MULTIPAP Study: Improving healthcare for patients with multimorbidity

2020 ◽  
Vol 70 (suppl 1) ◽  
pp. bjgp20X711257
Author(s):  
Alexandra Prados-Torres ◽  
Isabel del Cura-González ◽  
Juan Daniel Prados-Torres ◽  
Christiane Muth ◽  
Francisca Leiva-Fernández ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Healthcare Setting ◽  
Health Services Use ◽  
Medication Appropriateness Index ◽  
Old Patients ◽  
Secondary Outcomes ◽  
Young Old ◽  
Medication Appropriateness

BackgroundThe steady rise in multimorbidity entails serious consequences for our populations, challenges healthcare systems, and calls for specific clinical approaches of proven effectiveness. The MULTIPAP Study comprises three sequential projects (MULTIPAP and MULTIPAP Plus RCTs, and the MULTIPAP Cohort). Results of MULTIPAP RCT are presented.AimTo evaluate the effectiveness of a complex, patient-centred intervention in young-old patients with multimorbidity and polypharmacy.MethodPragmatic cluster-randomised clinical trial in a primary healthcare setting. GPs were randomly allocated to either conventional care or the MULTIPAP intervention based on the Ariadne Principles with two components: GPs e-training (that is, eMULTIPAP addresses specific, key concepts on multimorbidity, polypharmacy and shared decision-making) and GP–patient-centred interview. Young-old patients aged 65–74 years with multimorbidity and polypharmacy were included. Main outcome: difference in the Medication Appropriateness Index (MAI) after 6-month follow-up between groups. Secondary outcomes: MAI, quality of life, patient perception, health services use, treatment adherence and cost-effectiveness after 12-month follow-up.Results117 GPs from 38 Spanish primary health care recruited 593 patients randomly assigned to the intervention/control groups. Difference in MAI scores between groups in the intention-to-treat analysis after 6 months’ follow-up: −2.42 (−4.27 to −0.59), P = 0.009 (adjusted difference in mean MAI score −1.81(−3.35 to −0.27), P = 0.021). Secondary outcomes: not significant, including quality of life (adjusted difference in mean EQ-5D-5L (VAS) 2.94 (−1.39 to 7.28), P = 0.183, EQ-5D-5L (index) −0.006(−0.034 to 0.022), P = 0.689).ConclusionThe intervention significantly improved medication appropriateness. The observed quality of life improvement was not significant. GPs e-training in multimorbidity has shown to be feasible and well accepted by the professionals. Future studies may test whether this format facilitates implementation.

scholarly journals Task-oriented exercises improve disability of working patients with surgically-treated proximal humeral fractures. A randomized controlled trial with one-year follow-up

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Marco Monticone ◽  
Igor Portoghese ◽  
Daniele Cazzaniga ◽  
Valentina Liquori ◽  
Giuseppe Marongiu ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Controlled Trial ◽  
Rehabilitation Program ◽  
Group Differences ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
One Year ◽  
Task Oriented

Abstract Background General physiotherapy is a common means of rehabilitation after surgery for proximal humeral fracture (PHF). Better-targeted exercises seem worthy of investigation and the aim of this study was to assess the efficacy of a rehabilitation program including task-oriented exercises in improving disability, pain, and quality of life in patients after a PHF. Methods By means of a randomized controlled trial with one-year follow-up, 70 working patients (mean age of 49 ± 11 years; 41 females), who were selected for open reduction and internal fixation with plates caused by PHF, were randomized to be included in an experimental (n = 35) or control group (n = 35). There was a permuted-block randomization plan, and a list of program codes was previously created; subsequently, an automatic assignment system was used to conceal the allocation. The first group underwent a supervised rehabilitation program of task-oriented exercises based on patients’ specific job activities, and occupational therapy. The second group underwent general physiotherapy, including supervised mobility, strengthening and stretching exercises. Both groups individually followed programs of 60-min session three times per week for 12 weeks in the outpatient setting. The Disability Arm Shoulder Hand questionnaire (DASH; scores range from 0 to 100; primary outcome), a Pain intensity Numerical Rating Scale (scores range 0 to 10; secondary outcomes), and the Short-Form Health Survey (scores range from 0 to 100; secondary outcomes) assessed the interventions. Participants were evaluated before surgery, before and after rehabilitation (primary endpoint), and at the one-year follow-up (secondary endpoint). A linear mixed model analysis for repeated measures was carried out for each outcome measure (p < 0.05). Results Time, group and time by group showed significant effects for all outcome measures in favour of the experimental group. The DASH and the DASH work achieved clinically important between-group differences of 16.0 points (95% confidence interval [C.I.] 7.3 to 24.7) and 19.7 (95% C.I. 9.0 to 30.5) at follow-up, respectively. The NRS achieved a between-group difference of 2.9 (95% C.I. 1.0 to 3.9) at follow-up. As for SF-36, there were between-group differences ranging from 17.9 to 37.0 at follow-up. Conclusions A rehabilitation program based on task-oriented exercises was useful in improving disability, pain, and quality of life in working patients after PHFs. Improvements lasted for at least 12 months. Trial registration On 16/12/2019, the trial was retrospectively registered in the ISRCTN registry with the ID number 17996552.

