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Open Access 01-12-2019 | Study protocol

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

Authors: Ulrich Reininghaus, Annelie Klippel, Henrietta Steinhart, Thomas Vaessen, Martine van Nierop, Wolfgang Viechtbauer, Tim Batink, Zuzana Kasanova, Evelyne van Aubel, Ruud van Winkel, Machteld Marcelis, Therese van Amelsvoort, Mark van der Gaag, Lieuwe de Haan, Inez Myin-Germeys

Published in: Trials | Issue 1/2019

Abstract

Background

Psychotic 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/design

In 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 registration

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

Available only for authorised users

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Title: Efficacy of Acceptance and Commitment Therapy in Daily Life (ACT-DL) in early psychosis: study protocol for a multi-centre randomized controlled trial
Authors: Ulrich Reininghaus
Annelie Klippel
Henrietta Steinhart
Thomas Vaessen
Martine van Nierop
Wolfgang Viechtbauer
Tim Batink
Zuzana Kasanova
Evelyne van Aubel
Ruud van Winkel
Machteld Marcelis
Therese van Amelsvoort
Mark van der Gaag
Lieuwe de Haan
Inez Myin-Germeys
Publication date: 01-12-2019
Publisher: BioMed Central
Published in: Trials / Issue 1/2019
Electronic ISSN: 1745-6215
DOI: https://doi.org/10.1186/s13063-019-3912-4

At a glance: The STEP trials

Springer Medicine

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

Abstract

Background

Methods/design

Discussion

Trial registration

At a glance: The STEP trials

Springer Medicine

Abstract

Background

Methods/design

Discussion

Trial registration

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