scholarly journals Internet-assisted cognitive behavioural therapy with telephone coaching for anxious Finnish children aged 10–13 years: study protocol for a randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e045474
Author(s):  
Terhi Luntamo ◽  
Tarja Korpilahti-Leino ◽  
Terja Ristkari ◽  
Sanna Hinkka-Yli-Salomäki ◽  
Marjo Kurki ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Well Being ◽  
Childhood Anxiety ◽  
Behavioural Therapy ◽  
Cognitive Behavioural ◽  
Randomised Controlled ◽  
Telephone Coaching ◽  
The Impact

IntroductionChildhood anxiety is common, causes significant functional impairment and may lead to psychosocial problems by adulthood. Although cognitive behavioural therapy (CBT) is effective for treating anxiety, its availability is limited by the lack of trained CBT therapists and easily accessible local services. To address the challenges in both recognition and treatment, this study combines systematic anxiety screening in the general population with a randomised controlled trial (RCT) on internet-assisted CBT (ICBT) with telephone coaching. Child, family and intervention-related factors are studied as possible predictors or moderators, together with the COVID-19 pandemic.Methods and analysisThe study is an open two-parallel group RCT, stratified by sex, that compares ICBT with telephone coaching to an education control. Children aged 10–13 are screened at yearly school healthcare check-ups using five items from the Screen for Child Anxiety Related Disorders (SCARED) Questionnaire. The families of children who screen positive for anxiety are contacted to assess the family’s eligibility for the RCT. The inclusion criteria include scoring at least 22 points in the 41-item SCARED Questionnaire. The primary outcome is the SCARED child and parent reports. The secondary outcomes include the impact of anxiety, quality of life, comorbidity, peer relationships, perceptions of school, parental well-being and service use. Additional measures include demographics and life events, anxiety disorder diagnoses, as well as therapeutic partnerships, the use of the programme and general satisfaction among the intervention group.Ethics and disseminationThe study has been approved by the research ethics board of the Hospital District of South West Finland and local authorities. Participation is voluntary and based on informed consent. The anonymity of the participants will be protected and the results will be published in a scientific journal and disseminated to healthcare professionals and the general public.Trial registration numberClinicalTrials.gov NCT03310489, pre-results, initially released on 30 September 2017.

scholarly journals Digital cognitive–behavioural therapy for insomnia compared with digital patient education about insomnia in individuals referred to secondary mental health services in Norway: protocol for a multicentre randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050661
Author(s):  
Håvard Kallestad ◽  
Simen Saksvik ◽  
Øystein Vedaa ◽  
Knut Langsrud ◽  
Gunnar Morken ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trial ◽  
Patient Education ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Group Differences ◽  
Post Intervention ◽  
Cognitive Behavioural ◽  
Randomised Controlled

IntroductionInsomnia is highly prevalent in outpatients receiving treatment for mental disorders. Cognitive–behavioural therapy for insomnia (CBT-I) is a recommended first-line intervention. However, access is limited and most patients with insomnia who are receiving mental healthcare services are treated using medication. This multicentre randomised controlled trial (RCT) examines additional benefits of a digital adaptation of CBT-I (dCBT-I), compared with an online control intervention of patient education about insomnia (PE), in individuals referred to secondary mental health clinics.Methods and analysisA parallel group, superiority RCT with a target sample of 800 participants recruited from treatment waiting lists at Norwegian psychiatric services. Individuals awaiting treatment will receive an invitation to the RCT, with potential participants undertaking online screening and consent procedures. Eligible outpatients will be randomised to dCBT-I or PE in a 1:1 ratio. Assessments will be performed at baseline, 9 weeks after completion of baseline assessments (post-intervention assessment), 33 weeks after baseline (6 months after the post-intervention assessment) and 61 weeks after baseline (12 months after the post-intervention assessment). The primary outcome is between-group difference in insomnia severity 9 weeks after baseline. Secondary outcomes include between-group differences in levels of psychopathology, and measures of health and functioning 9 weeks after baseline. Additionally, we will test between-group differences at 6-month and 12-month follow-up, and examine any negative effects of the intervention, any changes in mental health resource use, and/or in functioning and prescription of medications across the duration of the study. Other exploratory analyses are planned.Ethics and disseminationThe study protocol has been approved by the Regional Committee for Medical and Health Research Ethics in Norway (Ref: 125068). Findings from the RCT will be disseminated via peer-reviewed publications, conference presentations, and advocacy and stakeholder groups. Exploratory analyses, including potential mediators and moderators, will be reported separately from main outcomes.Trial registration numberClinicalTrials.gov Registry (NCT04621643); Pre-results.

scholarly journals Rumination-focused cognitive–behavioural therapy for residual depression: phase II randomised controlled trial

