Effects of a Novel, Transdiagnostic, Hybrid Ecological Momentary Intervention for Improving Resilience in Youth (EMIcompass): Protocol for an Exploratory Randomized Controlled Trial

Background Most mental disorders first emerge in youth and, in their early stages, surface as subthreshold expressions of symptoms comprising a transdiagnostic phenotype of psychosis, mania, depression, and anxiety. Elevated stress reactivity is one of the most widely studied mechanisms underlying psychotic and affective mental health problems. Thus, targeting stress reactivity in youth is a promising indicated and translational preventive strategy for adverse mental health outcomes that could develop later in life and for improving resilience. Compassion-focused interventions offer a wide range of innovative therapeutic techniques that are particularly amenable to being implemented as ecological momentary interventions (EMIs), a specific type of mobile health intervention, to enable youth to access interventions in a given moment and context in daily life. This approach may bridge the current gap in youth mental health care. Objective This study aims to investigate the clinical feasibility, candidate underlying mechanisms, and initial signals of the efficacy of a novel, transdiagnostic, hybrid EMI for improving resilience to stress in youth—EMIcompass. Methods In an exploratory randomized controlled trial, youth aged between 14 and 25 years with current distress, a broad Clinical High At-Risk Mental State, or the first episode of a severe mental disorder will be randomly allocated to the EMIcompass intervention (ie, EMI plus face-to-face training sessions) in addition to treatment as usual or a control condition of treatment as usual only. Primary (stress reactivity) and secondary candidate mechanisms (resilience, interpersonal sensitivity, threat anticipation, negative affective appraisals, and momentary physiological markers of stress reactivity), as well as primary (psychological distress) and secondary outcomes (primary psychiatric symptoms and general psychopathology), will be assessed at baseline, postintervention, and at the 4-week follow-up. Results The first enrollment was in August 2019, and as of May 2021, enrollment and randomization was completed (N=92). We expect data collection to be completed by August 2021. Conclusions This study is the first to establish feasibility, evidence on underlying mechanisms, and preliminary signals of the efficacy of a compassion-focused EMI in youth. If successful, a confirmatory randomized controlled trial will be warranted. Overall, our approach has the potential to significantly advance preventive interventions in youth mental health provision. Trial Registration German Clinical Trials Register DRKS00017265; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017265 International Registered Report Identifier (IRRID) DERR1-10.2196/27462

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Effects of a Novel, Transdiagnostic, Hybrid Ecological Momentary Intervention for Improving Resilience in Youth (EMIcompass): Protocol for an Exploratory Randomized Controlled Trial (Preprint)

10.2196/preprints.27462 ◽

2021 ◽

Author(s):

Anita Schick ◽

Isabell Paetzold ◽

Christian Rauschenberg ◽

Dusan Hirjak ◽

Tobias Banaschewski ◽

...

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Stress Reactivity ◽

Controlled Trial ◽

Youth Mental Health ◽

Preventive Strategy ◽

Treatment As Usual ◽

Randomized Controlled ◽

Underlying Mechanisms ◽

Ecological Momentary

BACKGROUND Most mental disorders first emerge in youth and, in their early stages, surface as subthreshold expressions of symptoms comprising a transdiagnostic phenotype of psychosis, mania, depression, and anxiety. Elevated stress reactivity is one of the most widely studied mechanisms underlying psychotic and affective mental health problems. Thus, targeting stress reactivity in youth is a promising indicated and translational preventive strategy for adverse mental health outcomes that could develop later in life and for improving resilience. Compassion-focused interventions offer a wide range of innovative therapeutic techniques that are particularly amenable to being implemented as ecological momentary interventions (EMIs), a specific type of mobile health intervention, to enable youth to access interventions in a given moment and context in daily life. This approach may bridge the current gap in youth mental health care. OBJECTIVE This study aims to investigate the clinical feasibility, candidate underlying mechanisms, and initial signals of the efficacy of a novel, transdiagnostic, hybrid EMI for improving resilience to stress in youth—EMIcompass. METHODS In an exploratory randomized controlled trial, youth aged between 14 and 25 years with current distress, a broad Clinical High At-Risk Mental State, or the first episode of a severe mental disorder will be randomly allocated to the EMIcompass intervention (ie, EMI plus face-to-face training sessions) in addition to treatment as usual or a control condition of treatment as usual only. Primary (stress reactivity) and secondary candidate mechanisms (resilience, interpersonal sensitivity, threat anticipation, negative affective appraisals, and momentary physiological markers of stress reactivity), as well as primary (psychological distress) and secondary outcomes (primary psychiatric symptoms and general psychopathology), will be assessed at baseline, postintervention, and at the 4-week follow-up. RESULTS The first enrollment was in August 2019, and as of May 2021, enrollment and randomization was completed (N=92). We expect data collection to be completed by August 2021. CONCLUSIONS This study is the first to establish feasibility, evidence on underlying mechanisms, and preliminary signals of the efficacy of a compassion-focused EMI in youth. If successful, a confirmatory randomized controlled trial will be warranted. Overall, our approach has the potential to significantly advance preventive interventions in youth mental health provision. CLINICALTRIAL German Clinical Trials Register DRKS00017265; https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00017265 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/27462

