Helen Startup

Cognitive behavioural treatment of insomnia in individuals with persistent persecutory delusions: A pilot trial

Background and Objectives Insomnia is a putative causal factor for persecutory thinking. Recent epidemiological studies show a strong association of insomnia and paranoia. The clinical implication is that reducing insomnia will reduce paranoid delusions. This study, evaluating for the first time the treatment of insomnia in individuals with persecutory delusions, provides a test of this hypothesis. It was predicted that a brief cognitive behavioural intervention for insomnia (CBT-I) for individuals with persistent persecutory delusions and sleep difficulties would not only reduce the insomnia but that it would also reduce the paranoia. Methods Fifteen patients with persistent persecutory delusions and insomnia in the context of a psychotic disorder were each individually given a standard-format, four-session CBT-I intervention. Outcome assessments were conducted at pre-treatment, post-treatment and one-month follow-up. Results There were no missing data. Following the intervention, significant reductions were found in levels of insomnia and the persecutory delusions. The effect sizes were large, and the changes were maintained at the follow-up. At least two-thirds of participants made substantial improvements in insomnia and approximately half showed substantial reductions in the persecutory delusions. There were also reductions in levels of anomalies of experience, anxiety and depression. Limitations The main limitations are the absence of a control group and unblinded assessments. A more methodologically rigorous evaluation of this intervention is now warranted. Conclusions These preliminary findings suggest that CBT-I can be used to treat insomnia in individuals with persecutory delusions and that, consistent with the hypothesised causal role, it also lessens the delusions.

A randomised controlled trial of a worry intervention for individuals with persistent persecutory delusions

Recent research has shown that worry is associated with distressing paranoia. Therefore, the aim was to target worry in a therapeutic intervention for individuals with delusions. It was predicted that a worry intervention would reduce levels of worry and paranoia distress. Twenty-four individuals with persistent persecutory delusions and high levels of worry were randomly assigned to receive a four session cognitive-behavioural worry intervention (W-CBT) or treatment as usual (TAU). The worry intervention was specifically designed not to target the content of delusions. In this open-label evaluation, assessments of worry and paranoia were conducted at baseline, at one month (end of treatment) and at two months. The worry intervention achieved a statistically significant reduction in worry which was maintained at two month follow up. A significant reduction in delusional distress was also reported. There was an indication that the worry intervention may also reduce the frequency of paranoid thoughts but this was not statistically significant. In the first trial specifically for persecutory delusions, a brief worry intervention was shown to have benefits. The results support a causal role for worry in paranoid experience.

Out-patient psychological therapies for adults with anorexia nervosa: randomised controlled trial

BACKGROUND Very limited evidence is available on how to treat adults with anorexia nervosa and treatment outcomes are poor. Novel treatment approaches are urgently needed. AIMS To evaluate the efficacy and acceptability of a novel psychological therapy for anorexia nervosa (Maudsley Model of Anorexia Nervosa Treatment for Adults, MANTRA) compared with specialist supportive clinical management (SSCM) in a randomised controlled trial. METHOD Seventy-two adult out-patients with anorexia nervosa or eating disorder not otherwise specified were recruited from a specialist eating disorder service in the UK. Participants were randomly allocated to 20 once weekly sessions of MANTRA or SSCM and optional additional sessions depending on severity and clinical need (trial registration: ISRCTN62920529). The primary outcomes were body mass index, weight and global score on the Eating Disorders Examination at end of treatment (6 months) and follow-up (12 months). Secondary outcomes included: depression, anxiety and clinical impairment; neuropsychological outcomes; recovery rates; and additional service utilisation. RESULTS At baseline, patients randomised to MANTRA were significantly less likely to be in a partner relationship than those receiving SSCM (3/34 v. 10/36; P<0.05). Patients in both treatments improved significantly in terms of eating disorder and other outcomes, with no differences between groups. Strictly defined recovery rates were low. However, MANTRA patients were significantly more likely to require additional in-patient or day-care treatment than those receiving SSCM (7/34 v. 0/37; P = 0.004). CONCLUSIONS Adults with anorexia nervosa are a difficult to treat group. The imbalance between groups in partner relationships may explain differences in service utilisation favouring SSCM. This study confirms SSCM as a useful treatment for out-patients with anorexia nervosa. The novel treatment, MANTRA, designed for this patient group may need adaptations to fully exploit its potential.

Effects of cognitive behaviour therapy for worry on persecutory delusions in patients with psychosis (WIT): a parallel, single-blind, randomised controlled trial with a mediation analysis.

