|- candidate number||15463|
|- NTR Number||NTR4252|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||26-sep-2013|
|- Secondary IDs||NL46439.068.13 METC UM/AZM|
|- Public Title||Een dagelijks-leven interventie gericht op stress en beloning bij psychose|
|- Scientific Title||A real-time and real-world intervention focusing on stress and reward in at-risk mental state for psychosis|
|- hypothesis||We hypothesise ARMS individuals who receive an experimental daily-life ACT treatment to improve on measures of clinical and general functioning, stress-reactivity and reward-experience compared to individuals who receive standard ACT treatment and those who receive a control treatment.|
|- Healt Condition(s) or Problem(s) studied||Randomized controlled trial, Psychosis, Experience sampling method, |
|- Inclusion criteria||1. Age 15-35 years |
2. Mental competence*
3. Sufficient command of the Dutch language to understand and follow instructions
4. CAPE score >12
5. An ARMS as assessed by the CAARMS
|- Exclusion criteria||1. Daily drug use (based on Composite International Diagnostic Interview (CIDI) score)|
2. Severe endocrine, cardiovascular or brain disease
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2014|
|- planned closingdate||1-mrt-2018|
|- Target number of participants||150|
|- Interventions||Participants in the daily-life ACT group will receive five standard group ACT sessions, embedded in an six-week period during which they are trained to apply the skills learned during the sessions to their daily lives with help of a PsyMate®. Participants in the standard ACT group will only receive the five ACT sessions. All three groups will receive TAU from the clinic or institution they are admitted to.|
|- Primary outcome||The study’s main parameters are (sub-)clinical symptoms and general and social functioning, as measured with questionnaires and interviews.|
|- Secondary outcome||Secondary parameters are stress-reactivity, momentary cortisol fluctuations, reward-experience, and overall positive affect, as measured with the experience sampling method (ESM).|
|- Timepoints||pre-intervention measurement: T0|
intervention measurements: T1.1-T1.8 (during 8-week intervention)
post-intervention measurement: T2
Follow-up measurements: T3 (6 months), T4 (1 year) and T5 (2 years)
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Inez Myin-Germeys |
|- CONTACT for SCIENTIFIC QUERIES|| Inez Myin-Germeys |
|- Sponsor/Initiator ||Maastricht University Medical Center (MUMC+)|
(Source(s) of Monetary or Material Support)
|European Research Council (ERC)|
|- Brief summary||Rationale: Despite attempts to prevent or delay transition to psychosis with antipsychotic medication or traditional cognitive behavioural therapy (CBT), individuals with an at-risk mental state (ARMS) present with poor functioning and high levels of general psychopathology, even in the absence of transition. Acceptance and commitment therapy (ACT; a next generation CBT) is aimed at changing the relationship between the individual and his complaints through detachment and acceptance. Clinical improvement is achieved as a result of reduced distress and impairment, rather than the other way around. As such, ACT could be a particularly interesting candidate treatment for this vulnerable group. A promising new intervention method includes integration of the treatment in the daily-lives of the individuals using mobile technology, which could substantially increase the treatment effects.
Objective: The current project aims to investigate the efficacy of a new form of treatment that integrates ACT in the daily-lives of ARMS individuals using a small digital device (PsyMate®). We hypothesise the ARMS individuals who receive the experimental treatment to improve on measures of clinical and general functioning, stress-reactivity, and reward-experience compared to individuals who receive a standard ACT treatment and those who receive a control treatment.
Study design: A multi-centre randomised controlled trial (RCT) with three arms i) daily-life ACT, ii) standard ACT, and iii) treatment as usual (TAU), with measurements at pre-intervention, post-intervention, and follow-up at six, 12, and 24 months post-intervention.
Study population: ARMS individuals who seek help at a clinic or institution for sub-clinical psychotic complaints.
Intervention: Participants in the daily-life ACT group will receive five standard group ACT sessions, embedded in an six-week period during which they are trained to apply the skills learned during the sessions to their daily lives with help of a PsyMate®. Participants in the standard ACT group will only receive the five ACT sessions. All three groups will receive TAU from the clinic or institution they are admitted to.
Main study parameters/endpoints: The study’s main parameters are (sub-)clinical symptoms and general and social functioning, as measured by questionnaires and interviews, and stress-reactivity, momentary cortisol fluctuations, reward-experience, and overall positive affect, measured with the experience sampling method (ESM).
|- Main changes (audit trail)|
|- RECORD||26-sep-2013 - 27-mrt-2014|