scholarly journals Low-Intensity Guided Help Through Mindfulness (LIGHTMIND): study protocol for a randomised controlled trial comparing supported mindfulness-based cognitive therapy self-help to supported cognitive behavioural therapy self-help for adults experiencing depression

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Clara Strauss ◽  
Amy Arbon ◽  
Michael Barkham ◽  
Sarah Byford ◽  
Rebecca Crane ◽  
...  
2019 ◽  
Vol 23 (68) ◽  
pp. 1-94 ◽  
Author(s):  
Ailsa Russell ◽  
Daisy Gaunt ◽  
Kate Cooper ◽  
Jeremy Horwood ◽  
Stephen Barton ◽  
...  

Background Co-occurring depression frequently occurs in autism. Evidence-based psychological interventions have been successfully adapted to treat co-occurring anxiety, but there is little evidence about the usefulness of adapted cognitive–behavioural therapy for depression. To the authors’ knowledge, to date there have been no randomised trials investigating the usefulness of low-intensity cognitive–behavioural therapy for depression in autism. Objectives The objectives of the study were to (1) develop a low-intensity psychological intervention for depression adapted for autism, (2) assess the feasibility and patient and therapist acceptability of the intervention, (3) estimate the rates of recruitment and retention for a full-scale randomised controlled trial and (4) identify an appropriate measure of depression to be used in a full-scale randomised controlled trial. Design The study comprised a randomised controlled trial (n = 70) with a nested qualitative evaluation (n = 21). Seventy eligible and consenting participants were randomly allocated to guided self-help or to treatment as usual. Setting Adult autism services in two NHS regions. Participants Adults with a diagnosis of autism spectrum disorder with depression, that is, a Patient Health Questionnaire-9 items score of ≥ 10. People who had attended more than six sessions of cognitive–behavioural therapy in the previous 6 months were excluded. Interventions The low-intensity intervention (guided self-help) comprised materials for nine individual sessions, based on behavioural activation adapted for autism, facilitated by therapist guides (coaches) who were graduate-level psychologists who attended training and regular supervision. Treatment as usual was standard NHS care for depression. Main outcome measures Outcomes were measured 10, 16 and 24 weeks post randomisation using self-report and interview measures of depression, anxiety, obsessive–compulsive symptoms, social function and quality of life, and a health-care and service use questionnaire. As this was a feasibility study also designed to identify the most appropriate measure of depression, it was not possible to specify the primary outcome measure or outcome point a priori. Results The aims of the study were met in full. The guided self-help intervention was feasible and well received by participants and coaches. The majority of allocated participants attended the intervention in full. The most practical outcome point was determined to be 16 weeks. There were differential rates of attrition across the treatment groups: 86% of the guided self-help group remained in the study at 24 weeks, compared with 54% of treatment as usual group. The qualitative study suggested that guided self-help had enhanced credibility with participants at the point of randomisation. Inter-rater reliability of the interview measure of depression was less than adequate, limiting the conclusions that can be drawn from the prespecified sensitivity to change analyses. Conclusions The intervention was feasible and well received. Although this feasibility study was not a fully powered trial, it provided some evidence that the guided self-help intervention was effective in reducing depressive symptoms. A full-scale clinical effectiveness and cost-effectiveness trial of the intervention is warranted. Future work Improvements to the intervention materials as a result of qualitative interviews. Stakeholder consultation to consider future trial design, consider strategies to improve retention in a treatment as usual arm and select a self-report measure of depression to serve as the primary outcome measure. Trial registration Current Controlled Trials ISRCTN54650760. Funding This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 23, No. 68. See the NIHR Journals Library website for further project information. This study was also supported by the NIHR Biomedical Research Centre at the University Hospitals Bristol NHS Foundation Trust and the University of Bristol.


2020 ◽  
Author(s):  
Clara Strauss ◽  
Amy Arbon ◽  
Michael Barkham ◽  
Sarah Byford ◽  
Rebecca Crane ◽  
...  

