JMIR Publications

ABSTRACT

Background:

Chronic widespread pain (CWP) is common in primary healthcare and it is challenging to find successful treatments. Interventions addressing both stress and chronic pain may yield synergistic effects. Internet-based cognitive behavioral therapy (iCBT) reduces stress-related pain responses, while person-centered physical activity enhances function and resilience. Combined, they may target core mechanisms underlying CWP.

Objective:

The aim was to evaluate the effectiveness of a therapist-guided iCBT program designed for stress management combined with a face-to-face physiotherapist plan, compared to the physiotherapist-guided physical activity plan as stand-alone, on pain and associated symptoms in individuals with CWP.

Methods:

A multi-centre randomized controlled trial with parallel groups. Women and men with CWP, aged 18–70 years, were recruited via social media in Sweden. The intervention group received a therapist-guided 14-module iCBT program for stress combined with a face-to-face physiotherapist-guided physical activity plan, whereas the control group received a stand-alone physical activity plan. Primary outcomes were pain intensity and number of pain locations. Secondary outcomes were symptoms of stress, overall health, fatigue, depression, health-related quality of life and physical activity. All variables were self-assessed using paper-based questionnaires at baseline and after 6 months. The allocation was concealed. Participants and researchers were not blinded.

Results:

Of 129 randomized participants (64 intervention, 65 control), 82 (64%) completed the 6-month follow-up. In the intervention group, 37% completed all 14 iCBT modules, while 88 participants (46 intervention, 42 control) completed all three physiotherapy visits. No between-group differences were observed for change in any outcome, mean (95% CI): Pain intensity 1.7 (7.5,11.0); number of pain locations -0.8 (-2.2,0.6); Stress and Crisis inventory 2.0 (-3.3,7.4); Fibromyalgia impact questionnaire total score 2.7 (-3.7,9.2); global fatigue 3.0 (-7.2,13.3); Multidimensional fatigue inventory: general fatigue 0.1 (-1.1,1.3); physical fatigue 0.4 (-1.1,1.9); mental fatigue 0.4 (-1.1,2.0); reduced activity -2.8 (-0.5,2.1); reduced motivation -0.5 (-2.2,1.2); Hospital anxiety and depression scale: anxiety -0.8 (-2.3,0.7); depression -0.2 (-1.7,1.3); Short-Form 36 (SF-36) subscales: physical function 2,9 (-3.7,9.5); role physical -13.1 (-28.3,2.0); role emotional -4.0 (-22.8,14.8); energy/fatigue 3.4 (-4.0,10.8); emotional well-being -0.5 (-8.2,7.3); Social functioning -4.6 (-15.0,5.8); pain -3.1 (-9.8,3.6); general health -2.2 (-9.2,4.9); Leisure time physical activity instrument 0.9 (-1.3,3.1). Both groups improved in primary and secondary outcomes. Individual main goals were fully attained by 37% in the intervention group versus 19% in the control group (P=.018), and intermediate goals by 54% versus 36% (P =.014).

Conclusions:

This study is novel in that it examines the effect of a stress-targeting intervention on pain. In practice, clinicians can focus on collaboratively developing tailored physical activity plans with patients, while considering optional stress-management interventions to support behavioral change and facilitate individual goal attainment in selected patients potentially experiencing elevated levels of perceived stress. Given the high loss to follow-up, the results should be cautiously interpreted. Clinical Trial: Trial registration: ClinicalTrials.gov Identifier: NCT04624139. Date of registration: 2020-11-02. First participant enrolled: 2020-11-04. URL:https://clinicaltrials.gov/study/NCT04624139