Evidence map›Paper›PMID 31878966›Full record

ArticleTrials2019

Efficacy of Acceptance and Commitment Therapy in Daily Life (ACT-DL) in early psychosis: study protocol for a multi-centre randomized controlled trial.

Ulrich Reininghaus, Annelie Klippel, Henrietta Steinhart, Thomas Vaessen, Martine van Nierop, Wolfgang Viechtbauer, Tim Batink, Zuzana Kasanova, Evelyne van Aubel, Ruud van Winkel and 5 more

Erratum issuedAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 19 papers.

0numbers the graph read from it
0cells of the map it votes in
19citing 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.

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

19 citing papers in PubMed.

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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors.

Ulrich ReininghausDepartment of Public Mental Health, Central Institute of Mental Health, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany. ulrich.reininghaus@zi-mannheim.de.ORCID http://orcid.org/0000-0002-9227-5436
Annelie Klippel *Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.
Henrietta Steinhart *Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.
Thomas Vaessen *Department of Psychiatry and Psychology, School for Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.
Martine van NieropDepartment of Neurosciences, Psychiatry Research Group, Center for Contextual Psychiatry, KU Leuven, Leuven, Belgium.
Wolfgang ViechtbauerDepartment of Psychiatry and Psychology, School for Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.
Tim BatinkDepartment of Psychiatry and Psychology, School for Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.
Zuzana KasanovaDepartment of Neurosciences, Psychiatry Research Group, Center for Contextual Psychiatry, KU Leuven, Leuven, Belgium.
Evelyne van AubelDepartment of Neurosciences, Psychiatry Research Group, Center for Contextual Psychiatry, KU Leuven, Leuven, Belgium.
Ruud van WinkelUniversitair Psychiatrisch Centrum KU Leuven, Kortenberg, Belgium.
Machteld MarcelisDepartment of Psychiatry and Psychology, School for Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.
Therese van AmelsvoortDepartment of Psychiatry and Psychology, School for Mental Health and Neuroscience, Maastricht University, Maastricht, The Netherlands.
Mark van der GaagDepartment of Clinical Psychology, VU Amsterdam, Amsterdam, The Netherlands.
Lieuwe de HaanDepartment of Psychiatry, University of Amstderdam, Amsterdam, The Netherlands.
Inez Myin-GermeysDepartment of Neurosciences, Psychiatry Research Group, Center for Contextual Psychiatry, KU Leuven, Leuven, Belgium.

Funding

Deutsche Forschungsgemeinschaft 389624707EPA EP-C-13-022European Research Council 309767Nederlandse Organisatie voor Wetenschappelijk Onderzoek 451-13-022
6 · The paper itself

Abstract

backgroundPsychotic experiences, social functioning and general psychopathology are important targets for early intervention in individuals with Ultra-High-Risk state (UHR) and a first-episode psychosis (FEP). Acceptance and Commitment Therapy (ACT) is a promising, next-generation Cognitive Behavioural Therapy (CBT) that aims to modify these targets, but evidence on sustainable change and its underlying mechanisms in individuals' daily lives remains limited. The aim of the INTERACT study is to investigate the efficacy of a novel ecological momentary intervention, Acceptance and Commitment Therapy in Daily Life (ACT-DL) in a multi-centre randomised controlled trial of individuals with UHR or FEP. METHODS/

designIn a multi-centre randomised controlled trial, individuals aged 16-65 years with UHR or FEP will be randomly allocated to ACT-DL in addition to treatment as usual (TAU) as the experimental condition or a control condition of TAU only, which will include - for the entire study period - access to routine mental health care and, where applicable, CBT for psychosis (CBTp). Outcomes will be assessed at baseline (i.e. before randomisation), post-intervention (i.e. after the 8-week intervention period), and 6-month and 12-month follow-ups (i.e. 6 and 12 months after completing the intervention period) by blinded assessors. The primary outcome will be distress associated with psychotic experiences, while secondary outcomes will include (momentary) psychotic experiences, social functioning and psychopathology. Process measures to assess putative mechanisms of change will include psychological flexibility, stress sensitivity and reward experiences. In addition, acceptability, treatment adherence and treatment fidelity of ACT-DL will be assessed. DISCUSSION: The current study is the first to test the efficacy of ACT-DL in individuals with UHR and FEP. If this trial demonstrates the efficacy of ACT-DL, it has the potential to significantly advance the treatment of people with UHR and FEP and, more generally, provides initial support for implementing mHealth interventions in mental health services.

trial registrationNetherlands Trial Register, ID: NTR4252. Registered on 26 September 2013.

Indexed as

Acceptance and Commitment TherapyAdolescentAdultAgedCase-Control StudiesCognitive Behavioral TherapyEarly Medical InterventionFollow-Up StudiesHumansMental Health ServicesMiddle AgedMulticenter Studies as TopicNetherlandsPsychotic DisordersRandomized Controlled Trials as TopicTreatment Adherence and Compliance

Identifiers

PMID31878966
PMCPMC6933690

What OpenQuestion holds

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Registered trials

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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.