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.

Effectiveness of Predominantly Group Schema Therapy and Combined Individual and Group Schema Therapy for Borderline Personality Disorder: A Randomized Clinical Trial.

IMPORTANCE: Schema therapy (ST), delivered either in an individual or group format, has been compared with other active treatments for borderline personality disorder (BPD). To our knowledge, the 2 formats have not been compared with treatment as usual (TAU) or with each other. Such comparisons help determine best treatment practices. OBJECTIVE: To evaluate whether ST is more effectively delivered in a predominantly group or combined individual and group format and whether ST is more effective than optimal TAU for BPD. DESIGN, SETTING, AND PARTICIPANTS: In this multicenter, 3-arm randomized clinical trial conducted at 15 sites in 5 countries (Australia, Germany, Greece, the Netherlands, and the UK), outpatients aged 18 to 65 years who had BPD were recruited between June 29, 2010, and May 18, 2016, to receive either predominantly group ST (PGST), combined individual and group ST (IGST), or optimal TAU. Data were analyzed from June 4, 2019, to December 29, 2021. INTERVENTIONS: At each site, cohorts of 16 to 18 participants were randomized 1:1 to PGST vs TAU or IGST vs TAU. Both ST formats were delivered over 2 years, with 2 sessions per week in year 1 and the frequency gradually decreasing during year 2. Assessments were collected by blinded assessors. MAIN OUTCOMES AND MEASURES: The primary outcome was the change in BPD severity over time, assessed with the Borderline Personality Disorder Severity Index (BPDSI) total score. Treatment retention was analyzed as a secondary outcome using generalized linear mixed model survival analysis. RESULTS: Of 495 participants (mean [SD] age, 33.6 [9.4] years; 426 [86.2%] female), 246 (49.7%) received TAU, 125 (25.2%) received PGST, and 124 (25.0%) received IGST (1 of whom later withdrew consent). PGST and IGST combined were superior to TAU with regard to reduced BPD severity (Cohen d, 0.73; 95% CI, 0.29-1.18; P < .001). For this outcome, IGST was superior to TAU (Cohen d, 1.14; 95% CI, 0.57-1.71; P < .001) and PGST (Cohen d, 0.84; 95% CI, 0.09-1.59; P = .03), whereas PGST did not differ significantly from TAU (Cohen d, 0.30; 95% CI, -0.29 to 0.89; P = .32). Treatment retention was greater in the IGST arm than in the PGST (1 year: 0.82 vs 0.72; 2 years: 0.74 vs. 0.62) and TAU (1 year: 0.82 vs 0.73; 2 years: 0.74 vs 0.64) arms, and there was no significant difference between the TAU and PGST arms (1 year: 0.73 vs 0.72; 2 years: 0.64 vs 0.62). CONCLUSIONS AND RELEVANCE: In this randomized clinical trial, IGST was more effective and had greater treatment retention compared with TAU and PGST. These findings suggest that IGST is the preferred ST format, with high retention and continuation of improvement in BPD severity after the completion of treatment. TRIAL REGISTRATION: trialregister.nl Identifier: NTR2392.

The Association Between Benign Fasciculations and Health Anxiety: A Report of Two Cases and a Systematic Review of the Literature.

BACKGROUND: Benign fasciculation syndrome (BFS) is characterized by persistent spontaneous contractions of muscle fibers in the absence of a pathological cause. Patients with BFS often have concerns around having motor neuron disease, in some cases fulfilling the criteria for health anxiety disorder. Research on how BFS and health anxiety relate to one another and how they should be optimally managed together is sparse. OBJECTIVE: We report two cases of BFS associated with health anxiety. We also review the literature on the association between BFS and health anxiety. METHODS: We systematically reviewed the literature using MEDLINE, Embase, PsycINFO, and OpenGrey for studies investigating benign fasciculations and anxiety up to August 2018. RESULTS: Both cases were successfully treated for health anxiety disorder with cognitive-behavioral therapy (CBT) and antidepressant medication. We identified eight studies that met the inclusion criteria, describing a total of 384 patients. Most studies were of moderate quality. Patients with BFS tended to be male and in their 30s or 40s. There was an overrepresentation of clinicians. Anxiety symptoms were common and frequently coexisted alongside fasciculations. Health anxiety was overwhelmingly focused around motor neuron disease. CONCLUSION: A proportion of individuals with BFS experience anxiety around having motor neuron disease-to the point of developing health anxiety disorder. A bidirectional relationship may exist between BFS and health anxiety disorder. Clinicians should be alert to the possibility of health anxiety disorder in patients with BFS and have a low threshold to refer for psychiatric assessment. There is support for the role of psychological therapy, especially CBT, as well as pharmacotherapy, in the form of antidepressant medication. In severe or treatment-refractive cases, combined treatment may be indicated.