2011 ◽  
Vol 199 (4) ◽  
pp. 317-322 ◽  
Author(s):  
Edward R. Watkins ◽  
Eugene Mullan ◽  
Janet Wingrove ◽  
Katharine Rimes ◽  
Herbert Steiner ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Control Group ◽  
Specific Content ◽  
Cognitive Behavioural ◽  
Randomised Controlled ◽  
Major Depressive Episodes ◽  
Depressive Episodes

BackgroundAbout 20% of major depressive episodes become chronic and medication-refractory and also appear to be less responsive to standard cognitive–behavioural therapy (CBT).AimsTo test whether CBT developed from behavioural activation principles that explicitly and exclusively targets depressive rumination enhances treatment as usual (TAU) in reducing residual depression.MethodForty-two consecutively recruited participants meeting criteria for medication-refractory residual depression were randomly allocated to TAU v. TAU plus up to 12 sessions of individual rumination-focused CBT. The trial has been registered (ISRCTN22782150).ResultsAdding rumination-focused CBT to TAU significantly improved residual symptoms and remission rates. Treatment effects were mediated by change in rumination.ConclusionsThis is the first randomised controlled trial providing evidence of benefits of rumination-focused CBT in persistent depression. Although suggesting the internal validity of rumination-focused CBT for residual depression, the trial lacked an attentional control group so cannot test whether the effects were as a result of the specific content of rumination-focused CBT v. non-specific therapy effects.

scholarly journals Internet-based cognitive–behavioural therapy for prevention of depression during pregnancy and in the post partum (iPDP): a protocol for a large-scale randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (5) ◽  
pp. e036482 ◽  
Author(s):  
Daisuke Nishi ◽  
Kotaro Imamura ◽  
Kazuhiro Watanabe ◽  
Erika Obikane ◽  
Natsu Sasaki ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Pregnant Women ◽  
Cognitive Behavioural Therapy ◽  
Post Partum ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Cognitive Behavioural ◽  
Randomised Controlled ◽  
Major Depressive Episodes ◽  
Depressive Episodes

IntroductionThe objective of this randomised controlled trial (RCT) is to examine the effects of smartphone-based cognitive–behavioural therapy (CBT) in preventing the onset of major depressive episodes (MDE) among pregnant women.Methods and analysisThe target study population will be pregnant women of 16–20 weeks gestation who are currently users of ‘Luna Luna Baby’, the most widely used app for pregnant women in Japan. Those who meet the eligibility criteria will be randomly allocated to the 6-module internet CBT programme that was newly developed for pregnant women (n=2500), or to a treatment-as-usual control group (n=2500). Participants in the intervention groups will be required to complete the programme by 32 weeks gestation. The primary outcomes are the number of new onsets of MDE, measured by using WHO Composite International Diagnostic Interview 3.0 at 32 weeks gestation and 3 months post partum. Survival analysis will be conducted to test for the effectiveness of the intervention on the time to the onset of MDE.Ethics and disseminationThe study plan has been approved by the Research Ethics Review Board of the Graduate School of Medicine/Faculty of Medicine, the University of Tokyo (2019150NI). If the intervention programmes are found to produce a significant positive effect in this RCT, these programmes can be made available for all users of the app in the future.Trial registration numberUMIN000038190; Pre-results.

scholarly journals Cognitive–behavioural therapy for anxiety in dementia: pilot randomised controlled trial

2015 ◽  
Vol 206 (6) ◽  
pp. 509-516 ◽  
Author(s):  
Aimee Spector ◽  
Georgina Charlesworth ◽  
Michael King ◽  
Miles Lattimer ◽  
Susan Sadek ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Behavioural Therapy ◽  
Treatment As Usual ◽  
Pilot Randomised Controlled Trial ◽  
Cognitive Behavioural ◽  
Randomised Controlled ◽  
Effective Treatments

BackgroundAnxiety is common and problematic in dementia, yet there is a lack of effective treatments.AimsTo develop a cognitive–behavioural therapy (CBT) manual for anxiety in dementia and determine its feasibility through a randomised controlled trial.MethodA ten-session CBT manual was developed. Participants with dementia and anxiety (and their carers) were randomly allocated to CBT plus treatment as usual (TAU) (n= 25) or TAU (n= 25). Outcome and cost measures were administered at baseline, 15 weeks and 6 months.ResultsAt 15 weeks, there was an adjusted difference in anxiety (using the Rating Anxiety in Dementia scale) of (–3.10, 95% CI −6.55 to 0.34) for CBT compared with TAU, which just fell short of statistical significance. There were significant improvements in depression at 15 weeks after adjustment (–5.37, 95% CI −9.50 to −1.25). Improvements remained significant at 6 months. CBT was cost neutral.ConclusionsCBT was feasible (in terms of recruitment, acceptability and attrition) and effective. A fully powered RCT is now required.

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