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

2020 ◽  
Author(s):  
Clara Strauss ◽  
Amy Arbon ◽  
Michael Barkham ◽  
Sarah Byford ◽  
Rebecca Crane ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cognitive Therapy ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Treatment Options ◽  
Behavioural Therapy ◽  
Self Help ◽  
Cognitive Behavioural ◽  
Complete Treatment ◽  
Randomised Controlled

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])

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

2020 ◽  
Author(s):  
Clara Strauss ◽  
Amy Arbon ◽  
Michael Barkham ◽  
Sarah Byford ◽  
Rebecca Crane ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cognitive Therapy ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Treatment Options ◽  
Behavioural Therapy ◽  
Self Help ◽  
Cognitive Behavioural ◽  
Complete Treatment ◽  
Randomised Controlled

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.

scholarly journals Guided Self-Help Cognitive Behavioural Therapy for Depression in Primary Care: A Randomised Controlled Trial

PLoS ONE ◽  
2013 ◽  
Vol 8 (1) ◽  
pp. e52735 ◽  
Author(s):  
Christopher Williams ◽  
Philip Wilson ◽  
Jill Morrison ◽  
Alex McMahon ◽  
Walker Andrew ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomised Controlled Trial ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Self Help ◽  
Cognitive Behavioural ◽  
Randomised Controlled

scholarly journals Guided self-help for depression in autistic adults: the ADEPT feasibility RCT

2019 ◽  
Vol 23 (68) ◽  
pp. 1-94 ◽  
Author(s):  
Ailsa Russell ◽  
Daisy Gaunt ◽  
Kate Cooper ◽  
Jeremy Horwood ◽  
Stephen Barton ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Full Scale ◽  
Treatment As Usual ◽  
Low Intensity ◽  
Self Help ◽  
Cognitive Behavioural ◽  
Randomised Controlled

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.

scholarly journals Internet-delivered cognitive-behavioural therapy v. conventional guided self-help for bulimia nervosa: long-term evaluation of a randomised controlled trial

2013 ◽  
Vol 202 (2) ◽  
pp. 135-141 ◽  
Author(s):  
Gudrun Wagner ◽  
Eva Penelo ◽  
Christian Wanner ◽  
Paulina Gwinner ◽  
Marie-Louise Trofaier ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Bulimia Nervosa ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Self Help ◽  
Cognitive Behavioural ◽  
Registration Number ◽  
Randomised Controlled

BackgroundCognitive–behavioural therapy (CBT)-based guided self-help is recommended as a first step in the treatment of bulimia nervosa.AimsTo evaluate in a randomised controlled trial (Clinicaltrials.gov registration number: NCT00461071) the long-term effectiveness of internet-based guided self-help (INT-GSH) compared with conventional guided bibliotherapy (BIB-GSH) in females with bulimia nervosa.MethodA total of 155 participants were randomly assigned to INT-GSH or BIB-GSH for 7 months. Outcomes were assessed at baseline, month 4, month 7 and month 18.ResultsThe greatest improvement was reported after 4 months with a continued reduction in eating disorder symptomatology reported at month 7 and 18. After 18 months, 14.6% (n = 7/48) of the participants in the INT-GSH group and 25% (n = 7/28) in the BIB-GSH group were abstinent from binge eating and compensatory measures, 43.8% (n = 21/48) and 39.2% (n = 11/28) respectively were in remission. No differences regarding outcome between the two groups were found.ConclusionsInternet-based guided self-help for bulimia nervosa was not superior compared with bibliotherapy, the gold standard of self-help. Improvements remain stable in the long term.

scholarly journals Internet-based self-help for depression: randomised controlled trial

2005 ◽  
Vol 187 (5) ◽  
pp. 456-461 ◽  
Author(s):  
Gerhard Andersson ◽  
Jan Bergström ◽  
Fredrik Holländare ◽  
Per Carlbring ◽  
Viktor Kaldo ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Discussion Group ◽  
Behavioural Therapy ◽  
Web Based ◽  
Short Supply ◽  
Self Help ◽  
Cognitive Behavioural ◽  
Randomised Controlled

BackgroundMajor depression can be treated by means of cognitive–behavioural therapy but as skilled therapists are in short supply there is a need for self-help approaches. Many individuals with depression use the internet for discussion of symptoms and to share their experience.AimsTo investigate the effects of an internet-administered self-help programme including participation in a monitored, web-based discussion group, compared with participation in web-based discussion group only.MethodA randomised controlled trial was conducted to compare the effects of internet-based cognitive–behavioural therapy with minimal therapist contact (plus participation in a discussion group) with the effects of participation in a discussion group only.ResultsInternet-based therapy with minimal therapist contact, combined with activity in a discussion group, resulted in greater reductions of depressive symptoms compared with activity in a discussion group only (waiting-list control group). At 6 months' follow-up, improvement was maintained to a large extent.ConclusionsInternet-delivered cognitive–behavioural therapy should be pursued further as a complement or treatment alternative for mild-to-moderate depression.

scholarly journals Supported cognitive-behavioural therapy self-help versus treatment-as-usual for depressed informal caregivers of stroke survivors (CEDArS): feasibility randomised controlled trial

2020 ◽  
Vol 13 ◽  
Author(s):  
Paul Farrand ◽  
Joanne Woodford ◽  
Chelsea Coumoundouros ◽  
Frida Svedin
Keyword(s):  
Randomised Controlled Trial ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Informal Caregivers ◽  
Behavioural Therapy ◽  
Phase Iii ◽  
Stroke Survivors ◽  
Self Help ◽  
Cognitive Behavioural ◽  
Randomised Controlled

Abstract Demands placed on informal caregivers can result in an increased likelihood of experiencing common mental health difficulties that may affect their ability to undertake the caring role. Currently, however, few evidence-based interventions have been specifically developed for informal caregivers and available interventions are difficult to access. The Improving Access to Psychological Therapies (IAPT) programme aims to improve access to evidence-based psychological therapies for all groups and may therefore present an opportunity to meet informal caregiver needs. Located within the MRC Complex Intervention Framework, a Phase II feasibility randomised controlled trial (RCT) examines key methodological, procedural and clinical uncertainties associated with running a definitive Phase III RCT of an adapted written cognitive behavioural therapy (CBT) self-help intervention for informal caregivers of stroke survivors. Recruitment was low despite different recruitment strategies being adopted, highlighting significant challenges moving towards a Phase III RCT until resolved. Difficulties with study recruitment may reflect wider challenges engaging informal caregivers in psychological interventions and may have implications for IAPT services seeking to improve access for this group. Further attempts to develop a successful recruitment protocol to progress to a Phase III RCT examining effectiveness of the adapted CBT self-help intervention should be encouraged. Key learning aims After reading this article, readers should be able to: (1) Consider key feasibility issues with regard to recruitment and attrition when running a randomised controlled trial of an adapted written cognitive behavioural therapy (CBT) self-help intervention for informal caregivers of stroke survivors. (2) Understand potential barriers experienced by an informal caregiving population to accessing psychological interventions. (3) Appreciate implications for clinical practice to enhance access to IAPT services and low-intensity CBT working with an informal caregiver population.

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