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Efficacy of a blended low-intensity internet-delivered psychological programme in patients with multimorbidity in primary care: study protocol for a randomized controlled trial.

ABSTRACT: BACKGROUND:The World Health Organization (WHO) has included comorbidity between depression and a chronic disease among the 10 leading global health priorities. Although there is a high prevalence of multimorbidity, health care systems are mainly designed for the management of individual diseases. Given the difficulty in delivering face-to-face psychological treatments, alternative models of treatment delivery have been proposed, emphasizing the role of technologies such as the Internet. The aim of this study is to assess the efficacy in Primary Care (PC) of a blended low-intensity psychological intervention applied using information and communication technologies (ICTs) for the treatment of multimorbidity in PC (depression and type 2 diabetes/low back pain) by means of a randomized controlled trial (RCT). Our main hypothesis is that improved usual care combined with psychological therapy applied using ICTs will be more efficacious for improvement in the symptomatology of multimorbidity, compared to a group with only improved treatment as usual six months after the end of treatment. METHODS:A protocol has been designed combining a face-to-face intervention with a supporting online programme that will be tested by an RCT conducted in three different regions (Andalusia, Aragon and the Balearic Islands). The RCT will evaluate three hundred participants diagnosed with depression and type 2 diabetes/low back pain. Four highly experienced research groups specializing in clinical psychology are involved in this trial, and there will be ample possibilities for translation and transfer to usual clinical practice. DISCUSSION:This clinical trial will lead to improvement in financial sustainability, maximizing the use of resources and responding to principles of efficiency and effectiveness. Furthermore, based on the evaluation of the feasibility of implementing this intervention in primary care facilities, we expect to be able to suggest the intervention for incorporation into public policy. In conclusion, positive results of this study could have a significant impact on one of the most important health-related problems, multimorbidity. TRIAL REGISTRATION:ClinicalTrials.gov, NCT03426709 . Registered retrospectively on 08 February 2018.

SUBMITTER: Monreal-Bartolome A

PROVIDER: S-EPMC6371446 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Efficacy of a blended low-intensity internet-delivered psychological programme in patients with multimorbidity in primary care: study protocol for a randomized controlled trial.

Monreal-Bartolomé Alicia A Barceló-Soler Alberto A Castro Adoración A Pérez-Ara Mª Ángeles MÁ Gili Margalida M Mayoral Fermín F Hurtado Maria Magdalena MM Moreno Esperanza Varela EV Botella Cristina C García-Palacios Azucena A Baños Rosa M RM López-Del-Hoyo Yolanda Y García-Campayo Javier J

BMC psychiatry 20190211 1

<h4>Background</h4>The World Health Organization (WHO) has included comorbidity between depression and a chronic disease among the 10 leading global health priorities. Although there is a high prevalence of multimorbidity, health care systems are mainly designed for the management of individual diseases. Given the difficulty in delivering face-to-face psychological treatments, alternative models of treatment delivery have been proposed, emphasizing the role of technologies such as the Internet. ...[more]

