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; Machteld Marcelis; Therese van Amelsvoort; Mark van der Gaag; Lieuwe de Haan; Inez Myin-Germeys

doi:10.1186/s13063-019-3912-4

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, Machteld Marcelis, Therese van Amelsvoort, Mark van der Gaag, Lieuwe de Haan, Inez Myin-Germeys

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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.

Original language	English
Article number	769
Number of pages	12
Journal	Trials
Volume	20
Issue number	1
DOIs	https://doi.org/10.1186/s13063-019-3912-4
Publication status	Published - 26 Dec 2019

Keywords

ULTRA-HIGH-RISK
ECOLOGICAL MOMENTARY INTERVENTIONS
EXPERIENCE SAMPLING RESEARCH
SOCIAL FUNCTIONING SCALE
MISSING OUTCOME DATA
DSM-IV
PSYCHOLOGICAL PROCESSES
PSYCHOMETRIC PROPERTIES
EMOTIONAL DYSFUNCTION
CHILDHOOD TRAUMA

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1 Erratum / corrigendum / retractions

Correction to: Efficacy of Acceptance and Commitment Therapy in Daily Life (ACT-DL) in early psychosis: study protocol for a multi-centre randomized controlled trial
Reininghaus, U., Klippel, A., Steinhart, H., Vaessen, T., van Nierop, M., Viechtbauer, W., Batink, T., Kasanova, Z., van Aubel, E., van Winkel, R., Marcelis, M., van Amelsvoort, T., van der Gaag, M., de Haan, L. & Myin-Germeys, I., 16 Aug 2021, In: Trials. 22, 1, 1 p., 538.
Research output: Contribution to journal › Erratum / corrigendum / retractions › Academic

Open Access

Cite this

Reininghaus, U., Klippel, A., Steinhart, H., Vaessen, T., van Nierop, M., Viechtbauer, W., Batink, T., Kasanova, Z., van Aubel, E., van Winkel, R., Marcelis, M., van Amelsvoort, T., van der Gaag, M., de Haan, L., & Myin-Germeys, I. (2019). Efficacy of Acceptance and Commitment Therapy in Daily Life (ACT-DL) in early psychosis: study protocol for a multi-centre randomized controlled trial. Trials, 20(1), Article 769. https://doi.org/10.1186/s13063-019-3912-4

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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",

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.",

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

note = "Publisher Copyright: {\textcopyright} 2019 The Author(s).",

year = "2019",

month = dec,

day = "26",

doi = "10.1186/s13063-019-3912-4",

language = "English",

volume = "20",

journal = "Trials",

issn = "1745-6215",

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Reininghaus, U, Klippel, A, Steinhart, H, Vaessen, T, van Nierop, M, Viechtbauer, W, Batink, T, Kasanova, Z, van Aubel, E, van Winkel, R, Marcelis, M , van Amelsvoort, T, van der Gaag, M, de Haan, L & Myin-Germeys, I 2019, 'Efficacy of Acceptance and Commitment Therapy in Daily Life (ACT-DL) in early psychosis: study protocol for a multi-centre randomized controlled trial', Trials, vol. 20, no. 1, 769. https://doi.org/10.1186/s13063-019-3912-4

TY - JOUR

T1 - Efficacy of Acceptance and Commitment Therapy in Daily Life (ACT-DL) in early psychosis

T2 - study protocol for a multi-centre randomized controlled trial

AU - Reininghaus, Ulrich

AU - Klippel, Annelie

AU - Steinhart, Henrietta

AU - Vaessen, Thomas

AU - van Nierop, Martine

AU - Viechtbauer, Wolfgang

AU - Batink, Tim

AU - Kasanova, Zuzana

AU - van Aubel, Evelyne

AU - van Winkel, Ruud

AU - Marcelis, Machteld

AU - van Amelsvoort, Therese

AU - van der Gaag, Mark

AU - de Haan, Lieuwe

AU - Myin-Germeys, Inez

PY - 2019/12/26

Y1 - 2019/12/26

N2 - 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.

AB - 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.

KW - ULTRA-HIGH-RISK

KW - ECOLOGICAL MOMENTARY INTERVENTIONS

KW - EXPERIENCE SAMPLING RESEARCH

KW - SOCIAL FUNCTIONING SCALE

KW - MISSING OUTCOME DATA

KW - DSM-IV

KW - PSYCHOLOGICAL PROCESSES

KW - PSYCHOMETRIC PROPERTIES

KW - EMOTIONAL DYSFUNCTION

KW - CHILDHOOD TRAUMA

U2 - 10.1186/s13063-019-3912-4

DO - 10.1186/s13063-019-3912-4

M3 - Article

C2 - 31878966

SN - 1745-6215

VL - 20

JO - Trials

JF - Trials

IS - 1

M1 - 769

ER -

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

Abstract

Keywords

Access to Document

Research output

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

Cite this