Clinical Effectiveness and Cost-Effectiveness of Supported Mindfulness-Based Cognitive Therapy Self-help Compared With Supported Cognitive Behavioral Therapy Self-help for Adults Experiencing Depression: The Low-Intensity Guided Help Through Mindfulness (LIGHTMind) Randomized Clinical Trial.

Importance: Depression is prevalent. Treatment guidelines recommend practitioner-supported cognitive behavioral therapy self-help (CBT-SH) for mild to moderate depression in adults; however, dropout rates are high. Alternative approaches are required. Objective: To determine if practitioner-supported mindfulness-based cognitive therapy self-help (MBCT-SH) is superior to practitioner-supported CBT-SH at reducing depressive symptom severity at 16 weeks postrandomization among patients with mild to moderate depression and secondarily to examine if practitioner-supported MBCT-SH is cost-effective compared with practitioner-supported CBT-SH. Design, Setting, and Participants: This was an assessor- and participant-blinded superiority randomized clinical trial with 1:1 automated online allocation stratified by center and depression severity comparing practitioner-supported MBCT-SH with practitioner-supported CBT-SH for adults experiencing mild to moderate depression. Recruitment took place between November 24, 2017, and January 31, 2020. The study took place in 10 publicly funded psychological therapy services in England (Improving Access to Psychological Therapies [IAPT]). A total of 600 clients attending IAPT services were assessed for eligibility, and 410 were enrolled. Participants met diagnostic criteria for mild to moderate depression. Data were analyzed from January to October 2021. Interventions: Participants received a copy of either an MBCT-SH or CBT-SH workbook and were offered 6 support sessions with a trained practitioner. Main Outcomes and Measures: The preregistered primary outcome was Patient Health Questionnaire (PHQ-9) score at 16 weeks postrandomization. The primary analysis was intention-to-treat with treatment arms masked. Results: Of 410 randomized participants, 255 (62.2%) were female, and the median (IQR) age was 32 (25-45) years. At 16 weeks postrandomization, practitioner-supported MBCT-SH (n = 204; mean [SD] PHQ-9 score, 7.2 [4.8]) led to significantly greater reductions in depression symptom severity compared with practitioner-supported CBT-SH (n = 206; mean [SD] PHQ-9 score, 8.6 [5.5]), with a between-group difference of -1.5 PHQ-9 points (95% CI, -2.6 to -0.4; P = .009; d = -0.36). The probability of MBCT-SH being cost-effective compared with CBT-SH exceeded 95%. However, although between-group effects on secondary outcomes were in the hypothesized direction, they were mostly nonsignificant. Three serious adverse events were reported, all deemed not study related. Conclusions and Relevance: In this randomized clinical trial, practitioner-supported MBCT-SH was superior to standard recommended treatment (ie, practitioner-supported CBT-SH) for mild to moderate depression in terms of both clinical effectiveness and cost-effectiveness. Findings suggest that MBCT-SH for mild to moderate depression should be routinely offered to adults in primary care services. Trial Registration: isrctn.org Identifier: ISRCTN13495752.

Participant perspectives on the acceptability and effectiveness of mindfulness-based cognitive behaviour therapy approaches for obsessive compulsive disorder.

Cognitive behavioural therapy (CBT) which includes Exposure and Response (ERP) is a highly effective, gold standard treatment for Obsessive-Compulsive Disorder (OCD). Nonetheless, not all patients with OCD significantly benefit from CBT. This has generated interest in the potential benefits of Mindfulness-Based Interventions (MBIs), either integrated with CBT, to enhance engagement with ERP tasks, or delivered as a stand-alone, first-line or therapy to augment CBT. This paper reports on two qualitative studies that involved a thematic analysis of interview data with participants in a 10-week Mindfulness-Based ERP (MB-ERP) course (study 1) and a 9-week Mindfulness-Based Cognitive Therapy course adapted for OCD (MBCT-OCD) (study 2). Whilst MB-ERP integrated a mindfulness component into a standard ERP protocol, MBCT-OCD adapted the psychoeducational components of the standard MBCT for depression protocol to suit OCD, but without explicit ERP tasks. Three common main themes emerged across MB-ERP and MBCT-OCD: 'satisfaction with course features', 'acceptability of key therapeutic tasks 'and 'using mindfulness to respond differently to OCD'. Sub-themes identified under the first two main themes were mostly unique to MB-ERP or MBCT-OCD, with the exception of '(struggles with) developing a mindfulness practice routine' whilst most of the sub-themes under the last main theme were shared across MB-ERP and MBCT-OCD participants. Findings suggested that participants generally perceived both MBIs as acceptable and potentially beneficial treatments for OCD, in line with theorised mechanisms of change.

Low-Intensity Guided Help Through Mindfulness (LIGHTMIND): study protocol for a randomised controlled trial comparing supported mindfulness-based cognitive therapy self-help to supported cognitive behavioural therapy self-help for adults experiencing depression.

