By relating valid learning fMRI phenotypes to the earliest expression of psychopathology and response to non-pharmacological self-management treatment, the project will contribute to the new innovative field of practical neuroimaging in the earliest…
ID
Source
Brief title
Condition
- Adjustment disorders (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The neuroimaging effects, i.e. structural neuroimaging, and functional
neuroimaging analyzing BOLD signaling in brain regions of interest involved in
aversive learning, in reward learning and in anticipation of reward learning.
Secondary outcome
Reward experience, stress reactivity and salience reactivity as measured with
Experience sampling methodology.
Ancillary outcomes: changes in depression, psychosis and fear psychopathology
scores.
Background summary
Young people form over 25% of the world population, and it is during this phase
of life that mental disorders form the largest cause of *years lost because of
disability*. Self-management interventions for young people in the earliest
phase of expression of psychopathology are urgently required, but remain
underdeveloped.
Study objective
By relating valid learning fMRI phenotypes to the earliest expression of
psychopathology and response to non-pharmacological self-management treatment,
the project will contribute to the new innovative field of practical
neuroimaging in the earliest stages of psychopathology. Neuroimaging may
provide us with neural correlates indexing vulnerability for mental disorder,
some of which will be detectable already at the preclinical stages in the
general population. There is an urgent requirement for novel research
approaches helping to operationalize the earliest expression of dysfunction,
and elucidate targets for novel self-management approaches, which is what the
current project sets out to do. This knowledge is essential for understanding
the neural basis and early self-management of mental disorders across the age
range.
Study design
Three complementary randomized controlled trials (RCT*s) in three samples of
individuals with level 1b / sub-diagnostic high levels of psychopathology.
Intervention
A novel real-life self-management intervention, targeting core vulnerabilities
underlying mental disorders using experience sampling methodology (ESM) with
versus without feedback will combine (1) *detachment and acceptance* exercises
to reduce emotional reactivity to stress and (2) *behavioural activation* to
increase motivated behaviour.
• Anxiety Trial: exposure therapy in the clinical condition of phobia. The
Control condition consists of educational support treatment, or a waiting list
control group.
• Psychosis & Depression Trial: The Verum condition consists of a 5 session
ACT-training, then 6 weeks for 3 days a week of ESM assessments with signals at
random time-points to fill out questionnaires, followed by detachment and
acceptance exercises, as person-tailored and interactive feedback based on
their ESM. The Control condition consists of Discussion Groups + ESM without
exercises or feedback in addition.
Study burden and risks
Subjects will receive an interview and psychometric questionnaires for
dimensional assessment of psychopathology. Baseline assessment will include a
semi-structured interview for eligibility (Mini-D, 45 mins). Participants will
additionally receive a pre-and post intervention MADRS interview (45 minutes).
Furthermore, participants will be asked to fill in a questionnaire booklet
(fill-in time 45mins) covering several domains of psychological, social and
physical (dis)functioning. Furthermore, participating patients will be asked to
participate in pre- and post fMRI neuroimaging sessions (ca. 120 minutes,
containing neuropsychological tests assessing fear learning, reward learing and
anticipation of reward). Furthermore, participating subjects will be asked to
let us draw pre- and postintervention four bloodsamples for epigenetic
analyses. Venapuncture is optionally and has no consequences on participating
in the intervention. After inclusion in the trial all subjects will assess
using PsyMate® over a period of 15 days, their own feelings and symptoms in the
context of real life and provide information regarding these contexts (social
context, activities they are involved in, location), as well as appraisals of
the environment. After baseline, participants will be allocated to either the
verum or placebo condition. High-fear subjects will be allocated to either
therapy (i.e. exposure in vivo and modelling) lasting 4-5 hours supported by an
experienced psychiatrist and cognitive behavioural therapist in small groups
(3-5 persons) or to the comparison condition consisting of educational support
treatment. High subclinical depression or high subclinical psychosis subjects
will all receive a short 5 therapy session Acceptance and Commitment training
(ACT) as described and tested by Bach & Hayes, to learn them ACT exercises.
