Effect of coherent breathing on mental health and wellbeing: a randomised placebo-controlled trial.

Breathwork may offer simple tools for stress resilience. We conducted the largest parallel randomised-controlled trial on breathwork to date (NCT05676658) wherein 400 participants on the research platform Prolific were randomised, in blocks of 2 via remote software, to coherent breathing at ~ 5.5 breaths/min or a matched attention-placebo at 12 breaths/min, for ~ 10 min/day over 4 weeks. Participants were blinded to their allocated interventions, both of which were paced with equal inhalation:exhalation ratios. There were no differences on credibility and expectancy of benefit between conditions. At the primary timepoint post-intervention for the primary outcome subjective stress, there was no significant group by time interaction (F(1,377) = 0.089, p = 0.765, ηp2 < 0.001) nor main effect of group (F = 0.002, p = 0.961, ηp2 < 0.001), however there was a significant main effect of time (F = 72.1, p < 0.001, ηp2 = 0.161). Similar results were found at 1-month follow-up for stress and for secondary outcomes of anxiety, depression and wellbeing. There were overall improvements on these mental health and wellbeing outcomes from baseline to post-intervention and follow-up across both groups, yet the magnitude of this improvement was not different between arms. Accordingly, we found no measurable effect of coherent breathing over and above a well-designed breathwork placebo at improving mental health and wellbeing. Methodological considerations and recommendations for robust future research are discussed. Funder: Sasakawa Young Leaders Fellowship Fund, Tokyo, Japan.

Increasing access to CBT for psychosis patients: study protocol for a randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE3).

BACKGROUND: The National Institute for Health and Care Excellence (NICE) recommends that cognitive behaviour therapy (CBT) is offered to all patients with a psychosis diagnosis. However, only a minority of psychosis patients in England and Wales are offered CBT. This is attributable, in part, to the resource-intensive nature of CBT. One response to this problem has been the development of CBT in brief formats that are targeted at a single symptom and are deliverable by briefly trained therapists. We have developed Guided self-help CBT (the GiVE intervention) as a brief form of CBT for distressing voices and reported evidence for the feasibility of a randomised controlled trial (RCT) when the intervention was delivered by briefly trained therapists (assistant psychologists). This study will investigate the clinical and cost-effectiveness of the GiVE intervention when delivered by assistant psychologists following a brief training. METHODS: This study is a pragmatic, two-arm, parallel group, superiority RCT comparing the GiVE intervention (delivered by assistant psychologists) and treatment as usual to treatment as usual alone, recruiting across three sites, using 1:1 allocation and blind post-treatment and follow-up assessments. A nested qualitative study will develop a model for implementation. DISCUSSION: If the GiVE intervention is found to be effective when delivered by assistant psychologists, this intervention could significantly contribute to increasing access to evidence-based psychological interventions for psychosis patients. Furthermore, implementation across secondary care services within the UK's National Health Service may pave the way for other symptom-specific and less resource-intensive CBT-informed interventions for psychosis patients to be developed and evaluated. TRIAL REGISTRATION: Current Controlled Trials ISRCTN registration number: 12748453. Registered on 28 September 2022.

Feasibility and Preliminary Efficacy of Digital Interventions for Depressive Symptoms in Working Adults: Multiarm Randomized Controlled Trial.

BACKGROUND: Depressive symptoms are highly prevalent and have broad-ranging negative implications. Digital interventions are increasingly available in the workplace context, but supporting evidence is limited. OBJECTIVE: This study aimed to evaluate the feasibility, acceptability, and preliminary efficacy of 3 digital interventions for depressive symptoms in a sample of UK-based working adults experiencing mild to moderate symptoms. METHODS: This was a parallel, multiarm, pilot randomized controlled trial. Participants were allocated to 1 of 3 digital interventions or a waitlist control group and had 3 weeks to complete 6 to 8 short self-guided sessions. The 3 interventions are available on the Unmind mental health app for working adults and draw on behavioral activation, cognitive behavioral therapy, and acceptance and commitment therapy. Web-based assessments were conducted at baseline, postintervention (week 3), and at 1-month follow-up (week 7). Participants were recruited via Prolific, a web-based recruitment platform, and the study was conducted entirely on the web. Feasibility and acceptability were assessed using objective engagement data and self-reported feedback. Efficacy outcomes were assessed using validated self-report measures of mental health and functioning and linear mixed models with intention-to-treat principles. RESULTS: In total, 2003 individuals were screened for participation, of which 20.22% (405/2003) were randomized. A total of 92% (373/405) of the participants were retained in the study, 97.4% (295/303) initiated their allocated intervention, and 66.3% (201/303) completed all sessions. Moreover, 80.6% (229/284) of the participants rated the quality of their allocated intervention as excellent or good, and 79.6% (226/284) of the participants were satisfied or very satisfied with their intervention. All active groups showed improvements in well-being, functioning, and depressive and anxiety symptoms compared with the control group, which were maintained at 4 weeks. Hedges g effect sizes for depressive symptoms ranged from -0.53 (95% CI -0.25 to -0.81) to -0.74 (95% CI -0.45 to -1.03). CONCLUSIONS: All interventions were feasible and acceptable, and the preliminary efficacy findings indicated that their use may improve depressive symptoms, well-being, and functioning. The predefined criteria for a definitive trial were met. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number (ISRCTN) ISRCTN13067492; https://www.isrctn.com/ISRCTN13067492.

