Evidence map›Paper›PMID 33050952›Full record

ArticleTrials2020

Adjuvant psychotherapy in early-stage bipolar disorder: study protocol for a randomized controlled trial.

Thomas J Stamm, Julia C Zwick, Grace O'Malley, Lene-Marie Sondergeld, Martin Hautzinger

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02506322 (Adjuvant Psychotherapy for Relapse Prevention in Early Adulthood), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT02506322 nacompletednot on this map

Adjuvant Psychotherapy for Relapse Prevention in Early Adulthood (< 35 yr.) of Bipolar Disorder

TypeinterventionalSponsorUniversity Hospital TuebingenRan2015 to 2020Enrolled318ConditionsBipolar DisorderArmsSEKT - Cognitive-Behavioral-Emotional, FEST - Clinical Supportive Educational
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  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

5 authors.

Thomas J StammDepartment of Clinical Psychiatry and Psychotherapy, Brandenburg Medical School Theodor Fontane, Neuruppin, Germany. thomas.stamm@mhb-fontane.de.ORCID http://orcid.org/0000-0002-8557-629X
Julia C ZwickDepartment of Psychology, Clinical Psychology and Psychotherapy, University of Tübingen, Tübingen, Germany.
Grace O'MalleyDepartment of Clinical Psychiatry and Psychotherapy, Brandenburg Medical School Theodor Fontane, Neuruppin, Germany.
Lene-Marie SondergeldDepartment of Clinical Psychiatry and Psychotherapy, Brandenburg Medical School Theodor Fontane, Neuruppin, Germany.
Martin HautzingerDepartment of Psychology, Clinical Psychology and Psychotherapy, University of Tübingen, Tübingen, Germany.

Funding

Bundesministerium für Bildung und Forschung 01EE1404C
6 · The paper itself

Abstract

backgroundBipolar disorders are serious illnesses with a chronic course and a high rate of relapse. Typically, bipolar disorders onset during adolescence or early adulthood, with patients experiencing significant personal and social costs as a consequence of their illness. Despite this, to date, there is limited (controlled) evidence regarding the effectiveness of psychotherapy during the critical stages of the disorder (e.g., early onset). Some preliminary studies suggest that targeted, tailored early interventions in particular may improve disease prognosis. The proposed study examines the effectiveness of group psychotherapy on relapse prevention, global adaptive functioning, and neuropsychological functioning in early-stage bipolar disorder.

methodsIn this multicenter randomized controlled trial (RCT), 300 patients with bipolar disorder are randomized to one of two group psychotherapies: Specific Emotional-Cognitive Therapy (SECT; intervention group) or Emotion-Focused Supportive Therapy (EFST; active control group). Each therapy comprises of a total of 48-h sessions (delivered once a month) over a period of 4 months. Assessments take place at baseline (t1); 6 months follow-up, i.e., post-intervention (t2); 12 months follow-up (t3); and 18 months follow-up (t4), whereby 18 months follow-up is the primary time point of interest. DISCUSSION: The goal of this study is to test the effects of an innovative, specific group therapy relative to an active control condition in terms of rates of relapse, global functioning, and neuropsychological functioning. Pending the outcomes of the trial, it will be possible to establish a firm evidence base for accessible group psychotherapy adjuvant to routine psychiatric care for individuals with bipolar disorder.

trial registrationUSA: ClinicalTrials.gov NCT02506322 . Registered on 19 December 2014; Germany: German Clinical Trials Register DRKS00006013 . Registered on21 May 2015.

Indexed as

Bipolar DisorderCognitive Behavioral TherapyAdolescentAdultGermanyHumansMulticenter Studies as TopicPsychotherapyRandomized Controlled Trials as TopicTreatment OutcomeBipolar disorderCBTEarly interventionGroup psychotherapyRCT

Identifiers

PMID33050952
PMCPMC7552468

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Registered trials

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.