Efficacy of task-specific circuit training on physical activity levels and mobility of stroke patients: A randomized controlled trial

2020 ◽  
Vol 47 (4) ◽  
pp. 451-462
Author(s):  
Júlia Caetano Martins ◽  
Sylvie Nadeau ◽  
Larissa Tavares Aguiar ◽  
Aline Alvim Scianni ◽  
Luci Fuscaldi Teixeira-Salmela ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Post Intervention ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Experimental Group

BACKGROUND: Impaired mobility is related to low physical activity (PA) levels observed after stroke. Therapeutic approaches, such as task-specific circuit training (TSCT), used to improve mobility in individuals with stroke, could also improve PA levels. OBJECTIVE: To investigate the efficacy of TSCT, focused on both upper (UL) and lower (LL) limbs, in improving PA levels and mobility (primary outcomes), as well as muscle strength, exercise capacity, and quality of life (secondary outcomes) in subjects with stroke. METHODS: A randomized controlled trial with 36 subjects with chronic stroke was conducted. Experimental group: TSCT, involving both UL and LL. Control group: global stretching, memory exercises, and education sessions. Both groups received 60 minute sessions/week over 12 weeks. Outcomes were measured at baseline, post-intervention and 16 week follow-up. RESULTS: No changes were found for primary and secondary outcomes (0.11≤p≤0.99), except for quality of life, which improved in the experimental group post-intervention and 16 week follow-up (p = 0.02). CONCLUSION: TSCT focused on both UL and LL was not effective on PA levels and mobility of individuals with chronic stroke, however, improvements in quality of life were observed. Since this is the first study to investigate this combined training aimed at improving PA levels, future studies are necessary to better understand the impact of this type of intervention.

scholarly journals Pilot Randomized Controlled Trial of Individual Meaning-Centered Psychotherapy for Patients With Advanced Cancer

2012 ◽  
Vol 30 (12) ◽  
pp. 1304-1309 ◽  
Author(s):  
William Breitbart ◽  
Shannon Poppito ◽  
Barry Rosenfeld ◽  
Andrew J. Vickers ◽  
Yuelin Li ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Advanced Cancer ◽  
Symptom Burden ◽  
Well Being ◽  
Treatment Assessment ◽  
Spiritual Well Being ◽  
Secondary Outcomes ◽  
Anxiety Depression