Intrusive memories and rumination in patients with post-traumatic stress disorder: a phenomenological comparison.

The aim of the study was to investigate the phenomenological differences between intrusive memories and rumination in PTSD. The study population consisted of 31 patients with PTSD referred for cognitive behavioural therapy to specialist services. A semi-structured interview was used to examine the characteristics of the most prominent intrusive memory and rumination. Intrusive memories were predominantly sensory experiences of short duration, whereas rumination was predominantly a thought process of longer duration. Shame was associated more with rumination than with intrusive memories. Anxiety, helplessness, numbness, and threat were greater at the time of the trauma than when experiencing the intrusive memory. In contrast, feelings like anger and sadness were greater when experiencing intrusive memories than at the time of the event. The distinction between intrusive memories and rumination is of clinical importance as intrusive memories usually decrease with imaginal reliving of the trauma, whereas rumination may require different therapeutic strategies, such as rumination-focused or mindfulness-based cognitive therapy.

Neural responses to facial expressions of disgust but not fear are modulated by washing symptoms in OCD.

BACKGROUND: Washing symptoms in Obsessive-Compulsive Disorder (OCD) are associated with increased trait sensitivity to disgust. This study explored neural systems underlying sensitivity to symptom-unrelated disgust and fear in OCD using functional neuroimaging. METHODS: Seventeen OCD subjects and 19 controls viewed facial expressions of disgust and fear (versus neutral) presented just above the level of conscious awareness in a backward masking paradigm. RESULTS: The OCD group showed greater activation than controls in the left ventrolateral prefrontal cortex, but reduced activation in the thalamus, to facial expressions of disgust. There were no between-group differences in response to fear. Further analysis using a median-split to divide OCD subjects into high and low washers suggested that the enhanced ventrolateral prefrontal cortex response was being driven by predominantly female OCD subjects with high washing symptoms. These subjects also reported higher levels of trait sensitivity to disgust. CONCLUSIONS: These findings are consistent with previous reports of increased response to symptom-relevant and generally disgusting stimuli in neural regions associated with disgust and autonomic response processing in OCD patients with prominent washing symptoms. Together, these findings point to increased sensitivity to disgust stimuli as a component of the pathophysiology of the washing/contamination symptom dimension of OCD.

Deliberate self-harm (DSH) among older people: a retrospective study in Barnet, North London.

BACKGROUND: Rates of suicide remain high among older people and those who deliberately self harm are believed to be at an increased risk of killing themselves in the future. If older people who deliberately harm themselves are to be helped by developments in services we need to understand what currently happens to them in terms of service provision and outcome. METHODS: A retrospective paper and electronic case note survey was carried out on all older people living in the London Borough of Barnet who presented to Accident & Emergency Departments with DSH over a two-year period. Ensuing actions and events were then tracked. RESULTS: Forty-three older people with DSH were identified. 18/43 (42%) had previous contact with local psychiatric services. The main method of DSH was overdose of medication (36/43 or 84%). Compared to the general population there were more women and widows. There were similar levels of physical ill-health. Thirty-seven of 43 (86%) received documented psychiatric input outside of hospital following the DSH. The mean follow-up period was 789.0 days (SD 419.8) and during this time 8/43 (19%) had a further documented episode of DSH, and 18/43 (40%) died from natural causes. CONCLUSIONS: This study confirms the need for improved documentation of DSH and its coding; this needs to be reviewed at local and national level. The vast majority of older people who attempt suicide do have subsequent contact with psychiatric services. There is a strong likelihood of repeat DSH and a higher risk of death by natural causes, emphasising the need to conceptualise DSH as a risk factor relevant to all medical specialities.