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The effects of a novel, accessible, transdiagnostic ecological momentary intervention for improving resilience in youth (EMIcompass): study protocol for a randomized controlled trial

10.31234/osf.io/5qhdv ◽

2020 ◽

Author(s):

Anita Schick ◽

Isabell Pätzold ◽

Christian Rauschenberg ◽

Dusan Hirjak ◽

Tobias Banaschewski ◽

...

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Stress Reactivity ◽

Controlled Trial ◽

Youth Mental Health ◽

Preventive Strategy ◽

Ecological Momentary Intervention ◽

Randomized Controlled ◽

Underlying Mechanisms ◽

Ecological Momentary

Background: Most mental disorders first emerge in youth and, in their early stages, surface as subthreshold expressions of symptoms comprising a transdiagnostic phenotype. Elevated stress reactivity is one of the most widely studied psychological mechanisms underlying psychotic and affective mental health problems. Thus, targeting stress reactivity in youth is a promising indicated and translational preventive strategy for adverse mental health outcomes later in life and for improving resilience. Compassion-focused interventions (CFIs) offer a wide range of innovative therapeutic techniques particularly amenable to being implemented as an Ecological Momentary Intervention (EMI) to enable youth to access interventions in a given moment and context in daily life. This approach may bridge a gap in current youth mental health care. The aim of this study will be to investigate the clinical feasibility, candidate underlying mechanisms and initial signals of efficacy of a novel, accessible, transdiagnostic EMI for improving resilience to stress in youth (EMIcompass).Methods/Design: In an exploratory randomized controlled trial (RCT), youth aged 14-25 with current distress, a broad Clinical High At-Risk Mental State (CHARMS) or a first episode of a severe mental disorder will be randomly allocated to the EMIcompass intervention in addition to treatment as usual (TAU) or a control condition of TAU only. Primary (stress reactivity) and secondary candidate mechanisms (resilience, interpersonal sensitivity, threat anticipation, negative affective appraisals) as well as primary (psychological distress) and secondary outcomes (primary psychiatric symptoms, general psychopathology) will be assessed at baseline, post-intervention and 4-week follow-up. Discussion: The current study is the first to establish feasibility, evidence on underlying mechanisms, and preliminary signals of efficacy of a compassion-focused EMI in youth. If successful, a confirmatory RCT will be warranted. Overall, our approach has the potential to significantly advance preventive interventions in youth mental health provision. Trial registration number: German Trial Registry (DRKS), DRKS00017265; Date of registration: 31.07.2019.

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Efficacy of a Multicomponent Intervention for Fibromyalgia Based on Pain Neuroscience Education, Exercise Therapy, Psychological Support, and Nature Exposure (NAT-FM): Study Protocol of a Randomized Controlled Trial

International Journal of Environmental Research and Public Health ◽

10.3390/ijerph17020634 ◽

2020 ◽

Vol 17 (2) ◽

pp. 634 ◽

Cited By ~ 2

Author(s):

Mayte Serrat ◽

Juan P. Sanabria-Mazo ◽

Elna García-Troiteiro ◽

Anna Fontcuberta ◽

Corel Mateo-Canedo ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Study Protocol ◽

