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Background: Cognitive behaviour therapy (CBT) is recommended for the treatment of psychosis; however, only a small proportion of service users have access to this intervention. Smartphone technology using software applications (apps) could increase access to psychological approaches for psychosis. This paper reports the protocol development for a clinical trial of smartphone-based CBT.Methods/design: We present a study protocol that describes a single-blind randomised controlled trial comparing a cognitive behaviour therapy-informed software application (Actissist) plus Treatment As Usual (TAU) with a symptom monitoring software application (ClinTouch) plus TAU in early psychosis. The study consists of a 12-week intervention period. We aim to recruit and randomly assign 36 participants registered with early intervention services (EIS) across the North West of England, UK in a 2:1 ratio to each arm of the trial. Our primary objective is to determine whether in people with early psychosis the Actissist app is feasible to deliver and acceptable to use. Secondary aims are to determine whether Actissist impacts on predictors of first episode psychosis (FEP) relapse and enhances user empowerment, functioning and quality of life. Assessments will take place at baseline, 12 weeks (post-treatment) and 22-weeks (10 weeks post-treatment) by assessors blind to treatment condition. The trial will report on the feasibility and acceptability of Actissist and compare outcomes between the randomised arms. The study also incorporates semi-structured interviews about the experience of participating in the Actissist trial that will be qualitatively analysed to inform future developments of the Actissist protocol and app.Discussion: To our knowledge, this is the first controlled trial to test the feasibility, acceptability, uptake, attrition and potential efficacy of a CBT-informed smartphone app for early psychosis. Mobile applications designed to deliver a psychologically-informed intervention offer new possibilities to extend the reach of traditional mental health service delivery across a range of serious mental health problems and provide choice about available care.Trial Registration: ISRCTN34966555. Date of first registration: 12 June 2014. [ABSTRACT FROM AUTHOR]

A randomized controlled trial is reported in which three treatments were compared for the management of depression in Primary Care. The treatments were Treatment As Usual (TAU) carried out by the General Practitioners, Cognitive-Behaviour Therapy (CBT) or Interpersonal Psychotherapy (IPT). Measurements of depressive symptomatology were taken at Baseline (Time1), at end of treatment (Time2), and at 5-month follow-up (Time3). An initial analysis of the longitudinal data revealed that there were a significant number of missing values, especially in the Time3 follow-up for the TAU group. That is, the missing data were not missing at random within the dataset, which is one of the considerations for usual procedures for replacement of missing values (RMV). The paper presents, therefore, the outcome of different approaches to RMV and their consequences for conclusions about the relative efficacy of the treatment conditions. The results showed that clients in all conditions improved significantly, with at least some analyses showing superiority of IPT and CBT at end of treatment Time 2. However, by the follow-up clients in all conditions performed equally well. Copyright © 2012 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Background: CBT is a potentially effective treatment for anxiety disorders following TBI; however, empirical evidence has mainly come from clients with mild TBI. This paper describes a CBT-based anxiety treatment programme adapted for clients with more severe injuries. Two case studies are provided to illustrate the implementation of the programme, as a step toward larger scale testing of the programme's feasibility. Methods and procedures: A manualised adapted CBT treatment manual was used to deliver CBT in a standardised manner to two clients, one with severe and one with moderate TBI. Outcome was evaluated using a single-subject design with repeated measures of anxiety, mood and coping style at pre- and post-CBT. Results: The two clients demonstrated positive treatment response on either a measure of anxiety or a continuous measure of distress. Although neither demonstrated a clinically significant change according to the primary outcome measure (Hospital Anxiety and Depression Scale), they showed significant change in at least one corroborated measure of anxiety. Conclusions: This study suggests the potential utility of the adapted CBT programme for clients with moderate-severe TBI. Limitations of the single case studies were discussed, while noting how they would be addressed in a follow-up randomised controlled trial. [ABSTRACT FROM AUTHOR]

BackgroundChronic fatigue is a common symptom of multiple sclerosis (MS). A randomized controlled trial (RCT) showed that cognitive behavioural therapy (CBT) was more effective in reducing MS fatigue than relaxation training (RT). The aim of the current study was to analyse additional data from this trial to determine whether (1) CBT compared to RT leads to significantly greater changes in cognitions and behaviours hypothesized to perpetuate MS fatigue; (2) changes in these variables mediate the effect of CBT on MS fatigue; and (3) these mediation effects are independent of changes in mood.MethodSeventy patients (CBT, n=35; RT, n=35) completed the Cognitive and Behavioural Responses to Symptoms Questionnaire (CBSQ), the Brief Illness Perception Questionnaire (B-IPQ) modified to measure negative representations of fatigue, the Hospital Anxiety and Depression Scale (HADS), and the Chalder Fatigue Questionnaire (CFQ), pre- and post-therapy. Multiple mediation analysis was used to determine which variables mediated the change in fatigue.ResultsAvoidance behaviour and three cognitive variables (symptom focusing, believing symptoms are a sign of damage and a negative representation of fatigue) improved significantly more in the CBT than the RT group. Mediation analysis showed that changing negative representations of fatigue mediated the decrease in severity of fatigue. Change in anxiety covaried with reduction in fatigue but the mediation effect for negative representations of fatigue remained when controlling for improvements in mood.ConclusionsChange in beliefs about fatigue play a crucial role in CBT for MS fatigue. These beliefs and the role of anxiety deserve more attention in the further development of this intervention. [ABSTRACT FROM PUBLISHER]