PMID: 30744610

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Project description:BACKGROUND:Primary care is a major access point for the initial treatment of depression, but the management of these patients is far from optimal. The lack of time in primary care is one of the major difficulties for the delivery of evidence-based psychotherapy. During the last decade, research has focused on the development of brief psychotherapy and cost-effective internet-based interventions mostly based on cognitive behavioral therapy (CBT). Very little research has focused on alternative methods of treatment for depression using CBT. Thus, there is a need for research into other therapeutic approaches. OBJECTIVE:This study aimed to assess the effectiveness of 3 low-intensity, internet-based psychological interventions (healthy lifestyle psychoeducational program [HLP], focused program on positive affect promotion [PAPP], and brief intervention based on mindfulness [MP]) compared with a control condition (improved treatment as usual [iTAU]). METHODS:A multicenter, 4-arm, parallel randomized controlled trial was conducted between March 2015 and March 2016, with a follow-up of 12 months. In total, 221 adults with mild or moderate major depression were recruited in primary care settings from 3 Spanish regions. Patients were randomly distributed to iTAU (n=57), HLP (n=54), PAPP (n=56), and MP (n=54). All patients received iTAU from their general practitioners. The main outcome was the Spanish version of the Patient Health Questionnaire-9 (PHQ-9) from pretreatment (time 1) to posttreatment (time 2) and up to 6 (time 3) and 12 (time 4) months' follow-up. Secondary outcomes included the visual analog scale of the EuroQol, the Short-Form Health Survey (SF-12), the Positive and Negative Affect Schedule (PANAS), and the Pemberton Happiness Index (PHI). We conducted regression models to estimate outcome differences along study stages. RESULTS:A moderate decrease was detected in PHQ-9 scores from HLP (?=-3.05; P=.01) and MP (?=-3.00; P=.01) compared with iTAU at posttreatment. There were significant differences between all intervention groups and iTAU in physical SF-12 scores at 6 months after treatment. Regarding well-being, MP and PAPP reported better PHI results than iTAU at 6 months post treatment. PAPP intervention significantly decreased PANAS negative affect scores compared with iTAU 12 months after treatment. CONCLUSIONS:The low-intensity, internet-based psychological interventions (HLP and MP) for the treatment of depression in primary care are more effective than iTAU at posttreatment. Moreover, all low-intensity psychological interventions are also effective in improving medium- and long-term quality of life. PAPP is effective for improving health-related quality of life, negative affect, and well-being in patients with depression. Nevertheless, it is important to examine possible reasons that could be implicated for PAPP not being effective in reducing depressive symptomatology; in addition, more research is still needed to assess the cost-effectiveness analysis of these interventions. TRIAL REGISTRATION:ISRCTN Registry ISRCTN82388279; http://www.isrctn.com/ISRCTN82388279. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):RR2-10.1186/s12888-015-0475-0.

Project description:BACKGROUND:Depression is a common and serious problem among adolescents, but few seek or have access to therapy. Internet-delivered cognitive behavioral therapies (ICBTs), developed to increase treatment access, show promise in reducing depression. The inclusion of coach support in treatment is desired and may be needed. OBJECTIVE:The aim of this study was to determine the efficacy of an ICBT protocol blended with weekly real-time therapist sessions via chat; blended treatment, for adolescent depression, including major depressive episode (MDE). The protocol has previously been evaluated in a controlled study. METHODS:In a two-arm randomized controlled trial, adolescents 15 to 19 years of age were recruited through a community setting at the national level in Sweden (n=70) and allocated to either 8 weeks of treatment or to minimal attention control. Depression was assessed at baseline, at posttreatment, and at 12 months following treatment (in the intervention group). The primary outcome was self-reported depression level as measured with the Beck Depression Inventory II at posttreatment. The intervention was offered without the need for parental consent. RESULTS:Over two weeks, 162 adolescents registered and completed the baseline screening. Eligible participants (n=70) were on average 17.5 years of age (SD 1.15), female (96%, 67/70), suffered from MDE (76%, 53/70), had no previous treatment experience (64%, 45/70), and reported guardian(s) to be aware about their depression state (71%, 50/70). The average intervention completion was 74% (11.8 of 16 modules and sessions). Following the treatment, ICBT participants demonstrated a significant decrease in depression symptoms compared with controls (P<.001), corresponding to a large between-group effect (intention-to-treat analysis: d=0.86, 95% CI 0.37-1.35; of completer analysis: d=0.99, 95% CI 0.48-1.51). A significant between-group effect was observed in the secondary depression outcome (P=.003); clinically significant improvement was found in 46% (16/35) of ICBT participants compared with 11% (4/35) in the control group (P=.001). CONCLUSIONS:The results are in line with our previous study, further demonstrating that adolescents with depression can successfully be engaged in and experience significant improvement following ICBT blended with therapist chat sessions. Findings on participants' age and baseline depression severity are of interest in relation to used study methods. TRIAL REGISTRATION:ClinicalTrials.gov NCT02363205; https://clinicaltrials.gov/ct2/show/NCT02363205.

