scholarly journals Online CBT life skills programme for depression: A pilot randomised controlled trial. (Preprint)

2021 ◽  
Author(s):  
Christopher Williams ◽  
Carrie-Anne McClay ◽  
Rebeca Martinez ◽  
Jillian Morrison ◽  
Caroline Haig ◽  
...  
Keyword(s):  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Data Collection ◽  
Life Skills ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Social Consequences ◽  
Power Calculation ◽  
Retention Data ◽  
Randomised Controlled

BACKGROUND Depression is a common mental health problem with significant personal and social consequences. Studies have suggested that cognitive behavioural therapy (CBT) is an effective treatment for depression and anxiety when delivered one to one by an expert practitioner, but access to this talking therapy is often limited and waiting lists can be long. However, a range of low intensity interventions that can increase access to services are available including guided CBT self-help materials delivered via books, classes and as online packages. OBJECTIVE This project aimed to pilot a randomised controlled trial of an online CBT-based life skills course with community-based individuals experiencing depression. METHODS Individuals with symptoms of depression were recruited directly from the community via newspaper advertisements. Participants were remotely randomised to receive either immediate access (IA) or delayed access (DA) to a research version of the Living Life to the Full online CBT-based life skills package (3rd edition) with telephone support provided by non-specialist charity-based workers whilst they used the online intervention. The primary end point was at 3 months post-randomisation, at which point the delayed access group were offered the intervention. Levels of depression, anxiety, social functioning and satisfaction were assessed. RESULTS There was effective recruitment, randomisation and uptake with 19 Immediate Access (IA) and 17 Delayed Access Control (DAC) participants entering the pilot study via newspaper adverts and 13 of the 19 participants taking up the intervention. Overall (72%) were not currently under the care of their general practitioner (GP). The online package was acceptable to participants, the mean satisfaction score on the Client Satisfaction Questionnaire was 21 out of 32 (sd = 8.89). At three months, data collection was achieved from 28/36 (78%) of participants. The efficacy and retention data were used for a power calculation indicating that 72 participants in total will be required for a future substantive RCT. CONCLUSIONS The research design successfully tested the recruitment, data collection and intervention delivery. The pilot study has provided data for the required sample size for the full RCT. CLINICALTRIAL ISRCTN registry ID: ISRCTN12890709. Date assigned: 28/07/15. INTERNATIONAL REGISTERED REPORT RR2-10.1186/s13063-016-1336-y

scholarly journals Sleep Treatment Outcome Predictors (STOP) Pilot Study: a protocol for a randomised controlled trial examining predictors of change of insomnia symptoms and associated traits following cognitive–behavioural therapy for insomnia in an unselected sample

BMJ Open ◽  
2017 ◽  
Vol 7 (11) ◽  
pp. e017177 ◽  
Author(s):  
Dan Denis ◽  
Thalia C Eley ◽  
Fruhling Rijsdijk ◽  
Helena M S Zavos ◽  
Robert Keers ◽  
...  
Keyword(s):  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Cognitive Behavioural ◽  
Ethical Approval ◽  
Unselected Sample ◽  
Randomised Controlled

IntroductionCognitive–behavioural therapy for insomnia (CBT-I) leads to insomnia symptom improvements in a substantial proportion of patients. However, not everyone responds well to this treatment, and it is unclear what determines individual differences in response. The broader aim of this work is to examine to what extent response to CBT-I is due to genetic and environmental factors. The purpose of this pilot study is to examine feasibility of a design to test hypotheses focusing on an unselected sample, that is, without selection on insomnia complaints, in order to plan a larger behavioural genetics study where most participants will likely not have an insomnia disorder.Methods and analysisA two parallel-group randomised controlled trial is being conducted across three London universities. Female students (minimum age 18 years) enrolled on a psychology programme at one of the three sites were invited to participate. The target number of participants to be recruited is 240. Following baseline assessments, participants were randomly allocated to either the treatment group, where they received weekly sessions of digital CBT-I for 6 weeks, or the control group, where they completed an online puzzle each week for 6 weeks. Follow-up assessments have taken place mid-intervention (3 weeks) and end of intervention (6 weeks). A 6-month follow-up assessment will also occur. Primary outcomes will be assessed using descriptive statistics and effect size estimates for intervention effects. Secondary outcomes will be analysed using multivariate generalised estimating equation models.Ethics and disseminationThe study received ethical approval from the Research Ethics and Integrity subcommittee, Goldsmiths, University of London (application reference: EA 1305). DNA sample collection for the BioResource received ethical approval from the NRES Committee South Central—Oxford (reference number: 15/SC/0388). The results of this work shall be published in peer-reviewed journals.Trial registration numberNCT03062891; Results.

scholarly journals An external pilot study to test the feasibility of a randomised controlled trial comparing eye muscle surgery against active monitoring for childhood intermittent exotropia [X(T)]

