Project 1: Efficacy of CBT

Klingberg et al.
Cognitive behavioural therapy (CBT) for positive symptoms in psychotic disorders

Background and Aims
Even with advances in pharmacological treatments for schizophrenia and other psychotic disorders there is a subgroup of patients suffering from persistent positive symptoms. Although cognitive behavioural therapy (CBT) has strong empirical support in a diverse array of psychiatric disorders, only recently research has begun to examine its efficacy in psychotic disorders. The present study is designed to investigate the question whether or not CBT contributes to the reduction of positive symptoms. This question is not only of clinical relevance for optimisation of the specialised treatment but has also conceptual implications for the understanding of psychosis.

Objektives
The major objective of this trial is to show that CBT is efficacious in reducing positive symptoms when compared with Supportive Treatment. Thus, the primary endpoint of this study is the severity of positive symptoms.

Method and Design
This study is a multicentric, prospective, single-blind, randomised clinical trial, comparing Cognitive Behavioural Therapy (CBT) and Supportive Treatment (ST) with respect to the efficacy in reducing positive symptoms of psychotic disorders (parallel group design). CBT as well as ST consists of 20 sessions altogether, 163 participants receiving CBT and 163 participants receiving ST. For the first seven weeks of treatment sessions will be held weekly. The remaining sessions will take place fortnightly. Thus, the duration of treatment for each study patient will be approximately 36 weeks (i.e. 9 months). Pharmacological interventions (e.g. antipsychotics, antidepressants, anxiolytics, mood stabilizers, anticholinergics) in both groups will be applied outside the study in accordance with the clinical requirements of each patient.

Measurement
Positive Symptoms will be assessed using the Positive and Negative Syndrome Scale (PANSS) as this psychopathological rating scale is a common standard rating used in a wide range ofoutcome studies in schizophrenia.
The PANSS-Positive Score (Sum of PANSS Items P1,P2,P3,P4,P5,P6,P7) is defined as primary endpoint. The primary endpoint will be assessed 9 months after inclusion of the participant.
As persistent positive symptoms are chronic symptoms changes occur very slowly. Therefore, long follow-up periods are required to adequately assess clinically relevant changes. This study aims at assessing a 24-months follow-up after completion of treatment.
In addition, the following secondary endpoints will be assessed: Positive symptoms as assessed by more differentiated rating scales (PSYRATS, AMDP, SUMD), negative symptoms as assessed by the PANSS using a modified negative symptom factor, depressive symptoms (CDSS), symptom self ratings (SCL 90-R), self concepts (FSKN), the social status, direct and indirect costs (CSSRI), and neuropsychological assessments of vigilance/attention, secondary verbal memory, executive functioning, and social cognition skills.


Treatment conditions:

Cognitive Behavoiral Treatment (CBT)
Cognitive behavioural therapy for the treatment of positive symptoms in psychotic disorders is based on general CBT principles. Participants are seen as active, self responsible individuals. During all phases of the treatment patients are requested to actively participate in the treatment and to take responsibility for decisions how to proceed together with the therapist. The therapeutic process is built on the cooperation between patient and therapist. Whenever necessary, the therapist modifies his intervention in order to help the patient to engage in the therapeutic process.

Treatment is built on a case formulation: Patients and therapist will engage in developing a shared definition of the major problem of the patient. This formulation has to address (explicitly or implicitly) persistent positive symptoms. A shared formulation is thought to be a necessary prerequisite for a successful treatment.

The specific problems to be addressed in CBT are delusions and hallucinations. The treatment is aimed at helping the patient cope with these symptoms. A major principle of CBT is to link behaviour, emotion and cognition in order to provide for a detailed understanding of the patient's problems.
Psychotic symptoms are understood as result of dysfunctional ways of perceiving and interpreting social situations. CBT aims at correcting the person's misperceptions, irrational beliefs and reasoning biases as well as at reducing the distress caused by symptoms and the improvement of social functioning.