A systematic review and meta-analysis of digital interventions targeted at individuals with borderline personality disorder (BPD), emotionally unstable personality disorder (EUPD), and related symptoms.

OBJECTIVES: The present review investigates the impact of digital interventions for individuals with features of borderline personality disorder (BPD)/emotional unstable personality disorder (EUPD) as digital interventions show promise as therapeutic tools in underserved groups. BPD/EUPD features are identified as clinically relevant, yet previous reviews on the use of digital interventions fail to include subthreshold symptomatology. METHODS: Five online databases were searched for terminology in three categories: BPD/EUPD and related symptoms, mental-health interventions, and digital technology. Additionally, four relevant journals and two trial registers were searched for additional papers meeting the inclusion criteria. RESULTS: Twelve articles met all inclusion criteria. Meta-analyses revealed statistically significant differences in symptom measures between intervention and control groups at postintervention and decreases in BPD/EUPD symptomatology and well-being from pre- to postintervention. Service users' engagement, satisfaction, and acceptability of interventions were high. Results support the previous literature on the value of using digital interventions in populations with BPD/EUPD. CONCLUSION: Overall, it was identified that digital interventions show promise for successful implementation with this population.

Feasibility and preliminary efficacy of app-based audio tools to improve sleep health in working adults experiencing poor sleep: a multi-arm randomized pilot trial.

STUDY OBJECTIVES: Many adults without a diagnosed sleep disorder report poor sleep. Recently, there has been a dramatic increase in the use of app-based audio tools to aid sleep by the general public, yet there is a paucity of evidence on whether such tools are efficacious. This study evaluated the feasibility and preliminary efficacy of two categories of audio tools, comprising music and narrated stories, featured on the Unmind app. METHODS: We conducted an online, parallel, multi-arm, external pilot randomized controlled trial, with two intervention arms and a waitlist (WL) control group. Participants were working adults who were screened for poor sleep. Feasibility was assessed via objective and self-report measures. Preliminary efficacy was evaluated via self-report measures of sleep disturbance, work productivity, and other mental health outcomes, captured at baseline (t0) and following a 4-week intervention period (t1), and analyzed using mixed effects models with intention-to-treat principles. RESULTS: Three hundred participants were randomized, and 92% were retained at t1. 90.5% of participants completed at least one intervention session. 82.1% reported being "satisfied" or "very satisfied" with their intervention, and 84.3% rated their intervention as "good" or "excellent." The between-group Hedges' g effect size for sleep disturbance was 0.92 [0.63-1.22] and 1.09 [0.80-1.39] for the two interventions compared to the WL group. CONCLUSIONS: Both interventions are feasible and acceptable. Preliminary efficacy findings suggest that audio tools designed to aid sleep could have widespread financial and public health implications, and should be investigated in a definitive trial. CLINICAL TRIAL: International Standard Randomized Controlled Trial Number (ISRCTN), 12614821, http://www.isrctn.com/ISRCTN12614821.

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.

Effect of breathwork on stress and mental health: A meta-analysis of randomised-controlled trials.

