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Digital IAPT: the effectiveness & cost-effectiveness of internet-delivered interventions for depression and anxiety disorders in the Improving Access to Psychological Therapies programme: study protocol for a randomised control trial.

ABSTRACT: Depression 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.The 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.This 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.Current 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).

SUBMITTER: Richards D

PROVIDER: S-EPMC5833053 | biostudies-literature | 2018 Mar

REPOSITORIES: biostudies-literature

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Digital IAPT: the effectiveness & cost-effectiveness of internet-delivered interventions for depression and anxiety disorders in the Improving Access to Psychological Therapies programme: study protocol for a randomised control trial.

Richards Derek D Duffy Daniel D Blackburn Brid B Earley Caroline C Enrique Angel A Palacios Jorge J Franklin Matthew M Clarke Gabriella G Sollesse Sarah S Connell Sarah S Timulak Ladislav L

BMC psychiatry 20180302 1

<h4>Background</h4>Depression 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 a ...[more]

PMID: 29499675

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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:BackgroundMajor depression represents a pressing challenge for health care. In England, Increasing Access to Psychological Therapies (IAPT) services provide evidence-based psychological therapies in a stepped-care approach to patients with depression. While introduction of these services has successfully increased access to therapy, estimates suggest that about 50% of depressed patients who have come to the end of the IAPT pathway still show significant levels of symptoms. This study will investigate whether Mindfulness-Based Cognitive Therapy (MBCT), a group intervention combining training in mindfulness meditation and elements from cognitive therapy, can have beneficial effects in depressed patients who have not responded to high-intensity therapy in IAPT. It will seek to establish the effectiveness and cost-effectiveness of MBCT as compared to the treatment these patients would usually receive.MethodsIn a 2-arm randomised controlled trial, patients who currently meet the criteria for major depressive disorder and who have not sufficiently responded to at least 12 sessions of IAPT high-intensity therapy will be allocated, at a ratio of 1:1, to receive either MBCT (in addition to treatment as usual [TAU]) or continue with TAU only. Assessments will take place at baseline, 10 weeks and 34 weeks post-randomisation. The primary outcome will be reduction in depression symptomatology 34 weeks post-randomisation as assessed using the Public Health Questionnaire-9 (PHQ-9). Secondary outcomes will include depressive symptomatology at 10 weeks post-randomisation and other clinical outcomes measured at 10-week and 34-week follow-up, along with a series of binarised outcomes to indicate clinically significant and reliable change. Evaluations of cost-effectiveness will be based on assessments of service use costs collected using the Adult Service Use Schedule and health utilities derived from the EQ-5D.DiscussionThis trial will add to the evidence base for the use of MBCT in depressed treatment non-responders. It will constitute the first trial to test MBCT following non-response to psychological therapy, with results providing a direct estimate of efficacy within the IAPT pathway. As such, its results will offer an important basis for decisions regarding the adoption of MBCT for non-responders within IAPT.Trial registrationClinicalTrials.gov NCT05236959. Registered on 11 February 2022. ISRCTN 17755571. Registered on 2 February 2021.

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:BackgroundHealth anxiety is a prevalent and debilitating disorder associated with extensive use of healthcare services and reduced quality of life (QoL). Regional variability in specialised clinics or specialist healthcare providers limits access to evidence-based treatment, which may be overcome by internet-delivered Acceptance and Commitment Therapy (iACT).ObjectiveThis study investigated the cost effectiveness of iACT for severe health anxiety in adults.MethodsBased on a Danish randomised controlled trial (March 2016-March 2017), the economic evaluation compared costs and effects between iACT and an active control condition (iFORUM). Effectiveness was measured using self-report questionnaires. The cost analysis applied a societal perspective. Resource use and healthcare costs were extracted from the Danish National Registries. Linear regression analysis was applied using change in costs/effectiveness outcomes as the dependant variable. Time, group, and interaction between time and group were independent variables. The primary outcome was the proportion of clinically significant improvements, defined as a ≥ 25% reduction in two measures of health anxiety. The probability of cost effectiveness was presented in a cost-effectiveness acceptability curve for a range of threshold values for willingness to pay.ResultsNo significant differences were detected in healthcare costs between groups; however, the iACT group significantly improved in all effectiveness outcomes. The economic analysis showed that, from the healthcare perspective, iACT was associated with an incremental cost-effectiveness ratio of €33 per additional case of clinically significant improvement compared with iFORUM and that, from the societal perspective, iACT dominated iFORUM because it was more effective and less expensive.ConclusionsWe found no statistically significant differences in costs between groups; however, iACT for severe health anxiety may be cost effective, as evidenced by significant differences in effect.Trial registry numberClinicaltrials.gov, no. NCT02735434.

