Research aimed at improving both mood and weight (RAINBOW) in primary care: A type 1 hybrid design randomized controlled trial

Abstract

Effective interventions targeting comorbid obesity and depression are critical given the increasing prevalence and worsened outcomes for patients with both conditions. RAINBOW is a type 1 hybrid design randomized controlled trial. The objective is to evaluate the clinical and cost effectiveness and implementation potential of an integrated, technology-enhanced, collaborative care model for treating comorbid obesity and depression in primary care. Obese and depressed adults (n=404) will be randomized to usual care enhanced with the provision of a pedometer and information about the health system’s services for mood or weight management (control) or with the Integrated Coaching for Better Mood and Weight (I-CARE) program (intervention). The 12-month I-CARE program synergistically integrates two proven behavioral interventions: problem-solving therapy with as-needed intensification of pharmacotherapy for depression (PEARLS) and standardized behavioral treatment for obesity (Group Lifestyle Balance™). It utilizes traditional (e.g., office visits and phone consults) and emerging care delivery modalities (e.g., patient web portal and mobile applications). Follow-up assessments will occur at 6, 12, 18, and 24 months. We hypothesize that compared with controls, I-CARE participants will have greater improvements in weight and depression severity measured by the 20-item Depression Symptom Checklist at 12 months, which will be sustained at 24 months. We will also assess I-CARE’s cost-effectiveness and use mixed methods to examine its potential for reach, adoption, implementation, and maintenance. This study offers the potential to change how obese and depressed adults are treated—through a new model of accessible and integrative lifestyle medicine and mental health expertise—in primary care.

Mobile Apps for the Management of Comorbid Overweight/Obesity and Depression/Anxiety: A Systematic Review

“…Another study included people with no clinical diagnosis of mental disorder but with psychological distress. e studies by Williams et al [44], Ma et al [45], and their colleagues included patients with clinically significant depression, the studies by Naslund and colleagues [46,47] included patients with diagnoses of severe mental health illness (i.e., schizophrenia, bipolar disorder, major depressive disorder), and the study by Levinson and colleagues [48] included exclusively patients with eating disorders. Actual sample sizes ranged from 10 (pilot study with patients with severe mental illness recruited from one community mental health centre) to 219 (randomized control trial including people with psychological distress recruited by advertisements in local newspapers from three Finnish cities).…”

“…Regarding the use of mobile apps, the studies by Ma et al [45], Naslund et al [46,47], and their colleagues included apps to monitor physical activity alone or with dietary intake: MyFitnessPal, Fitbit, and Nike FuelBan; the last two were designed to synchronize with their corresponding physical devices. e study by Levinson and colleagues [48] described a mobile app aiming at keeping track of not only comportments but also cognitions and emotions in relation to eating disorders, behaviours, and anxiety.…”

“…e two studies by Naslund and colleagues [46,47] and the one by Levinson and colleagues [48] were neither randomized nor blinded. Although the other four studies [44,45,49,50] were randomized controlled trials, only the study by Ma and colleagues [45] was blind. Although the target populations of the studies were diverse (e.g., pregnant women and people with an eating disorder or a severe mental illness), according to their reports, a common bias is the recruitment by convenience sampling, which limits the generalization of their results.…”

“…It must be noticed that the target sample was people with an eating disorder, not all of them (probably only a few) with overweight/obesity and/or depression/anxiety. e RAIN-BOW/ENGAGE studies [44,45] reported on an intervention designed for the management of both weight and depression. Yet, the use of a mobile app was exclusively for recording physical activity and did not include the recording of any mental dimension.…”

Problem Solving Therapy-induced Amygdala Engagement Mediates Weight Loss and Lifestyle Behavior Change in Patients With Obesity and Depression: A Randomized Controlled Trial

“…All participants provided written informed consent. Protocols of the RAINBOW and ENGAGE trials were previously published (23,24).…”