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The effectiveness of behavioral activation for persons with a psychotic disorder and negative symptoms: a multicentre randomized controlled trial


- candidate number21112
- NTR NumberNTR4989
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-dec-2014
- Secondary IDsNL47108.042.13 METC 2013.513
- Public TitleThe effectiveness of behavioral activation for persons with a psychotic disorder and negative symptoms: a multicentre randomized controlled trial
- Scientific TitleThe effectiveness of behavioral activation for persons with a psychotic disorder and negative symptoms: a multicentre randomized controlled trial
- ACRONYMBANS
- hypothesis
- Healt Condition(s) or Problem(s) studiedSchizophrenia, Psychosis, Negative symptoms, Behavioral activation
- Inclusion criteria- Primary diagnosis of schizophrenia or schizoaffective disorder (DSM-IV-TR) - Mild to severe negative symptoms negative symptoms, measured by Positive And Negative Syndrome Scale (PANSS, > 15 on Negative Syndrome Scale) - 18-65 years old - Ability to give informed consent
- Exclusion criteria- Co-morbid neurological disorder - Substance dependence (not substance abuse)
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-dec-2014
- planned closingdate1-dec-2016
- Target number of participants148
- InterventionsParticipants 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. Participants in the control group will receive 15 weekly individual sessions of befriending, carried out by a nurse.
- Primary outcomeDegree of negative symptoms
- Secondary outcome- Frontal brain activity, measured with a Near Infraredspectro Scopy - Soocial functioning - Depression - Quality of life
- TimepointsT0: baseline assessment T1: post treatment assessment (15 weeks) T2: follow-up assessment (6 months)
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIES Aaltsje Malda
- CONTACT for SCIENTIFIC QUERIES Aaltsje Malda
- Sponsor/Initiator GGZ Friesland, RijksUniversiteit Groningen
- Funding
(Source(s) of Monetary or Material Support)
RijksUniversiteit Groningen
- Publications
- Brief summaryNegative 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.
- Main changes (audit trail)
- RECORD4-dec-2014 - 21-mrt-2015


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