Participants in the experimental arm will continue to do PsyMate® assessments
over a period of 6 weeks for 3 days a week including ACT-exercises. During the
first 6 weeks of PsyMate® treatment, high-symptom subjects will also receive
feedback on how daily life activities, events and social situations relate to
momentary affective responses. Feedback will be given weekly, after each 3-day
assessment period (thus 6 feedback moments). The feedback will be given
verbally, written and graphically in clear pie charts and bar graphs, according
to a standardized protocol. Subjects allocated in the control arm will so the 6
week Psymate® assessment without the therapy exercises. After the intervention
all subjects will do a shorter psychometrical test battery again, a final 7-day
PsyMate® assessment, and a fMRI neuroimaging session, using the same
neuropsychological tasks assessing fear learning, reward learning and reward
anticipation.
The total burden of time required for subjects with no or low psychopathology
will therefore be: 15 hours.
The total burden of time required in participating therefore in the high-fear
subjects is: 20 hours (excl PsyMate-time).
The total burden of time required in participating therefore in the subclinical
depression or subclinical psychosis subjects is: 21 hours excl PsyMate-time.
The benefit of this new therapeutic intervention, extending the psychotherapy
beyond the clinical setting targeting real-world and real-time
person-environment interactions may prove to be a powerful treatment for
patients in mental disorder. ESM-based interventions are based on providing the
individual with targeted feedback from patterns of reactivity in daily life,
enabling the individual to identify and remedy dysfunctional patterns of
reactivity in response to environmental challenges. In our laboratory, several
ESM-based psychotherapies incorporating techniques from Acceptance and
Commitment Therapy and Mindfulness are being developed and several randomized
controlled trials with ESM-based psychotherapies are currently being developed.
In addition, the current project would lay the ground for evaluation of how
changes induced by ESM-based therapies are mediated by changes in fMRI
phenotypes of neural learning and salience measures (possibly providing a basis
for novel pharmacological interventions), as well as of experimental psychology
tasks of these (possibly providing the basis for novel psychological therapies).
The project will therefore contribute to the elucidation of alterations in
brain function that are predictive of psychopathology and thus may contribute
to the knowledge base required for the development of novel treatment and
preventive strategies.
Vijverdalseweg 1
Maastricht 6226NB
NL
Vijverdalseweg 1
Maastricht 6226NB
NL
Listed location countries
Age
Inclusion criteria
All subjects for the adolescent/young adult sample will be Dutch speaking and aged 16-25 years.
Inclusion criteria for high-fear subject sample is the presence of a specific phobia, diagnosed prior to the experiment using a structured psychiatric interview (Mini International Neuropsychiatric Interview, MINI).[25]
Inclusion criteria for the stage 1b high-depression and psychosis subject sample are stage 1b psychopathology of depressive and or psychotic symptomatology, which is defined as moderate but subthreshold symptoms of depression using the Montgomery-Asberg Depression Rating Scale (MADRS) with a cut-off score = 10, AND/OR subthreshold symptoms of psychosis using the Community Assessment of Psychic Experiences (CAPE) with a cut-off score = 10, with moderate neurocognitive changes and functional decline to caseness (Global Assessment of Functioning [GAF] < 70).[28] Subjects with a minor depression according to DSM-IV will be included. Depression and psychosis subjects will be included at the inclusion phase as if one sample, because of the expected high co-occurrence of above cut-off scores on the CAPE and MADRS in the same subjects.
Inclusion criteria for the the low-no psychopathology subjects are absence or below threshold severity of symptomatology, which is defined as scores below 7 on the MADRS and below 10 on the CAPE and a STAI score < 44, and GAF > 70, without a psychiatric history.
Exclusion criteria
Contra-indications for (f)MRI are use of pacemaker, metal implants, pregnancy, left-handedness or a history of claustrophobia.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL41929.068.12 |
| Other | NTR-code 14248 |
| OMON | NL-OMON24727 |