Purpose Spiritual well-being and sense of meaning are important concerns for clinicians who care for patients with cancer. We developed Individual Meaning-Centered Psychotherapy (IMCP) to address the need for brief interventions targeting spiritual well-being and meaning for patients with advanced cancer. Patients and Methods Patients with stage III or IV cancer (N = 120) were randomly assigned to seven sessions of either IMCP or therapeutic massage (TM). Patients were assessed before and after completing the intervention and 2 months postintervention. Primary outcome measures assessed spiritual well-being and quality of life; secondary outcomes included anxiety, depression, hopelessness, symptom burden, and symptom-related distress. Results Of the 120 participants randomly assigned, 78 (65%) completed the post-treatment assessment and 67 (56%) completed the 2-month follow-up. At the post-treatment assessment, IMCP participants demonstrated significantly greater improvement than the control condition for the primary outcomes of spiritual well-being (b = 0.39; P <.001, including both components of spiritual well-being (sense of meaning: b = 0.34; P = .003 and faith: b = 0.42; P = .03), and quality of life (b = 0.76; P = .013). Significantly greater improvements for IMCP patients were also observed for the secondary outcomes of symptom burden (b = −6.56; P < .001) and symptom-related distress (b = −0.47; P < .001) but not for anxiety, depression, or hopelessness. At the 2-month follow-up assessment, the improvements observed for the IMCP group were no longer significantly greater than those observed for the TM group. Conclusion IMCP has clear short-term benefits for spiritual suffering and quality of life in patients with advanced cancer. Clinicians working with patients who have advanced cancer should consider IMCP as an approach to enhance quality of life and spiritual well-being.

scholarly journals Enhancing self-management of multimorbidity in primary care: A randomised controlled trial

2020 ◽  
pp. bjgp20X714185
Author(s):  
Lynn O' Toole ◽  
Deirdre Connolly ◽  
Fiona Boland ◽  
Susan Smith
Keyword(s):  
Quality Of Life ◽  
Primary Care ◽  
Self Management ◽  
Activity Participation ◽  
Health Related Quality ◽  
Related Quality ◽  
Health Related ◽  
Secondary Outcomes

Abstract Background: Effective primary care interventions for multimorbidity are needed. Aim: To evaluate the effectiveness of a group-based six-week occupational therapy led self-management support programme (OPTIMAL) for patients with multimorbidity. Design and Setting: A pragmatic parallel randomised trial across eight primary care teams in Eastern Ireland with 149 patients with multimorbidity. The intervention was OPTIMAL with a usual care comparison. Methods: Primary outcomes were health-related quality of life (EQ5D) and frequency of activity participation (FAI). Secondary outcomes included independence in activities of daily living, occupational performance and satisfaction, anxiety and depression, self-efficacy and healthcare utilisation. Complete case linear regression analyses were conducted. Age (<65/ ≥65 years) and the number of chronic conditions (<4/ ≥4) were explored further. Results: 124 participants (83%) and 121 (81%) participants had complete data at immediate and six-month post-intervention follow-up. Intervention participants had a significant improvement in EQ-VAS at immediate follow-up (Adjusted MD=7.86; 95% CI 0.92 to 14.80) but no difference in the index score (Adjusted MD= 0.04; 95% CI -0.06 to 0.01) or FAI (Adjusted MD = 1.22; 95% CI -0.84 to 3.29). At six-month follow-up there were no differences in primary outcomes. There were mixed results for secondary outcomes. Pre-planned sub-group analyses suggested participants aged <65 years were more likely to benefit. Conclusions: OPTIMAL was not effective in improving health related quality of life or activity participation at six-month follow up. Pre-planned sub-group analyses results suggest that future research should target younger adults (age <65 years) with multimorbidity.

scholarly journals Exercise for patients with major depression: a systematic review with meta-analysis and trial sequential analysis

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e014820 ◽  
Author(s):  
Jesper Krogh ◽  
Carsten Hjorthøj ◽  
Helene Speyer ◽  
Christian Gluud ◽  
Merete Nordentoft
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Adverse Events ◽  
Sequential Analysis ◽  
Trial Sequential Analysis ◽  
Depression Severity ◽  
Serious Adverse Events ◽  
Secondary Outcomes

