Can we use Ecological Momentary Assessment for real-world patients with schizophrenia? A study of acceptability of the passive smartphone-based app Evidence-Based Behavior (eB2). (Preprint)

BACKGROUND Ecological momentary assessment (EMA) tools collect real-time data on patients’ behaviour and functioning and may be useful interventions. However, concerns have been voiced regarding acceptability of EMA among patients with schizophrenia and what may underlie this remains poorly understood. OBJECTIVE To investigate acceptability of a passive smartphone-based EMA app, the Evidence-Based Behavior (eB2), among patients with schizophrenia spectrum disorders and putative variables underlying this. METHODS Participants came from an ongoing randomised controlled trial (RCT) of metacognitive training - outpatients with schizophrenia spectrum disorders (SSD) (F20-29-ICD10 codes), age 18-64 - none of whom received any financial compensation. Those who consented to installation of the eB2 app (users) were compared with those who did not (non-users) in sociodemographic, clinical, premorbid adjustment (Premorbid Adjustment Scale -PAS-), neurocognitive, psychopathological, insight and metacognitive variables. A multivariable binary logistic regression tested the influence of the above (independent) variables on ‘being user vs. non-user’ (acceptability), which was the main outcome measure. RESULTS Out of N=77 RCT participants, n=24 subjects (31%) consented to eB2, which remained installed at the end of the study (median follow-up=14.50 weeks) in n=14 subjects (70%). Users were younger and had a high education level, better premorbid adjustment, better executive function (according to the Trail Making Test) and higher cognitive insight levels (measured with the Beck Cognitive Insight Scale) than non-users (univariate analyses), although only age (OR 0.93, 95% CI 0.86-0.99; P=.048) and early adolescence PAS (OR 0.75, 95% CI 0.61-0.93; P=.010) survived the multivariable regression model, thus predicting eB2 acceptability. CONCLUSIONS Acceptability of a passive smartphone-based EMA app among SSD participants in this RCT where no participant received financial compensation was, as expected, relatively low, and linked with being young and good premorbid adjustment. Further research should examine how to increase EMA acceptability to SSD patients, particularly older participants and those with poor premorbid adjustment. CLINICALTRIAL This stusy is part of a randmised controlled trial which has been registered at ClinicalTrials.gov (NCT04104347) since the 26/09/2019. URL of registry https://clinicaltrials.gov/ct2/show/NCT04104347

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Metacognitive training (MCT) for schizophrenia improves cognitive insight: A randomized controlled trial in a Chinese sample with schizophrenia spectrum disorders

Behaviour Research and Therapy ◽

10.1016/j.brat.2014.11.008 ◽

2015 ◽

Vol 64 ◽

pp. 38-42 ◽

Cited By ~ 35

Author(s):

Kino C.K. Lam ◽

Christy P.S. Ho ◽

Jimmy C. Wa ◽

Salina M.Y. Chan ◽

Kevin K.N. Yam ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Controlled Trial ◽

Schizophrenia Spectrum Disorders ◽

Chinese Sample ◽

Metacognitive Training ◽

Randomized Controlled ◽

Cognitive Insight ◽

Schizophrenia Spectrum ◽

Spectrum Disorders

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S41. RANDOMISED CONTROLLED TRIAL OF METACOGNITIVE TRAINING COMPARED WITH PSYCHOEDUCATION IN PATIENTS WITH SCHIZOPHRENIA SPECTRUM DISORDERS: EFFECTS ON INSIGHT

Schizophrenia Bulletin ◽

10.1093/schbul/sbaa031.107 ◽

2020 ◽

Vol 46 (Supplement_1) ◽

pp. S47-S48

Author(s):

Javier-David Lopez-Morinigo ◽

Adela Sánchez Escribano-Martínez ◽

Verónica González Ruiz-Ruano ◽

Laura Mata-Iturralde ◽

Sergio Sánchez-Alonso ◽

...

