Cognitive Behavioural Therapy- Social Functioning In Adolescence With Recent Onset Schizophrenia

NCT03217955 | Completed

• 1 other identifier: NL46776.018.13
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

Brief Summary

Rationale: There is growing consensus that targeting negative symptoms such as social withdrawal is essential to be able to preserve social participation, thereby reducing the high yearly costs of schizophrenia. Aaron T. Beck, founder of Cognitive Behavioural Therapy (CBT), and colleagues have developed and investigated a new CBT approach, in which they target inactivity in a chronic schizophrenia population with severe negative symptoms The therapy is based on accumulating evidence that dysfunctional beliefs in conjunction with neurocognitive impairments can impede social functioning. These results suggest that CBT can be highly successful in establishing clinically meaningful improvements. However, the therapy has not yet been investigated in a recent-onset population. Objective: To evaluate the applicability and (cost-) effectiveness of a shortened, partly group based, Cognitive Behavioural Therapy focussing on social activation (CBTsa) in patients with recent onset schizophrenia. Hypotheses: 1) the investigators hypothesized that CBT focused on social activation (CBTsa) in a recent-onset population will result in a substantial reduction in severity of negative symptoms, in particular social withdrawal. 2\) The investigators expected that CBTsa would lead to an improvement in terms of Quality of Life and overall functioning. 3\) The investigators expected this intervention to result in a reduction in need for care and QALY gain as a consequence of improvement in symptoms and social functioning. Study design: Single blind randomized controlled trial with 6 month-follow up. Study population: Patients between 18 and 35 years old with negative symptoms of at least moderate severity, and who have been recently (\< 2yrs) diagnosed with schizophrenia. Intervention (if applicable): Individual and group-based CBT intervention targeting social withdrawal. Main study parameters/endpoints: Change in negative symptoms, Social functioning, and quality of life, Productivity losses.

Conditions

Psychotic Disorders

Outcome Measures

Primary Outcomes (3)

• Level of social engagement

  Level of social engagement as measured by experiences sampling method

  3 months (at study completion)

• Negative symptoms

  Negative symptoms as measured with PANSS

  3 months (at study completion)

• Negative symptoms

  Negative symptoms as measured with BNSS

  3 months (at study completion)

Secondary Outcomes (7)

• Quality of Life

  3 months (at study completion)

• Global functioning

  3 months (at study completion)

• Productivity losses

  3 months (at study completion)

• Positive and General Symptomatology

  3 months (at study completion)

• Depression

  3 months (at study completion)

Study Arms (2)

CBT-SA

EXPERIMENTAL

1. Group sessions for 4 weeks, two sessions per week, 60 minutes per session, two trainers (a CBT therapist and a CBT assistant); eight participants, and; 2. Individual sessions (crystallizing learned skills, focus on individual needs) during 6-8 weeks, one session per week, 45 minutes per session

Behavioral: CBT-SA; Behavioral: Standard Treatment

Standard Treatment

ACTIVE COMPARATOR

Participants in both study conditions will receive ST. Participants are hospitalized or attending day-treatment at the Department of Early Psychosis, Amsterdam, the psychosis department of the ABC team, Utrecht, Parnassia Den Haag and collaborating (local community) mental health centers.

Behavioral: Standard Treatment

Interventions

CBT-SA BEHAVIORAL

Info has been included in arm description

CBT-SA

Standard Treatment BEHAVIORAL

Info has been included in arm description

CBT-SA; Standard Treatment

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• recent onset schizophrenia or related disorder (start antipsychotic medication \<2 yr);
• Social withdrawal (\> 3 moderate severity on the PANSS N4; Passive/apathic social withdrawal; range 0-7);
• Aged 18-35 years;
• Fluent in Dutch
• IQ\>70;
• Able and willing to give informed consent

You may not qualify if:

• Younger than eighteen years of age;
• No mastery of the Dutch language;

Sponsors & Collaborators

• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): lead
• Arkin: collaborator
• Vroege Psychose ABC - Utrecht: collaborator
• Centrum Eerste Psychose, Utrecht, Netherlands: collaborator
• GGZ inGeest: collaborator

Related Publications (4)

• Staring AB, Ter Huurne MA, van der Gaag M. Cognitive Behavioral Therapy for negative symptoms (CBT-n) in psychotic disorders: a pilot study. J Behav Ther Exp Psychiatry. 2013 Sep;44(3):300-6. doi: 10.1016/j.jbtep.2013.01.004. Epub 2013 Feb 1.

  PMID: 23454550 BACKGROUND

• Grant PM, Huh GA, Perivoliotis D, Stolar NM, Beck AT. Randomized trial to evaluate the efficacy of cognitive therapy for low-functioning patients with schizophrenia. Arch Gen Psychiatry. 2012 Feb;69(2):121-7. doi: 10.1001/archgenpsychiatry.2011.129. Epub 2011 Oct 3.

  PMID: 21969420 BACKGROUND

• Verma S, Subramaniam M, Abdin E, Poon LY, Chong SA. Symptomatic and functional remission in patients with first-episode psychosis. Acta Psychiatr Scand. 2012 Oct;126(4):282-9. doi: 10.1111/j.1600-0447.2012.01883.x. Epub 2012 May 23.

  PMID: 22616617 BACKGROUND

• Wijnen BFM, Pos K, Velthorst E, Schirmbeck F, Chan HY, de Haan L, van der Gaag M, Evers SMAA, Smit F. Economic evaluation of brief cognitive behavioural therapy for social activation in recent-onset psychosis. PLoS One. 2018 Nov 12;13(11):e0206236. doi: 10.1371/journal.pone.0206236. eCollection 2018.

  PMID: 30419038 DERIVED

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Lieuwe de Haan, Ph.D.

  Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomisation is coordinated a staff member of the psychosis department who is not involved in the research team and not familiar with both the assessments or intervention procedure. The results of the randomization is concealed from the assessors. Every effort has been made to keep assessors blind to treatment condition, using the following strategies: research workers were not involved in the randomization process, therapists and research workers made use of different (secured) agendas, and work locations / rooms in order tot minimize the chance of potential blind breaks; patients will be frequently reminded by assessors not to talk about treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychotic Disorders

Model Details: The present study entails a single-blind two-level RCT directed at patients with recent onset schizophrenia. Participants are randomly assigned to intervention condition (Cognitive Behavioral Therapy- Social Activation (CBTsa) plus Standard Treatment (ST)), or to the control condition (ST alone). A baseline test battery is employed to examine causes of social withdrawal and interaction with treatment outcome. Follow-up assessments (repetition test battery) will take place directly after the intervention period and 6 months post-treatment.

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 14, 2017
• Study Start: May 6, 2014
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: July 14, 2017

Record last verified: 2017-07