ObjectivesTo assess the benefits and harms of exercise in patients with depression.DesignSystematic reviewData sourcesBibliographical databases were searched until 20 June 2017.Eligibility criteria and outcomesEligible trials were randomised clinical trials assessing the effect of exercise in participants diagnosed with depression. Primary outcomes were depression severity, lack of remission and serious adverse events (eg, suicide) assessed at the end of the intervention. Secondary outcomes were quality of life and adverse events such as injuries, as well as assessment of depression severity and lack of remission during follow-up after the intervention.ResultsThirty-five trials enrolling 2498 participants were included. The effect of exercise versus control on depression severity was −0.66 standardised mean difference (SMD) (95% CI −0.86 to −0.46; p<0.001; grading of recommendations assessment, development and evaluation (GRADE): very low quality). Restricting this analysis to the four trials that seemed less affected of bias, the effect vanished into −0.11 SMD (−0.41 to 0.18; p=0.45; GRADE: low quality). Exercise decreased the relative risk of no remission to 0.78 (0.68 to 0.90; p<0.001; GRADE: very low quality). Restricting this analysis to the two trials that seemed less affected of bias, the effect vanished into 0.95 (0.74 to 1.23; p=0.78). Trial sequential analysis excluded random error when all trials were analysed, but not if focusing on trials less affected of bias. Subgroup analyses found that trial size and intervention duration were inversely associated with effect size for both depression severity and lack of remission. There was no significant effect of exercise on secondary outcomes.ConclusionsTrials with less risk of bias suggested no antidepressant effects of exercise and there were no significant effects of exercise on quality of life, depression severity or lack of remission during follow-up. Data for serious adverse events and adverse events were scarce not allowing conclusions for these outcomes.Systematic review registrationThe protocol was published in the journalSystematic Reviews: 2015; 4:40.

A randomized controlled trial (RCT) of long-term follow-up for early stage breast cancer comparing family physician to specialist care: A report of secondary outcomes

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 6003-6003
Author(s):  
E. Grunfeld ◽  
J. Julian ◽  
M. Levine ◽  
K. Pritchard ◽  
D. Coyle ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Patient Satisfaction ◽  
Cancer Patients ◽  
Family Physician ◽  
Early Stage ◽  
Breast Cancer Patients ◽  
Secondary Outcomes

6003 Background: Breast cancer patients usually receive follow-up in specialist cancer clinics. We have reported that family physician follow-up of breast cancer patients is a safe and acceptable alternative to specialist follow-up as measured by the primary clinical outcome of the rate of serious clinical events (Grunfeld et al, JCO 2006;24(6)). We report here the secondary outcomes of this trial: quality of life domains, patient satisfaction and patients’ costs. Methods: Women with early stage breast cancer who had completed adjuvant therapy (patients may have continued on adjuvant hormonal therapy), who were disease free and between 9 and 15 months after diagnosis, were allocated to receive follow-up in a cancer clinic according to usual practice (CC arm) or follow-up from their own family physician (FP arm). For patients without recurrence, quality of life (QL) measured by the SF36, patient satisfaction, and patients’ costs were measured every 6 months. For patients with recurrence QL measured by the EORTC QLQ C-30 was measured at the time of recurrence. Results: 483 patients were allocated to the FP arm and 485 to the CC arm. Median follow-up was 3.5 years. There were no significant differences between groups on change scores for SF36 subscales to 24 months, or EORTC functional subscale scores at the time of recurrence. Patients’ costs of follow-up (travel costs, out-of-pocket expenses, and lost earnings) were significantly less to 24 months (p < 0.02) in the FP arm. Although costs were less between 36 and 48 months, these were not significant. Conclusions: Family physician follow-up of breast cancer patients does not have a negative impact on clinical or QL outcomes and is less costly for patients. No significant financial relationships to disclose.

Subjective forgetfulness is associated with lower quality of life in middle-aged and young-old individuals: A 9-year follow-up in older participants from the Maastricht Aging Study

2009 ◽  
Vol 13 (5) ◽  
pp. 699-705 ◽  
Author(s):  
Martine E.M. Mol ◽  
Martin P.J. van Boxtel ◽  
Dick Willems ◽  
Frans R.J. Verhey ◽  
Jelle Jolles
Keyword(s):  
Quality Of Life ◽  
Middle Aged ◽  
Aging Study ◽  
Young Old

Tracking Lower Urinary Tract Symptoms and Tamsulosin Side Effects Among Older Men using the PERSONAL app: Feasibility and Usability Study (Preprint)

2021 ◽  
Author(s):  
Austin W Lee ◽  
Stacey A Kenfield ◽  
Elizabeth Y Wang ◽  
Anthony Enriquez ◽  
Akinyemi Oni-Orisan ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Side Effects ◽  
Lower Urinary Tract ◽  
Older Men ◽  
Mobile App ◽  
Urinary Tract Symptoms ◽  
Secondary Outcomes ◽  
Lower Urinary

