Cognitive Behavioural Therapy- Social Functioning In Adolescence With Recent Onset Schizophrenia
Condition: Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

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.
    

Detailed description: 
      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; a subgroup that has always believed
      to be highly treatment resistant. The therapy is based on accumulating evidence that
      dysfunctional beliefs in conjunction with neurocognitive impairments can impede functioning.
      Its primary focus is to help patients overcome isolation and inactivity, thereby improve
      quality of life, rather than primarily focussing on the reduction of psychotic symptoms.
      Grant, Beck and colleagues found that patients treated with CBT not only showed more
      improvement in global functioning than patients in the Standard Treatment condition, they
      also showed a greater reduction in avolition/apathy and psychotic symptoms. These results
      suggest that CBT can be highly successful in establishing clinically meaningful improvements.

      Thus far, this intervention had only been investigated in patients with chronic schizophrenia
      although there is increasing evidence that social withdrawal is also prominent in the early
      phase of the illness. Moreover, there is growing consensus that early intervention is more
      effective in improving illness course than intervention at a later stage of the illness.

      In the present study the investigators aimed to examine whether a relatively short, partly
      group based CBT targeting negative symptoms in recent-onset schizophrenia patients results in
      reduced social withdrawal, need for care and improvement in quality of life and in overall
      functioning compared to treatment as usual.

      Primary Objective:

      The primary aim of this project was to examine a shortened (+/- 20 sessions) and partly
      group-based version of the new and promising CBT approach tested in a chronic population
      (from now: 'Cognitive Behavioural Therapy - Social Activation' (CBTsa)), for its
      applicability and effectiveness in a recent-onset population. The CBTsa has been adjusted to
      the specific needs of the young recent-onset cohort.

      Secondary Objective(s):

      A secondary aim was explore the cost-effectiveness of this new intervention (i.e. the balance
      between costs and health outcomes for CBTsa compared with treatment as usual(ST).

      Hypotheses:

        1. CBT focused on social activation (CBTsa) will result in a substantial reduction in
           severity of negative symptoms, and in particular social withdrawal

        2. The intervention will result in a reduction in need for care and QALY gain as a
           consequence of improvement in symptoms and social functioning.

        3. CBTsa will lead to an improvement in terms of Quality of Life and overall functioning
           and symptomatology.

      Study Design The present study entails a single-blind two-level RCT directed at patients with
      recent onset schizophrenia. Participants will be randomly assigned to intervention condition
      (Cognitive Behavioral Therapy- Social Activation (CBTsa) plus Standard Treatment (ST)), or to
      the control condition (ST alone). Patients will be stratified by sex, as females with recent
      onset schizophrenia have a better prognosis and may respond differentially to CBTsa. A
      baseline test battery will be 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 population/ datasources Study sample: patients hospitalized or attending day-treatment
      or receiving outpatient care at one of the participating centers. To maximize engagement,
      group therapy will be incorporated in the day program. Individual therapy sessions will be
      delivered flexibly (time, location). All participants are embedded within a low-threshold
      intensive outreaching care system (aligned with our academic department).
    

Intervention name(s): CBT-SA; Standard Treatment
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Info has been included in arm description; Info has been included in arm description
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 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.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment