We aim to evaluate the efficacy and applicability of a CBT intervention for relevant persistent comorbid OCS in patients with a psychotic disorder. We hypothesize that 1) CBT of comorbid OCS will result in a clinical relevant reduction in severity…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the change in OCS severity as assessed by the
Yale-Brown-Obsessive-Compulsive Scale (YBOCS) compared to the waiting list
condition.
Secondary outcome
Secondary endpoints are changes in symptoms of psychosis and depression, social
functioning, and quality of life.
Background summary
Patients with psychotic disorders frequently report co-occurring
obsessive-compulsive symptoms (OCS), with 12% fulfilling the criteria for an
obsessive-compulsive disorder (OCD). Comorbid OCS are associated with
additional impairments, lower quality of life and a less favourable prognosis.
Although cognitive behavioural therapy (CBT) is considered treatment of first
choice in primary OCD, evidence concerning treatment options of comorbid OCS in
patients with a psychotic disorder is largely lacking and most patients remain
untreated.
Study objective
We aim to evaluate the efficacy and applicability of a CBT intervention for
relevant persistent comorbid OCS in patients with a psychotic disorder.
We hypothesize that 1) CBT of comorbid OCS will result in a clinical relevant
reduction in severity of OCS. 2) We further expect that CBT will lead to an
improvement in overall psychopathology, increased quality of life and overall
functioning
Study design
Monocentric single blind randomized controlled trial with 3 month-follow up.
Intervention
Manualized CBT will be applied over a period of 12 weeks.
Study burden and risks
Burden: Patients will undergo a 1-hour structured interview during baseline
assessment and will be asked to fill in additional questionnaires via an online
platform, which will take another 30 min. These assessments will be repeated
pre-treatment, post-treatment and at 3-month follow-up. Risks: In general, no
risks, side effects or adverse effects have been described with respect to CBT.
Benefits: In the vast majority of published cases the application of CBT for
comorbid OCS resulted in significant decrease of symptom severity and stable
remitted psychosis or even improvement of psychotic symptoms during treatment.
With this intervention we hope to diminish OCS and to thereby improve the
quality of life and functional outcome of participants.
Meibergdreef 5
Amsterdam 1105 AZ
NL
Meibergdreef 5
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
1) Obsessive-compulsive symptoms (YBOCS * 12 for at least 2 months)
2) Age range of 18 to 50 years
3) Diagnosis of a schizophrenia spectrum disorder according to the Diagnostic and Statistical Manual of Mental Disorders 5
5) Good command of the Dutch language
6) Able and willing to give written informed consent
Exclusion criteria
1) Rumination or repetitive behaviour solely related to psychotic symptoms. Positive symptoms as such are not an exclusion criterion; only when they are considered to be the primary cause of OCS-like symptoms or when they are so severe that primary treatment focused on positive symptoms is called for (more than one PANSS item of the positive subscale has a score of 5 or when one PANSS item of the positive subscale has a score of 6 or more).
2) Sever intellectual impairment, defined as an estimated IQ<70
3) Psychopathology precipitated by an organic cause
4) High suicidality, operationalized as having a high suicidality score on the M.I.N.I. with the last suicide attempt within the past six months.
5) Changes in medication (mood regulators, antipsychotics) within one months prior to the inclusion of the study
6) Not being able to travel
7) Participant is in seclusion or admitted to a closed ward.
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 | NL54107.018.15 |