BACKGROUND Continuous alpha 1a-blockade is first-line management for lower urinary tract symptoms (LUTS) amongst older men with suspected benign prostatic hyperplasia (BPH). Variable efficacy and safety for individual men necessitate a more personalized, data-driven approach to prescribing and deprescribing tamsulosin for LUTS in older men. OBJECTIVE We aimed to evaluate the feasibility and usability of using the PERSONAL (PlacEbo-controlled, Randomized, patient-Selected Outcomes, N-of-1 triALs) mobile app for tracking daily LUTS severity and medication side effects among older men receiving chronic tamsulosin therapy. METHODS We recruited patients from the University of California, San Francisco healthcare system to participate in a two-week pilot study. The primary objectives were to assess recruitment feasibility, study completion rates, frequency of symptom tracking, duration of tracking sessions, and app usability rankings measured using a follow-up survey. As secondary outcomes, we evaluated whether daily symptom tracking led to changes in LUTS severity, perceptions of tamsulosin, overall quality of life, and medication adherence between baseline and follow-up surveys as well as perceived app utility. RESULTS We enrolled 19 men within 23 days and 100% of participants completed the study. Each participant selected a unique combination of symptoms to track and recorded data in the PERSONAL app a median of 11 out of 14 days (79% daily completion rate). Median app session duration was 44 seconds (IQR: 33). On a scale of 1 (“Strongly Disagree”) to 5 (“Strongly Agree”), participants reported that the PERSONAL app was easy to use (mean=4.3, standard deviation [SD]=1.0), others could learn to use it quickly (mean=4.2, SD=0.9), and they felt confident using the app (mean=4.4, SD=0.8). LUTS severity, quality of life, and medication adherence remained unchanged after the 2-week study period. Fewer men were satisfied with tamsulosin after using the app (14/19 participants versus 17/19 participants at baseline), although perceived benefit from tamsulosin remained unchanged (95% at baseline and at follow-up). 58% of men agreed that the PERSONAL app can help people like them manage their urinary symptoms. CONCLUSIONS This pilot study demonstrated high feasibility and usability of the PERSONAL mobile app to track patient-selected urinary symptoms and tamsulosin side effects among older men taking tamsulosin for LUTS. We observed no adverse consequences of daily symptom monitoring on our secondary outcomes. This proof-of-concept study establishes a framework for future mobile app studies, such as digital N-of-1 trials, to collect comprehensive individual-level data for personalized LUTS management in older men.

scholarly journals 89 Randomised Controlled Trial of the Effect of Tai Chi on Postural Balance of People with Dementia

2019 ◽  
Vol 48 (Supplement_4) ◽  
pp. iv18-iv27
Author(s):  
Samuel Nyman ◽  
Wendy Ingram ◽  
Jeanette Sanders ◽  
Peter Thomas ◽  
Sarah Thomas ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Tai Chi ◽  
Controlled Trial ◽  
Community Dwelling ◽  
Timed Up And Go ◽  
People With Dementia ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Introduction We investigated the effect of Tai Chi exercise on postural balance among people with dementia (PWD), and the feasibility of a definitive trial on falls prevention. Method We conducted a randomised controlled trial. Dyads, comprising community-dwelling PWD and their informal carer (N=85), were randomised to usual care (n=43) or usual care plus the intervention (n=42). For the intervention, over 20 weeks, Tai Chi classes were provided weekly and Tai Chi home practice was facilitated by the carer. The primary outcome was the timed up and go test. Secondary outcomes for PWD included functional balance, static balance, fear of falling, cognitive functioning, quality of life, and falls. Secondary outcomes for carers included dynamic balance, static balance, quality of life, and carer burden. Outcomes were assessed six months post-baseline, except for falls, which were collected prospectively over the six-month follow-up period. Results For PWD, there was no significant difference at follow-up on the timed up and go test (mean difference [MD] = 0.82, 95% confidence interval [CI] = -2.17, 3.81, standardised effect size [ES] = 0.14). Among the secondary outcomes, at follow-up, PWD in the Tai Chi group had significantly higher quality of life (MD = 0.051, 95% CI = 0.002, 0.100, ES = 0.51) and a significantly lower rate of falls (rate ratio = 0.35, 95% CI =0.15, 0.81), which was no longer significant when an outlier was removed. Carers in the Tai Chi group at follow-up were significantly worse on the timed up and go test (MD = 1.83, 95% CI = 0.12, 3.53, ES = 0.61). The remaining secondary outcomes were not significant. No serious adverse events were related to participation in Tai Chi. Conclusion With refinement, this Tai Chi intervention has potential to reduce the incidence of falls and improve quality of life among community-dwelling PWD.