Summary Background Worry might be a contributory causal factor in the occurrence of persecutory delusions in patients with psychotic disorders. Therefore we postulated that reducing worry with cognitive behaviour therapy (CBT) would reduce persecutory delusions. Methods For our two-arm, assessor-blinded, randomised controlled trial (Worry Intervention Trial [WIT]), we recruited patients aged 18–65 years with persistent persecutory delusions but non-affective psychosis from two centres: the Oxford Health National Health Service (NHS) Foundation Trust (Oxford, UK) and the Southern Health NHS Foundation Trust (Southampton, UK). The key inclusion criteria for participants were a score of at least 3 on the Psychotic Symptoms Rating Scale (PSYRATS) denoting a current persecutory delusion; that the delusion had persisted for at least 3 months; a clinical diagnosis of schizophrenia, schizoaffective disorder, or delusional disorder; and a clinically significant level of worry. We randomly assigned (1:1) eligible patients, using a randomly permuted block procedure with variable block sizes and division by four strata, to either six sessions of worry-reduction CBT intervention done over 8 weeks added to standard care (the CBT-intervention group), or to standard care alone (the control group). The assessors were masked to patient allocations and did their assessments at week 0 (baseline), 8 weeks (end of treatment), and 24 weeks, follow-up. The primary outcomes were worry measured by the Penn State Worry Questionnaire (PSWQ) and delusions measured by the PSYRATS-delusion scale; we did the analyses in the intention-to-treat population, and also did a planned mediation analysis. This trial is registered with the ISRCTN Registry (number ISRCTN23197625) and is closed to new participants. Findings From Nov 1, 2011, to Sept 9, 2013, we recruited 150 eligible participants and randomly assigned 73 to the CBT intervention group, and 77 to the control group. 143 patients (95%) provided primary outcome follow-up data. Compared with standard care alone, at 8 weeks the CBT intervention significantly reduced worry (mean difference 6·35 [SE 1·56] PSWQ units, 95% CI 3·30–9·40; p<0·001) and persecutory delusions (2·08 [SE 0·73] PSYRATS units, 95% CI 0·64–3·51; p=0·005). The reductions were maintained to 24 weeks follow-up. The mediation analysis suggested that the change in worry accounted for 66% of the change in delusion. No patients died or were admitted to secure units during our study. Six suicide attempts (two in the CBT intervention group, and four in the control group) and two serious violent incidents (one in each group) were noted, but no adverse events were deemed related to the treatments or the assessments. Interpretation To our knowledge, this is the first large trial focused on persecutory delusions. We have shown that long-standing delusions were significantly reduced by a brief intervention targeted on worry, although the limitations for our study include no determination of the key elements within the intervention. Our results suggest that worry might cause paranoia, and that worry intervention techniques might be a beneficial addition to the standard treatment of psychosis. Funding Efficacy and Mechanism Evaluation programme, which is a UK Medical Research Council and National Institute of Health Research partnership.

A randomized controlled trial of internet-based cognitive-behavioural therapy for bulimia nervosa or related disorders in a student population.

BACKGROUND Bulimic eating disorders are common among female students, yet the majority do not access effective treatment. Internet-based cognitive-behavioural therapy (iCBT) may be able to bridge this gap. METHOD Seventy-six students with bulimia nervosa (BN) or eating disorder not otherwise specified (EDNOS) were randomly assigned to immediate iCBT with e-mail support over 3 months or to a 3-month waiting list followed by iCBT [waiting list/delayed treatment control (WL/DTC)]. ED outcomes were assessed with the Eating Disorder Examination (EDE) at baseline, 3 months and 6 months. Other outcomes included depression, anxiety and quality of life. RESULTS Students who had immediate iCBT showed significantly greater improvements at 3 and 6 months than those receiving WL/DTC in ED and other symptoms. CONCLUSIONS iCBT with e-mail support is efficacious in students with bulimic disorders and has lasting effects.

Efficacy of cognitive behavioural therapy for sleep improvement in patients with persistent delusions and hallucinations (BEST): a prospective, assessor-blind, randomised controlled pilot trial.

Summary Background Sleep disturbance occurs in most patients with delusions or hallucinations and should be treated as a clinical problem in its own right. However, cognitive behavioural therapy (CBT)—the best evidence-based treatment for insomnia—has not been tested in this patient population. We aimed to pilot procedures for a randomised trial testing CBT for sleep problems in patients with current psychotic experiences, and to provide a preliminary assessment of potential benefit. Methods We did this prospective, assessor-blind, randomised controlled pilot trial (Better Sleep Trial [BEST]) at two mental health centres in the UK. Patients (aged 18–65 years) with persistent distressing delusions or hallucinations in the context of insomnia and a schizophrenia spectrum diagnosis were randomly assigned (1:1), via a web-based randomisation system with minimisation to balance for sex, insomnia severity, and psychotic experiences, to receive either eight sessions of CBT plus standard care (medication and contact with the local clinical team) or standard care alone. Research assessors were masked to group allocation. Assessment of outcome was done at weeks 0, 12 (post-treatment), and 24 (follow-up). The primary efficacy outcomes were insomnia assessed by the Insomnia Severity Index (ISI) and delusions and hallucinations assessed by the Psychotic Symptoms Rating Scale (PSYRATS) at week 12. We did analysis by intention to treat, with an aim to provide confidence interval estimation of treatment effects. This study is registered with ISRCTN, number 33695128. Findings Between Dec 14, 2012, and May 22, 2013, and Nov 7, 2013, and Aug 26, 2014, we randomly assigned 50 patients to receive CBT plus standard care (n=24) or standard care alone (n=26). The last assessments were completed on Feb 10, 2015. 48 (96%) patients provided follow-up data. 23 (96%) patients offered CBT took up the intervention. Compared with standard care, CBT led to reductions in insomnia in the large effect size range at week 12 (adjusted mean difference 6·1, 95% CI 3·0–9·2, effect size d=1·9). By week 12, nine (41%) of 22 patients receiving CBT and one (4%) of 25 patients receiving standard care alone no longer had insomnia, with ISI scores lower than the cutoff for insomnia. The treatment effect estimation for CBT covered a range from reducing but also increasing delusions (adjusted mean difference 0·3, 95% CI −2·0 to 2·6) and hallucinations (−1·9, −6·5 to 2·7). Three patients, all in the CBT group, had five adverse events, although none were regarded as related to study treatment. Interpretation Our findings show that CBT for insomnia might be highly effective for improving sleep in patients with persistent delusions or hallucinations. A larger, suitably powered phase 3 study is now needed to provide a precise estimate of the effects of CBT for sleep problems, both on sleep and psychotic experiences. Funding Research for Patient Benefit Programme, National Institute for Health Research.