Deliberate control of the breath (breathwork) has recently received an unprecedented surge in public interest and breathing techniques have therapeutic potential to improve mental health. Our meta-analysis primarily aimed to evaluate the efficacy of breathwork through examining whether, and to what extent, breathwork interventions were associated with lower levels of self-reported/subjective stress compared to non-breathwork controls. We searched PsycInfo, PubMed, ProQuest, Scopus, Web of Science, ClinicalTrials.gov and ISRCTN up to February 2022, initially identifying 1325 results. The primary outcome self-reported/subjective stress included 12 randomised-controlled trials (k = 12) with a total of 785 adult participants. Most studies were deemed as being at moderate risk of bias. The random-effects analysis yielded a significant small-to-medium mean effect size, g = - 0.35 [95% CI - 0.55, - 0.14], z = 3.32, p = 0.0009, showing breathwork was associated with lower levels of stress than control conditions. Heterogeneity was intermediate and approaching significance, χ211 = 19, p = 0.06, I2 = 42%. Meta-analyses for secondary outcomes of self-reported/subjective anxiety (k = 20) and depressive symptoms (k = 18) showed similar significant effect sizes: g = - 0.32, p < 0.0001, and g = - 0.40, p < 0.0001, respectively. Heterogeneity was moderate and significant for both. Overall, results showed that breathwork may be effective for improving stress and mental health. However, we urge caution and advocate for nuanced research approaches with low risk-of-bias study designs to avoid a miscalibration between hype and evidence.

A thematic analysis of barriers and facilitators to participant engagement in group exposure and response prevention therapy for obsessive-compulsive disorder.

Exposure and response prevention (ERP) is the gold standard in the treatment of the obsessive-compulsive disorder (OCD). It can be delivered effectively using an individual or group therapy format. Nonetheless, a sizeable proportion of people diagnosed with OCD do not experience OCD symptom remission following ERP. Research suggests that participant engagement with ERP tasks predicts therapy outcomes but there is little consistent evidence across studies on what predicts engagement. A recent meta-analysis of participant engagement in cognitive-behavioral therapy for OCD found that group ERP had a comparatively lower dropout rate than individual ERP. Little is known about participant perceptions of ERP to guide an understanding of how the group therapy format may affect participant engagement. This study conducted a qualitative exploration of what helps or hinders participants' engagement in group ERP. It involved thematic analysis of semi-structured interview data collected at a 6-month follow-up from 15 adults with OCD who took part in group ERP. The study identified five main themes that captured participants' perceived facilitators and barriers to engagement in therapy: 'Group processes', 'Understanding how to overcome OCD', 'Personal relevance', 'Personal circumstances', and 'Attitudes towards ERP', which captured dynamically inter-related barriers and facilitators at the level of the client, therapist, therapy and social environment. Each theme and associated sub-themes are discussed in turn, followed by a consideration of the study's limitations and implications.

Pilot randomised controlled trial of a remotely delivered online intervention for adolescent mental health problems in India: lessons learned about low acceptability and feasibility during the COVID-19 pandemic.

BACKGROUND: 'POD Adventures' is a gamified problem-solving intervention delivered via smartphone app, and supported by non-specialist counsellors for a target population of secondary school students in India during the COVID-19 pandemic. AIMS: To evaluate the feasibility and acceptability of undertaking a randomised controlled trial of POD Adventures when delivered online with telephone support from counsellors. METHOD: We conducted a parallel, two-arm, individually randomised pilot-controlled trial with 11 secondary schools in Goa, India. Participants received either the POD Adventures intervention delivered over 4 weeks or usual care comprising information about local mental health services and national helplines. Outcomes were assessed at two timepoints: baseline and 6 weeks post-randomisation. RESULTS: Seventy-nine classroom sensitisation sessions reaching a total of 1575 students were conducted. Ninety-two self-initiated study referrals (5.8%) were received, but only 11 participants enrolled in the study. No intervention arm participants completed the intervention. Outcomes at 6 weeks were not available for intervention arm participants (n = 5), and only four control arm participants completed outcomes. No qualitative interviews or participant satisfaction measures were completed because participants could not be reached by the study team. CONCLUSIONS: Despite modifications to address barriers arising from COVID-19 restrictions, online delivery was not feasible in the study context. Low recruitment and missing feasibility and acceptability data make it difficult to draw conclusions about intervention engagement and indicative clinical outcomes. Prior findings showing high uptake, adherence and engagement with POD Adventures when delivered in a school-based context suggest that an online study and delivery posed the biggest barriers to study participation and engagement.

Health Care Workers' Need for Headspace: Findings From a Multisite Definitive Randomized Controlled Trial of an Unguided Digital Mindfulness-Based Self-help App to Reduce Healthcare Worker Stress.

