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ID
Source
Brief title
Health condition
At-risk mental state for psychosis (ARMS) or first episode psychosis (FEP)
Sponsors and support
Intervention
Outcome measures
Primary outcome
The study’s main parameters are distress related to psychotic experiences, general and social functioning, and (sub-)clinical symptoms as measured with questionnaires and interviews.
Secondary outcome
Secondary parameters are stress-reactivity, reward-experience, and overall positive affect, as measured with the experience sampling method (ESM).
Background summary
Rationale: Despite treatment with antipsychotic medication or traditional cognitive behavioural therapy (CBT), individuals at early stages of psychotic illness - those with an at-risk mental state (ARMS) or first episode psychosis (FEP) - present with poor functioning and high levels of psychopathology. Acceptance and commitment therapy (ACT) is aimed at changing the relationship between the individual and their 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 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 daily-life (ACT-DL) of individuals at early stages of psychotic illness using a smartphone app (PsyMate®). We hypothesise that the individuals who receive the experimental treatment improve on measures of distress related to psychotic experiences, global and social functioning, psychotic experiences, and psychopahtology compared to individuals who receive a control treatment.
Study design: A multi-centre randomised controlled trial with two arms i) ACT-DL inaddition to treatment as usual (TAU) and ii) TAU only, with measurements at pre-intervention, post-intervention, and follow-up at six and 12 months post-intervention.
Study population: ARMS and FEP individuals who seek help at a clinic or institution for (sub-)clinical psychotic experiences.
Intervention: Participants in the ACT-DL group will receive one psychoeducation session followed by seven standard ACT sessions, embedded in an eight-week period during which they are trained to apply the skills learned during the sessions to their daily lives with help of the PsyMate® smartphone app. Both groups will receive TAU from the clinic or institution they are admitted to.
Main study parameters/endpoints: The study’s main parameters are distress related to psychotic experiences, global and social functioning, psychotic experiences, and psychopathology as measured using questionnaires and interviews.
Study objective
We hypothesise that ARMS and FEP individuals who receive the ACT-DL treatment will improve on measures of distress related to psychotic experiences, global and social functioning, psychotic experiences, and psychopahtology compared to individuals who receive TAU only.
Study design
pre-intervention measurement: T0
intervention measurements: T1.1-T1.8 (during eight-week intervention)
post-intervention measurement: T2
follow-up measurements: T3 (6 months), and T4 (12 months)
Intervention
Participants in the ACT-DL group will receive seven standard group ACT sessions and a psychoeducation session, embedded in an eight-week period during which they are trained to apply the skills learned during the sessions to their daily lives with help of a PsyMate® smartphone app. Both groups will receive TAU from the clinic or institution they are admitted to.
Inez Myin-Germeys
Maastricht 6200 MD
The Netherlands
+3216320953
inez.germeys@kuleuven.be
Inez Myin-Germeys
Maastricht 6200 MD
The Netherlands
+3216320953
inez.germeys@kuleuven.be
Inclusion criteria
1. Age 15-65 years
2. Mental competence
3. Sufficient command of the Dutch language to understand and follow instructions
4. PQ score >6
5. An ARMS or FEP as assessed by the CAARMS
Exclusion criteria
1. Presence of drug/alcohol dependence or abuse (based on sections K and L of the Mini International Neuropsychiatric Interview) as primary diagnosis. Exception: early remission criterion according to DSM V is met (“After full criteria for substance/alcohol use disorder were previously met, none of the criteria for substance/alcohol use disorder have been met for at least three months but for less than twelve months (with the exception that the criterion A4, "craving, or a strong desire or urge to use drug in question", may be met.”)
2. Severe endocrine, cardiovascular or brain disease
3. Diagnosis of organic psychosis
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4107 |
| NTR-old | NTR4252 |
| CCMO | NL46439.068.13 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| OMON | NL-OMON47082 |