scholarly journals A Web- and Mobile-Based Intervention for Comorbid, Recurrent Depression in Patients With Chronic Back Pain on Sick Leave (Get.Back): Pilot Randomized Controlled Trial on Feasibility, User Satisfaction, and Effectiveness

10.2196/16398 ◽  
2020 ◽  
Vol 7 (4) ◽  
pp. e16398
Author(s):  
Sandra Schlicker ◽  
Harald Baumeister ◽  
Claudia Buntrock ◽  
Lasse Sander ◽  
Sarah Paganini ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Health Insurance ◽  
Depressive Symptom ◽  
Sick Leave ◽  
Symptom Severity ◽  
User Satisfaction ◽  
Depressive Symptom Severity ◽  
Secondary Outcomes

Background Chronic back pain (CBP) is linked to a higher prevalence and higher occurrence of major depressive disorder (MDD) and can lead to reduced quality of life. Unfortunately, individuals with both CBP and recurrent MDD are underidentified. Utilizing health care insurance data may provide a possibility to better identify this complex population. In addition, internet- and mobile-based interventions might enhance the availability of existing treatments and provide help to those highly burdened individuals. Objective This pilot randomized controlled trial investigated the feasibility of recruitment via the health records of a German health insurance company. The study also examined user satisfaction and effectiveness of a 9-week cognitive behavioral therapy and Web- and mobile-based guided self-help intervention Get.Back in CBP patients with recurrent MDD on sick leave compared with a waitlist control condition. Methods Health records from a German health insurance company were used to identify and recruit participants (N=76) via invitation letters. Study outcomes were measured using Web-based self-report assessments at baseline, posttreatment (9 weeks), and a 6-month follow-up. The primary outcome was depressive symptom severity (Center for Epidemiological Studies–Depression); secondary outcomes included anxiety (Hamilton Anxiety and Depression Scale), quality of life (Assessment of Quality of Life), pain-related variables (Oswestry Disability Index, Pain Self-Efficacy Questionnaire, and pain intensity), and negative effects (Inventory for the Assessment of Negative Effects of Psychotherapy). Results The total enrollment rate with the recruitment strategy used was 1.26% (76/6000). Participants completed 4.8 modules (SD 2.6, range 0-7) of Get.Back. The overall user satisfaction was favorable (mean Client Satisfaction Questionnaire score=24.5, SD 5.2). Covariance analyses showed a small but statistically significant reduction in depressive symptom severity in the intervention group (n=40) at posttreatment compared with the waitlist control group (n=36; F1,76=3.62, P=.03; d=0.28, 95% CI −0.17 to 0.74). Similar findings were noted for the reduction of anxiety symptoms (F1,76=10.45; P=.001; d=0.14, 95% CI −0.31 to 0.60) at posttreatment. Other secondary outcomes were nonsignificant (.06≤P≤.44). At the 6-month follow-up, the difference between the groups with regard to reduction in depressive symptom severity was no longer statistically significant (F1,76=1.50, P=.11; d=0.10, 95% CI −0.34 to 0.46). The between-group difference in anxiety at posttreatment was maintained to follow-up (F1,76=2.94, P=.04; d=0.38, 95% CI −0.07 to 0.83). There were no statistically significant differences across groups regarding other secondary outcomes at the 6-month follow-up (.08≤P≤.42). Conclusions These results suggest that participants with comorbid depression and CBP on sick leave may benefit from internet- and mobile-based interventions, as exemplified with the positive user satisfaction ratings. The recruitment strategy via health insurance letter invitations appeared feasible, but more research is needed to understand how response rates in untreated individuals with CBP and comorbid depression can be increased. Trial Registration German Clinical Trials Register DRKS00010820; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00010820.

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