Brief coping strategy enhancement for the treatment of distressing voices in the context of borderline personality disorder: A comparison with outcomes in the context of psychosis.

BACKGROUND: Voice hearing in the context of Borderline Personality Disorder (BPD) has traditionally been regarded as transient and an experience that lacks legitimacy. Consequently, there are no evidence-based treatments for the voices reported by BPD patients. Contrary to the traditional view, there is a growing literature suggesting that voice hearing in the context of BPD can be an enduring and distressing experience which shares similarities with voice hearing in the context of psychosis. Given these similarities, the aim of this study was to explore whether brief Coping Strategy Enhancement developed in the context of psychosis can be used to treat distressing voice hearing in the context of BPD. METHOD: This was a service evaluation carried out in a specialist NHS service delivering psychological therapies for distressing voices. Patients with either a BPD (n = 46) or a psychosis diagnosis (n = 125) received four sessions of Coping Strategy Enhancement (CSE). The primary outcome was voice-related distress. The pre-post outcomes for BPD patients were explored and compared with those achieved by the psychosis patients. RESULTS: Both the BPD and psychosis groups experienced a significant reduction in voice-related distress after CSE compared with baseline. The interaction between diagnosis group and time was small and statistically non-significant. CONCLUSION: These findings suggest a brief CSE intervention developed in the context of psychosis can be an effective starting point in the treatment of distressing voice hearing in the context of BPD. Such interventions have the potential to be integrated into broader BPD treatment programmes for those who hear voices.

A service evaluation of a group mindfulness-based intervention for distressing voices: how do findings from a randomized controlled trial compare with routine clinical practice?

BACKGROUND: Person-based cognitive therapy (PBCT) was developed as a treatment for psychosis. The effectiveness of group PBCT was examined in the Mindfulness for Voices (M4V) randomized controlled trial and generated promising results. Group PBCT was implemented as a trans-diagnostic treatment for distressing voices within the Sussex Voices Clinic (SVC), a specialist secondary care mental health service. AIM: To conduct a service evaluation of engagement, outcomes and cost of group PBCT within SVC, and to compare engagement and outcomes from routine practice with the M4V trial. Secondary aims were to explore predictors of levels of engagement and change in group PBCT. METHOD: Service level data from 95 SVC patients were evaluated. Descriptive statistics, hypothesis tests and linear regression models were used. The primary clinical outcome was voice-related distress. Engagement levels and pre-post effect sizes were estimated; associated predictors were explored. RESULTS: Fifty-nine per cent of patients completed group PBCT within SVC, compared with 72% within M4V. Completers within SVC had lower baseline depression scores compared with non-completers. There were significant improvements in voice-related distress (Cohen's d = -0.47; p = 0.001), subjective recovery (Cohen's d = 0.35; p = 0.001) and depression (Cohen's d = -0.20; p = 0.044); these outcomes were comparable to M4V. Higher baseline subjective recovery and lower depression both predicted improvement in voice-related distress. Therapy within SVC cost an average of £214 per patient. CONCLUSION: PBCT groups can be delivered trans-diagnostically in routine clinical practice. Engagement was lower when compared with an RCT, but outcomes were comparable. The low level of resources involved suggests that group PBCT can offer value for money.

Brief Coping Strategy Enhancement for Distressing Voices: an Evaluation in Routine Clinical Practice.

BACKGROUND: Hearing voices can be a common and distressing experience. Psychological treatment in the form of cognitive behavioural therapy for psychosis (CBTp) is effective, but is rarely available to patients. The barriers to increasing access include a lack of time for clinicians to deliver therapy. Emerging evidence suggests that CBTp delivered in brief forms can be effective and offer one solution to increasing access. AIMS: We adapted an existing form of CBTp, coping strategy enhancement (CSE), to focus specifically on distressing voices in a brief format. This intervention was evaluated within an uncontrolled study conducted in routine clinical practice. METHOD: This was a service evaluation comparing pre-post outcomes in patients who had completed CSE over four sessions within a specialist out-patient service within NHS Mental Health Services. The primary outcome was the distress scale of the Psychotic Symptoms Rating Scale - Auditory Hallucinations (PSYRATS-AH). RESULTS: Data were available from 101 patients who had completed therapy. A reduction approaching clinical importance was found on the PSYRATS distress scale post-therapy when compared with the baseline. CONCLUSIONS: The findings from this study suggest that CSE, as a focused and brief form of CBTp, can be effective in the treatment of distressing voices within routine clinical practice. Within the context of the limitations of this study, brief CSE may best be viewed as the beginning of a therapeutic conversation and a low-intensity intervention in a stepped approach to the treatment of distressing voices.