BACKGROUND: Depression has serious personal, family and economic consequences. It is estimated that it will cost £12.15 billion to the economy each year in England by 2026. Improving access to psychological therapies (IAPT) is the National Health Service talking therapies service in England for adults experiencing anxiety or depression. Over 1 million people are referred to IAPT every year, over half experiencing depression. Where symptoms of depression are mild to moderate, people are typically offered cognitive behavioural therapy (CBT) self-help (CBT-SH) supported by a psychological well-being practitioner. The problem is that over half of people who complete treatment for depression in IAPT remain depressed despite receiving National Institute of Health and Care Excellent recommended treatment. Furthermore, less than half of IAPT service users complete treatment. This study seeks to investigate the effectiveness of an alternative to CBT-SH. Mindfulness-based cognitive therapy (MBCT) differs from CBT in focus, approach and practice, and may be more effective with a higher number of treatment completions. METHODS/DESIGN: This is a definitive randomised controlled trial comparing supported MBCT self-help (MBCT-SH) with CBT-SH for adults experiencing mild to moderate depression being treated in IAPT services. We will recruit 410 participants experiencing mild to moderate depression from IAPT services and randomise these to receive either an MBCT-based self-help workbook or a CBT-based self-help workbook. Participants will be asked to complete their workbook within 16 weeks, with six support sessions with a psychological well-being practitioner. The primary outcome is depression symptom severity on treatment completion. Secondary outcomes are treatment completion rates and measures of generalized anxiety, well-being, functioning and mindfulness. An exploratory non-inferiority analysis will be conducted in the event the primary hypothesis is not supported. A semi-structured interview with participants will guide understanding of change processes. DISCUSSION: If the findings from this randomised controlled trial demonstrate that MBCT-SH is more effective than CBT-SH for adults experiencing depression, this will provide evidence for policy makers and lead to changes to clinical practice in IAPT services, leading to greater choice of self-help treatment options and better outcomes for service users. If the exploratory non-inferiority analysis is conducted and this indicates non-inferiority of MBCT-SH in comparison to CBT-SH this will also be of interest to policy makers when seeking to increase service user choice of self-help treatment options for depression. TRIAL REGISTRATION: Current Controlled Trial registration number: ISRCTN 13495752. Registered on 31 August 2017 (www.isrctn.com/ISRCTN13495752).

Mindfulness-based exposure and response prevention for obsessive compulsive disorder: Findings from a pilot randomised controlled trial.

BACKGROUND: Only about half of people with obsessive compulsive disorder (OCD) show clinically significant improvement following the recommended therapy, exposure and response prevention (ERP), partly due to poor therapy acceptability. A mindfulness-based approach to ERP (MB-ERP) has the potential to improve acceptability and outcomes. METHODS: This was an internal pilot randomised controlled trial (RCT) of group MB-ERP compared to group ERP. 37 participants meeting DSM-IV OCD criteria were randomly allocated to MB-ERP or ERP. RESULTS: Both groups improved in OCD symptom severity. However, MB-ERP did not lead to clinically important improvements in OCD symptom severity at post-intervention compared to ERP - the minimum clinically important difference was not contained in the 95% confidence intervals. There were negligible between-group differences in engagement and MB-ERP did not appear to have broader benefits compared to ERP on depression, wellbeing or OCD-related beliefs. Conversely, MB-ERP led to medium/medium-large improvements in mindfulness compared to ERP. CONCLUSIONS: MB-ERP is unlikely to lead to clinically meaningful improvements in OCD symptom severity compared to ERP alone. We underline the importance of adhering to treatment guidelines recommending ERP for OCD. Insufficient attention may have been given to mindfulness practice/discussion in MB-ERP and further research is recommended to explore this possibility.

Mindfulness-based exposure and response prevention for obsessive compulsive disorder: study protocol for a pilot randomised controlled trial.

BACKGROUND: Obsessive Compulsive Disorder (OCD) is a distressing and debilitating condition affecting 1-2% of the population. Exposure and response prevention (ERP) is a behaviour therapy for OCD with the strongest evidence for effectiveness of any psychological therapy for the condition. Even so, only about half of people offered ERP show recovery after the therapy. An important reason for ERP failure is that about 25% of people drop out early, and even for those who continue with the therapy, many do not regularly engage in ERP tasks, an essential element of ERP. A mindfulness-based approach has the potential to reduce drop-out from ERP and to improve ERP task engagement with an emphasis on accepting difficult thoughts, feelings and bodily sessions and on becoming more aware of urges, rather than automatically acting on them. METHODS/DESIGN: This is a pilot randomised controlled trial of mindfulness-based ERP (MB-ERP) with the aim of establishing parameters for a definitive trial. Forty participants diagnosed with OCD will be allocated at random to a 10-session ERP group or to a 10-session MB-ERP group. Primary outcomes are OCD symptom severity and therapy engagement. Secondary outcomes are depressive symptom severity, wellbeing and obsessive-compulsive beliefs. A semi-structured interview with participants will guide understanding of change processes. DISCUSSION: Findings from this pilot study will inform future research in this area, and if effect sizes on primary outcomes are in favour of MB-ERP in comparison to ERP, funding for a definitive trial will be sought. TRIAL REGISTRATION: Current Controlled Trials registration number ISRCTN52684820. Registered on 30 January 2014.