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 Cognitiv...
| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2019-12-01
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| Series: | Trials |
| Online Access: | https://doi.org/10.1186/s13063-019-3912-4 |
| _version_ | 1819295530595909632 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Ulrich Reininghaus |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-24T04:43:41Z |
| format | Article |
| id | doaj.art-55479442b696401894d8b41ec4828af5 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-24T04:43:41Z |
| publishDate | 2019-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-55479442b696401894d8b41ec4828af52022-12-21T17:14:44ZengBMCTrials1745-62152019-12-0120111210.1186/s13063-019-3912-4Efficacy of Acceptance and Commitment Therapy in Daily Life (ACT-DL) in early psychosis: study protocol for a multi-centre randomized controlled trialUlrich Reininghaus0Annelie Klippel1Henrietta Steinhart2Thomas Vaessen3Martine van Nierop4Wolfgang Viechtbauer5Tim Batink6Zuzana Kasanova7Evelyne van Aubel8Ruud van Winkel9Machteld Marcelis10Therese van Amelsvoort11Mark van der Gaag12Lieuwe de Haan13Inez Myin-Germeys14Department of Public Mental Health, Central Institute of Mental Health, Medical Faculty Mannheim, University of HeidelbergDepartment of Psychiatry and Psychology, School for Mental Health and Neuroscience, Maastricht UniversityDepartment of Psychiatry and Psychology, School for Mental Health and Neuroscience, Maastricht UniversityDepartment of Psychiatry and Psychology, School for Mental Health and Neuroscience, Maastricht UniversityDepartment of Neurosciences, Psychiatry Research Group, Center for Contextual Psychiatry, KU LeuvenDepartment of Psychiatry and Psychology, School for Mental Health and Neuroscience, Maastricht UniversityDepartment of Psychiatry and Psychology, School for Mental Health and Neuroscience, Maastricht UniversityDepartment of Neurosciences, Psychiatry Research Group, Center for Contextual Psychiatry, KU LeuvenDepartment of Neurosciences, Psychiatry Research Group, Center for Contextual Psychiatry, KU LeuvenUniversitair Psychiatrisch Centrum KU LeuvenDepartment of Psychiatry and Psychology, School for Mental Health and Neuroscience, Maastricht UniversityDepartment of Psychiatry and Psychology, School for Mental Health and Neuroscience, Maastricht UniversityDepartment of Clinical Psychology, VU AmsterdamDepartment of Psychiatry, University of AmstderdamDepartment of Neurosciences, Psychiatry Research Group, Center for Contextual Psychiatry, KU LeuvenAbstract 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.https://doi.org/10.1186/s13063-019-3912-4 |
| spellingShingle | 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 Efficacy of Acceptance and Commitment Therapy in Daily Life (ACT-DL) in early psychosis: study protocol for a multi-centre randomized controlled trial Trials |
| title | Efficacy of Acceptance and Commitment Therapy in Daily Life (ACT-DL) in early psychosis: study protocol for a multi-centre randomized controlled trial |
| title_full | Efficacy of Acceptance and Commitment Therapy in Daily Life (ACT-DL) in early psychosis: study protocol for a multi-centre randomized controlled trial |
| title_fullStr | Efficacy of Acceptance and Commitment Therapy in Daily Life (ACT-DL) in early psychosis: study protocol for a multi-centre randomized controlled trial |
| title_full_unstemmed | Efficacy of Acceptance and Commitment Therapy in Daily Life (ACT-DL) in early psychosis: study protocol for a multi-centre randomized controlled trial |
| title_short | Efficacy of Acceptance and Commitment Therapy in Daily Life (ACT-DL) in early psychosis: study protocol for a multi-centre randomized controlled trial |
| title_sort | efficacy of acceptance and commitment therapy in daily life act dl in early psychosis study protocol for a multi centre randomized controlled trial |
| url | https://doi.org/10.1186/s13063-019-3912-4 |
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