Understanding clinician attitudes towards implementation of guided self-help cognitive behaviour therapy for those who hear distressing voices: using factor analysis to test normalisation process theory.

BACKGROUND: The Normalisation Process Theory (NPT) has been used to understand the implementation of physical health care interventions. The current study aims to apply the NPT model to a secondary mental health context, and test the model using exploratory factor analysis. This study will consider the implementation of a brief cognitive behaviour therapy for psychosis (CBTp) intervention. METHODS: Mental health clinicians were asked to complete a NPT-based questionnaire on the implementation of a brief CBTp intervention. All clinicians had experience of either working with the target client group or were able to deliver psychological therapies. In total, 201 clinicians completed the questionnaire. RESULTS: The results of the exploratory factor analysis found partial support for the NPT model, as three of the NPT factors were extracted: (1) coherence, (2) cognitive participation, and (3) reflexive monitoring. We did not find support for the fourth NPT factor (collective action). All scales showed strong internal consistency. Secondary analysis of these factors showed clinicians to generally support the implementation of the brief CBTp intervention. CONCLUSIONS: This study provides strong evidence for the validity of the three NPT factors extracted. Further research is needed to determine whether participants' level of seniority moderates factor extraction, whether this factor structure can be generalised to other healthcare settings, and whether pre-implementation attitudes predict actual implementation outcomes.

Body-related behaviours and cognitions in the eating disorders.

BACKGROUND: Different body-related behaviours and cognitions (checking, avoidance, comparison, display) have been shown to be related to unhealthy eating attitudes in a non-clinical sample. AIMS: This study tested whether the use of body-related behaviours is higher in eating-disordered women than in non-clinical women. It also examined whether the use of body-related behaviours is associated with psychological characteristics (particularly anxiety, depression and narcissistic characteristics), controlling for age and eating pathology. METHOD: Ninety-nine adult women with diagnosed eating disorders (mean age = 30.4 years, SD = 9.44; mean body mass index = 21.9, SD = 6.39) completed standardized measures of eating pathology, anxiety and depression, narcissistic characteristics, and body-related behaviours and cognitions. RESULTS: The Body-Related Behaviours Scale (BRBS) had acceptable levels of internal consistency in this group, and its scales were only weakly to moderately correlated with each other. There were no differences between diagnostic groups, but the clinical group had higher scores that a previous non-clinical sample on three of the scales. The four body-related behaviours had different patterns of association with eating pathology, depression and narcissistic features. However, anxiety was not associated with BRBS scores. CONCLUSIONS: The findings support the importance of a wide range of body-related behaviours and cognitions in understanding the eating disorders. However, the lack of an association with anxiety is counter to the suggestion that the various behaviours measured by the BRBS reflect safety behaviours on the part of sufferers. Depression and narcissistic features might be more important in maintaining such behaviours.

Predictors of treatment outcome of psychological therapies for common mental health problems (CMHP) in older adults: A systematic literature review.

Identifying factors that impact psychological treatment outcomes in older people with common mental health problems (CMHP) has important implications for supporting healthier and longer lives. The aim of the present study was to synthesise the evidence on predictors of psychological treatment outcomes in older people (aged 65+). PubMed, Scopus, Web of Science and PsycINFO were searched and 3929 articles were identified and screened, with 42 studies (N = 7978, M age = 68.9, SD age = 2.85) included: depression: k = 21, anxiety: k = 11, panic disorder: k = 3, mixed anxiety & depression: k = 3, PTSD: k = 2, various CMHP: k = 2, with CBT being the most common treatment (71%). The review identified 28 factors reported as significant predictors of treatment outcome in at least one study, across different domains: psychosocial (n = 9), clinical (n = 6), treatment-related (n = 6), socio-demographic (n = 4), neurobiological (n = 3). Homework completion was the most consistent predictor of positive treatment outcome. Baseline symptom severity was the most frequently studied significant predictor and across all conditions, with higher baseline symptom severity largely linked to worse treatment outcomes. No significant effects on treatment outcome were reported for gender, income and physical comorbidities. For a large majority of factors evidence was mixed or inconclusive. Further studies are required to identify factors affecting psychological treatment outcomes, which will be important for the development of personalised treatment approaches.