BACKGROUND: Health care workers experience high stress. Accessible, affordable, and effective approaches to reducing stress are lacking. In-person mindfulness-based interventions can reduce health care worker stress but are not widely available or accessible to busy health care workers. Unguided, digital, mindfulness-based self-help (MBSH) interventions show promise and can be flexibly engaged with. However, their effectiveness in reducing health care worker stress has not yet been explored in a definitive trial. OBJECTIVE: This study aimed to investigate the effectiveness of an unguided digital MBSH app (Headspace) in reducing health care worker stress. METHODS: This was a definitive superiority randomized controlled trial with 2182 National Health Service staff in England recruited on the web and allocated in a 1:1 ratio to fully automated Headspace (n=1095, 50.18%) or active control (Moodzone; n=1087, 49.82%) for 4.5 months. Outcomes were subscales of the Depression, Anxiety, and Stress (primary outcome) Scale short form; Short Warwick Edinburgh Mental Well-being Scale; Maslach Burnout Inventory; 15-item Five-Facet Mindfulness Questionnaire minus Observe items; Self-Compassion Scale-Short Form; Compassionate Love Scale; Penn State Worry Questionnaire; Brooding subscale of the Ruminative Response Scale; and sickness absence. RESULTS: Intention-to-treat analyses found that Headspace led to greater reductions in stress over time than Moodzone (b=-0.31, 95% CI -0.47 to -0.14; P<.001), with small effects. Small effects of Headspace versus Moodzone were found for depression (b=-0.24, 95% CI -0.40 to -0.08; P=.003), anxiety (b=-0.19, 95% CI -0.32 to -0.06; P=.004), well-being (b=0.14, 95% CI 0.05-0.23; P=.002), mindfulness (b=0.22, 95% CI 0.09-0.34; P=.001), self-compassion (b=0.48, 95% CI 0.33-0.64; P<.001), compassion for others (b=0.02, 95% CI 0.00-0.04; P=.04), and worry (b=-0.30, 95% CI -0.51 to -0.09; P=.005) but not for burnout (b=-0.19, -0.04, and 0.13, all 95% CIs >0; P=.65, .67, and .35), ruminative brooding (b=-0.06, 95% CI -0.12 to 0.00; P=.06), or sickness absence (γ=0.09, 95% CI -0.18 to 0.34). Per-protocol effects of Headspace (454/1095, 41.46%) versus Moodzone (283/1087, 26.03%) over time were found for stress, self-compassion, and compassion for others but not for the other outcomes. Engagement (practice days per week) and improvements in self-compassion during the initial 1.5-month intervention period mediated pre- to postintervention improvements in stress. Improvements in mindfulness, rumination, and worry did not mediate pre- to postintervention improvements in stress. No serious adverse events were reported. CONCLUSIONS: An unguided digital MBSH intervention (Headspace) can reduce health care workers' stress. Effect sizes were small but could have population-level benefits. Unguided digital MBSH interventions can be part of the solution to reducing health care worker stress alongside potentially costlier but potentially more effective in-person mindfulness-based interventions, nonmindfulness courses, and organizational-level interventions. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number ISRCTN15424185; https://tinyurl.com/rv9en5kc.

Feasibility and Preliminary Efficacy of Web-Based and Mobile Interventions for Common Mental Health Problems in Working Adults: Multi-Arm Randomized Pilot Trial.

