Dataset Information

A randomised controlled trial to investigate the clinical effectiveness and cost effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for depressed non-responders to Increasing Access to Psychological Therapies (IAPT) high-intensity therapies: study protocol.

ABSTRACT:

Background

Major 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.

Methods

In 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.

Discussion

This 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 registration

ClinicalTrials.gov NCT05236959. Registered on 11 February 2022. ISRCTN 17755571. Registered on 2 February 2021.

SUBMITTER: Barnhofer T

PROVIDER: S-EPMC9851098 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

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Publications

A randomised controlled trial to investigate the clinical effectiveness and cost effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for depressed non-responders to Increasing Access to Psychological Therapies (IAPT) high-intensity therapies: study protocol.

Barnhofer Thorsten T Dunn Barnaby D BD Strauss Clara C Ruths Florian F Barrett Barbara B Ryan Mary M Ladwa Asha A Stafford Frances F Fichera Roberta R Baber Hannah H McGuinness Ailis A Metcalfe Isabella I Harding Delilah D Walker Sarah S Ganguli Poushali P Rhodes Shelley S Young Allan A Warren Fiona F

Trials 20230119 1

<h4>Background</h4>Major 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 wi ...[more]

PMID: 36658663

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Project description:BackgroundEmerging evidence has shown that mindfulness-based cognitive therapy (MBCT) is effective in improving depressive symptoms in the older population. However, the accessibility to MBCT is limited by the shortage of psychotherapists or mindfulness teachers. One potential solution is to involve social workers, who have the knowledge and skills to promote individual and community well-being in various settings, in delivering modified MBCT to enhance its accessibility and sustainability. This study examined the effectiveness of an eight-week age-modified MBCT led by different mental health professionals (mindfulness teacher only vs. mindfulness teacher and social worker) in improving mental health outcomes as compared with a control group.MethodsOlder adults (N = 112) were recruited through five community-based centres for older adults and mental wellness in Hong Kong. Participants were allocated to one of three groups: (1) mindfulness teacher-led modified MBCT, (2) social worker/teacher co-led modified MBCT (50% led by social workers and 50% led by mindfulness teacher), or (3) control (care as usual). The age-modified MBCT consisted of eight weekly sessions, with age-related modifications including more sitting meditation, shortened duration of each session, and the removal of the retreat. Outcome variables (i.e., depressive symptoms, anxiety symptoms, perceived stress, and mindfulness) were assessed at baseline (T0), after the intervention (T1), and four weeks after the intervention (T2), through self-reported questionnaires. Linear mixed models were performed while controlling for demographic variables to examine changes in outcome variables between the groups.ResultsParticipants from the age-modified MBCT intervention groups (teacher-led and social worker/teacher co-led) showed significantly greater reductions in depressive symptoms and stress, as well as greater increase in mindful non-reactivity, compared to the control group post-intervention. No significant interaction effect of time and group was found for anxiety and both overall mindfulness and its other facets. The improvements in mental health and mindfulness outcomes post-intervention were not significantly different between the teacher-led and social worker/teacher co-led MCBT groups.DiscussionAge-modified MBCT is beneficial in managing depressive and stress symptoms and in improving mindful non-reactivity among older adults at risk for depression. The findings support the feasibility and effectiveness of partial task-shifting in the delivery of MBCT to trained social workers. Future studies may explore the possibility for social workers in leading MBCTs independently to further improve its scalability and service accessibility for older adults in the community.Trial registrationClinicalTrials.gov NCT05995587. Retrospectively registered on 16 August 2023.

Project description:BackgroundAddressing the wider determinants of mental health alongside psychological therapy could improve mental health service outcomes and population mental health.ObjectivesTo estimate the effectiveness of an enhanced 'Improving Access to Psychological Therapies' (IAPT) mental health service compared with traditional IAPT in England. Alongside traditional therapy treatment, the enhanced service included well-being support and community service links.DesignA real-world evaluation using IAPT's electronic health records.SettingThree National Health Service IAPT services in England.ParticipantsData from 17 642 service users classified as having a case of depression and/or anxiety at baseline.InterventionWe compared the enhanced IAPT service (intervention) to an IAPT service in a different region providing traditional treatment only (geographical control), and the IAPT service with traditional treatment before additional support was introduced (historical control).Primary outcome measuresPatient Health Questionnaire-9 (PHQ-9) Depression Scale (score range: 0-27) and Generalised Anxiety Disorder-7 (GAD-7) Anxiety Scale (score range: 0-21); for both, lower scores indicate better mental health. Propensity scores were used to estimate inverse probability of treatment weights, subsequently used in mixed effects regression models.ResultsSmall improvements (mean, 95% CI) were observed for PHQ-9 (depression) (-0.21 to -0.32 to -0.09) and GAD-7 (anxiety) (-0.23 to -0.34 to -0.13) scores in the intervention group compared with the historical control. There was little evidence of statistically significant differences between intervention control and geographical control.ConclusionsEmbedding additional health and well-being (H&W) support into standard IAPT services may lead to improved mental health outcomes. However, the lack of improved outcomes compared with the geographical control may instead reflect a more general improvement to the intervention IAPT service. It is not clear from our findings whether an IAPT service with additional H&W support is clinically superior to traditional IAPT models.

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:ObjectivesThe primary aim was to explore state- and trait-level effects and candidate mechanisms of four Mindfulness-Based Cognitive Therapy (MBCT) practices.MethodOne hundred sixty adults self-selected from the general population were randomized to one of four mindfulness practices: body scan, mindful movement, breath and body, and befriending. Study 1 explored state-level self-compassion, mindfulness, decentering (mechanisms), and pleasantness of thoughts, emotions, and body sensations at multiple time points using two single mindfulness sessions. Study 2 explored trait-level self-compassion, mindfulness, decentering, interoceptive awareness, attentional control (mechanisms), anxiety, depression, and psychological quality of life pre-post 2 weeks of daily practice.ResultsIn study 1, state-level effects were demonstrated in all candidate mechanisms and outcomes within the whole sample across time points (d = 0.27 to 0.86), except for state decentering. After controlling for pre-scores and additional covariates, no between-group effects were found (p = 0.050 to 0.973). In study 2, trait-level effects were demonstrated in psychological quality of life and most candidate mechanisms within the whole sample (d = 0.26 to 0.64) but no between-group effects were found (p = 0.080 to 0.805). Within the whole sample, after controlling for pre-scores, changes in mindfulness, self-compassion, decentering, and interoceptive awareness (i.e. body listening) were associated with improvements in psychological quality of life (r = 0.23 to 0.40) and self-led mindfulness practice (r = 0.18 to 0.23).ConclusionsFuture research should test the generated hypotheses using well-designed, adequately powered, and theory-driven studies that address universal and specific mechanisms in different populations and contexts.Pre-registrationThis study is not pre-registered.Supplementary informationThe online version contains supplementary material available at 10.1007/s12671-023-02193-6.

Dataset Information

A randomised controlled trial to investigate the clinical effectiveness and cost effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for depressed non-responders to Increasing Access to Psychological Therapies (IAPT) high-intensity therapies: study protocol.

Background

Methods

Discussion

Trial registration

Publications

A randomised controlled trial to investigate the clinical effectiveness and cost effectiveness of Mindfulness-Based Cognitive Therapy (MBCT) for depressed non-responders to Increasing Access to Psychological Therapies (IAPT) high-intensity therapies: study protocol.

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