Keyword(s):

Primary Outcome ◽

Controlled Trial ◽

Group Differences ◽

Schizophrenia Spectrum Disorders ◽

Metacognitive Training ◽

Cognitive Insight ◽

Schizophrenia Spectrum ◽

Spectrum Disorders ◽

Randomised Controlled

Abstract Background Insight in schizophrenia spectrum disorders (SSD) has been linked with positive outcomes. However, the effect size of previous treatments on insight has been relatively small to date. The metacognitive basis of insight in SSD has led to speculation that metacognitive training (MCT) may improve insight and clinical outcomes in SSD. Methods Design: Single-center, assessor-blind, parallel-group, randomised controlled trial (RCT). Sample: Participants are recruited from the outpatient clinic of Hospital Universitario Fundación Jiménez Díaz (Madrid, Spain) over June-December 2019. Inclusion criteria: i) age: 18–64 years, both inclusive, at the study inception; ii) diagnosis: SSD based on the Mini International Neuropsychiatric Interview (Sheehan et al., 1998) and iii) IQ>70 according to the Wechsler Adults Intelligence Scale-IV (Wechsler, 1981). Those with organic and drugs-induced psychosis, poor level of Spanish and/or lack of cooperativeness are excluded. Intervention: Participants are randomised to receive eight weekly group sessions of MCT or group psychoeducation (PSE) and they will be assessed at: T0) at baseline; T1) after treatment and T2) at 1-year follow-up, although follow-up data are not available yet. Co-primary outcome measures: clinical and cognitive insight dimensions, which will be measured by the Schedule for Assessment of Insight (Expanded version) (SAI-E) (Kemp & David, 1997), and the Beck Cognitive Insight Scale (BCIS) (Beck et al., 2004), respectively. Secondary outcome measures: i)Symptom severity-Positive and Negative Syndrome Scale (Kay et al., 1987); ii)Functioning-General Assessment of Functioning (Endicott et al., 1976), World Health Organization Disability Scale (WHO, 2012) and Satisfaction Life Domains Scale (Carlson et al., 2009), and only at follow-up (T2) iii)Suicidal Behaviour and iv) Hospitalizations. Power calculations: To reach a power of β=80% and detect a between-group difference of two points on the SAI-E total scores, which is considered to be clinically meaningful -effect size of 0.33-, the estimated sample size at the end of the study is n=126. Statistics: Student’s T-test and Mann-Whitney U tests were used as appropriate to compare between-group differences before- and after-treatment, i.e., the changes from baseline to post-treatment scores. The protocol of the study is registered at ClinicalTrials.gov (NCT04104347). Results n=49 subjects have been assessed at baseline so far (26 males, age: 47.0±10.2 years, diagnosis of schizophrenia -F20-ICD10-, n=36, 73.5%). Fifteen individuals (MCT: n=8; controls: n=7) have completed the treatment and the post-treatment assessment (T1). ‘After-treatment-T1 - baseline-T0’ scores difference means/medians between-group differences (MCT vs. PSE) were: SAI-E total insight 1.00 vs. -2.00, p=0.050; SAI-E illness awareness 0.62±2.20 vs. -0.43±1.62, p=0.316; SAI-E symptom relabelling 0.37±3.38 vs. -1.86±2.34, p=0.167; SAI-E treatment compliance 0.00 vs. 0.00, p>0.05,ns; BCIS self-reflectiveness 0.50±3.78 vs. -1.43±2.22, p=0.259, BCIS self-certainty 1.62±2.97 vs. 0.00±2.44, p=0.298 and BCIS Composite Index -1.13±5.62 vs. -2.17±3.49, p=0.698. Discussion This is the first RCT testing the effect of group MCT on insight (as primary outcome) in a sample of unselected patients with SSD in comparison with psychoeducation. Two main findings emerged from the results. First, MCT appears to improve clinical and cognitive insight in SSD. Second, MCT was shown to be superior to PSE in changing insight. Whether the above MCT-related insight improvement is maintained at longer-term and whether this has an impact on clinical and social outcomes are yet to be established, which will be properly looked at in this trial.

