Cognitive–behavioural therapy for adult attention-deficit hyperactivity disorder:a proof of concept randomised controlled trial

Objective: To investigate efficacy, patient acceptability and feasibility of formulation-based cognitive–behavioural therapy (CBT) for adults with attention-deficit hyperactivity disorder (ADHD). NICE guidelines for adult ADHD recommend further research into psychological treatments. Method: Sixty participants with adult ADHD were randomly allocated to treatment as usual (TAU) vs. TAU plus up to 16 sessions of individual formulation-based CBT for ADHD. Results: Adding formulation-based CBT to TAU for ADHD significantly improved ADHD symptoms on the Barkley Current Symptoms Scale and scores on the Work and Social Adjustment Scale. Adjusted effect sizes (ES) were 1.31 and 0.82 respectively. There were also significant improvements on secondary outcomes including independently evaluated clinical global improvement, self-rated anxiety, depression, global distress and patient satisfaction (adjusted effect sizes 0.52–1.01). Conclusions: This is the first randomised controlled trial to provide preliminary evidence of efficacy and acceptability of individual formulation-based CBT for ADHD when added to TAU over TAU alone. This approach now needs to be tested in a larger multicentred randomised controlled trial.</p

App-based food-specific inhibitory control training as an adjunct to treatment as usual in binge-type eating disorders: a feasibility trial

Current treatments for binge eating disorder (BED) and bulimia nervosa (BN) only show moderate efficacy, warranting the need for novel interventions. Impairments in food-related inhibitory control contribute to BED/BN and could be targeted by food-specific inhibitory control training (ICT). The aim of this study was to establish the feasibility and acceptability of augmenting treatment for individuals with BN/BED with an ICT app (FoodT), which targets motor inhibition to food stimuli using a go/no-go paradigm. Eighty patients with BED/BN receiving psychological and/or pharmacological treatment were randomly allocated to a treatment-as-usual group (TAU; n = 40) or TAU augmented with the 5-min FoodT app daily (n = 40) for 4 weeks. This mixed-methods study assessed feasibility outcomes, effect sizes of clinical change, and acceptability using self-report measures. Pre-registered cut-offs for recruitment, retention, and adherence were met, with 100% of the targeted sample size (n = 80) recruited within 12 months, 85% of participants retained at 4 weeks, and 80% of the FoodT + TAU group completing ≤8 sessions. The reduction in binge eating did not differ between groups. However, moderate reductions in secondary outcomes (eating disorder psychopathology: SES = −0.57, 95% CI [-1.12, −0.03]; valuation of high energy-dense foods: SES = −0.61, 95% CI [-0.87, −0.05]) were found in the FoodT group compared to TAU. Furthermore, small greater reductions in food addiction (SES = −0.46, 95% CI [-1.14, 0.22]) and lack of premeditation (SES = −0.42, 95% CI [-0.77, −0.07]) were found in the FoodT group when compared to TAU. The focus groups revealed acceptability of FoodT. Participants discussed personal barriers (e.g. distractions) and suggested changes to the app (e.g. adding a meditation exercise). Augmenting treatment for BED/BN with a food-specific ICT app is feasible, acceptable, and may reduce clinical symptomatology with high reach and wide dissemination

The Cognitive Remediation in Bipolar (CRiB) pilot study: Study protocol for a randomised controlled trial

