Combined Internet-Based Cognitive Behavioral Therapy and Face-to-Face Physiotherapy in Primary Health Care for Chronic Widespread Pain: Randomized Controlled Trial.

backgroundFinding successful treatments for chronic widespread pain (CWP) in primary care is challenging. Interventions addressing both stress and pain may yield synergistic effects. Internet-based cognitive behavioral therapy (iCBT) reduces stress-related pain responses, while physical activity enhances function and resilience. Combined, they may target core CWP mechanisms.

objectiveThis study aimed to evaluate the effectiveness of therapist-guided iCBT for stress management combined with physiotherapist-guided physical activity, compared to stand-alone physical activity, on pain and associated symptoms in individuals with CWP.

methodsParticipants with CWP, aged 18-70 years, were recruited in this parallel, multicenter randomized controlled trial via social media in Sweden. The intervention group received a 14-module iCBT program plus a physical activity plan; the control group received the physical activity plan only. Primary outcomes were pain intensity and pain locations. Secondary outcomes included stress, fatigue, depression, and quality of life. Variables were self-assessed using paper questionnaires at baseline and 6 months. Allocation was concealed; participants and researchers were not blinded.

resultsOf 129 participants (64 intervention, 65 control), 82 (64%) completed the 6-month follow-up. In the intervention group, 37% (16/43) completed all 14 iCBT modules. No between-group differences were observed for change in any outcome: pain intensity (mean 1.7, 95% CI -7.5 to 11.0), pain locations (mean -0.8, 95% CI -2.2 to 0.6), Stress and Crisis Inventory (mean 2.0, 95% CI -3.3 to 7.4), Fibromyalgia Impact Questionnaire (mean 2.7, 95% CI -3.7 to 9.2), global fatigue (mean 3.0, 95% CI -7.2 to 13.3), Multidimensional Fatigue Inventory (general fatigue: mean 0.1, 95% CI -1.1 to 1.3; physical: mean 0.4, 95% CI -1.1 to 1.9; mental: mean 0.4, 95% CI -1.1 to 2.0; reduced activity: mean -2.8, 95% CI -0.5 to 2.1; reduced motivation mean -0.5, 95% CI -2.2 to 1.2), Hospital Anxiety and Depression Scale (anxiety: mean -0.8, 95% CI -2.3 to 0.7; depression: mean -0.2, 95% CI -1.7 to 1.3), and Short-Form 36 subscales (physical function: mean 2.9, 95% CI -3.7 to 9.5; role physical: mean -13.1, 95% CI -28.3 to 2.0; role emotional: mean -4.0, 95% CI -22.8 to 14.8; energy/fatigue: mean 3.4, 95% CI -4.0 to 10.8; emotional well-being: mean -0.5, 95% CI -8.2 to 7.3; social functioning: mean -4.6, 95% CI -15.0 to 5.8; pain: mean -3.1, 95% CI -9.8 to 3.6; general health: mean -2.2, 95% CI -9.2 to 4.9). Both groups improved across several outcomes. Main goals were attained by 37% (17/46) in the intervention group vs 19% (8/42) in controls (P=.02), and intermediate goals by 54% (25/46) vs 36% (15/42; P=.01).

conclusionsThis study novelly examines stress-targeting interventions for pain. Clinicians could focus on tailored physical activity plans while considering optional stress management to support behavioral change and goal attainment. Due to high loss to follow-up, results should be interpreted cautiously.

trial registrationClinicalTrials.gov NCT04624139; https://clinicaltrials.gov/study/NCT04624139.