Project description:BackgroundInternet-delivered psychological treatments (IDPTs) are built on evidence-based psychological treatment models, such as cognitive behavioral therapy, and are adjusted for internet use. The use of internet technologies has the potential to increase access to evidence-based mental health services for a larger proportion of the population with the use of fewer resources. However, despite extensive evidence that internet interventions can be effective in the treatment of mental health disorders, user adherence to such internet intervention is suboptimal.ObjectiveThis review aimed to (1) inspect and identify the adaptive elements of IDPT for mental health disorders, (2) examine how system adaptation influences the efficacy of IDPT on mental health treatments, (3) identify the information architecture, adaptive dimensions, and strategies for implementing these interventions for mental illness, and (4) use the findings to create a conceptual framework that provides better user adherence and adaptiveness in IDPT for mental health issues.MethodsThe review followed the guidelines from Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA). The research databases Medline (PubMed), ACM Digital Library, PsycINFO, CINAHL, and Cochrane were searched for studies dating from January 2000 to January 2020. Based on predetermined selection criteria, data from eligible studies were analyzed.ResultsA total of 3341 studies were initially identified based on the inclusion criteria. Following a review of the title, abstract, and full text, 31 studies that fulfilled the inclusion criteria were selected, most of which described attempts to tailor interventions for mental health disorders. The most common adaptive elements were feedback messages to patients from therapists and intervention content. However, how these elements contribute to the efficacy of IDPT in mental health were not reported. The most common information architecture used by studies was tunnel-based, although a number of studies did not report the choice of information architecture used. Rule-based strategies were the most common adaptive strategies used by these studies. All of the studies were broadly grouped into two adaptive dimensions based on user preferences or using performance measures, such as psychometric tests.ConclusionsSeveral studies suggest that adaptive IDPT has the potential to enhance intervention outcomes and increase user adherence. There is a lack of studies reporting design elements, adaptive elements, and adaptive strategies in IDPT systems. Hence, focused research on adaptive IDPT systems and clinical trials to assess their effectiveness are needed.

Project description:BackgroundDepression and anxiety are common mental health disorders worldwide. The UK's Improving Access to Psychological Therapies (IAPT) programme is part of the National Health Service (NHS) designed to provide a stepped care approach to treating people with anxiety and depressive disorders. Cognitive Behavioural Therapy (CBT) is widely used, with computerised and internet-delivered cognitive behavioural therapy (cCBT and iCBT, respectively) being a suitable IAPT approved treatment alternative for step 2, low- intensity treatment. iCBT has accumulated a large empirical base for treating depression and anxiety disorders. However, the cost-effectiveness and impact of these interventions in the longer-term is not routinely assessed by IAPT services. The current study aims to evaluate the clinical and cost-effectiveness of internet-delivered interventions for symptoms of depression and anxiety disorders in IAPT.MethodsThe study is a parallel-groups, randomised controlled trial examining the effectiveness and cost-effectiveness of iCBT interventions for depression and anxiety disorders, against a waitlist control group. The iCBT treatments are of 8 weeks duration and will be supported by regular post-session feedback by Psychological Wellbeing Practitioners. Assessments will be conducted at baseline, during, and at the end of the 8-week treatment and at 3, 6, 9, and 12-month follow-up. A diagnostic interview will be employed at baseline and 3-month follow-up. Participants in the waitlist control group will complete measures at baseline and week 8, at which point they will receive access to the treatment. All adult users of the Berkshire NHS Trust IAPT Talking Therapies Step 2 services will be approached to participate and measured against set eligibility criteria. Primary outcome measures will assess anxiety and depressive symptoms using the GAD-7 and PHQ-9, respectively. Secondary outcome measures will allow for the evaluation of long-term outcomes, mediators and moderators of outcome, and cost-effectiveness of treatment. Analysis will be conducted on a per protocol and intention-to-treat basis.DiscussionThis study seeks to evaluate the immediate and longer-term impact, as well as the cost effectiveness of internet-delivered interventions for depression and anxiety. This study will contribute to the already established literature on internet-delivered interventions worldwide. The study has the potential to show how iCBT can enhance service provision, and the findings will likely be generalisable to other health services.Trial registrationCurrent Controlled Trials ISRCTN ISRCTN91967124. DOI: https://doi.org/10.1186/ISRCTN91967124 . Web: http://www.isrctn.com/ISRCTN91967124 . Clinicaltrials.gov : NCT03188575. Trial registration date: June 8, 2017 (prospectively registered).

