Randomised trial of fluoxetine and cognitive-behavioural therapy (CBT) versus fluoxetine alone in adolescents with persistent major depression (MD).

2012 ◽  
Author(s):  
Ian Goodyer
Keyword(s):  
Major Depression ◽  
Cognitive Behavioural Therapy ◽  
Randomised Trial ◽  
Behavioural Therapy ◽  
Cognitive Behavioural

scholarly journals Stepped care and cognitive–behavioural therapy for bulimia nervosa: randomised trial

2011 ◽  
Vol 198 (5) ◽  
pp. 391-397 ◽  
Author(s):  
James E. Mitchell ◽  
Stewart Agras ◽  
Scott Crow ◽  
Katherine Halmi ◽  
Christopher G. Fairburn ◽  
...  
Keyword(s):  
Bulimia Nervosa ◽  
Cognitive Behavioural Therapy ◽  
Relative Effectiveness ◽  
Randomised Trial ◽  
Behavioural Therapy ◽  
Individual Therapy ◽  
Stepped Care ◽  
Self Help ◽  
Treatment Conditions ◽  
Cognitive Behavioural

BackgroundThis study compared the best available treatment for bulimia nervosa, cognitive–behavioural therapy (CBT) augmented by fluoxetine if indicated, with a stepped-care treatment approach in order to enhance treatment effectiveness.AimsTo establish the relative effectiveness of these two approaches.MethodThis was a randomised trial conducted at four clinical centres (Clinicaltrials.gov registration number: NCT00733525). A total of 293 participants with bulimia nervosa were randomised to one of two treatment conditions: manual-based CBT delivered in an individual therapy format involving 20 sessions over 18 weeks and participants who were predicted to be non-responders after 6 sessions of CBT had fluoxetine added to treatment; or a stepped-care approach that began with supervised self-help, with the addition of fluoxetine in participants who were predicted to be non-responders after six sessions, followed by CBT for those who failed to achieve abstinence with self-help and medication management.ResultsBoth in the intent-to-treat and completer samples, there were no differences between the two treatment conditions in inducing recovery (no binge eating or purging behaviours for 28 days) or remission (no longer meeting DSM–IV criteria). At the end of 1-year follow-up, the stepped-care condition was significantly superior to CBT.ConclusionsTherapist-assisted self-help was an effective first-level treatment in the stepped-care sequence, and the full sequence was more effective than CBT suggesting that treatment is enhanced with a more individualised approach.

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

2007 ◽  
Vol 191 (6) ◽  
pp. 521-527 ◽  
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.

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

BMJ Open ◽  
2014 ◽  
Vol 4 (10) ◽  
pp. e006359 ◽  
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.

scholarly journals Treating depression with a smartphone-delivered self-help cognitive behavioural therapy for insomnia: Study protocol for a parallel group randomized controlled trial

2020 ◽  
Author(s):  
Victoria Ka-Ying Hui ◽  
Christy Yim-Fan Wong ◽  
Eric Ka-Yiu ◽  
Fiona Yan-Yee Ho ◽  
Christian S Chan
Keyword(s):  
Randomized Controlled Trial ◽  
Hong Kong ◽  
Major Depression ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Smartphone Application ◽  
Behavioural Therapy ◽  
Randomized Controlled ◽  
Self Help ◽  
Cognitive Behavioural

Abstract Background Depression is a major public health concern. Emerging research has shown that cognitive behavioural therapy for insomnia (CBT-I) is effective in treating individuals with comorbid insomnia and depression. Traditional face-to-face CBT-I encounters many obstacles related to feasibility, accessibility, and help-seeking stigma. CBT-I delivered via smartphone application could be a potential solution. This paper aims to report a protocol designed to evaluate the efficacy of a self-help smartphone-based CBT-I, compared to a waitlist control, for people with major depression and insomnia. Methods A two-arm parallel randomized controlled trial is conducted in a target sample of 285 non-suicidal Hong Kong Chinese older than 17 years of age with major depression and insomnia. Participants complete an online rapid screening, followed by a telephone diagnostic interview. Those who meet the eligibility criteria are randomized in a ratio of 1:1 to receive either CBT-I immediately or to a waitlist control condition. The CBT-I consists of six weekly modules and is delivered through a smartphone application proACT-S. This smartphone app has been pilot tested and revamped to improve user experience. An online randomized algorithm is used to perform randomization to ensure allocation concealment. The primary outcomes are changes over the measurement points in sleep quality, insomnia severity, and depression severity. The secondary outcomes include changes over the measurement points in anxiety, subjective health, treatment expectancy, and acceptability of treatment. Assessments are administered at baseline, post-intervention, and 6-week follow up. The recruitment is underway. Important adverse events, if any, are documented. Multilevel linear mixed model based on intention-to-treat principle will be conducted to examine the efficacy of the CBT-I interventions. Discussion It is expected that proACT-S is an efficacious brief sleep-focused self-help treatment for people with major depression and insomnia. If proven efficacious, due to its self-help nature, proACT-S may be applicable as a community-based early intervention, reducing the burden of the public healthcare system in Hong Kong.

scholarly journals Protocol for a feasibility randomised trial of low-intensity interventions for antenatal depression: ADAGIO trial comparing interpersonal counselling with cognitive behavioural therapy

BMJ Open ◽  
2019 ◽  
Vol 9 (8) ◽  
pp. e032649
Author(s):  
Jenny Ingram ◽  
Debbie Johnson ◽  
Sarah Johnson ◽  
Heather A O'Mahen ◽  
David Kessler ◽  
...  
Keyword(s):  
Cognitive Behavioural Therapy ◽  
Feasibility Study ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Well Being ◽  
Behavioural Therapy ◽  
Advisory Group ◽  
Low Intensity ◽  
Cognitive Behavioural ◽  
Study Results

IntroductionOne in eight women suffer from depression during pregnancy. Currently, low-intensity brief treatment based on cognitive behavioural therapy (CBT) is the only talking treatment widely available in the National Health Service (NHS) for mild and moderate depression. CBT involves identifying and changing unhelpful negative thoughts and behaviours to improve mood. Mothers in our patient advisory groups requested greater treatment choice. Interpersonal counselling (IPC) is a low-intensity version of interpersonal therapy. It may have important advantages during pregnancy over CBT because it targets relationship problems, changes in role and previous losses (eg, miscarriage). We aim to compare CBT and IPC for pregnant women with depression in a feasibility study.Methods and analysisA two-arm non-blinded randomised feasibility study of 60 women will be conducted in two UK localities. Women with depression will be identified through midwife clinics and ultrasound scanning appointments and randomised to receive six sessions of IPC or CBT. In every other way, these women will receive usual care. Women thought to have severe depression will be referred for more intensive treatment. After 12 weeks, we will measure women’s mood, well-being, relationship satisfaction and use of healthcare. Women, their partners and staff providing treatments will be interviewed to understand whether IPC is an acceptable approach and whether changes should be introduced before applying to run a larger trial.Several groups of patients with depression during pregnancy have contributed to our study design. A patient advisory group will meet and advise us during the study.Ethics and disseminationStudy results will inform the design of a larger multicentre randomised controlled trial (RCT). Our findings will be shared through public engagement events, papers and reports to organisations within the NHS. National Research Ethics Service Committee approved the study protocol.Trial registration numberISRCTN11513120.

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