Effects of brief remote high ventilation breathwork with retention on mental health and wellbeing: a randomised placebo-controlled trial.

High ventilation breathwork with retention (HVBR) has been growing in popularity over the past decade and might be beneficial for mental and physical health. However, little research has explored the potential therapeutic effects of brief, remotely delivered HVBR and the tolerability profile of this technique. Accordingly, we investigated the effects of a fully-automated HVBR protocol, along with its tolerability, when delivered remotely in a brief format. This study (NCT06064474) was the largest blinded randomised-controlled trial on HVBR to date in which 200 young, healthy adults balanced for gender were randomly allocated in blocks of 2 by remote software to 3 weeks of 20 min daily HVBR (fast breathing with long breath holds) or a placebo HVBR comparator (15 breaths/min with short breath holds). The trial was concealed as a 'fast breathwork' study wherein both intervention and comparator were masked, and only ~ 40% guessed their group assignment with no difference in accuracy between groups. Both groups reported analogous credibility and expectancy of benefit, subjective adherence, positive sentiment, along with short- and long-term tolerability. At post-intervention (primary timepoint) for stress level (primary outcome), we found no significant group × time interaction, F(1,180) = 1.98, p = 0.16, ηp2 = 0.01, d = 0.21), nor main effect of group, (F = 0.35, p = 0.55, ηp2 < 0.01) but we did find a significant main effect of time, (F = 13.0, p < 0.01, ηp2 = 0.07). There was a significant improvement in stress pre-post-intervention in both groups, however there was no significant difference in such improvement between groups. In addition to stress at follow-up, we found no significant group x time interactions for secondary trait outcomes of anxiety, depression, mental wellbeing, and sleep-related impairment. This was also the case for state positive and negative affect after the first session of breathwork and at post-intervention. Brief remote HVBR therefore may not be more efficacious at improving mental health than a well-designed active comparator in otherwise healthy, young adults.

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.

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.

Patients' perspectives of barriers and facilitators to accessing support through primary care for common mental health problems in England: A systematic review.

BACKGROUND: Common mental disorders (CMDs) are prevalent throughout the population. Psychological therapy is often sought via primary care; however, equitable access is not commonplace. This review aims to investigate the barriers and facilitators adults experiencing CMDs perceive when accessing evidence-based psychological treatment in England. METHODS: A qualitative systematic review with meta-synthesis was conducted (PROSPERO CRD42020227039). Seven electronic databases were searched for papers from 2008 to October 2022. RESULTS: Searches identified 30 studies from which three themes were developed with seven subthemes. Stigma and patients' perceptions and understandings of CMDs impacted their help-seeking decision-making and engagement with services. This meant that services were not used as a first resort for help-seeking. Upon reaching services, patients appeared to perceive primary care as not prioritising mental health problems, nor as being the place where they would be supported, particularly as healthcare professionals did not appear to know about CMDs and therapy was seen as difficult to access. The interaction between healthcare professional and patients was seen as pivotal to whether patients accessed support or not. LIMITATIONS: The review is limited to research conducted within England. Additionally, it only explores access barriers prior to treatment experiences. CONCLUSION: Knowledge, attitudinal, systemic and relational barriers and facilitators were identified. Future research should focus on developing stigma reduction initiatives. Clinical implications include provision of standardised training across primary care HCP (healthcare professionals).

Does trait mindfulness mediate the relationship between borderline personality symptoms and emotion dysregulation?

