The overall aim of the current study is to investigate the efficacy of a novel, accessible, transdiagnostic ecological momentary intervention for improving self-esteem (*SELFIE*) and examine underlying epigenetic mechanisms in youth with prior…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
transdiagnostic study population, i.e., all youth exposed to childhood trauma)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcomes will be the level of self-esteem as measured with Ecological
Momentary Assessment using the PsyMate® App, the Rosenberg Self-Esteem Scale,
and semi-structured interviews.
Secondary outcome
Secondary outcomes will be implicit self-esteem, positive and negative
schematic beliefs of self, resilience, self-compassion, emotional well-being,
general psychopathology, functioning, and quality of life. Given that exposure
to trauma and response to treatment may be reflected at the biological level in
distinct epigenetic signatures, levels of DNA methylation in NR3C1 (i.e.
glucocorticoid receptor 1 gene) and SLCA4 (i.e. the serotonin transporter gene)
will be measured using targeted sequencing.
Background summary
The majority of mental disorders first emerge in youth and, as such, contribute
substantially to disease burden. Three quarters of adult mental disorders
emerge before the age of 25, and 50% before the age of 16. This onset phase
disrupts critical age-specific developmental, interpersonal, occupational and
educational milestones and indicates a need for close scrutiny of the complex
interplay between risk and protective factors in childhood, and the value of a
preventive intervention to improve well-being, enhance resilience and prevent
morbidity later in life. Evidence has accrued linking childhood trauma as a
major risk factor, with a range of mental disorders via pathways through
self-esteem. Therefore, targeting low self-esteem in youth exposed to childhood
trauma is a promising strategy for preventing adult mental disorder, but our
current psychological help strategies remain difficult to access and accept for
youth, calling for novel, youth-friendly approaches. The recent rapid advances
in information and communication technologies have led to the development of
mobile Health (mHealth) and, most prominently, ecological momentary
interventions (EMIs), which provide a unique opportunity to deliver
youth-friendly, personalized, real-time, guided self-help interventions.
Study objective
The overall aim of the current study is to investigate the efficacy of a novel,
accessible, transdiagnostic ecological momentary intervention for improving
self-esteem (*SELFIE*) and examine underlying epigenetic mechanisms in youth
with prior exposure to childhood trauma.
Study design
In an exploratory randomized controlled trial with two conditions, participants
will be randomly allocated to i) the SELFIE intervention in addition to
treatment as usual (TAU) (experimental condition) or ii) TAU only (control
condition). Participants who received the SELFIE-intervention will be asked by
the contact person of the site to partake in a single interview for qualitative
data collection. If so, a separate appointment will be made for the one-hour
interview.
Intervention
Participants allocated to the experimental condition will receive the
manualised SELFIE with a trained clinical psychologist within a 6-week period
after randomization in addition to TAU. The intervention will consist of three
to four sessions with a trained clinical psychologist, on-demand e-mail
contact, and the SELFIE using a guided self-help approach administered through
a smartphone-based PsyMate® App to allow for interactive, personalized,
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 five assessments of our main study parameters using
clinical interviews, questionnaires and six-day EMA periods. These measurements
will be equal for all groups and require a time investment for each participant
of approximately 18-20 hours hours for all assessments over a period of 2 years
and 2 months. Given that all participants are expected to benefit from
participation, the burden is deemed to be justifiable. Participants randomised
in the SELFIE group will receive in addition 3 therapeutic sessions of 45-60
minutes and are expected to practice SELFIE exercises using the PsyMate.
Vijverdalseweg 1
Maastricht 6226 NB
NL
Vijverdalseweg 1
Maastricht 6226 NB
NL
Listed location countries
Age
Inclusion criteria
1. Aged between 12 and 26 years
2. Score on questionnaires:
* RSES <26
* CTQ of:
- Emotional abuse * 13
- Physical abuse * 10
- Sexual abuse * 8
- Physical neglect * 10
- Emotional neglect * 15
* and/or RBQ score of:
- Reported being bullied "sometimes", "frequently" or "constantly" and/or
- Classified the experience as *quite serious* or *extremely serious"
* and/or CECA (parental conflict) score of:
- Frequency score of "regularly" or "often" and/or
- Severity score of *serious* or *violent"
3. Willingness to participate in the SELFIE intervention
4. Ability to give written informed consent (parental consent in case of <16
years)
Exclusion criteria
1. Insufficient command of Dutch so that the self-esteem EMI cannot be followed
and outcomes cannot be reasonably assessed in Dutch
2. Psychiatric symptoms due to an organic cause
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 | NL64393.068.17 |
OMON | NL-OMON28387 |