Effectiveness of a Guided Internet- and Mobile-Based Intervention for Patients with Chronic Back Pain and Depression (WARD-BP): A Multicenter, Pragmatic Randomized Controlled Trial

Abstract

<b><i>Introduction:</i></b> There is neither strong evidence on effective treatments for patients with chronic back pain (CBP) and depressive disorder nor sufficiently available mental health care offers. <b><i>Objective:</i></b> The aim is to assess the effectiveness of internet- and mobile-based interventions (IMI) as a scalable approach for treating depression in a routine care setting. <b><i>Methods:</i></b> This is an observer-masked, multicenter, pragmatic randomized controlled trial with a randomization ratio of 1:1.<b><i></i></b>Patients with CBP and diagnosed depressive disorder (mild to moderate severity) were recruited from 82 orthopedic rehabilitation clinics across Germany. The intervention group (IG) received a guided depression IMI tailored to CBP next to treatment-as-usual (TAU; including medication), while the control group (CG) received TAU. The primary outcome was observer-masked clinician-rated Hamilton depression severity (9-week follow-up). The secondary outcomes were: further depression outcomes, pain-related outcomes, health-related quality of life, and work capacity. Biostatistician blinded analyses using regression models were conducted by intention-to-treat and per protocol analysis. <b><i>Results:</i></b> Between October 2015 and July 2017, we randomly assigned 210 participants (IG, <i>n</i> = 105; CG, <i>n</i> = 105), mostly with only a mild pain intensity but substantial pain disability. No statistically significant difference in depression severity between IG and CG was observed at the 9-week follow-up (β = –0.19, 95% CI –0.43 to 0.05). Explorative secondary depression (4/9) and pain-related (4/6) outcomes were in part significant (<i>p</i> < 0.05). Health-related quality of life was significantly higher in the IG. No differences were found in work capacity. <b><i>Conclusion:</i></b> The results indicate that an IMI for patients with CBP and depression in a routine care setting has limited impact on depression. Benefits in pain and health-related outcomes suggest that an IMI might still be a useful measure to improve routine care.

Digital interventions for the treatment of depression: A meta-analytic review.

“…Interventions have employed a variety of therapeutic approaches—from cognitive behavioral therapy (CBT; Andersson, 2009) to acceptance and commitment therapy (ACT; Brown et al, 2016), psychodynamic approaches (Johansson et al, 2013), and interpersonal psychotherapy (Donker, Bennett, et al, 2013). Digital interventions have also been investigated in the treatment of people with depressive symptoms and comorbid somatic conditions (Bendig et al, 2018), including diabetes (Ebert et al, 2017; Newby et al, 2017; Nobis et al, 2015), musculoskeletal diseases (Baumeister et al, 2021; O’Moore et al, 2018; Sander, Paganini et al, 2020), and epilepsy (Meyer et al, 2019). As depression and (chronic) somatic conditions frequently co-occur—leading to substantial adverse effects for patients, including poor treatment compliance, increased symptom burden, additional medical complications and higher treatment costs (Barnett et al, 2012; Goldberg, 2010)—digital interventions may provide an adjunctive psychotherapeutic measure to address the interdependency of physical and mental conditions and improve the continuity of care in cases where specially trained health care practitioners may not be readily available (Fineberg, 2012; Shrank et al, 2019; Singla et al, 2018).…”

Neuroimaging Mechanism of Cognitive Behavioral Therapy in Pain Management

“…In recent 2 years, a large number of clinical studies had taken CBT as a management measure of different kinds of pain, including mixed unlocated chronic pain [ 7 – 18 ], back pain [ 19 , 20 ], low back pain [ 21 – 26 ], chronic pancreatitis [ 27 ], fibromyalgia [ 28 , 29 ], functional abdominal pain [ 30 ], trigeminal neuralgia [ 31 ], haemophilia pain [ 32 ], osteoarthritis pain [ 33 – 35 ], perioperative pain [ 36 – 39 ], orofacial pain [ 40 ], diabetic peripheral neuropathic pain [ 41 ], and provoked vestibulodynia [ 42 ]. Previous studies on structural changes in the brain of patients with chronic pain indicated the presence of neuroplasticity in areas associated with the experience and anticipation of pain [ 43 ].…”

Impacts of Digital Care Programs for Musculoskeletal Conditions on Depression and Work Productivity: Longitudinal Cohort Study

“…To date, digital intervention studies have been focused on either pain and disability [29][30][31] or on mental health and pain [26,27,32,33], with only a few studies assessing the impact of either dimension (MSK pain and depression) on work-related productivity [27,[34][35][36].…”

“…With more than 62.5% of the global population now able to access the internet (according to Worldwide Digital Population estimates as of January 2022 [ 21 ]), digital interventions may offer highly scalable solutions to deliver evidence-based interdisciplinary interventions [ 22 ], thereby democratizing access and improving the continuity of care in cases where specially trained health care practitioners may not be readily available [ 23 ], and also promoting adherence to treatment by facilitating therapeutic alliance (defined as collaboration between therapeutic participants to foster healing) [ 24 , 25 ]. Digital interventions have therefore been explored for the treatment of depression and MSK diseases [ 26 , 27 ]. In 2021, the US Department of Health and Human Services’ Substance Abuse and Mental Health Services Administration released an evidence-based resource guide system recommending the use of telehealth for people with serious mental health disorders such as depression, noting that the benefits of telehealth services in this context may extend beyond improvement in morbid psychological conditions, including chronic pain and pain-related disability [ 28 ].…”