A RCT on the effectiveness of Behavioral Activation for Negative Symptoms (BANS) for negative symptoms in schizophrenia

Negative symptoms are highly prevalent in psychotic disorders and have been
associated with poor prognosis, lower social functioning and reduced quality of
life. Despite the attention these symptoms receive, so far no evident treatment
strategies are available. Major depression shares several features with
negative symptoms: loss of goal directed behavior and amotivation. Moreover,
anticipatory pleasure, or the ability to experience pleasure related to future
activities, is diminished in both. Behavioral activation (BA) is a
well-researched and effective treatment strategy for depression. BA focuses on
stimulating behavior, in which therapist and patient cooperatively analyse
potential rewarding activities and plan these activities subsequently. Recent
pilot data showed that behavioral activation might be effective in patients
with negative symptoms in schizophrenia.

Primary objective of the study is to investigate whether Behavioral Activation
for Negative Symptoms (BANS) improves negative symptoms. Secondary objective is
to investigate whether effects of BANS on negative symptoms is mediated or
moderated by the ability to experience anticipatory pleasure. We also want to
examine whether improvement in negative symptoms is associated with frontal
hypo-activity. Finally, we want to examine whether Behavioral Activation for
Negative Symptoms leads to better social functioning, improved quality of life
and objective increase in activities.

The study is a Randomized Controlled Trial (RCT). The intervention (BANS) will
be compared with a group receiving befriending.

Participants in the treatment condition will receive the Behavioral Activation
for Negative Symptoms (BANS). This behavioral therapy focuses on regaining
activities. Increased pleasurable activities and associated reward, is expected
to diminish apathy. The therapy will consist of 15 hours of individual therapy,
carried out by a nurse. In this therapy, the activity level of the patient
increases gradually, with activities that are in accordance with patients
personal life values. The therapy is standardized with a treatment protocol
(see Appendix C). The therapists receive a two-day training. All sessions will
be audio-taped and scored by a blind assessor to monitor therapists* adherence
to the treatment protocol. Therapists will receive weekly supervision.
Participants in the control group will receive 15 sessions of befriending.
They have the option to receive the therapy when the trial is completed

Before treatment two assessments will take place; first diagnosis will be
verified as well as inclusion criterion ( approximately 1 hour), followed by
baseline assessment of approximately 2,5 hours, which can be subdivided in two
assessments of 1,5 (questionnaires and interviews) and 1 hour (NIRS).
Post-treatment assessment (1,5 and 1 hour) and follow-up assessment (1.5 hours)
will take place directly after the intervention and six months later. Thirty
participants (15 per condition) will participate on voluntary basis in a
sub-study Experience Sampling and use a PsyMate during a total period of three
weeks (six days prior (ES1), six days after intervention (ES2), and at follow
up (ES2)) They are required to fill out a simple digital questionnaire at ten
random moments a day (total of 3*6*10= 180 measurements of 2 minutes (total:
360 minutes). Patients are asked to wear in the same period of experience three
times for a period of one week, an validated actimeter (ActiCal) for the
continuous recording of motor activity.The proposed intervention consists of 15
hours of individual behavioral activation for negative symptoms therapy, the
control condition receives an equal amount of befriending sessions.
The risks involved are minimal. No risks are expected deriving from
participating with the BANS intervention. With regard to NIRS, extensive safety
experiments have shown no (cumulative) physical or genetic harmful effects.