Project description:BackgroundGreater access to evidence-based psychological treatments is needed. This review aimed to evaluate whether internet-delivered psychological treatments for mood and anxiety disorders are efficacious, noninferior to established treatments, safe, and cost-effective for children, adolescents and adults.MethodsWe searched the literature for studies published until March 2013. Randomized controlled trials (RCTs) were considered for the assessment of short-term efficacy and safety and were pooled in meta-analyses. Other designs were also considered for long-term effect and cost-effectiveness. Comparisons against established treatments were evaluated for noninferiority. Two reviewers independently assessed the relevant studies for risk of bias. The quality of the evidence was graded using an international grading system.ResultsA total of 52 relevant RCTs were identified whereof 12 were excluded due to high risk of bias. Five cost-effectiveness studies were identified and three were excluded due to high risk of bias. The included trials mainly evaluated internet-delivered cognitive behavioral therapy (I-CBT) against a waiting list in adult volunteers and 88% were conducted in Sweden or Australia. One trial involved children. For adults, the quality of evidence was graded as moderate for the short-term efficacy of I-CBT vs. waiting list for mild/moderate depression (d = 0.83; 95% CI 0.59, 1.07) and social phobia (d = 0.85; 95% CI 0.66, 1.05), and moderate for no efficacy of internet-delivered attention bias modification vs. sham treatment for social phobia (d = -0.04; 95% CI -0.24, 0.35). The quality of evidence was graded as low/very low for other disorders, interventions, children/adolescents, noninferiority, adverse events, and cost-effectiveness.ConclusionsI-CBT is a viable treatment option for adults with depression and some anxiety disorders who request this treatment modality. Important questions remain before broad implementation can be supported. Future research would benefit from prioritizing adapting treatments to children/adolescents and using noninferiority designs with established forms of treatment.

Project description:BackgroundFamily caregivers are more likely to experience insomnia relative to noncaregivers but have significant barriers to accessing gold standard cognitive behavioral therapy for insomnia treatment. Delivering interventions to caregivers through the internet may help increase access to care, particularly among higher-intensity caregivers who provide assistance with multiple care tasks over many hours per week. Although there are existing internet interventions that have been thoroughly studied and demonstrated as effective in the general population, the extent to which these interventions may be effective for caregivers without tailoring to address this population's unique psychosocial needs has not been studied.ObjectiveThe goal of this trial is to determine what tailoring may be necessary for which caregivers to ensure they receive optimal benefit from an existing evidence-based, internet-delivered cognitive behavioral therapy for insomnia program named Sleep Healthy Using the Internet (SHUTi). Specifically, we will test the association between caregivers' engagement with SHUTi and their caregiving context characteristics (ie, caregiving strain, self-efficacy, and guilt) and environment (ie, proximity to care recipient; functional status, cognitive status, and problem behavior of care recipient; and type of care provided). Among caregivers using the program, we will also test the associations between change in known treatment mechanisms (sleep beliefs and sleep locus of control) and caregiving context factors.MethodsA total of 100 higher-intensity caregivers with significant insomnia symptoms will be recruited from across the United States to receive access to SHUTi in an open-label trial with mixed methods preassessments and postassessments. At postassessment (9 weeks following preassessment completion), participants will be categorized according to their engagement with the program (nonusers, incomplete users, or complete users). Study analyses will address 3 specific aims: to examine the association between caregivers' engagement with SHUTi and their caregiving context (aim 1a); to describe caregivers' barriers to and motivations for SHUTi engagement from open-ended survey responses (aim 1b); and among caregivers using SHUTi, to determine whether cognitive mechanisms of change targeted by SHUTi are associated with differences in caregiving context (aim 2).ResultsInstitutional review board approvals have been received. Data collection is anticipated to begin in December 2021 and is expected to be completed in 2023.ConclusionsFindings will inform the next research steps for tailoring and testing SHUTi for optimal impact and reach among caregivers. Beyond implication to the SHUTi program, the findings will be translatable across intervention programs and will hold significant promise to reduce inefficiencies in developing digital health interventions for caregivers while also increasing their impact and reach for this underserved population.Trial registrationClinicalTrials.gov; NCT04986904; https://clinicaltrials.gov/ct2/show/NCT04986904?term=NCT04986904.International registered report identifier (irrid)PRR1-10.2196/34792.

