To examnine the effectiveness of psychological interventions and psychopharmacological interventions compared to placebo-control.
ID
Source
Brief title
Condition
- Somatic symptom and related disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are improvement in intensity of conversion symptoms
as measured with the VRMC (Moene et al. 2002), the number of conversion
symptoms as measured with the SCID I and improvement on the Clinical Global
Improvement Scale.
Secondary outcome
Secundary outcome measurues will be general psychopathology measures, f.i.
depression, anxiety and physical complaints and daily life functioning.
Background summary
Conversion disorder is a psychiatric disorder which is categorized in the
DSM-IV as a somatoform disorder. It is characterized by disturbances of the
voluntary motor or sensory functions. Although these symptoms suggest
neurological or organic causes, they lack an adequate medical explanation
(American Psychiatric Association, 1994). It is a highly impairing disorder
associated with high psychological and economical costs. To date there is no
agreement on the most effective treatment of conversion disorder. Recently,
some studies showed support for the use of antidepressants (Voon & Lang, 2005)
and psychological interventions (Moene, et al., 2002; Moene et al., 2003).
However, these studies suffer from several methodological impairments and
randomized controlled studies comparing the effectiveness of pharmacotherapy in
the treatment of conversion disorder are still lacking. In this randomized
placebo controlled study we will examine the treatment effects of psychological
interventions and citalopram in patients with conversion disorder (motor type).
Study objective
To examnine the effectiveness of psychological interventions and
psychopharmacological interventions compared to placebo-control.
Study design
The conducted research is a randomized placebo controlled study. Assessments
are conducted pre-treatment, post treatment and at 3 and 12 months follow-up.
Intervention
Participants are randomly assigned to one of three conditions. Patients in the
psychological intervention condition receive a manualized psychological
treatment, which consists of 10 weekly sessions with a therapist. Participants
in the antidepressant condition will receive citalopram (20-60mg) and will have
a two-weekly contact with the psychiatrist. For the placebo-control condition
the same protocol as the antidepressant group will be followed, only
participants will receive a placebo drug. Patients in the placebo-condition
will be offered effective treatment after the post treatment assessment.
Study burden and risks
The burden and risks of the current study are limited. Both the psychological
treatment and treatment with antidepressants is expected to be an effective
form of treatment. Compared to treatment as usual participants will invest some
extra time because of the assessments. However, the amount of extra time is
limited and spread over fifteen months.
Tarweweg 2
6534 AM Nijmegen
Nederland
Tarweweg 2
6534 AM Nijmegen
Nederland
Listed location countries
Age
Inclusion criteria
1) Current DSM-IV disorder of Conversion Disorder motor type as established with a structured diagnostic interview (MINI)
2) Age minimum of 18 years
3) Duration of symptoms at least one month
4) Exclusive neurological examinations must have taken place (e.g. MRI, EMG, etc.) in which no neurological or other somatic explanation for the symptoms is found.
Exclusion criteria
1) A neurological disorder that can fully explain the symptoms as concluded by neurological examination (MRI, EMG, etc.)*
2) Psychosis or delusion disorder (current or in the past)
3) Suicidality
4) Mental retardation
5) Substance abuse or dependence
6) Hypersensitivity to citalopram
7)The use of citalopram currently or in the past when described in an adequate dosage to treat conversion symptoms
8)The use of another SSRI (currently)
9) Reduced hepatic or renal function
10) Pregnancy and lactation
11)The use of a drug which has known negative interaction effects with citalopram:
a) MAO inhibiters (currently or recent)
b) pimozide
12) Difficulty to understand the Dutch language.
* A concomitant neurological disorder is no exclusion criteria when symptoms are not fully explained by the condition and criteria for conversion disorder are met.
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2008-004167-19-NL |
| CCMO | NL23917.091.08 |