BACKGROUND: There is growing interest in digital platforms as a means of implementing scalable, accessible, and cost-effective mental health interventions in the workplace. However, little is known about the efficacy of such interventions when delivered to employee groups. OBJECTIVE: This study aims to evaluate the feasibility and preliminary efficacy of a digital mental health platform for the workplace, which incorporates evidence-based practices such as cognitive behavioral therapy and acceptance and commitment therapy. A total of 3 brief, unguided interventions designed to address stress, anxiety, and resilience, respectively, are evaluated. The primary aim is to determine the feasibility of the study methods and interventions in preparation for a definitive randomized controlled trial. METHODS: The study used a fully remote, parallel, multi-arm, external pilot randomized controlled trial, with 3 intervention arms and a no-intervention control group. Participants were working adults representative of the general UK population with respect to age, sex, and ethnicity who were recruited from a web-based participant platform. Primary outcomes included objective and self-report measures of feasibility, acceptability, engagement, transferability, relevance, and negative effects. Secondary outcomes included 4 self-report measures of mental health and well-being, completed at baseline (time point 0 [t0]), postintervention (time point 1 [t1]), and the 1-month follow-up (time point 2 [t2]). Secondary outcomes were analyzed via linear mixed-effects models using intention-to-treat principles. Preregistered criteria for progression to a definitive trial were evaluated. RESULTS: Data were collected between January and March of 2021. A total of 383 working adult participants meeting trial eligibility were randomized, of whom 356 (93%) were retained at t2. Objective engagement data showed that 67.8% (196/289) of participants randomized to an intervention arm completed their intervention. Overall, 87.1% (203/233) of participants reported being satisfied or very satisfied with their intervention and rated the quality of their intervention as good or excellent. All intervention groups reported significantly greater improvements than the control group on at least one secondary outcome at t1, with between-group Hedges g effect sizes for the pooled interventions ranging from 0.25 (95% CI 0.05-0.46) to 0.43 (95% CI 0.23-0.64). All the improvements were maintained at t2. CONCLUSIONS: The study methods were feasible, and all preregistered criteria for progression to a definitive trial were met. Several minor protocol amendments were noted. Preliminary efficacy findings suggest that the study interventions may result in improved mental health outcomes when offered to working adults. TRIAL REGISTRATION: ISRCTN Registry 80309011; http://www.isrctn.com/ISRCTN80309011.

Headspace for parents: qualitative report investigating the use of a mindfulness-based app for managing parents' stress during COVID-19.

BACKGROUND: Stress can compromise parental well-being and may contribute to harsh and critical parenting styles, which are in turn associated with children's conduct problems. Coronavirus disease 2019 (COVID-19)-related restrictions are likely to have exacerbated parental stress as, for many, UK-based family life was altered considerably. Mindfulness has been demonstrated to improve stress management and emotion regulation when delivered to parents in person, however, more accessible online interventions are under-researched. AIMS: To provide preliminary data on family well-being and parent-child relationships as well as the acceptability and usability of the Headspace app - a self-delivered mindfulness-based intervention - for parents in low-risk families during the early days of the COVID-19 pandemic. METHOD: We provided 12 parents with access to Headspace, and collected qualitative data (semi-structured interviews and 5 minute speech samples) immediately following the initial COVID-19 lockdown in the UK. The resulting transcripts were thematically analysed. RESULTS: Most parents reported Headspace to be acceptable and useful - improvements in parents' own sleep were particularly noted - and there was high adherence to the intervention. However, difficulties related to family well-being and parent-child relationships following the lockdown were also reported. CONCLUSIONS: As a result of the confounding impact of COVID-19 restrictions, and varied access to app content, we were unable to determine any outcomes to be a result of practising mindfulness specifically. However, COVID-19 has had a profound impact on many UK-based families, including those previously at low risk, and our results demonstrate that Headspace may have beneficial effects for parents. There is a need to more rigorously test this tool with a broader range of families.

A Guided Internet-Based Problem-Solving Intervention Delivered Through Smartphones for Secondary School Pupils During the COVID-19 Pandemic in India: Protocol for a Pilot Randomized Controlled Trial.

BACKGROUND: "POD Adventures" is a gamified mental health intervention delivered via a smartphone app and supported by counsellors for a target population of secondary school students in India. This paper describes the protocol for a pilot randomized controlled trial of a remotely delivered version of the intervention in the context of COVID-19 restrictions. OBJECTIVE: Our objectives are to assess the feasibility of research procedures and intervention delivery and to generate preliminary estimates of the effectiveness of the intervention to inform the sample size calculation of a full-scale trial. METHODS: We will conduct a parallel, 2-arm, individually randomized pilot controlled trial in 11 secondary schools in Goa, India. This pilot trial aims to recruit 70 participants with a felt need for psychological support. Participants will receive either the POD Adventures intervention delivered over 4 weeks or usual care comprising information about local mental health services and national helplines. Outcomes will be assessed at two timepoints: baseline and 6 weeks post randomization. RESULTS: The first participant was enrolled on January 28, 2021, and 6-week assessment completed on April 4, 2021. Owing to a second wave of the COVID-19 pandemic in India, schools in Goa were closed on April 22, 2021. Trial participants are currently receiving the intervention or completing follow-up assessments. CONCLUSIONS: This pilot trial will help understand the feasibility of implementing and evaluating a remotely delivered digital mental health intervention in a low-resource setting. Our findings will be used to design future trials that can address difficulties of accessing psychosocial support in-person and support wider efforts to scale up evidence-based mental health interventions for young people. TRIAL REGISTRATION: ClinicalTrials.gov NCT04672486; https://clinicaltrials.gov/ct2/show/NCT04672486. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/30339.

