Project 6: CBT for adolescents

Bechdolf et al.
Development and pilot evaluation of modified cognitive behavioural therapy (mCBT) for adolescents with early onset psychosis

Objectives
In the last decade cognitive behavioural therapy (CBT) approaches for patients with schizophrenia have been developed, which were especially designed to reduce severity of positive symptoms, readmission rates, treatment non-compliance and disability (e.g. Garety et al., 2001). Although CBT addresses the key problems of early onset psychosis (EOP) treatment and first evaluations of CBT in adults with schizophrenia are promising (e. g. Kuipers et al., 1998; Sensky et al., 2000; Tarrier et al., 2004 ; reviews by Pilling et al., 2002; Jones et al., 2005), no experiences with CBT in adolescents with EOP are available. Therefore, the present study is conducted to develop a modified CBT (mCBT) for adolescents with EOP, to explore its acceptance and feasibility and to provide data for a realistic estimation of achievable effect size.

Design
This pilot study is a multicenter, prospective, parallel group, randomised controlled trial. 42 patients will be recruited into the trial. All participants will receive individual optimised standard psychiatric treatment (TAU = treatment as usual). Modified behavioural cognitive therapy (mCBT) will be provided for 50 % of the patients (n =21) in addition to TAU.
mCBT is an outpatient treatment which consitsts of 20 individual sessions in nine months (four sessions in the first four weeks, followed by fortnightly sessions) and five psychoeducation sessions with parents. All sessions will be conducted by specifically trained psychotherapists on the basic of a treatment manual.


Methods and primary obejctive
The primary endpoint of the first funding period will be the positive psychotic syndrome of the PANSS (sum of items P1-P7) at T9 (post treatment assessment, 9 months after inclusion). The range of points P1-P7 is 7 to 49. PANSS has been used as reliable and valid endpoint in a large number of clinical trials. Monthly assessments during the treatment phase will closely monitor the course of symptoms and will contribute to a high validity of the last-observation-carried-forward analysis.

Inclusion/Exclusion Criteria
Inclusion criteria
1) Schizophrenia (DSM IV 295.1, 295.3, 295.6, 295.9), schizophreniform (DSM IV 295.4), schizoaffective disorder (DSM IV 295.7) or delusional disorder (DSM IV 297.1) as assessed by SCID-I Interview
2) Score of 4 or more on one of the PANSS-Items „Delusion" (P1), „Hallucinations" (P3) or „Unusual thought content" (G9)
3) Positive psychotic symptoms for four weeks or more
4) Fluently German speaking
5) Age between 14 and 20
Exclusion criteria
6) IQ < 80, measured by CFT-20
7) diagnosis of delirium, dementia, amnestic or other cognitive disorder, psychiatric disorders due to a somatic factor or related to psychotropic substances according to DSM IV; diseases of the central nervous system
8) alcohol- or drug dependence according to DSM IV
9) Travel time to the study centre of less than one hour