ovel Self-management Techniques for Early Expression of Psychopathology: An Experimental Study Linking Neural and Mental State Reactivity Phenotypes: SMARTSCAN (Self-Management of Altered environmental Reactivity Treatment SCANning)

Completed

• Conditions: psychosis or fear; stage 1b subdiagnostic levels of depression; 10001302

• Registration Number: NL-OMON43911
• Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2018-06-30
• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 199

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The neuroimaging effects, i.e. structural neuroimaging, and functional<br /><br>neuroimaging analyzing BOLD signaling in brain regions of interest involved in<br /><br>aversive learning, in reward learning and in anticipation of reward learning. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Reward experience, stress reactivity and salience reactivity as measured with<br /><br>Experience sampling methodology.<br /><br>Ancillary outcomes: changes in depression, psychosis and fear psychopathology<br /><br>scores.</p><br>