The overall aim of the current study is to investigate the efficacy and clinical feasibility of a novel, accessible, transdiagnostic, ecological momentary, compassion-focused intervention for improving emotional resilience to stress (*EMOCOMPASS*)…
ID
Source
Brief title
Condition
- Other condition
- Schizophrenia and other psychotic disorders
Synonym
Health condition
angst en depressieve symptomen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Stress sensitivity, psychotic, anxiety and depressive symptoms measured with
Ecological Momentary Assessment (EMA) and other validated measures will be the
primary outcomes, which will be obtained before randomization (*baseline*), at
the end of the 3-week intervention period (*post-intervention*), and after a
4-week and 10-week follow-up period (*follow-up*). Our primary hypothesis
relates to endpoints at the end of treatment.
Secondary outcome
The secondary study parameters will be threat anticipation, appraisal of
emotions, interpersonal sensitivity, and general psychopathology, measured with
EMA and other validated measures. As the primary outcomes, secondary outcomes
will be obtained before randomization (*baseline*), at the end of the 3-week
intervention period (*post-intervention*), and after a 4-week and 10 week
follow-up period (*follow-up*).
Background summary
Most mental disorders first emerge in youth and, as such, contribute
substantially to global disease burden. Therefore, interventions that aim to
prevent mental health problems should be targeting youth. In recent years, this
has become particularly evident for psychotic disorders. There is now
increasing evidence that risk for psychotic disorder manifests already at a
developmentally earlier stage in the form of subclinical psychotic experiences,
which have been reported to be common among adolescents. Contemporary models of
psychosis have proposed several psychological mechanisms that may contribute
across different phenomenological and temporal stages to the development of
psychosis. To date, the psychological mechanism most widely studied in daily
life is elevated stress sensitivity, characterized by intense emotional
reactions to minor stressors and routine daily hassles.
Recent research further suggests that subclinical psychotic experiences often
co-occur with anxiety and depression, which may reflect a transdiagnostic
phenotype associated with a range of subsequent psychopathological outcomes.
Thus, screening for, and targeting the underlying mechanisms of, this
transdiagnostic phenotype of psychosis, anxiety and/or depression in youth is a
promising selective prevention strategy for preventing adverse outcomes later
in life.
Psychological help, however, remains difficult to access for youth and has
limited efficacy under real-world conditions, calling for novel approaches. The
recent rapid technological advances provide a unique opportunity to deliver
youth-friendly, accessible, personalized, real-time mobile health
interventions, most prominently, ecological momentary interventions.
Study objective
The overall aim of the current study is to investigate the efficacy and
clinical feasibility of a novel, accessible, transdiagnostic, ecological
momentary, compassion-focused intervention for improving emotional resilience
to stress (*EMOCOMPASS*) in an exploratory randomized controlled trial in
help-seeking youth with psychotic symptoms and/or symptoms of common mental
disorders (i.e., mood or anxiety disorders).
Study design
In an exploratory randomized controlled trial, youth aged 15-26 with psychotic,
anxiety and/or depressive symptoms referred to Virenze, Mondriaan Maastricht
and GGzE Eindhoven will be randomly allocated to the ecological momentary,
compassion-focused intervention (EMOCOMPASS) in addition to treatment as usual
(TAU) (experimental condition) or a control condition of TAU only over a study
period of 2,5 years. Data will be collected before randomization (*baseline*),
at the end of the 3-week intervention period (*post-intervention*), and after a
4-week and a 10-week follow-up period (*follow-up*).
Intervention
Participants in the experimental condition will receive the ecological
momentary, compassion-focused intervention (EMOCOMPASS),which will consist of
three face-to-face sessions (1 training session, 1 follow-up *booster* session
2 weeks later, and 1 review session at the end of the 3-week intervention
period) with a trained psychologist (supervised by an expert clinical
psychologist in compassion-focused therapy), on-demand e-mail/phone contact,
and a 3-week compassion-focused ecological momentary intervention administered
through an App on a dedicated electronic device to allow for interactive,
real-time and real-world transfer of intervention components in individuals*
daily lives.
Study burden and risks
There are no health-risks associated with participation. The total time
investment for participation during the intervention
period depends on group relatedness.
There will be four assessments of our main study parameters using
questionnaires and six-day ESM periods. These measurements will be equal for
all groups and require a time investment of approximately 14 hours in total,
divided over a period of 3,5 months. Given that all participants are expected
to benefit from participation, the burden is deemed to be justifiable.
Participants randomised in the EMOCOMPASS group will receive in addition 3
therapeutic sessions of 15 minutes to 1 hour and are expected to practice
EMOCOMPASS exercises daily under the guidance of the PsyMate.
John F. Kennedylaan 301
Heerlen 6419 XZ
NL
John F. Kennedylaan 301
Heerlen 6419 XZ
NL
Listed location countries
Age
Inclusion criteria
1. Age from 15 until 26 years
2. Score of 6 or above on the PQ, a T-score of 63 or above on the BSI, and/or a score above the cutoff on the SQ-48 (i.e., on the social phobia (>9), depression (>8), or anxiety (>11) subscale)
3. Willingness to participate in the compassion-focused ecological momentary intervention
4. Ability to give written informed consent independently
Exclusion criteria
1. Insufficient command of Dutch so that the compassioned-focused ecological momentary intervention cannot be followed and outcomes cannot be reasonably assessed in Dutch
2. Clinical diagnosis of alcohol or substance dependency, severe endocrine, cardiovascular or organic brain disease
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60031.068.16 |