Project description:BACKGROUND:Anxiety conditions are debilitating and prevalent throughout the world. Acceptance and Commitment Therapy (ACT) is an effective, acceptance-based behavioral therapy for anxiety. However, there are treatment barriers (eg, financial, geographical, and attitudinal), which prevent people from accessing it. To overcome these barriers, internet-delivered ACT (iACT) interventions have been developed in recent years. These interventions use websites to deliver ACT information and skill training exercises on the Web, either as pure self-help or with therapist guidance. OBJECTIVE:This systematic review aimed to examine the therapeutic impact of iACT on all anxiety conditions. METHODS:The EMBASE, MEDLINE, ProQuest Central, PsycINFO, Scopus, and Web of Science databases were searched up to September 2018. The titles and abstracts of remaining records after deduplication were screened by 2 authors with a total of 36 full-text articles being retained for closer inspection next to eligibility criteria. Empirical studies of all designs, population types, and comparator groups were included if they appraised the impact of iACT treatment on any standardized measure of anxiety. Included studies were appraised on methodological quality and had their data extracted into a standardized coding sheet. Findings were then tabulated, and a narrative synthesis was performed because of the heterogeneity found between studies. RESULTS:A total of 20 studies met inclusion criteria. There were 11 randomized controlled trials (RCTs) and 9 uncontrolled pilot studies. Participants across all studies were adults. The anxiety conditions treated were as follows: generalized anxiety disorder (GAD), social anxiety disorder (SAD), illness anxiety disorder (IAD), and general anxiety symptoms, with or without comorbid physical and mental health problems. A total of 18 studies reported significant anxiety reduction after iACT treatment. This was observed in studies that delivered iACT with (n=13) or without (n=5) therapist guidance. The average attrition rate across all included studies during the active iACT treatment phase was 19.19%. In the 13 studies that assessed treatment satisfaction, participants on average rated their iACT experience with above average to high treatment satisfaction. CONCLUSIONS:These findings indicate that iACT can be an efficacious and acceptable treatment for adults with GAD and general anxiety symptoms. More RCT studies are needed to corroborate these early iACT findings using empirical treatments in active control groups (eg, internet-delivered cognitive behavioral therapy). This would potentially validate the promising results found for SAD and IAD as well as address the full spectrum of anxiety disorders.

Project description:Few studies have evaluated the implementation of ICBT in regular child and adolescent mental health services (CAMHS). This study aimed to explore the acceptability, feasibility, and effectiveness of ICBT for children and adolescents with anxiety disorders and obsessive-compulsive disorder (OCD) within a rural CAMHS. The study also explored outcome predictors and long-term outcomes. Eighty-three participants were consecutively recruited from a non-specialized CAMHS in Region Jämtland Härjedalen in northern Sweden. Therapist-guided ICBT was offered during 12 weeks to children aged 8-17 with an anxiety disorder or OCD. Acceptability and feasibility measures included treatment adherence, treatment satisfaction, and adverse events. The primary outcome measure was the Clinical Global Impression-Severity. Secondary measures of effectiveness included clinician-, self-, and parent-ratings of symptom severity and functional impairment. Assessments were completed at baseline, post-treatment, and three-month follow-up (primary endpoint). A two-year follow up was conducted using medical records. Potential predictors included both patient characteristics and treatment variables. Results indicated that ICBT was both acceptable and feasible according to study measures. Statistically significant improvements were found from baseline to the three-month follow-up on clinician rated severity (B [SE] = -0.92 [0.09]; p < .001), as well as on all secondary measures. Forty-three percent of participants no longer fulfilled criteria for their principal disorder at the three-month follow-up. No serious adverse events were reported. Clinical improvement was highest among children with higher functioning at baseline (B [SE] = -0.05 [0.02]; p < .05). Forty-six percent of participants had been in contact with CAMHS during the two-year follow-up period, mainly for reasons other than their initial diagnosis. Findings suggest that ICBT could be an acceptable and feasible treatment option for young people with anxiety disorders and OCD in rural non-specialized CAMHS settings. Further studies are needed to confirm treatment effectiveness in this setting. Trial registration: NCT02926365.

Project description:BackgroundThe 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.MethodsA 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.DiscussionThis 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 registrationClinicalTrials.gov, NCT03426709 . Registered retrospectively on 08 February 2018.

Dataset Information

Digital IAPT: the effectiveness & cost-effectiveness of internet-delivered interventions for depression and anxiety disorders in the Improving Access to Psychological Therapies programme: study protocol for a randomised control trial.

Publications

Digital IAPT: the effectiveness & cost-effectiveness of internet-delivered interventions for depression and anxiety disorders in the Improving Access to Psychological Therapies programme: study protocol for a randomised control trial.

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