BACKGROUND: Emotion dysregulation is core to many biopsychosocial models of Borderline Personality Disorder (BPD) and is often targeted as part of their associated psychological therapies. Several distinct specialist psychotherapies are thought to be effective for people diagnosed with BPD but it is unclear whether they share common change mechanisms. Some evidence suggests that Mindfulness Based Interventions improve competency in emotion regulation as well as trait mindfulness, which are both plausibly associated with good treatment outcomes. It is unclear whether the association between the severity of BPD symptoms and emotion dysregulation is mediated by trait mindfulness. Would improvement in trait mindfulness mediate an association between lower severity of BPD symptoms and fewer problems of emotion dysregulation? METHODS: One thousand and twelve participants completed online, single time-point, self-report questionnaires. RESULTS: As predicted, the severity of BPD symptoms was significantly and positively associated with emotion dysregulation with a large effect size (r = .77). Trait mindfulness mediated this relationship as the 95% confidence interval for the indirect effect did not cross zero (size of direct effect = .48 and size of indirect effect = .29 [.25, .33]. CONCLUSIONS: The relationship between the severity of BPD symptoms and emotion dysregulation was confirmed in this dataset. As hypothesised, this relationship was mediated by trait mindfulness. Process measures of emotion dysregulation and mindfulness should be included in intervention studies for people diagnosed with BPD to understand if improvements in these factors are a universal occurrence with good response to treatment. Other process measures should also be explored to identify other factors involved in the relationship between BPD symptoms and emotion dysregulation.

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.

OUTdoor Swimming as a nature-based Intervention for DEpression (OUTSIDE): study protocol for a feasibility randomised control trial comparing an outdoor swimming intervention to usual care for adults experiencing mild to moderate symptoms of depression.

BACKGROUND: Depression is common and the prevalence increasing worldwide; at least 1 in 10 people will experience depression in their lifetime. It is associated with economic costs at the individual, healthcare and societal level. Recommended treatments include medication and psychological therapies. However, given the long waiting times, and sometimes poor concordance and engagement with these treatments, a greater range of approaches are needed. Evidence for the potential of outdoor swimming as an intervention to support recovery from depression is emerging, but randomised controlled trials (RCTs) evaluating clinical and cost-effectiveness are lacking. This study seeks to investigate the feasibility of conducting a definitive superiority RCT, comparing an 8-session outdoor swimming course offered in addition to usual care compared to usual care only, in adults who are experiencing mild to moderate symptoms of depression. Feasibility questions will examine recruitment and retention rates, acceptability of randomisation and measures, and identify the primary outcome measure that will inform the sample size calculation for a definitive full-scale RCT. This study will also explore potential facilitators and barriers of participation through evaluation questionnaires, focus-group discussions and interviews. METHODS/DESIGN: To address these aims and objectives, a feasibility superiority RCT with 1:1 allocation will be undertaken. We will recruit 88 participants with mild to moderate symptoms of depression through social prescribing organisations and social media in three sites in England. Participants will be randomised to either (1) intervention (8-session outdoor swimming course) plus usual care or (2) usual care only. Both groups will be followed up for a further 8 weeks. DISCUSSION: If findings from this feasibility RCT are favourable, a fully powered RCT will be conducted to investigate the clinical- and cost-effectiveness of the intervention. Findings from the definitive trial will provide evidence about outdoor swimming for depression for policymakers and has the potential to lead to greater choice of interventions for adults experiencing symptoms of depression. TRIAL REGISTRATION: Current controlled trial registration number is ISRCTN 90851983 registered on 19 May 2022.

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: 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.

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.

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.

Group person-based cognitive therapy for chronic depression: a pilot randomized controlled trial.

OBJECTIVE: This pilot randomized controlled trial (RCT) assesses Person-Based Cognitive Therapy (PBCT), an integration of cognitive therapy and mindfulness, as a treatment for chronic depression. METHOD: Twenty-eight participants with chronic depression were randomly allocated to treatment as usual (TAU) or PBCT group plus TAU. Assessments of depression (Beck Depression Inventory, BDI-II) and mindfulness (Southampton Mindfulness Questionnaire) were conducted before and after therapy. RESULTS: Intention-to-treat analysis found significant group by time interactions for both depression and mindfulness. Secondary analyses showed depression and mindfulness scores significantly improved for PBCT participants but not for TAU participants, with 64% of PBCT participants showing reliable improvement in depression, compared with 0% of TAU participants. CONCLUSIONS: PBCT is a promising treatment for chronic depression. Findings suggest a full RCT would be warranted.

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.

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.

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.