The primary goal of the project is to investigate the effectiveness of providing personalized mental health care to patients with OCD, compared to exposure and response prevention (ERP) in the tradi-tional context of a therapist*s room. We will do…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is a difference in treatment outcome as measured with
the Yale Brown Obsessive-Compulsive Scale (YBOCS) and the World Health
Organization Quality of Life (WHOQOL-bref)
Secondary outcome
The 16-item self-report Quick Inventory of Depressive Symptomatology (QIDS)
The Positive and Negative Affect Schedule (PANAS)
The NEO Five Factor Inventory (NEO-FFI)
The State-Trait Anxiety Inventory (STAI)
General Self-Efficacy Scale (GSES)
Treatment Credibility Questionnaire (TCQ)
Technology Acceptance Model (TAM)
Experience sampling data
Log data NiceDay
The Prodromal Questionnaire (PQ-16)
The Trauma Screening Questionnaire (TSQ)
Screener for Substance Abuse
Background summary
This study aims to compare personalized exposure and ESM feedback sessions with
exposure as usual in patients with obsessive-compulsive disorder. We will do
this by applying experience sam-pling methodology (ESM), using the smartphone
application *NiceDay*, which collects both objective and subjective data in
real-time and real-place. Exposure and response prevention (ERP) will be
pro-vided in a personalized way, in the patient*s own environment where and
when support is needed. Personalized feedback based on ESM data will be used to
identify triggers and protective factors for symptom severity and to optimize
the effect of ERP.
Study objective
The primary goal of the project is to investigate the effectiveness of
providing personalized mental health care to patients with OCD, compared to
exposure and response prevention (ERP) in the tradi-tional context of a
therapist*s room. We will do so by personalizing existing evidence based
treatment (ERP) by using a smartphone app (NiceDay). We will use NiceDay as a
tool to personalize exposure exercises, moving therapy out of the therapist
room and into real time and world increasing the eco-logical validity of
interventions. A second goal is to explore if our treatment approach increases
pa-tients* self-directedness, (perceived) autonomy, motivation for and active
participation in the thera-peutic process and to investigate whether this is a
mediating factor in treatment effect.
Another goal of this study is to identify different subgroups of patients on a
network level in order to create more insight in the heterogenic group of OCD
patients. Furthermore, we are interested in how feasible the use of a
smartphone app, network models and personalized feedback is in perception of
both patients and therapists.
Study design
The design of the study will be a 20 sessions (on a weekly basis) 2 group (ERP,
ERP with Niceday and ESM feedback) randomized controlled clinical trial with
repeated measurements at baseline (T0), 5 weeks (T1), 10 weeks (T2), 15 weeks
(T3), post-treatment (T4), 6 weeks follow-up (T5), 3 months follow-up (T6) and
a year follow-up (T7).
Intervention
One group will receive exposure with response prevention as usual, the other
group will receive exposure with response prevention with smartphone
application NiceDay.
Study burden and risks
There are no risks associated with participation in the study. The only burden
could be the five as-sessments consisting of questionnaires and interviews and
the daily collection of ESM data through participant*s smartphone.
Lijnbaan 4
Den Haag 2512VA
NL
Lijnbaan 4
Den Haag 2512VA
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all
of the following criteria: A OCD diagnosis according to DSM 5 criteria, with
further psychometric profiling using non-DSM based (multidimensional) rating
scales.
Exclusion criteria
Severe comorbidity in the psychiatric field (psychosis,
addiction/intoxication), insufficient fluency in the Dutch language, medication
use that has not been stable for 3 months.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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 | NL68816.058.19 |
OMON | NL-OMON22344 |