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 ◽  
...  

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.

BMJ Open ◽  
2020 ◽  
Vol 10 (2) ◽  
pp. e029735
Author(s):  
Nariko Katayama ◽  
Atsuo Nakagawa ◽  
Chika Kurata ◽  
Yohei Sasaki ◽  
Dai Mitsuda ◽  
...  

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.


2008 ◽  
Vol 20 (4) ◽  
pp. 199-206 ◽  
Author(s):  
Caroline Bell ◽  
Shamina Bhika ◽  
Richard Porter ◽  
Chris Frampton ◽  
Janet Carter ◽  
...  

Background:Previous studies have suggested that antidepressant treatment of depression may potentiate dopamine transmission through increased sensitivity of postsynaptic D2 receptors.Method:D2 receptor function was assessed in 24 patients with major depression before and 16 patients after 16 weeks of treatment with cognitive behavioural therapy (CBT) using a challenge with a selective D2 antagonist, sulpiride. Four hundred milligrams of sulpiride was administered orally on two test days and response was measured by the change in prolactin levels and changes in self-rating scale measures of mood, anxiety and pleasure.Results:The prolactin response to sulpiride (as measured by the maximum prolactin level) was significantly increased after CBT (z = −2.792, p = 0.005). Sulpiride resulted in an improvement on mood ratings on both test days, but after CBT, this effect was significantly diminished as measured by the Profile of Mood States score (t = −2.27, p = 0.038).Conclusions:After 16 weeks of CBT, we detected an enhanced prolactin response to sulpiride, suggesting an increased sensitivity of D2 receptor functioning.


2003 ◽  
Vol 182 (4) ◽  
pp. 303-311 ◽  
Author(s):  
Robert C. Durham ◽  
Moyra Guthrie ◽  
R. Victor Morton ◽  
David A. Reid ◽  
Linda R. Treliving ◽  
...  

BackgroundEvidence for the efficacy of cognitive–behavioural therapy for schizophrenia is promising but evidence for clinical effectiveness is limited.AimsTo test the effectiveness of cognitive–behavioural therapy delivered by clinical nurse specialists in routine practice.MethodOf 274 referrals, 66 were allocated randomly to 9 months of treatment as usual (TAU), cognitive–behavioural therapy plus TAU (CBT) or supportive psychotherapy plus TAU (SPT) and followed up for 3 months.ResultsTreatment effects were modest but the CBT condition gave significantly greater improvement in overall symptom severity than the SPT or TAU conditions combined (F (1,53)=4.14; P=0.05). Both the CBT and SPT conditions combined gave significantly greater improvement in severity of delusions than did the TAU condition (F (1,53)=4.83; P=0.03). Clinically significant improvements were achieved by 7/21 in the CBT condition (33%), 3/19 in the SPT condition (16%) and 2/17 in the TAU condition (12%).ConclusionsCognitive–behavioural therapy delivered by clinical nurse specialists is a helpful adjunct to routine care for some people with chronic psychosis.


2009 ◽  
Vol 40 (1) ◽  
pp. 9-24 ◽  
Author(s):  
D. Lynch ◽  
K. R. Laws ◽  
P. J. McKenna

BackgroundAlthough cognitive behavioural therapy (CBT) is claimed to be effective in schizophrenia, major depression and bipolar disorder, there have been negative findings in well-conducted studies and meta-analyses have not fully considered the potential influence of blindness or the use of control interventions.MethodWe pooled data from published trials of CBT in schizophrenia, major depression and bipolar disorder that used controls for non-specific effects of intervention. Trials of effectiveness against relapse were also pooled, including those that compared CBT to treatment as usual (TAU). Blinding was examined as a moderating factor.ResultsCBT was not effective in reducing symptoms in schizophrenia or in preventing relapse. CBT was effective in reducing symptoms in major depression, although the effect size was small, and in reducing relapse. CBT was ineffective in reducing relapse in bipolar disorder.ConclusionsCBT is no better than non-specific control interventions in the treatment of schizophrenia and does not reduce relapse rates. It is effective in major depression but the size of the effect is small in treatment studies. On present evidence CBT is not an effective treatment strategy for prevention of relapse in bipolar disorder.


2015 ◽  
Vol 207 (3) ◽  
pp. 227-234 ◽  
Author(s):  
Mats Hallgren ◽  
Martin Kraepelien ◽  
Agneta öjehagen ◽  
Nils Lindefors ◽  
Zangin Zeebari ◽  
...  

