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

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

Interventions

BEHAVIORAL

CBT-SA

Info has been included in arm description

BEHAVIORAL

Standard Treatment

Info has been included in arm description

Sponsors & Collaborators

• Arkin

  collaborator INDUSTRY

• Vroege Psychose ABC - Utrecht

  collaborator UNKNOWN

• Centrum Eerste Psychose, Utrecht, Netherlands

  collaborator UNKNOWN

• GGZ inGeest

  collaborator OTHER

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

  lead OTHER

Principal Investigators

• Lieuwe de Haan, Ph.D. · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-05-06

Primary Completion

2017-03-01

Completion

2017-03-01