Manualized Group Cognitive-behavioral Therapy for Social Anxiety in First Episode Psychosis

Summary

Social anxiety represents one of the most prevalent comorbid conditions in schizophrenia and related psychosis. Schizophrenia patients with comorbid social anxiety often exhibit impaired social functioning, an increased risk for relapse, and higher rates of suicide. Social anxiety is a treatable condition but has, in the context of psychosis, received only scant attention thus far. There is strong evidence that cognitive-behavioral therapy (CBT) for the treatment of social anxiety is very effective, whether it is delivered individually or in a group setting, and studies have shown that a group setting is more effective than individual therapy. Providing a CBT intervention for social anxiety represents an effective way to empower people with this illness.

The investigators have conducted a preliminary study using an uncontrolled design to assess feasibility and initial benefits of a new manualized group CBT intervention for social anxiety specifically adapted for people with psychosis. The investigators observed a significant reduction in social anxiety symptoms across three groups of first episode psychosis (FEP) participants (n=29) following completion of this 13-week intervention, and observed large effect sizes confirming a significant positive influence of this intervention. The investigators now propose to conduct a randomized controlled trial to fully assess the efficacy of this intervention. The main objective of this research proposal is to contrast the impact of a CBT intervention for the treatment of social anxiety in first episode psychosis with another control condition involving computer assisted cognitive remediation therapy (CACRT). Both interventions will be offered in a group setting, and will therefore have the exact same parameters. A secondary objective of this study is to examine the impact of reduced social anxiety on measures of clinical and functional outcome.

For this trial, 120 patients with recent onset psychotic disorder (defined as within 5 years from their first episode of psychosis) and with social anxiety will be clinically assessed. These participants will be recruited from five different first episode psychosis programs in the Montreal area and referred by their treatment team. They will then be randomly assigned to either the CBT or CACRT conditions. Both interventions will involve 13 weekly group sessions. At the end of group interventions and at two follow-ups (3-month \& 6-month), the presence and severity of social anxiety symptoms will be assessed. It is hypothesized that compared to the CACRT group, individuals receiving the CBT intervention will show a reduction in symptoms associated with social anxiety (as determined with multiple self-report and clinician rated measures). This effect will be maintained at follow-ups. In addition, the investigators also hypothesize that the CBT group will show better clinical outcome, defined as the length of symptomatic remission at follow-ups. For functional outcome, they will show significant improvement on a self-report measure a clinician-rated measure of recovery. This study will be one of the first to specifically target social anxiety in people with psychosis using a psychosocial intervention. As such, it will tackle an important problem that is interfering with recovery and with the actualization of functional roles.

Conditions

• Social Phobia
• Psychosis

Interventions

BEHAVIORAL

Manualized group Cognitive-behavioral therapy (CBT) for social anxiety in first episode psychosis

All CBT sessions will be conducted in English or French by trained clinicians with the aid of a group CBT script that we have developed over the last two years. The script will provide a general outline for each session, remind the therapist about relevant CBT principles, and provide examples of topics and homework that may be useful in each session. This intervention will include: i) Psychoeducation on social anxiety disorder; ii) Cognitive Restructuring; iii) Exposure component; iv) Use of Thought Records to identify, explore and dispute negative thoughts about dysfunctional self-identity and core beliefs related to the onset and presence of diagnosis of schizophrenia. The latter module specifically examines stigmatization and self-stigmatization that are contributing factors to social anxiety. Each of the 13 group sessions consisting of 6-8 participants on average, will last for 1.5 hour each. One session per week will be provided for the 13-week period.

BEHAVIORAL

Group Computer assisted cognitive remediation therapy

This group intervention has been developed by Dr. Bowie a co-applicant on the current proposal. This intervention involves completing cognitive training activities on a computer, documenting and attempting new strategies for solving problems, and doing 'bridging activities'. The target domains of cognition to be trained are processing speed, attention, memory and executive functions. The investigators will perform 13 weekly sessions of 1.5 hours. The software Brain Training Pro (http://www.scientificbraintrainingpro.fr), which has been used extensively in the field of schizophrenia, will be used. Each 1.5 hour session will be conducted with groups of 6-8 participants. The therapist's interventions, while minimal, are meant to emphasize the link between activities in the CACRT sessions and day-to-day activities that people do.

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Douglas Mental Health University Institute

  lead OTHER

Principal Investigators

• Martin M Lepage, Ph.D. · Douglas Mental Health University Institute

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

35 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2019-12-19

Completion

2019-12-19

Countries

• Canada

Study Locations