"A Smartphone-Based Intervention With Diaries and Therapist Feedback to Reduce Catastrophizing and Increase Functioning in Women With Chronic Widespread Pain. Part 2: 11-month Follow-up Results of a Randomized Trial"

Abstract

Background: Internet-based interventions are increasingly used to support self-management of individuals with chronic illnesses. Web-based interventions may also be effective in enhancing self-management for individuals with chronic pain, but little is known about long-term effects. Research on Web-based interventions to support self-management following participation in pain management programs is limited. Objective: The aim is to examine the long-term effects of a 4-week smartphone-intervention with diaries and therapist-written feedback following an inpatient chronic pain rehabilitation program, previously found to be effective at short-term and 5-month follow-ups. Methods: 140 women with chronic widespread pain, participating in a 4-week inpatient rehabilitation program, were randomized into two groups: with or without a smartphone intervention after the rehabilitation. The smartphone intervention consisted of one face-to-face individual session and 4 weeks of written communication via a smartphone, consisting of three diaries daily to elicit pain-related thoughts, feelings, and activities, as well as daily personalized written feedback based on cognitive behavioral principles from a therapist. Both groups were given access to an informational website to promote constructive self-management. Outcomes were measured with self-reported paper-and-pencil format questionnaires with catastrophizing as the primary outcome measure. Secondary outcomes included daily functioning and symptom levels, acceptance of pain, and emotional distress. Results: By the 11-month follow-up, the favorable between-group differences previously reported post-intervention and at 5-month follow-up on catastrophizing, acceptance, functioning, and symptom level were no longer evident (P>.10). However, there was more improvement in catastrophizing scores during the follow-up period in the intervention group (M=-2.36, SD 8.41) compared to the control group (M=.40, SD 7.20), P=.045. Also, per protocol within-group analysis showed a small positive effect (Cohen’s d=.33) on catastrophizing in the intervention group (P=.04) and no change in the control group from the smartphone intervention baseline to 11-month follow-up. A positive effect (Cohen’s d=.73) on acceptance was found within the intervention group (P<.001) but not in the control group. Small to large negative effects were found within the control group on functioning and symptom levels, emotional distress, and fatigue (P=.05) from the intervention baseline to the 11-month follow-up. Conclusion: The long-term results of this randomized trial are ambiguous. No significant between-group effect was found on the study variables at 11-month follow-up. However, the within-group analyses, comparing the baseline for the smartphone intervention to the 11-month data, indicated changes in the desired direction in catastrophizing and acceptance in the intervention group but not within the control group. This study provides modest evidence supporting the long-term effect of the intervention. Trial Registration: Clinicaltrials.gov NCT01236209; http://www.clinicaltrials.gov/ct2/show/NCT01236209 (Archived by WebCite at http://www.webcitation.org/6FF7KUXo0)