Project description:BackgroundInternet-delivered psychological interventions (IPIs) have been shown to be effective for a variety of psychological concerns, including postpartum depression. Human-supported programs produce better adherence and larger effect sizes than unsupported programs; however, what it is about support that affects outcomes is not well understood. Therapeutic alliance is one possibility that has been found to contribute to outcomes; however, the specific mechanism is not well understood. Participant perspectives and qualitative methodology are nearly absent from the IPI alliance research and may help provide new directions.ObjectiveIn this study, we aimed to provide participant perspectives on engagement with an IPI for postpartum depression to help inform alliance research, development of new IPIs, and inform resource allocation.MethodsA qualitative methodology was used to explore participant perspectives of veteran women's engagement with the MomMoodBooster program, a human-supported internet-delivered intervention for postpartum depression. Participants were asked 4 open-ended questions with the 3-month postintervention survey, "In what ways did you find the MomMoodBooster most helpful?" "How do you think the MomMoodBooster could have been improved?" "In what ways did you find the personal coach calls to be helpful?" and "How do you think the personal coach calls could have been improved?"ResultsData were collected from 184 participants who responded to at least 1 of the open-ended questions. These were analyzed using thematic analysis and a process of reaching a consensus among coders. The results suggest that not only the engagement with the support person is perceived as a significant contributor to participant experiences while using the MomMoodBooster content but also the relationship factors are particularly meaningful. The results provide insights into the specific qualities of the support person that were perceived as most impactful, such as warmth, empathy and genuineness, and feeling normalized and supported. In addition, the results provide insight into the specific change processes that can be targeted through support interactions, such as encouraging self-reflection and self-care and challenging negative thinking.ConclusionsThese data emphasize the importance of relationship factors between support persons and an IPI program for postpartum depression. The findings suggest that focusing on specific aspects of the alliance and the therapeutic relationship could yield fruitful directions for the training of support personnel and for future alliance-based research of internet-delivered treatments.

Project description:BackgroundDepression is the principal cause of disability in the world. High prevalence rates of depression in general populations and college students have been found worldwide and in various cultural groups. Low-intensity cognitive behavioural internet-delivered treatment has demonstrated efficacy in high-income-countries (HICs). However little is known of their potential for adaptation and efficacy in low and middle-income countries.MethodsStudy (1) involves the cultural adaptation of the Space from Depression cognitive-behaviour internet-delivered programme with an asynchronous support for depressive symptoms. This includes initial researcher/clinician adaptation and the integration of cultural assessment feedback of the programme by a panel of experts and users through the theoretically-based Cultural Relevance Questionnaire (CRQ). Study (2) describes the implementation of the culturally adapted intervention using a randomised controlled trial methodology. The efficacy trial will include an active treatment group and a waiting-list control group of participants meeting eligibility criteria (mild to moderate depression symptoms). The active condition will consist of 7 weekly modules of internet-delivered cognitive behavioural therapy (iCBT) Space from Depression, with post-session feedback support. The primary outcome will be the Patient Health Questionnaire (PHQ-9). The study also involves collection of client reported significant events and client satisfaction with the internet-delivered treatment. Data will be collected at baseline and at post-treatment (week 7), and at follow-up (week 20/3 months). Analysis will be conducted on the intention-to-treat basis.DiscussionThe study seeks to establish a theoretically robust methodology for culturally adapting internet-delivered interventions for mental health disorders and to evaluate the efficacy of a culturally adapted internet-delivered treatment for depression in Colombia, with support. The study will be a first contribution to a method for culturally adapting internet-delivered interventions and also a first to examine the efficacy of such an adapted intervention in Latin America.Trial registrationClinical trials NCT03062215. Retrospectively registered 14th February 2017.

Dataset Information

Efficacy of a blended low-intensity internet-delivered psychological programme in patients with multimorbidity in primary care: study protocol for a randomized controlled trial.

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Efficacy of a blended low-intensity internet-delivered psychological programme in patients with multimorbidity in primary care: study protocol for a randomized controlled trial.

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