An experimental exploration of behavioral and cognitive–emotional aspects of intolerance of uncertainty in eating disorder patients

OBJECTIVE Intolerance of uncertainty (IU) is an important concept in eating disorders (ED). Cognitive, emotional, and behavioral features of IU amongst individuals with and without ED were investigated. METHOD Participants completed the intolerance of uncertainty scale (IUS) and four versions of a data-gathering task varying in difficulty/uncertainty, and rated their Beads task experience. RESULTS ED groups had significantly higher IUS scores than healthy controls (HC). Bulimia Nervosa (BN) participants requested more cues than HC and Anorexia Nervosa (AN) participants before making decisions. ED groups found the task more distressing than HC participants, with those with BN feeling more uncertain and less confident in their decisions, and those with AN attributing greater importance in making the correct decision. DISCUSSION While both ED groups reported raised IUS scores only BN participants engaged in an elevated evidence requirement data gathering style. Future research might benefit from further exploration of the role of perseverative processes in BN.

Theory of mind in bulimia nervosa

OBJECTIVE This study aimed to investigate theory of mind (ToM) in individuals with bulimia nervosa (BN), an area neglected by empirical research despite social functioning difficulties in this disorder and evidence of ToM deficits in people with anorexia nervosa (AN). METHOD ToM was assessed in 48 BN and 34 Eating Disorder Not Otherwise Specified BN-type (EDNOS-BN) outpatients and 57 healthy controls (HCs) using the Reading the Mind in the Eyes and the Reading the Mind in the Films (RMF), an ecologically valid task novel to BN research. RESULTS Overall performance in BN and EDNOS-BN groups was equivalent to HCs on both tasks. Individuals with BN had enhanced negative emotion recognition on the RMF. DISCUSSION Individuals with AN and BN have distinct socio-cognitive profiles. Further research into social cognition is required to establish the link between interpersonal difficulties and psychopathology in people with BN.

Developing treatments of persistent persecutory delusions: The impact of an emotional processing and metacognitive awareness intervention

Worry has been implicated in increasing the levels of distress associated with persecutory delusions. It may partly cause this distress via the impediment of emotional processing of upsetting experiences. The clinical implication is that enhancing emotional processing of paranoid experiences will reduce distress. We therefore piloted a new brief intervention-the Emotional Processing and Metacognitive Awareness (EPMA)-on 12 patients with persistent persecutory delusions. The intervention was predominately influenced by written emotional disclosure and lasted for three sessions. The delusions were assessed at baseline, preintervention and postintervention and during a one-month follow-up. It was found that EPMA particularly reduced levels of delusion distress, and this was maintained at follow-up. The effect sizes were large but were likely overestimated given the absence of a control group and assessments that were not blind. These preliminary findings suggest that simply encouraging patients to talk, in the right way, about their delusions can be beneficial.

The interaction of affective with psychotic processes: a test of the effects of worrying on working memory, jumping to conclusions, and anomalies of experience in patients with persecutory delusions.

Worry has traditionally been considered in the study of common emotional disorders such as anxiety and depression, but recent studies indicate that worry may be a causal factor in the occurrence and persistence of persecutory delusions. The effect of worry on processes traditionally associated with psychosis has not been tested. The aim of the study was to examine the short-term effects of a bout of worry on three cognitive processes typically considered markers of psychosis: working memory, jumping to conclusions, and anomalous internal experience. Sixty-seven patients with persecutory delusions in the context of a non-affective psychotic disorder were randomised to a worry induction, a worry reduction, or a neutral control condition. They completed tests of the cognitive processes before and after the randomisation condition. The worry induction procedure led to a significant increase in worry. The induction of worry did not affect working memory or jumping to conclusions, but it did increase a range of mild anomalous experiences including feelings of unreality, perceptual alterations, and temporal disintegration. Worry did not affect the occurrence of hallucinations. The study shows that a period of worry causes a range of subtle odd perceptual disturbances that are known to increase the likelihood of delusions. It demonstrates an interaction between affective and psychotic processes in patients with delusions.