Accelerating the development of a psychological intervention to restore treatment decision-making capacity in patients with schizophrenia-spectrum disorder: a study protocol for a multi-site, assessor-blinded, pilot Umbrella trial (the DEC:IDES trial).

BACKGROUND: A high proportion of patients diagnosed with schizophrenia-spectrum disorders will at some point in their lives be assessed as not having the capacity to make their own decisions about pharmacological treatment or inpatient care ('capacity'). Few will be helped to regain it before these interventions proceed. This is partly because effective and safe methods to do so are lacking. Our aim is to accelerate their development by testing, for the first time in mental healthcare, the feasibility, acceptability and safety of running an 'Umbrella' trial. This involves running, concurrently and under one multi-site infrastructure, multiple assessor-blind randomised controlled trials, each of which is designed to examine the effect on capacity of improving a single psychological mechanism ('mechanism'). Our primary objectives are to demonstrate feasibility of (i) recruitment and (ii) data retention on the MacArthur Competence Assessment Tool-Treatment (MacCAT-T; planned primary outcome for a future trial) at end-of-treatment. We selected three mechanisms to test: 'self-stigma', low self-esteem and the 'jumping to conclusions' bias. Each is highly prevalent in psychosis, responsive to psychological intervention, and hypothesised to contribute to impaired capacity. METHODS: Sixty participants with schizophrenia-spectrum diagnoses, impaired capacity and one or more mechanism(s) will be recruited from outpatient and inpatient mental health services in three UK sites (Lothian, Scotland; Lancashire and Pennine; North West England). Those lacking capacity to consent to research could take part if the key criteria were met, including either proxy consent (Scotland) or favourable Consultee advice (England). They will be allocated to one of three randomised controlled trials, depending on which mechanism(s) they have. They will then be randomised to receive, over an 8-week period and in addition to treatment as usual (TAU), 6 sessions of either a psychological intervention which targets the mechanism, or 6 sessions of assessment of the causes of their incapacity (control condition). Participants are assessed at 0 (baseline), 8 (end-of-treatment) and 24 (follow-up) weeks post-randomisation using measures of capacity (MacCAT-T), mechanism, adverse events, psychotic symptoms, subjective recovery, quality of life, service use, anxiety, core schemata and depression. Two nested qualitative studies will be conducted; one to understand participant and clinician experiences and one to investigate the validity of MacCAT-T appreciation ratings. DISCUSSION: This will be the first Umbrella trial in mental healthcare. It will produce the first 3 single-blind randomised controlled trials of psychological interventions to support treatment decision-making in schizophrenia-spectrum disorder. Demonstrating feasibility will have significant implications not only for those seeking to support capacity in psychosis, but also for those who wish to accelerate the development of psychological interventions for other conditions. TRIAL REGISTRATION: ClinicalTrials.gov NCT04309435 . Pre-registered on 16 March 2020.

Effectiveness of interpersonal psychotherapy for community living depressed women involved with the justice system.

BACKGROUND: Despite the prevalence of depression among women in the justice system, and its potentially significant consequences, there is a dearth of studies investigating psychological treatments for depression in this context, especially outside prison. AIMS: Our aim was to gather preliminary data on whether individual interpersonal psychotherapy (IPT) is an acceptable and effective treatment for depression in women at an early stage in the justice system. METHOD: In this pilot study, IPT was offered to 24 depressed women following their first or second contact with the justice system. The women were assessed using a range of scales to quantify depression, anxiety, post-traumatic stress disorder (PTSD) and social support. Multilevel models were used to explore interactions between change in depression and other features given the multiplicity and complexity of problems. Details on engagement and attrition were also collected. RESULTS: Therapy attrition was low, despite challenging life-circumstances and depression scores followed a linear trajectory with scores significantly decreasing over the time (ß = -0.59, SE = 0.07, p < 0.001). Participants with more adverse life events, attachment related anxiety and lower social support had poorer outcomes. CONCLUSIONS AND IMPLICATIONS: Results are encouraging. More than half of the hard-to-reach women who were eligible did engage, and retention rates suggest the therapy was acceptable to them. Depression scores improved, and potential factors affecting treatment outcome were identified. A randomised controlled trial is now warranted, ensuring adequate supplementary support for women with dependants living on their own and without employment.