Can a little bit of mindfulness do you good? A systematic review and meta-analyses of unguided mindfulness-based self-help interventions.

Over the last decade there has been an explosion of interest in mindfulness-based self-help (MBSH) interventions. While widely available and extensively promoted, there is little consensus on their impact in public health or healthcare contexts. We present a systematic review and meta-analyses of 83 randomized controlled trials, comparing unguided MBSH to control conditions on outcomes of depression, mindfulness, anxiety, stress and/or wellbeing/ quality of life. A random effects model was used to compute post-intervention, between-groups effect sizes for each outcome. MBSH demonstrated small, statistically significant effects at post-interventions for outcomes of depression (g = -0.23), mindfulness (g = 0.37) anxiety (g = -0.25), stress (g = -0.41) and wellbeing/ quality of life (g = 0.34). Significant effects were retained at follow-up for mindfulness, stress and wellbeing/ quality of life but not for depression or anxiety. Planned moderator analyses demonstrated significantly larger effects of MBSH when compared to inactive, versus active-control conditions on all outcomes except wellbeing/ quality of life, and non-digital MBSH interventions demonstrated significantly greater effects on depression, mindfulness and wellbeing/ quality of life outcomes than digitally-delivered MBSH. When studies that utilised samples selected for mental and physical health-related difficulties were respectively compared to studies that utilised unselected samples, no significant moderation effects were observed. In sum, these findings provide evidence for the effectiveness of unguided MBSH in public health settings and the practical, access-related implications of this are discussed.

Is clinician-supported use of a mindfulness smartphone app a feasible treatment for depression? A mixed-methods feasibility study.

Depression is the leading cause of disability globally and has serious consequences for the individual, their family and for society. Effective, accessible and affordable treatments are urgently needed. In-person group-based mindfulness-based interventions are an effective treatment for depression, but are not widely available and can be costly. Clinician supported use of mindfulness self-help resources such as mindfulness smartphone applications could widen access at a reduced cost, but there are key feasibility questions that need answering. This is a mixed-methods feasibility study of a blended intervention involving the mindfulness smartphone app Headspace alongside six clinician support sessions with mental health treatment seeking adults experiencing moderate to moderately severe symptoms of depression. In line with recommendations for feasibility studies, we examine whether: (1) it is possible to recruit participants to this novel intervention, (2) participants engage with the intervention, (3) participants and clinicians find the intervention acceptable, and (4) pre-post outcomes on measures of depression (primary outcome), anxiety, wellbeing, mindfulness, self-compassion, rumination and worry indicate effectiveness. Findings show that recruitment is feasible with 54 participants enrolled in the intervention within a 6-month window. In terms of engagement, 44.4% completed at least 80% of recommended Headspace sessions and 72.2% of participants attended at least three clinician support sessions. Clinician-supported Headspace was deemed acceptable by participants and clinicians. Pre-post effect sizes were statistically significant and in the small-medium or medium-large range on all outcomes, with an effect size of d = 0.69 (95% CI: 0.34-1.04) for the primary outcome of depression symptom severity. The number of Headspace sessions engaged with was associated with greater reduction in depression symptom severity. Findings suggest that a blended intervention combining Headspace with clinician support has potential as a first-line treatment for moderate/moderately severe depression, but findings are too preliminary to recommend the intervention outside of a research trial. Important caveats are noted including the need for future research to examine predictors of engagement with Headspace sessions so that engagement can be enhanced, to measure the longer term effects of such interventions and to better understand the potential for lasting negative effects of the intervention so that these can be minimised.

Chatbot-Based Assessment of Employees' Mental Health: Design Process and Pilot Implementation.