Background: People with bipolar disorder often show difficulties with cognitive functioning, and though these difficulties are identified as important targets for intervention, few treatment options are available. Preliminary evidence suggests that cognitive remediation therapy (a psychological treatment proven beneficial for people diagnosed as having schizophrenia) is helpful for people with bipolar disorders. We are conducting a pilot trial to determine whether individual, computerised, cognitive remediation therapy (CRT) for people with bipolar disorder 1) increases cognitive function; 2) improves global functioning, goal attainment and mood symptoms; 3) is acceptable and feasible for participants; and 4) can be addressed in a comprehensive, larger, randomised, controlled trial. Methods/design: The study is designed as a two-arm, randomised, controlled trial comparing cognitive remediation therapy with treatment-as-usual (TAU) for euthymic bipolar patients. Participants are eligible to take part if aged between 18 and 65 with a diagnosis of bipolar disorder (type I) and currently in euthymic state, and no neurological, substance or personality disorder diagnoses. Sixty participants will be recruited (mainly through secondary and tertiary care) and will be block-randomised to receive either treatment-as-usual alone or in addition to a 12-week course of cognitive remediation therapy totalling 20–40 therapy hours. The intervention will comprise regular sessions with a therapist and computer-based training. Research assessments will take place before and after the intervention period and at a 12-week follow-up, and will include evaluation of neuropsychological, symptom-related, demographic and social factors, as well as collecting qualitative data regarding CRT expectations and satisfaction. Intention-to-treat analyses will examine the efficacy of cognitive remediation therapy primarily on cognition and additionally on functioning, quality of life and mood symptoms. Furthermore, we will examine the acceptability of CRT and undertake a preliminary health economics analysis to ascertain the cost of delivering the intervention. Discussion: The results of this trial will provide valuable information about whether cognitive remediation therapy may be beneficial for people diagnosed with bipolar disorder in a euthymic state. Trial Registration: ISRCTN registry, ISRCTN32290525. Registered on 2 March 2016

Cognitive remediation therapy for patients with bipolar disorder: a randomised proof-of-concept trial

Objectives: Cognitive remediation therapy (CRT) may benefit people with bipolar disorder type I and II for whom cognitive impairment is a major contributor to disability. Extensive research has demonstrated CRT to improve cognition and psychosocial functioning in people with different diagnoses, but randomised trials of evidenced therapy programmes are lacking for bipolar disorders. The Cognitive Remediation in Bipolar (CRiB) study aimed to determine whether an established CRT programme is feasible and acceptable for people with bipolar disorders. Methods: This proof‐of‐concept, single‐blind randomised trial recruited participants aged 18‐65 with bipolar disorder, not currently experiencing an episode. They were 1:1 block randomised to treatment‐as‐usual (TAU) with or without individual CRT for 12 weeks. The partly computerised CRT programme (“CIRCuiTS”) was therapist‐led and is evidence‐based from trials in those with psychotic illnesses. Data were collected and analysed by investigators blinded to group allocation. The main outcomes (week 13 and 25) examined participant retention, intervention feasibility and putative effects of CRT on cognitive and psychosocial functioning via intention‐to‐treat analyses. Trial registration: ISRCTN ID32290525. Results: Sixty participants were recruited (02/2016‐06/2018) and randomised to CRT (n = 29) or TAU (n = 31). Trial withdrawals were equivalent (CRT n = 2/29; TAU n = 5/31). CRT satisfaction indicated high acceptability. Intention‐to‐treat analyses (N = 60) demonstrated greater improvements for CRT‐ than TAU‐randomised participants: at both week 13 and 25, CIRCuiTS participants showed larger improvements in the following domains (week 25 effect sizes reported here): IQ (SES = 0.71, 95% CI [0.29,1.13]), working memory (SES = 0.70, 95% CI [0.31,1.10]), executive function (SES = 0.93, 95% CI [0.33,1.54]), psychosocial functioning (SES = 0.49, 95% CI [0.18,0.80]) and goal attainment (SES = 2.02, 95% CI [0.89,3.14]). No serious adverse events were reported. Conclusions: CRT is feasible for individuals with bipolar disorders and may enhance cognition and functioning. The reported effect sizes from this proof‐of‐concept trial encourage further investigation in a definitive trial

Out-patient triple chronotherapy for the rapid treatment and maintenance of response in depression : feasibility and pilot randomised controlled trial

Background Triple chronotherapy (sleep deprivation for 36 h, followed by 4 days of advancing the time of sleep and daily morning bright-light therapy for 6 months) has demonstrated benefits for the rapid treatment of depressive symptoms in four small controlled trials of in-patients. Aims To test the feasibility of recruitment and delivery of triple chronotherapy for out-patients with depression (ISRCTN17706836; NCT03405493). Method In a single-blind trial, 82 participants were randomised to triple chronotherapy or a control intervention. The primary outcome was the number of participants recruited per month and adherence to the protocol. Secondary outcomes included the 6-item Hamilton Rating Scale for Depression (HRSD-6) at 1 week. Timings of observer ratings were baseline and 1, 2, 4, 8 and 26 weeks after randomisation. Results The triple chronotherapy group stayed awake for the planned 36 h and 89.9% adhered to the plan of phase advance of their sleep over the following 4 days. We achieved our recruitment target (60 participants completed the trial within 13 months). There were no reported adverse side-effects. We found a significant difference between the groups by intention-to-treat analysis for the HRSD-6 at weeks 1, 8 and 26. There was a large effect size of Cohen's d = 0.8 on HRSD-6 score at week 1, increasing to d = 1.30 at week 26. A response (≥50% reduction in symptoms) was achieved by 33.3% in the triple chronotherapy group and 16.2% in the control group. This stayed relatively steady until week 26 (35.9 v. 13.9%). Conclusions Triple chronotherapy produced a significant and rapid benefit after 1 week in out-patients with depression that was sustained at 26 weeks. Cost-effectiveness trials with a larger clinical sample are required