Abstract Background: Depression has serious personal, family and economic consequences. It is estimated that it will cost £12.15 billion to the economy each year in England by 2026. Improving Access to Psychological Therapies (IAPT) is the National Health Service talking therapies service in England for adults experiencing anxiety or depression. Over 1 million people are referred to IAPT every year, over half experiencing depression. Where symptoms of depression are mild/moderate, people are typically offered Cognitive Behavioural Therapy (CBT) self-help supported by a psychological wellbeing practitioner (PWP). The problem is that over half of people who complete treatment for depression in IAPT remain depressed despite receiving National Institute of Health and Care Excellent (NICE) recommended treatment. Furthermore, less than half of IAPT service users complete treatment. This study seeks to investigate the effectiveness of an alternative to CBT self-help. Mindfulness-based cognitive therapy differs from CBT in focus, approach and practice and may be more effective with a higher number of treatment completions. Methods/Design: This is a definitive randomised controlled trial comparing supported mindfulness-based cognitive therapy self-help (MBCT-SH) with supported cognitive behavioural therapy self-help (CBT-SH) for adults experiencing mild/moderate depression being treated in IAPT services. Four hundred and ten participants experiencing mild/moderate depression will be recruited from IAPT services and randomised to receive either an MBCT-based self-help workbook or a CBT-based self-help workbook. Participants will be asked to complete their workbook within 16 weeks, with six support sessions with a PWP. The primary outcome is depression symptom severity upon treatment completion. Secondary outcomes are treatment completion rates and measures of generalized anxiety, wellbeing, functioning and mindfulness. An exploratory non-inferiority analysis will be conducted in the event the primary hypothesis is not supported. A semi-structured interview with participants will guide understanding of change processes.Discussion: If the findings from this randomised controlled trial demonstrate that MBCT-SH is more effective than CBT-SH for adults experiencing depression, this will provide evidence for policy makers and lead to changes to clinical practice in IAPT services, leading to greater choice of self-help treatment options and better outcomes for service users. If the exploratory non-inferiority analysis is conducted and this indicates non-inferiority of MBCT-SH in comparison to CBT-SH this will also be of interest to policy makers when seeking to increase service user choice of self-help treatment options for depression. Trial registration: Current Controlled Trial registration number ISRCTN 13495752. Registered on 31 August 2017 (www.isrctn.com/ISRCTN13495752).Protocol Version: Version 1 (18 January 2020)Date first participant randomised: 24 November 2017Trial Sponsor: Sussex Partnership NHS Foundation Trust ([email protected])


2020 ◽  
Author(s):  
Clara Strauss ◽  
Amy Arbon ◽  
Michael Barkham ◽  
Sarah Byford ◽  
Rebecca Crane ◽  
...  

Abstract Background Depression has serious personal, family and economic consequences. It is estimated that it will cost £12.15 billion to the economy each year in England by 2026. Improving Access to Psychological Therapies (IAPT) is the National Health Service talking therapies service in England for adults experiencing anxiety or depression. Over 1 million people are referred to IAPT every year, over half experiencing depression. Where symptoms of depression are mild/moderate, people are typically offered Cognitive Behavioural Therapy (CBT) self-help supported by a psychological wellbeing practitioner (PWP). The problem is that over half of people who complete treatment for depression in IAPT remain depressed despite receiving National Institute of Health and Care Excellent (NICE) recommended treatment. Furthermore, less than half of IAPT service users complete treatment. This study seeks to investigate the effectiveness of an alternative to CBT self-help. Mindfulness-based cognitive therapy differs from CBT in focus, approach and practice and may be more effective with a higher number of treatment completions. Methods/Design This is a definitive randomised controlled trial comparing supported mindfulness-based cognitive therapy self-help (MBCT-SH) with supported cognitive behavioural therapy self-help (CBT-SH) for adults experiencing mild/moderate depression being treated in IAPT services. Four hundred and ten participants experiencing mild/moderate depression will be recruited from IAPT services and randomised to receive either an MBCT-based self-help workbook or a CBT-based self-help workbook. Participants will be asked to complete their workbook within 16 weeks, with six support sessions with a PWP. The primary outcome is depression symptom severity upon treatment completion. Secondary outcomes are treatment completion rates and measures of generalized anxiety, wellbeing, functioning and mindfulness. An exploratory non-inferiority analysis will be conducted in the event the primary hypothesis is not supported. A semi-structured interview with participants will guide understanding of change processes. Discussion If the findings from this randomised controlled trial demonstrate that MBCT-SH is more effective than CBT-SH for adults experiencing depression, this will provide evidence for policy makers and lead to changes to clinical practice in IAPT services, leading to greater choice of self-help treatment options and better outcomes for service users. If the exploratory non-inferiority analysis is conducted and this indicates non-inferiority of MBCT-SH in comparison to CBT-SH this will also be of interest to policy makers when seeking to increase service user choice of self-help treatment options for depression.


PLoS ONE ◽  
2013 ◽  
Vol 8 (1) ◽  
pp. e52735 ◽  
Author(s):  
Christopher Williams ◽  
Philip Wilson ◽  
Jill Morrison ◽  
Alex McMahon ◽  
Walker Andrew ◽  
...  

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