BackgroundDepression is common and tends to be recurrent. Alternative treatments are needed that are non-stigmatising, accessible and can be prescribed by general medical practitioners.AimsTo compare the effectiveness of three interventions for depression: physical exercise, internet-based cognitive–behavioural therapy (ICBT) and treatment as usual (TAU). A secondary aim was to assess changes in self-rated work capacity.MethodA total of 946 patients diagnosed with mild to moderate depression were recruited through primary healthcare centres across Sweden and randomly assigned to one of three 12-week interventions (trail registry: KCTR study ID: KT20110063). Patients were reassessed at 3 months (response rate 78%).ResultsPatients in the exercise and ICBT groups reported larger improvements in depressive symptoms compared with TAU. Work capacity improved over time in all three groups (no significant differences).ConclusionsExercise and ICBT were more effective than TAU by a general medical practitioner, and both represent promising non-stigmatising treatment alternatives for patients with mild to moderate depression.


2006 ◽  
Vol 189 (6) ◽  
pp. 527-532 ◽  
Author(s):  
Christine Barrowclough ◽  
Gillian Haddock ◽  
Fiona Lobban ◽  
Steve Jones ◽  
Ron Siddle ◽  
...  

BackgroundThe efficacy of cognitive–behavioural therapy for schizophrenia is established, but there is less evidence for a group format.AimsTo evaluate the effectiveness of group cognitive – behavioural therapy for schizophrenia.MethodIn all, 113 people with persistent positive symptoms of schizophrenia were assigned to receive group cognitive – behavioural therapy or treatment as usual. The primary outcome was positive symptom improvement on the Positive and Negative Syndrome Scales. Secondary outcome measures included symptoms, functioning, relapses, hopelessness and self-esteem.ResultsThere were no significant differences between the cognitive-behavioural therapy and treatment as usual on measures of symptoms or functioning or relapse, but group cognitive – behavioural therapy treatment resulted in reductions in feelings of hopelessness and in low self-esteem.ConclusionsAlthough group cognitive – behavioural therapy may not be the optimum treatment method for reducing hallucinations and delusions, it may have important benefits, including feeling less negative about oneself and less hopeless for the future.


2005 ◽  
Vol 186 (4) ◽  
pp. 324-330 ◽  
Author(s):  
Lucia R. Valmaggia ◽  
Mark van der Gaag ◽  
Nicholas Tarrier ◽  
Marieke Pijnenborg ◽  
Cees J. Slooff

BackgroundThere is increasing evidence that cognitive–behavioural therapy can be an effective intervention for patients experiencing drug-refractory positive symptoms of schizophrenia.AimsTo investigate the effects of cognitive–behavioural therapy on in-patients with treatment-refractory psychotic symptoms.MethodManualised therapy was compared with supportive counselling in a randomised controlled study. Both interventions were delivered by experienced psychologists over 16 sessions of treatment. Therapy fidelity was assessed by two independent raters. Participants underwent masked assessment at baseline, after treatment and at 6 months' follow-up. Main outcome measures were the Positive and Negative Syndrome Scale and the Psychotic Symptoms Rating Scale. The analysis was by intention to treat.ResultsParticipants receiving cognitive–behavioural therapy had improved with regard to auditory hallucinations and illness insight at the post-treatment assessment, but these findings were not maintained at follow-up.ConclusionsCognitive–behavioural therapy showed modest short-term benefits over supportive counselling for treatment-refractory positive symptoms of schizophrenia.


1995 ◽  
Vol 167 (5) ◽  
pp. 653-658 ◽  
Author(s):  
K. C. M. Wilson ◽  
M. Scott ◽  
M. Abou-Saleh ◽  
R. Burns ◽  
J. R. M. Copeland

BackgroundWe examine the effects of cognitive-behavioural therapy (CBT) as an adjuvant to acute physical treatment and lithium maintenance therapy in reducing depression severity over a follow-up year in elderly depressed patients.MethodThe study consists of three phases. During the acute treatment and continuation phase, 17 of 31 patients received CBT as an adjuvant to treatment as usual. During the maintenance phase of 1 year, subjects were entered into a double-blind, placebo-controlled study of low-dose lithium therapy.ResultsReceiving adjuvant CBT significantly reduced patients' scores on the Hamilton Rating Scale for Depression during the follow-up year (repeated measures analyses of variance; P = 0.007). No significant differences were found between lithium and placebo maintenance therapy.ConclusionsCBT can be adapted as an adjuvant therapy in the treatment of severely depressed elderly patients and reduces depression severity during follow-up. The prophylactic failure of long-term lithium therapy may be explained through poor compliance.


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