Emotional Regulation ◽

Controlled Trial ◽

Fibromyalgia Impact Questionnaire ◽

Number Needed To Treat ◽

Treatment As Usual ◽

Randomized Controlled ◽

Activity Therapy ◽

Ecological Momentary

The study protocol of a prospective and randomized controlled trial for the assessment of the efficacy of nature activity therapy for people with Fibromyalgia (NAT-FM) is described. The primary outcome is the mean change from baseline in the Revised Fibromyalgia Impact Questionnaire (FIQR) score at post-treatment (12 weeks) and at 9 months of follow-up, and secondary outcomes are changes in the positive affect, negative affect, pain, fatigue, self-efficacy, catastrophising, and emotional regulation. A total of 160 patients with fibromyalgia will be divided into two arms: treatment-as-usual (TAU) and NAT-FM+TAU. Pre, during, post, +6, and +9 months assessments will be carried out, as well as an ecological momentary assessment (EMA) of intrasession and intersessions. Results will be subjected to a mixed group (NAT-FM+TAU vs. TAU) × phase (pre, post, +6 months, +9 months) general linear model. EMA intrasession measurements will be subjected to a 2 (pre vs. post) × 5 (type of activity) mixed-effects ANOVA. EMA between-session measurements obtained from both arms of the study will be analysed on both a time-domain and frequency-domain basis. Effect sizes and number needed to treat (NNT) will be computed. A mediation/moderation analysis will be conducted.

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Feasibility and Effectiveness of a Web-Based Positive Psychology Program for Youth Mental Health: Randomized Controlled Trial

Journal of Medical Internet Research ◽

10.2196/jmir.3176 ◽

2014 ◽

Vol 16 (6) ◽

pp. e140 ◽

Cited By ~ 55

Author(s):

Vijaya Manicavasagar ◽

Deserae Horswood ◽

Rowan Burckhardt ◽

Alistair Lum ◽

Dusan Hadzi-Pavlovic ◽

...

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Positive Psychology ◽

Controlled Trial ◽

Youth Mental Health ◽

Web Based ◽

Randomized Controlled ◽

Psychology Program

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Save the children by treating their mothers (PriVileG-M-study) - study protocol: a sequentially randomized controlled trial of individualized psychotherapy and telemedicine to reduce mental stress in pregnant women and young mothers and to improve Child’s health

BMC Psychiatry ◽

10.1186/s12888-019-2279-0 ◽

2019 ◽

Vol 19 (1) ◽

Author(s):

M. Bischoff ◽

V. Howland ◽

J. Klinger-König ◽

S. Tomczyk ◽

S. Schmidt ◽

...

Keyword(s):

Mental Health ◽

Randomized Controlled Trial ◽

Pregnant Women ◽

Health Professionals ◽

Mental Stress ◽

Controlled Trial ◽

Maternal Sensitivity ◽

Control Group ◽

Randomized Controlled ◽

Ecological Momentary

Abstract Background As early as pregnancy, maternal mental stress impinges on the child’s development and health. Thus, this may cause enhanced risk for premature birth, lowered fetal growth, and lower fetal birth weight as well as enhanced levels of the stress hormone cortisol and lowered levels of the bonding hormone oxytocin. Maternal stress further reduces maternal sensitivity for the child’s needs which impairs the mother-child-interaction and bonding. Therefore, prevention and intervention studies on mental stress are necessary, beginning prenatally and applying rigorous research methodology, such as randomized controlled trials, to ensure high validity. Methods A randomized controlled trial is used to assess the impact of psychotherapy and telemedicine on maternal mental stress and the child’s mental and physical health. Mentally stressed pregnant women are randomized to an intervention (IG) and a not intervened control group. The IG receives an individualized psychotherapy starting prenatal and lasting for 10 months. Afterwards, a second randomization is used to investigate whether the use of telemedicine can stabilize the therapeutic effects. Using ecological momentary assessments and video recordings, the transfer into daily life, maternal sensitivity and mother-child-bonding are assessed. Psycho-biologically, the synchronicity of cortisol and oxytocin levels between mother and child are assessed as well as the peptidome of the colostrum and breast milk, which are assumed to be essential for the adaptation to the extra-uterine environment. All assessments are compared to an additional control group of healthy women. Finally, the results of the study will lead to the development of a qualification measure for health professionals to detect mental stress, to treat it with low-level interventions and to refer those women with high stress levels to mental health professionals. Discussion The study aims to prevent the transgenerational transfer of psychiatric and somatic disorders from the mother to her child. The effects of the psychotherapy will be stabilized through telemedicine and long-term impacts on the child’s and mothers’ mental health are enhanced. The combination of psychotherapy, telemedicine and methodologies of ecological momentary assessment, video recording and bio banking are new in content-related and methodological manner. Trial registration German Clinical Trials Register: DRKS00017065. Registered 02 May 2019. World Health Organization, Universal Trial Number: U1111–1230-9826. Registered 01 April 2019.

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