Participants engage in monitoring own thoughts, feelings and behaviours. They are encouraged to test alternative ways of coping with the target symptom. Strategies for the treatment of delusions and delusional processing of hallucinations are to review the information processing (perception bias, jumping to conclusions, attributional bias, theory of mind deficit), to engage in schema work in order to modify potentially delusion related self schemata, to plan activities for reality testing which will provide evidence for or against the delusional conviction, and to help patients reduce the disruption of life and daily activities caused by the delusions. Strategies to reduce hallucinations are to improve the patients coping strategies (e.g. systematic distraction strategies), and to identify and change social or internal stimuli related with increased hallucinatory experiences.

Major stages of CBT can be described as follows:
• Engagement (strategies to foster motivation for treatment participation)
• Assessment (regarding symptoms and social problems)
• developing understanding of psychotic symptoms (normalisation and information)
• case formulation and treatment planning
• specific techniques designed to address major symptoms
• specific techniques designed to address dysfunctional beliefs
• specific techniques designed to improve social functioning

Supportive Treatment (ST)
Supportive Treatment (ST) will be used as comparison intervention in order to control for non-specific elements of therapeutic contact. Psychotherapy outcome is generally thought of as consisting of both specific and non-specific effects. Non-specific effects like emotional support, therapeutic attention, empathic listening, implementation of therapeutic optimism and others are the result of every successful therapeutic relationship In contrast, therapeutic outcome which is directly linked to well defined and specific treatment strategies is called specific effect. It is hypothesised that CBT produces specific and non-specific factors whereas ST should only result in non-specific factors.

ST does not rely on specific theories or assumptions about the causes of positive symptoms in psychotic disorders. ST will focus on the patients' experiences and daily activities. The sessions will focus on neutral topics, such as hobbies, sports, and current affairs. Therapists will engage in listening to the patient, in being empathic, in helping the patient structure the available time, discussing problems in a way friends would do.

Thus, ST is thought as an active treatment with respect to the patient-therapist relationship and with respect to therapeutic commitment (Penn et al. 2004). In the treatment of patients suffering from psychotic disorders these ingredients are viewed to be essential as it has been shown consistently that the social network of these patients is limited. To have at least one trustworthy person to talk to may be the most important ingredient in any kind of treatment.

However, with respect to specific processes related to modification of psychotic beliefs ST is not an active treatment. Strategies specifically designed to change misperceptions or reasoning biases are not part of ST. Psychotic or affective symptoms were not directly tackled in any way.
The research therapists in this study are responsible for administering both CBT and ST treatment.

Major aspects of ST will be:
• Engagement
• Assessment of social problems and interests of the patient
• Treatment planning
• focus on housing, work, leisure time, hobbies, events, as adequate.

Inclusion/Exclusion Criteria
1) Fulfilling diagnostic criteria of schizophrenia (DSM-IV 295.1, 295.2, 295.3, 295.6, 295.9), schizophreniform disorder (DSM IV, 295.4), schizoaffective disorder (DSM-IV 295.7), delusional disorder (DSM IV 297.1), confirmed by a structured clinical interview (SCID-I);
2) A score of 4 or more on the PANSS-items "Delusions" (P1) or "Hallucinations" (P3) representing a moderate or severe symptom intensity;
3) Presence of positive symptoms for at least three months with or without compliance regarding antipsychotic medication;
4) Fluency regarding the German language;
5) Age between 18 and 59;
6) Verbal IQ > 80 assessed by the "Mehrfachwahl Wortschatz Intelligenz-Test" (MWT-B);
7) No organic brain disease (other than schizophrenia) according to standard patient examination procedures;
8) No diagnosis of substance abuse or substance dependence according to DSM-IV/SCID-I as primary clinical problem implying the intention of the institution responsible for treatment to initiate a specialised treatment of substance abuse/dependence;
9) Travel time to the study centre of less than 1 hour;
10) Willingness to give informed consent.