2015 ◽  
Vol 19 (39) ◽  
pp. 1-144 ◽  
Author(s):  
Michael Clarke ◽  
Vanessa Hogan ◽  
Deborah Buck ◽  
Jing Shen ◽  
Christine Powell ◽  
...  
Keyword(s):  
Pilot Study ◽  
Randomised Controlled Trial ◽  
Data Collection ◽  
Technology Assessment ◽  
Controlled Trial ◽  
Health Technology ◽  
Evidence Base ◽  
Intermittent Exotropia ◽  
Active Monitoring ◽  
Randomised Controlled

IntroductionThe evidence base for the treatment of strabismus (squint) is poor. Our main aim is to improve this evidence base for the treatment of a common type of childhood squint {intermittent exotropia, [X(T)]}. We conducted an external pilot study in order to inform the design and conduct of a future full randomised controlled trial (RCT).MethodsChildren of between 6 months and 16 years with a recent diagnosis of X(T) were eligible for recruitment. Participants were recruited from secondary care at the ophthalmology departments at four UK NHS foundation trusts. Participants were randomised to either active monitoring or surgery. This report describes the findings of the Pilot Rehearsal Trial and Qualitative Study, and assesses the success against the objectives proposed.Recruitment and retentionThe experience gained during the Pilot Rehearsal Trial demonstrates the ability to recruit and retain sites that are willing to randomise children to both trial arms, and for parents to agree to randomisation of their children to such a study. One child declined the group allocation. A total of 231 children were screened (expected 240), of whom 138 (60%) were eligible (expected 228: 95%) and 49 (35% of eligible) children were recruited (expected 144: 63% of eligible). Strategies that improved recruitment over the course of the trial are discussed, together with the reasons why fewer children were eligible for recruitment than initially anticipated. Attrition was low. Outcome data were obtained for 47 of 49 randomised children.Trial processes and data collectionThe Trial Management processes proved effective. There were high levels of completion on all of the data collection forms. However, the feedback from the treatment orthoptists revealed that some modifications should be made to the length and frequency of the health service assessment and travel assessment questionnaires, thus reducing the burden on participants in the main trial. Modifications to the wording of the questions also need to be made.Monitoring of biasChildren who recruited to the trial were older and had more severe strabismus than those children eligible but declining participation. Strategies to account for this in a full trial are proposed.Reasons for participation or declining studyThese were identified using qualitative interviews. The principal reasons for declining entry into the study were strong preferences for and against surgical treatment.HarmsThere were no serious unexpected adverse events. Two children had overcorrection of their X(T) with reduction in binocular vision following surgery, which is in line with previous studies. No children in the active monitoring arm developed a constant strabismus although two showed some reduction in control.ConclusionsThe SamExo study has demonstrated that it is possible to recruit and retain participants to a randomised trial of surgery compared with active monitoring for X(T). For longer-term full RCTs, in order to maximise the generalisability of future studies, consideration needs to be given to planning more time and clinic appointments to assess eligibility and to allow consideration of participation; the greater use of research nurses for recruitment; and accommodating the strong preferences of some parents both for and against surgical intervention.Trial registrationCurrent Controlled Trials ISRCTN44114892.FundingThis project was funded by the NIHR Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 19, No. 39. See the NIHR Journals Library website for further project information.

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 Computerised cognitive–behavioural therapy for adults with intellectual disability: randomised controlled trial

2017 ◽  
Vol 211 (2) ◽  
pp. 95-102 ◽  
Author(s):  
Patricia Cooney ◽  
Catherine Jackman ◽  
David Coyle ◽  
Gary O'Reilly
Keyword(s):  
Intellectual Disability ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Outcome Measure ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Primary Outcome Measure ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundDespite the evidence base for computer-assisted cognitive–behavioural therapy (CBT) in the general population, it has not yet been adapted for use with adults who have an intellectual disability.AimsTo evaluate the utility of a CBT computer game for adults who have an intellectual disability.MethodA 2 × 3 (group × time) randomised controlled trial design was used. Fifty-two adults with mild to moderate intellectual disability and anxiety or depression were randomly allocated to two groups: computerised CBT (cCBT) or psychiatric treatment as usual (TAU), and assessed at pre-treatment, post-treatment and 3-month follow-up. Forty-nine participants were included in the final analysis.ResultsA significant group x time interaction was observed on the primary outcome measure of anxiety (Glasgow Anxiety Scale for people with an Intellectual Disability), favouring cCBT over TAU, but not on the primary outcome measure of depression (Glasgow Depression Scale for people with a Learning Disability). A medium effect size for anxiety symptoms was observed at post-treatment and a large effect size was observed after follow-up. Reliability of Change Indices indicated that the intervention produced clinically significant change in the cCBT group in comparison with TAU.ConclusionsAs the first application of cCBT for adults with intellectual disability, this intervention appears to be a useful treatment option to reduce anxiety symptoms in this population.

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