BACKGROUND: Stress, burnout, and mental health problems such as depression and anxiety are common, and can significantly impact workplaces through absenteeism and reduced productivity. To address this issue, organizations must first understand the extent of the difficulties by mapping the mental health of their workforce. Online surveys are a cost-effective and scalable approach to achieve this but typically have low response rates, in part due to a lack of interactivity. Chatbots offer one potential solution, enhancing engagement through simulated natural human conversation and use of interactive features. OBJECTIVE: The aim of this study was to explore if a text-based chatbot is a feasible approach to engage and motivate employees to complete a workplace mental health assessment. This paper describes the design process and results of a pilot implementation. METHODS: A fully automated chatbot ("Viki") was developed to evaluate employee risks of suffering from depression, anxiety, stress, insomnia, burnout, and work-related stress. Viki uses a conversation style and gamification features to enhance engagement. A cross-sectional analysis was performed to gain first insights of a pilot implementation within a small to medium-sized enterprise (120 employees). RESULTS: The response rate was 64.2% (77/120). In total, 98 employees started the assessment, 77 of whom (79%) completed it. The majority of participants scored in the mild range for anxiety (20/40, 50%) and depression (16/28, 57%), in the moderate range for stress (10/22, 46%), and at the subthreshold level for insomnia (14/20, 70%) as defined by their questionnaire scores. CONCLUSIONS: A chatbot-based workplace mental health assessment seems to be a highly engaging and effective way to collect anonymized mental health data among employees with response rates comparable to those of face-to-face interviews.

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).

Increasing access to CBT for psychosis patients: a feasibility, randomised controlled trial evaluating brief, targeted CBT for distressing voices delivered by assistant psychologists (GiVE2).

BACKGROUND: The National Institute for Health and Care Excellence (NICE) recommends that Cognitive Behaviour Therapy for psychosis (CBTp) is offered to all patients with a psychosis diagnosis. However, only a minority of psychosis patients in England and Wales are offered CBTp. This is attributable, in part, to the resource-intensive nature of CBTp. One response to this problem has been the development of CBTp in brief formats that are targeted at a single symptom and the mechanisms that maintain distress. We have developed a brief form of CBTp for distressing voices and reported preliminary evidence for its effectiveness when delivered by highly trained therapists (clinical psychologists). This study will investigate the delivery of this intervention by a cost-effective workforce of assistant psychologists following a brief training and evaluate the acceptability and feasibility of conducting a future, definitive, randomised controlled trial (RCT). METHODS: This is a feasibility study for a pragmatic, three-arm, parallel-group, superiority 1:1:1 RCT comparing a Guided self-help CBT intervention for voices and treatment as usual (GiVE) to Supportive Counselling and treatment as usual (SC) to treatment as usual alone (TAU), recruiting across two sites, with blinded post-treatment and follow-up assessments. A process evaluation will quantitatively and qualitatively explore stakeholder experience. DISCUSSION: Expected outcomes will include an assessment of the feasibility of conducting a definitive RCT, and data to inform the calculation of its sample size. If evidence from a subsequent, fully powered RCT suggests that GiVE is clinically and cost-effective when delivered by briefly trained assistant psychologists, CBTp offered in these less resource-intensive forms has the potential to generate benefits for individual patients (reduced distress, enhanced recovery and enhanced quality of life), service-level patient benefit (increased access to evidence-based psychological therapies) and economic benefits to the NHS (in terms of the reduced use of mental health inpatient services). TRIAL REGISTRATION: Current Controlled Trials, ISRCTN registration number: 16166070. Registered on 5 February 2019.

Preliminary Evaluation of the Engagement and Effectiveness of a Mental Health Chatbot.

Background: Mental health difficulties are highly prevalent, yet access to support is limited by barriers of stigma, cost, and availability. These issues are even more prevalent in low- and middle-income countries, and digital technology is one potential way to overcome these barriers. Digital mental health interventions are effective but often struggle with low engagement rates, particularly in the absence of human support. Chatbots could offer a scalable solution, simulating human support at a lower cost. Objective: To complete a preliminary evaluation of engagement and effectiveness of Vitalk, a mental health chatbot, at reducing anxiety, depression and stress. Methods: Real world data was analyzed from 3,629 Vitalk users who had completed the first phase of a Vitalk program ("less anxiety," "less stress" or "better mood"). Programs were delivered through written conversation with a chatbot. Engagement was calculated from the number of responses sent to the chatbot divided by days in the program. Results: Users sent an average of 8.17 responses per day. For all three programs, target outcome scores reduced between baseline and follow up with large effect sizes for anxiety (Cohen's d = -0.85), depression (Cohen's d = -0.91) and stress (Cohen's d = -0.81). Increased engagement resulted in improved post-intervention values for anxiety and depression. Conclusion: This study highlights a chatbot's potential to reduce mental health symptoms in the general population within Brazil. While findings show promise, further research is required.