Is the performance on pretreatment exposure, assessed by the BAT-procedure, related to symptom change after 12 weeks of specialized clinical CBT, in patients with Obsessive-Compulsive Disorder?
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Dependent variables:
1/ Difference in score on YBOCS assessed at start of treatment and after 12
weeks (continuous data);
2/ Response to treatment (>=35% OCD symptom reduction) yes/no;
3/ Remission (post-treatment YBOCS score <=8) yes/no.
Secondary outcome
Secondary outcome measures will be
- Difference in score on quality of life, assessed by the Euroquol at start of
treatment and after 12 weeks.
- Proportion of dropouts.
- Outcome at 16 and 40 weeks.
Background summary
Rationale: Obsessive-compulsive disorder (OCD) is a serious, disabling and
often chronic psychiatric disorder, with a severe impact on daily functioning
for patients and their families. (Bobes J, González MP et al. 2001; Subramaniam
M, Abdin E et al. 2012). First en second step- interventions of the
multidisciplinairy treatment guidelines can help, but 40-50% (Farris, McLean et
al. 2013; Olatunji, Davis et al. 2013) does not benefit from regular treatment.
From these patients 50-60% benefit from a specialized residential or daytime
treatment, with Cognitive Behavioral Therapy (CBT) as major component (which
we will call specialized clinical CBT in this protocol). 40-50% can be regarded
as non-responders (Stewart, Stack et al. 2005). We cannot yet identify these
patients on an individual level before we start the treatment. If we could do
so, this would save a lot of medical costs and most of all, demoralisation for
the patient and give us the possibility to think of alternatives in an earlier
stage. In CBT exposure to feared situations is a important intervention.
Research and clinical (Keijsers, Minnen et al. 2004; Simpson, Maher et al.
2011; Cammin- Nowak, Helbig-Lang et al. 2013; Glenn, Golinelli et al. 2013)
imply that patients who are not willing or able to truly come to exposure to
their feared situations during treatment, don*t benefit from the treatment. We
want to study whether the extent to which patients truly expose themselves to
their feared situations before the start of their treatment, predicts symptom
change after specialized clinical CBT.. We want to develop a Behavior Approach
Test (BAT) to measure the extent of the exposure before the start of treatment.
Study objective
Is the performance on pretreatment exposure, assessed by the BAT-procedure,
related to symptom change after 12 weeks of specialized clinical CBT, in
patients with Obsessive-Compulsive Disorder?
Study design
Study design: This study is a longitudinal hypothesis-testing study.
Study burden and risks
A participant is asked to do a pretreatment exposure-session at home under
guidance of a nurce, of a duration of about an hour. During the BAT-procedure a
participant is likely to experience distress. During the BAT heartrate is
assessed. Furthermore the participant is asked to fill in questionnaires during
the intake program, after 12 weeks of treatment and at follow up at 18 and 40
weeks after start treatment. Any possible risks are no different from the
regular treatment and are considered low.
Johanniterlaan 7
Harderwijk 3841 DS
NL
Johanniterlaan 7
Harderwijk 3841 DS
NL
Listed location countries
Age
Inclusion criteria
Referred patients (aged >18years), who meet a primary DSM-IV diagnosis of OCD, follow a specialized residential treatment with CBT as main component and give informed consent.
Exclusion criteria
Referred patients suffering from a psychotic disorder, an organic mental disorder, substance dependence, or mental retardation.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL57070.029.16 |