Accepted for/Published in: Journal of Medical Internet Research
Date Submitted: Jan 9, 2024
Date Accepted: Oct 9, 2024
(closed for review but you can still tweet)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Efficacy of a blended low-intensity internet-delivered psychological programme in patients with multimorbidity in primary care: a randomized controlled trial
ABSTRACT
Background:
Multimorbidity is a highly prevalent phenomenon whose presence causes profound physical, psychological and economic impact. It hinders help-seeking, diagnosis, quality of care and adherence to treatment, and it poses a significant dilemma for present-day health care systems.
Objective:
The aim of this study was to assess the effectiveness of improved treatment as usual (iTAU) combined with a blended, low-intensity psychological intervention delivered using information and communication technologies for the treatment of multimorbidity symptoms (depression, and type 2 diabetes or low back pain) in primary care (PC) settings.
Methods:
A two-armed, parallel group, superiority randomized controlled trial was designed for this study. Participants diagnosed with depression and either type 2 diabetes or low back pain (n=183) were randomized to ‘Intervention + iTAU’ (combining a face-to-face intervention with a supporting online programme), or ‘iTAU’ alone. The main outcome consisted of a standardized composite score that considered (I) severity of depressive symptoms and (IIa) diabetes control or (IIb) pain intensity and physical disability at three months after the end of treatment as the primary endpoint. Differences between the groups were estimated using mixed effects linear regression models, and mediation evaluations were conducted using path analyses to evaluate the potential mechanistic role of positive and negative affectivity, and openness to the future.
Results:
At three-month follow-up, the Intervention + iTAU group (vs iTAU) exhibited greater reductions in composite multimorbidity score (B = -0.34; 95% CI = -0.64, -0.04; g = 0.39), as well as in depression and negative affect, and improvements in perceived health, positive affect and openness to the future. Similar positive effects were observed post-intervention, also with improvements in physical disability. No significant differences were found in glycosylated haemoglobin, pain intensity or disability at three-month follow-up. Path analyses indicated a significant impact from the intervention on the primary outcome and mediated by positive and negative affect.
Conclusions:
The present study supports the efficacy of a low-intensity psychological intervention applied in a blended format on multimorbidity in PC. It justifies exploration of the conceptualization of depression in type 2 diabetes, as well as analysis of the implementation of such interventions in routine clinical practice. Clinical Trial: ClinicalTrials.gov NCT03426709. Registered on 8 February 2018.
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