The study is a randomized controlled trial,with
assessments at baseline (pretreatment),at 9 month
(post-treatment) and 18 month follow-up. The
standard-blind randomization was carried out by
an independent medical technology unit of the
university hospital with the help of a minimization
procedure (30) taking into account gender,chronicity
of illness (more- or less-than 5 years) and
severity of symptoms (with or without a PANSS-P
rating of 5). The randomization was applied
separately for two geographical areas (treatment
centres). In order to be included in the study
patients had to meet the following criteria:
• suffering from auditory hallucinations,sustaining
for more than 2 years with adequate
treatment;
• previous treatment with at least two antipsychotic
drugs for an adequate period;
• no abuse of psychoactive drugs or alcohol as
primary target for treatment;
• IQ above 80;
• no previous CBT-treatment for auditory hallucinations;
• a diagnosis according to DSM-IV within
the schizophrenia spectrum [schizophrenia,
Integrated treatment improves quality of life
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schizoaffective disorder and psychotic disorder
not otherwise specified (NOS)];
• written informed consent.
The recruitment and study procedures were
approved by the medical ethical board of the
University Hospital Groningen (MEC 95/07/161).
Most of the patients that were included received
some kind of community care,but some were living
in sheltered accommodations. The case managers
of the community care teams in the region were
asked to check their caseload for eligible patients
and to seek their permission to be contacted by a
researcher. Subsequently one of the researchers
(FJN or GvdW) contacted the patient and gave full
information about the study. From November
1998 till May 2000,100 patients were approached
for a screening with the schedules for clinical
assessment in neuropsychiatry (SCAN)-interview
(31) to ascertain diagnosis and other inclusion
criteria. Twenty-two subjects were not included
because of primary substance abuse,absence of
hallucinations,not being properly medicated,low
intelligence,or incoherence. All eligible patients
consented to participation at this stage. Recruitment
and treatment took place in mental health
centres in the cities of Groningen/Enschede,and
Leeuwarden.
We included 78 subjects. Two subjects were
removed from the study after randomization: one
turned out to have concealed his primary substance
abuse in the first interview,the other one was
assigned to the control condition,but erroneously
received the experimental treatment. Thus,the final
sample size was 76 patients of whom 37 were
included in the experimental condition and 39 in
the control condition. This study aims at a followup
about 9 as well as 18 months later with respect
to symptomatology,functioning and quality of life
as primary outcome. Seven patients (9%) were lost
at the 9-months follow-up (one died of natural
causes),and another six patients (8%) at the
18-month follow-up,so eventually 63 patients
(83%) completed all three waves: 84% in the
experimental condition and 82% in the control
condition. All analyses are based on these patients.
Drop-outs did not differ significantly on any of the
relevant baseline variables.