The relationship between attachment insecurity and experiences on the paranoia continuum: A meta-analysis.

OBJECTIVES: Attachment has long been theorized to play a key role in the development of paranoia. Associations between both constructs have been reported over the last decade, but have ranged widely in magnitude to date. The present study is the first publication to synthesize existing literature and provide a meta-analytic estimate of the attachment-paranoia relationship. METHODS: A systematic search of studies available up to January 2019 was conducted using Embase, MEDLINE, CINAHL, PsycINFO, OpenGrey, and ProQuest Dissertations & Theses Global. This yielded 26 studies which met inclusion criteria (N = 10,539; mean age range 16-47; 45% male). Data were analysed using random effects models with restricted maximum likelihood variance estimator. Age and sex were examined as moderators in meta-regressions. RESULTS: Paranoia was significantly associated with attachment anxiety (r = .38; 95% CI: 0.32, 0.44; p < .0001; I2  = 88%; k = 26) and attachment avoidance (r = .24; 95% CI: 0.18, 0.29; p < .0001; I2  = 79%; k = 26). The strength of these associations did not differ between clinical and non-clinical participant samples. Neither age nor sex moderated identified relationships. CONCLUSIONS: There is a moderate association between both constructs of interest. These findings suggest that attachment insecurity may be an active agent in the aetiology and/or maintenance of experiences on the paranoia continuum. Implications for psychological treatment, for example, consideration of attachment status in formulations, are briefly discussed. PRACTITIONER POINTS: Paranoia is associated with both attachment anxiety and attachment avoidance. These associations are of similar strength for people with and without psychosis. Attachment may contribute to the development and/or maintenance of paranoia. It may be beneficial to target attachment in psychological therapies for psychosis.

Decision-making ability in psychosis: a systematic review and meta-analysis of the magnitude, specificity and correlates of impaired performance on the Iowa and Cambridge Gambling Tasks.

To identify factors which may help or hinder decision-making ability in people with psychosis, we did a systematic review and meta-analysis of their performance on the Iowa and Cambridge Gambling Tasks. Analysis of 47 samples found they had moderately poorer performance than healthy individuals (N = 4264, g = -0.57, 95% confidence interval (CI) -0.66 to -0.48). Few studies (k = 8) used non-psychotic clinical comparator groups, although very low-quality evidence (k = 3) found people with bipolar disorder may perform better. Negative symptoms (k = 13, N = 648, r = -0.17, 95% CI -0.26 to -0.07) and lower IQ (k = 11, N = 525, r = 0.20, 95% CI 0.29-0.10), but not positive symptoms (k = 10, N = 512, r = -0.01, 95% CI -0.11 to 0.08), each had small-moderate associations with poorer decision-making. Lower quality evidence suggested general symptoms, working memory, social functioning, awareness of emotional responses to information, and attentional bias towards gain are associated with decision-making, but not education, executive functioning or overall symptoms. Meta-regression suggested an inverse association between decision-making and depression severity (k = 6, Q = 6.41, R2 100%, p = 0.01). Those taking first-generation (k = 6, N = 305, g = -0.17, 95% CI -0.40 to 0.06, p = 0.147) or low-dose antipsychotics (k = 5, N = 442, g = -0.19, 95% CI -0.44 to 0.06, p = 0.139) had unimpaired decision-making. Although meta-regression found no linear association between dose and performance, non-reporting of the dose was common and associated with larger impairments (k = 46, Q = 4.71, R2 14%, p = 0.03). Those supporting people with psychosis to make decisions, including treatment decisions, should consider the potential effect of these factors. Interventionist-causal trials are required to test whether reducing antipsychotic dose and treating anxiety and depression can improve decision-making in this group.