Is digital cognitive behavioural therapy for insomnia effective in treating sub-threshold insomnia: A pilot RCT

Objective/Background: CBT for insomnia (CBT-I) is useful for many. It is currently unknown if those with sub-threshold insomnia also benefit. Here we assessed whether CBT-I is both feasible and acceptable in participants with sub-threshold insomnia. The primary aims were to evaluate participation rates and treatment acceptability, and to establish an effect size for symptom improvement. Patients/Methods: A total of 199 female participants (Mage 20 ± 5 years) took part. Following baseline assessments, participants were randomly allocated to either a 6-week digital CBT-I intervention or a 6-week session control group receiving puzzles. Additional assessments were performed 3-weeks, 6-weeks, and 6-months later. Results: Participation in each survey wave did not differ between the groups (ps > .140), though adherence to weekly tasks was lower in the CBT-I group, p = .02. Treatment acceptability was high (M (SD) = 33.61 (4.82), range 6 – 42). The CBT-I group showed greater improvement in insomnia symptoms at the end of the intervention compared to the control group (p = .013, d = 0.42), with significant variation in outcome (M = 4.69, SD = 5.41). Sub-threshold participants showed a similar pattern of results, whilst those meeting insomnia criteria showed a smaller between-group difference. CBT-I led to improvements in anxiety, paranoia and perceived stress between baseline and end of intervention. Changes in insomnia symptoms were mediated by cognitions about sleep and somatic pre-sleep arousal. Conclusions: CBT-I provides a benefit even in sub-threshold insomnia. CBT-I may be useful as an early preventative intervention to tackle sleep problems before they manifest as chronic insomnia

A comparison of non-verbal maternal care of male and female infants in India and the United Kingdom: the parent-infant caregiving touch scale in two cultures

Differences in infant caregiving behavior between cultures have long been noted, although the quantified comparison of touch-based caregiving using uniform standardized methodology has been much more limited. The Parent-Infant Caregiving Touch scale (PICTS) was developed for this purpose and programming effects of early parental tactile stimulation (stroking) on infant hypothalamic-pituitary adrenal (HPA)-axis functioning (stress-response system), cardiovascular regulation and behavioral outcomes, similar to that reported in animals, have now been demonstrated. In order to inform future studies examining such programming effects in India, we first aimed to describe and examine, using parametric and non-parametric item-response methods, the item-response frequencies and characteristics of responses on the PICTS, and evidence for cross-cultural differential item functioning (DIF) in the United Kingdom (UK) and India. Second, in the context of a cultural favoring of male children in India, we also aimed to test the association between the sex of the infant and infant “stroking” in both cultural settings. The PICTS was administered at 8–12 weeks postpartum to mothers in two-cohort studies: The Wirral Child Health and Development Study, United Kingdom (n = 874) and the Bangalore Child Health and Development Study, India (n = 395). Mokken scale analysis, parametric item-response analysis, and structural equation modeling for categorical items were used. Items for two dimensions, one for stroking behavior and one for holding behavior, could be identified as meeting many of the criteria required for Mokken scales in the United Kingdom, only the stroking scale met these criteria in the sample from India. Thus, while a comparison between the two cultures was possible for the stroking construct, comparisons for the other non-verbal parenting constructs within PICTS were not. Analyses revealed higher rates of early stroking being reported for the United Kingdom than India, but no sex differences in rates in either country and no differential sex difference by culture. We conclude that PICTS items can be used reliably in both countries to conduct further research on the role of early tactile stimulation in shaping important child development outcomes