Neural and clinical changes of cognitive behavioural therapy versus talking control in patients with major depression: a study protocol for a randomised clinical trial

IntroductionWhile major depression causes substantial distress and impairment for affected individuals and society, the effectiveness of cognitive behavioural therapy (CBT) in treating the condition has been established. However, the therapeutic mechanism underlying the efficacy of CBT remains unknown. This study aimed to describe a protocol for a randomised controlled trial that will measure the CBT-induced clinical and neural changes in patients with non-psychotic major depression.Methods and analysisThe current study is a 16-week assessor-blinded, randomised, parallel-group trial with a 12-month follow-up as part of usual depression care at an outpatient clinic. Patients aged 20–69 years with major depressive disorder will be randomly assigned to receive either CBT in addition to their usual treatment or talking control in addition to their usual treatment for 16 weeks. The primary outcome is the functional changes in the brain areas that have been associated with future-oriented thinking at 16 weeks; secondary outcomes include changes in functional brain connectivity, severity and changes in the scores of objective and subjective clinical depression symptoms, proportion of responders and remitters and quality of life. The intention-to-treat analysis will be used.Ethics and disseminationAll protocols and the informed consent form are compliant with the Ethics Guideline for Clinical Research (Japanese Ministry of Health, Labour and Welfare). Ethical Review Committees at the Keio University School of Medicine have approved the study protocol (version 3, 11 September 2017). We will disseminate research findings to scientific and general audiences through national and international conference presentations as well as lay summaries to the general public, including mental health consumer and publications in international peer-reviewed psychiatry and brain imaging journals.Trial registration numberUMIN Clinical Trials Registry (UMIN000018155); Pre-results.

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Effectiveness of cognitive behavioural therapy augmentation in major depression treatment (ECAM study): study protocol for a randomised clinical trial

BMJ Open ◽

10.1136/bmjopen-2014-006359 ◽

2014 ◽

Vol 4 (10) ◽

pp. e006359 ◽

Cited By ~ 4

Author(s):

Atsuo Nakagawa ◽

Mitsuhiro Sado ◽

Dai Mitsuda ◽

Daisuke Fujisawa ◽

Toshiaki Kikuchi ◽

...

Keyword(s):

Major Depression ◽

Cognitive Behavioural Therapy ◽

Study Protocol ◽

Rating Scale ◽

Behavioural Therapy ◽

Depression Symptoms ◽

Routine Practice ◽

Depression Care ◽

Treatment As Usual ◽

Cognitive Behavioural

IntroductionMajor depression is a serious mental disorder that causes substantial distress and impairment in individuals and places an enormous burden on society. Although antidepressant treatment is the most common therapy provided in routine practice, there is little evidence to guide second-line therapy for patients who have failed to respond to antidepressants. The aim of this paper is to describe the study protocol for a randomised controlled trial that measures the clinical effectiveness of cognitive behavioural therapy (CBT) as an augmentation strategy to treat patients with non-psychotic major depression identified as suboptimal responders to usual depression care.Methods and analysisThe current study is a 16-week assessor-blinded randomised, parallel-groups superiority trial with 12-month follow-up at an outpatient clinic as part of usual depression care. Patients aged 20–65 years with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Major Depressive Disorder who have experienced at least one failed trial of antidepressants as part of usual depression care, will be randomly assigned to receive CBT plus treatment as usual, or treatment as usual alone. The primary outcome is the change in clinician-rated 17-item GRID-Hamilton Depression Rating Scale (GRID-HAMD) score at 16 weeks, and secondary outcomes include severity and change in scores of subjective depression symptoms, proportion of responders and remitters, safety and quality of life. The primary population will be the intention-to-treat patients.Ethics and disseminationAll protocols and the informed consent form comply with the Ethics Guideline for Clinical Research (Japanese Ministry of Health, Labour and Welfare). Ethics review committees at the Keio University School of Medicine and the Sakuragaoka Memorial Hospital approved the study protocol. The results of the study will be disseminated at several research conferences and as published articles in peer-reviewed journals. The study will be implemented and reported in line with the CONSORT statement.Trial registration numberUMIN Clinical Trials Registry: UMIN000001218.

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Religiously-Integrated Cognitive Behavioural Therapy for Major Depression in Chronic Medical Illness: Review of Results from a Randomized Clinical Trial

Health and Social Care Chaplaincy ◽

10.1558/hscc.v4i2.31655 ◽

2016 ◽

Vol 4 (2) ◽

pp. 237-253 ◽

Cited By ~ 1

Author(s):

Harold G Koenig ◽

Nathan A Boucher ◽

Keisha-Gaye N O’Garo ◽

Michelle Pearce

Keyword(s):

Clinical Trial ◽

Major Depression ◽

Randomized Clinical Trial ◽

Cognitive Behavioural Therapy ◽

Behavioural Therapy ◽

Medical Illness ◽

Chronic Medical Illness ◽

Cognitive Behavioural

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The STRIDE (Strategies to Increase confidence, InDependence and Energy) study: cognitive behavioural therapy-based intervention to reduce fear of falling in older fallers living in the community - study protocol for a randomised controlled trial

Trials ◽

10.1186/1745-6215-15-210 ◽

2014 ◽

Vol 15 (1) ◽

Cited By ~ 16

Author(s):

Steve W Parry ◽

Vincent Deary ◽

Tracy Finch ◽

Claire Bamford ◽

Neil Sabin ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Cognitive Behavioural Therapy ◽

Study Protocol ◽

Fear Of Falling ◽

Controlled Trial ◽

Behavioural Therapy ◽

Community Study ◽

Cognitive Behavioural ◽

Randomised Controlled

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Cost-effectiveness of selective serotonin reuptake inhibitors and routine specialist care with and without cognitive–behavioural therapy in adolescents with major depression

The British Journal of Psychiatry ◽

10.1192/bjp.bp.107.038984 ◽

2007 ◽

Vol 191 (6) ◽

pp. 521-527 ◽

Cited By ~ 53

Author(s):

Sarah Byford ◽

Barbara Barrett ◽

Chris Roberts ◽

Paul Wilkinson ◽

Bernadka Dubicka ◽

...

Keyword(s):

Cost Effectiveness ◽

Major Depression ◽

Cognitive Behavioural Therapy ◽

Serotonin Reuptake ◽

Selective Serotonin Reuptake Inhibitors ◽

Clinical Care ◽

Cost Effective ◽

Behavioural Therapy ◽

Short Term ◽

Cognitive Behavioural

BackgroundMajor depression is an important and costly problem among adolescents, yet evidence to support the provision of cost-effective treatments is lacking.AimsTo assess the short-term cost-effectiveness of combined selective serotonin reuptake inhibitors (SSRIs) and cognitive–behavioural therapy (CBT) together with clinical care compared with SSRIs and clinical care alone in adolescents with major depression.MethodPragmatic randomised controlled trial in the UK. Outcomes and costs were assessed at baseline, 12 and 28 weeks.ResultsThe trial comprised 208 adolescents, aged 11–17 years, with major or probable major depression who had not responded to a brief initial psychosocial intervention. There were no significant differences in outcome between the groups with and without CBT. Costs were higher in the group with CBT, although not significantly so (P=0.057). Cost-effectiveness analysis and exploration of the associated uncertainty suggest there is less than a 30% probability that CBT plus SSRIs is more cost-effective than SSRIs alone.ConclusionsA combination of CBT plus SSRIs is not more cost-effective in the short-term than SSRIs alone for treating adolescents with major depression in receipt of routine specialist clinical care.

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