Feasibility, acceptability, and fidelity of remote-delivered abbreviated mindfulness-based cognitive therapy interventions for patients with migraine and depressive symptoms.

Abstract

Objective: This study was an open-label single-arm clinical trial evaluating the fidelity, feasibility, acceptability, and clinical signal of abbreviated mindfulness-based cognitive therapy (MBCT-brief) delivered either via telephone (MBCT-T) or by video conferencing (MBCT-V) for people with migraine and comorbid depressive symptoms.

Background: Migraine is commonly comorbid with elevated depressive symptoms. MBCT reduces depressive symptoms and shows promise to reduce migraine-related disability. An abbreviated and remotely delivered version of MBCT could increase access to care.

Methods: People with migraine and elevated depressive symptoms were recruited from a large urban health system. Participants were assigned in blocks of eight to receive an evidence-based MBCT-brief treatment, including eight weekly group classes and home practice delivered via telephone (MBCT-T) or video (MBCT-V); MBCT-T was randomly selected for the first block. Sessions were recorded and coded for treatment fidelity. Feasibility was assessed via session attendance (primary), homework completion, recruitment rate, and survey completion rate. Acceptability was assessed via the eight-item Client Satisfaction Questionnaire (CSQ-8; primary), the Credibility/Expectancy Questionnaire (CEQ), the System Usability Scale (SUS), and items assessing survey acceptability. Participants completed the Headache Disability Inventory (HDI) and Quick Inventory of Depressive Symptomatology-Self Report 16-item (QIDS-SR₁₆) at baseline, mid-treatment, and post-treatment. Feasibility and acceptability rates were compared to a priori benchmarks.

Results: Participants (n = 16) were all female with a mean (standard deviation [SD]) age of 45 (13) years, the majority of whom identified as White (13/16, 81%) and non-Hispanic (14/16, 88%). The intervention met the a priori criteria set for therapist fidelity to treatment protocol (mean [SD] MBCT-Treatment Acceptability and Competence Scale Adherence score 2.9 [0.2]), feasibility (mean [SD] session attendance was 7.9/8 [0.3]), and acceptability (mean [SD] CSQ-8 score 28.8 [3.3]) for the entire sample and for each treatment arm. The usability of the remote-delivery system was high across study participants (mean [SD] SUS score 84.8 [11.0]). Survey procedures were broadly deemed acceptable, with at least 80% participants either endorsing "Agree" or "Strongly Agree" across all items. Using Wilcoxon tests, we observed significant reductions in both the HDI (pre-treatment median [interquartile range] score 63 [40, 70] vs. post-treatment 36 [26, 54], p = 0.004) and the QIDS-SR₁₆ (pre-treatment median [interquartile range] score 8 [5, 13] vs. post-treatment 4 [3, 6], p = 0.003).

Conclusion: We found that remotely delivered MBCT-brief for migraine and depressive symptoms was feasible and acceptable to patients in both the telephone and video modalities. Intervention was associated with significant post-treatment reductions in headache-related disability and depressive symptomatology, findings that must be interpreted cautiously in the absence of a control group.