention group and 34 in the control group. No significant differences were found between the groups in baseline demographic characteristics and scale scores (p > 0.05). The intervention group demonstrated statistically significant improvements in all scales following treatment: the HADS-A median score decreased from 13.00 to 10.00 (p < 0.001), the FIQ median score decreased from 71.80 to 51.52 (p < 0.001), and the BHS median score decreased from 7.00 to 4.00 (p < 0.001). In contrast, the control group showed no significant changes on any scale (p > 0.05). Individualized CBT, added to routine treatment, addresses anxiety, depression, sleep quality, disease impact, and other issues in FMS patients. Integrating individualized CBT protocols into clinical practice for fibromyalgia management should be encouraged.