Evidence map›Paper›PMID 32102803›Full record

ArticleBMJ open2020

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

Nariko Katayama, Atsuo Nakagawa, Chika Kurata, Yohei Sasaki, Dai Mitsuda, Shigetsugu Nakao, Sayuri Mizuno, Mire Ozawa, Yuko Nakagawa, Natsumi Ishikawa and 6 more

Open access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.6field-weighted citation impact, top 32% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Review
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 2 institutions in 1 country.

Nariko KatayamaDepartment of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.ORCID 0000-0003-2103-0287
Atsuo NakagawaDepartment of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan anakagawa@keio.jp.ORCID 0000-0002-2294-2571
Chika KurataDepartment of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.
Yohei SasakiDepartment of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.
Dai MitsudaDepartment of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.
Shigetsugu NakaoDepartment of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.
Sayuri MizunoDepartment of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.
Mire OzawaDepartment of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.
Yuko NakagawaDepartment of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.
Natsumi IshikawaDepartment of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.
Satoshi UmedaDepartment of Psychology, Keio University Faculty of Letters, Minato-ku, Japan.
Yuri TerasawaDepartment of Psychology, Keio University Faculty of Letters, Minato-ku, Japan.
Hajime TabuchiDepartment of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.
Toshiaki KikuchiDepartment of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.
Takayuki AbeAssociation of International Arts and Science, Yokohama City University School of Data Science, Yokohama, Japan.
Masaru MimuraDepartment of Neuropsychiatry, Keio University School of Medicine, Shinjuku-ku, Japan.
Keio University · JPYokohama City University · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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 ANALYSIS: The 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 DISSEMINATION: All 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 NUMBER: UMIN Clinical Trials Registry (UMIN000018155); Pre-results.

Indexed as

Cognitive Behavioral TherapyMajor Depressive DisorderPatient Education as TopicAdultDepressionFemaleHumansMaleMiddle AgedPsychiatric Status Rating ScalesQuality-Adjusted Life YearsRandomized Controlled Trials as TopicTreatment Outcomeclinical protocolscognitive behaviour therapyfunctional MRImajor depressive disorderrandomised controlled trial

Identifiers

PMID32102803
PMCPMC7045124
OpenAlexW3008427981

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.