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

TL;DR

Individualized cognitive-behavioral therapy added to routine treatment produced statistically significant improvements in anxiety, depression, sleep quality, hopelessness, and disease severity in fibromyalgia syndrome patients, while routine treatment alone showed no significant changes on any scale.

Key Findings

Individualized CBT significantly reduced anxiety scores in fibromyalgia patients compared to routine treatment alone.

  • HADS-A median score decreased from 13.00 to 10.00 in the intervention group (p < 0.001)
  • The control group showed no significant changes on the HADS-A (p > 0.05)
  • Outcomes were assessed using the Hospital Anxiety and Depression Scale (HADS) anxiety subscale (HADS-A)
  • Assessment was conducted before and after the 10-week intervention

Individualized CBT significantly reduced disease impact scores as measured by the Fibromyalgia Impact Questionnaire.

  • FIQ median score decreased from 71.80 to 51.52 in the intervention group (p < 0.001)
  • The control group showed no significant changes on the FIQ (p > 0.05)
  • The FIQ was used to measure fibromyalgia disease severity and overall impact
  • The baseline FIQ score of 71.80 indicates high disease burden at study entry

Individualized CBT significantly reduced hopelessness scores in fibromyalgia patients.

  • BHS median score decreased from 7.00 to 4.00 in the intervention group (p < 0.001)
  • The control group showed no significant changes on the Beck Hopelessness Scale (p > 0.05)
  • Hopelessness was measured using the Beck Hopelessness Scale (BHS)
  • Assessment was conducted before and after the 10-week CBT program

Individualized CBT produced statistically significant improvements in depression and sleep quality in fibromyalgia patients.

  • The intervention group demonstrated statistically significant improvements in HADS-D (depression subscale) and Jenkins Sleep Scale (JSS) scores following treatment
  • The control group showed no significant changes on either the HADS-D or JSS (p > 0.05)
  • Sleep quality was measured using the Jenkins Sleep Scale (JSS)
  • Specific pre/post median scores for HADS-D and JSS were not reported in the abstract

The study randomized 70 fibromyalgia patients but experienced notable dropout, with 57 completing the trial.

  • 70 patients meeting 2016 American College of Rheumatology diagnostic criteria were randomized 1:1 into intervention (n = 35) and control (n = 35) groups
  • 57 patients completed the study: 23 in the intervention group and 34 in the control group
  • Dropout was disproportionate, with 12 patients lost from the intervention group versus 1 from the control group
  • No significant differences were found between groups in baseline demographic characteristics and scale scores (p > 0.05)
  • The study was conducted in a tertiary physical therapy and rehabilitation clinic as a single-blind randomized controlled trial

The CBT intervention was individualized, delivered by a psychologist over 10 weeks, and administered in addition to routine treatment.

  • The intervention group received a 10-week individualized CBT program administered by a psychologist
  • CBT was added to routine treatment, while the control group received only routine treatment
  • The trial was single-blind in design
  • Outcomes were assessed before and after the intervention using five validated scales: HADS-A, HADS-D, JSS, FIQ, and BHS

What This Means

This research suggests that adding individualized talk therapy (specifically cognitive-behavioral therapy, or CBT) to standard medical treatment can meaningfully help people with fibromyalgia syndrome manage several aspects of their condition. In this study, 70 patients were randomly assigned to receive either their usual treatment alone or usual treatment plus a 10-week personalized CBT program delivered by a psychologist. After the program ended, patients who received CBT showed significant improvements in anxiety, depression, hopelessness, sleep quality, and the overall impact of fibromyalgia on their daily lives. Patients who only received standard treatment showed no meaningful improvement in any of these areas. The improvements were measured using standardized questionnaires. For example, anxiety scores dropped from a median of 13 to 10, disease impact scores dropped from 71.80 to 51.52, and hopelessness scores dropped from 7 to 4 — all statistically significant changes. This is notable because fibromyalgia is a complex chronic pain condition that does not respond fully to medication alone, and the psychological and emotional burden it places on patients is substantial. One important limitation of this study is that more patients dropped out of the CBT group (12 out of 35) than the control group (1 out of 35), which could affect how generalizable the results are. Despite this, the authors concluded that individualized CBT protocols should be encouraged as part of routine clinical care for fibromyalgia, suggesting that psychological treatment tailored to the individual patient may be a valuable addition to existing fibromyalgia management strategies.

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Citation

Kocyigit B, &#xd6;zt&#xfc;rk G, S&#xf6;nmez M, Yerkebayeva S, Assylbek M. (2026). Individualized cognitive-behavioral therapy improves anxiety, depression, sleep quality, hopelessness, and disease severity in fibromyalgia syndrome: a single-blind randomized controlled trial.. Rheumatology international. https://doi.org/10.1007/s00296-026-06146-9