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Randomised controlled trial of Compensatory Cognitive Training and a Computerised Cognitive Remediation programme

Trials ◽

10.1186/s13063-020-04743-y ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Frances Dark ◽

Ellie Newman ◽

Victoria Gore-Jones ◽

Veronica De Monte ◽

Marta I. Garrido ◽

...

Keyword(s):

Cognitive Impairment ◽

Randomised Controlled Trial ◽

Outcome Measures ◽

Cognitive Training ◽

Controlled Trial ◽

Schizophrenia Spectrum Disorders ◽

Cognitive Interventions ◽

Schizophrenia Spectrum ◽

Spectrum Disorders ◽

Randomised Controlled

Abstract Background Compensation and adaptation therapies have been developed to improve community functioning via improving neurocognitive abilities in people with schizophrenia. Various modes of delivering compensation and adaptation therapies have been found to be effective. The aim of this trial is to compare two different cognitive interventions, Compensatory Cognitive Training (CCT) and Computerised Interactive Remediation of Cognition–Training for Schizophrenia (CIRCuiTS). The trial also aims to identify if mismatch negativity (MMN) can predict an individual’s response to the compensation and adaptation programmes. Methods This study will use a randomised, controlled trial of two cognitive interventions to compare the impact of these programmes on measures of neurocognition and function. One hundred clinically stable patients aged between 18 and 65 years with a diagnosis of a schizophrenia spectrum disorder will be recruited. Participants will be randomised to either the CCT or the CIRCuiTS therapy groups. The outcome measures are neurocognition (BACS), subjective sense of cognitive impairment (SSTICS), social functioning (SFS), and MMN (measured by EEG) in people with schizophrenia spectrum disorders. Discussion This trial will determine whether different approaches to addressing the cognitive deficits found in schizophrenia spectrum disorders are of comparable benefit using the outcome measures chosen. This has implications for services where cost and lack of computer technology limit the implementation and dissemination of interventions to address cognitive impairment in routine practice. The trial will contribute to the emerging evidence of MMN as a predictor of response to cognitive interventions. Trial registration Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12618000161224. Registered on 2 February 2018. Protocol version: 4.0, 18 June 2018.

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A Randomized Clinical Trial of Oxytocin or Galantamine in Schizophrenia: Assessing the Impact on Behavioral, Lexical, and Self-Report Indicators of Social Affiliation

Schizophrenia Bulletin Open ◽

10.1093/schizbullopen/sgaa001 ◽

2020 ◽

Vol 1 (1) ◽

Author(s):

Kristen R Dwyer ◽

Alexandra M Andrea ◽

Christina L G Savage ◽

Ryan D Orth ◽

LeeAnn Shan ◽

...

Keyword(s):

Negative Symptoms ◽

Controlled Trial ◽

Self Report ◽

Schizophrenia Spectrum Disorders ◽

Social Affiliation ◽

Subjective Responses ◽

Randomized Controlled ◽

Schizophrenia Spectrum ◽

Spectrum Disorders ◽

The Impact

Abstract Prior studies examining the impact of oxytocin on negative symptoms in schizophrenia have yielded mixed results. The current study explored whether oxytocin can improve more proximal indicators of social affiliation as indicated by changes in behavior, language and subjective indices of social affiliation among individuals with schizophrenia spectrum disorders during a role-play designed to elicit affiliative responses. We tested the hypothesis that daily intranasal oxytocin administered for 6 weeks would improve social affiliation as manifested by increased social skill ratings, use of positive, affiliative, and social words, and subjective responses from a previously published randomized controlled trial. Forty outpatients with schizophrenia or schizoaffective disorder were randomized to the oxytocin, galantamine, or placebo group and completed affiliative role-plays and self-report questionnaires of affect, reactions to the affiliative confederate, and willingness to interact at baseline and post-treatment. Results demonstrated that oxytocin was not effective at improving behavioral or subjective indicators of social affiliation. This study adds to a growing literature that the prosocial effects of oxytocin in schizophrenia are limited or null.

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