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ID
Source
Brief title
Health condition
Obsessive Compulsive disorders (OCD)
Sponsors and support
Intervention
Outcome measures
Primary outcome
YBOCS (every week from baseline to return-to-baseline; also at 6 months FU)
Secondary outcome
SCID-I, OCI-R, OBQ-44, BDI-II, WHOQOL-BREF (baseline, after treatment, 6 months FU);
WHOQOL-BREF (also last session EMDR);
VASs (last session of a) exploration phase, and b) EMDR);
Actual drop-out.
Background summary
Background and Objectives: A widely accepted first-line treatment for obsessive-compulsive disorder (OCD) is exposure and response prevention (ERP). However, approximately half of the patients do not respond optimally to this treatment, and about 25% of OCD patients refuse the treatment or drop-out prematurely. Hence, the development of innovative strategies for OCD is of paramount importance. Recent studies suggest that overall treatment resistance is likely associated with the intrusive images (e.g., causing illness and death) that 90% of the OCD patients experience. Eye Movement Desensitization and Reprocessing (EMDR) has established efficacy in reducing the impact of traumatic images in various disorders. Therefore, the aim is to critically evaluate the additive effect of EMDR to ERP on treatment acceptability, drop-out, and outcome.
Study objective
The aim of this study is to critically examine the effect of EMDR added to ERP on treatment acceptability and outcome in patients with OCD.
Study design
Using a multiple baseline single case series design 10 OCD patients first enter a baseline phase of 3 to 7 weeks (no-treatment control condition), followed by a 4 weeks exploration phase (attention control condition). Hereafter patients start the active treatment phase (6 sessions EMDR + 15 sessions ERP; treatment condition), followed by a 6 weeks return-to-baseline phase (no-treatment control condition). OCD severity is weekly assessed using the YBOCS (primary outcome measure) from start baseline to end of return-to-baseline phase, and at 6 months FU. Secondary outcome measures (SCID-I, OCI-R, OQ-44, BDI-II, WHOQOL-BREF) are completed at start baseline, after treatment, and after 6 months FU. Also two VASs on a) willingness to fully engage in ERP, and b) inclination to drop out during ERP are administered after the exploration phase (in which ERP is explained), and after EMDR. Finally, actual drop-out is monitored.
Intervention
There are weekly sessions. In the exploration phase 4 sessions of 45 minutes each are held for case conceptualisation and psycho-education. This is followed by the active treatment phase with a total of 21 sessions of 90 minutes each: 4 sessions exploration; 6 sessions (90 min.) EMDR; 15 sessions (90 min) Exposure and Respons Prevention (ERP)
Inclusion criteria
Patients are eligible when: a) they meet sufficient criteria for OCD, as established with the Structured Clinical Interview for DSM-IV disorders, and b) their total score on the YBOCS is over 15 (moderate to severe OCD symptoms).
Exclusion criteria
Patients are excluded when: a) they already received ERP or EMDR less than 1 year ago, or b) they suffer from psychotic disorders, substance abuse/addiction, or a severe depression (score on Beck Depression Inventory-II >30), or c) insufficient knowledge of the Dutch language, or d) mental retardation (IQ<80). The use of anti-depressants is permitted, provided that dosages are kept constant during the study, and usage has started at least 3 months before entering the trial.
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 |
|---|---|
| NTR-new | NL7426 |
| NTR-old | NTR7668 |
| Other | : 17/562 |
Summary results
Back to the future. In: HJ Oppenheim, H. Hornsveld, E. ten Broeke & A. de Jongh, Praktijkboek EMDR, Deel II. Pearson: Amsterdam