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

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ClinicalTrials.gov Identifier: NCT02294409
Recruitment Status : Recruiting
First Posted : November 19, 2014
Last Update Posted : May 8, 2017
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Martin Lepage, McGill University

Brief 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.


Condition or disease Intervention/treatment Phase
Social Phobia Psychosis Behavioral: Manualized group Cognitive-behavioral therapy (CBT) for social anxiety in first episode psychosis Behavioral: Group Computer assisted cognitive remediation therapy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Manualized Group Cognitive-behavioral Therapy for Social Anxiety in First Episode Psychosis: A Randomized Controlled Trial
Study Start Date : October 2014
Estimated Primary Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cognitive-behavioral therapy (CBT)
Manualized group cognitive-behavioral therapy for social anxiety in first episode psychosis
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.

Active Comparator: Computer assisted Cognitive Remediation therapy (CACRT)
Group computer assisted cognitive remediation therapy
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.




Primary Outcome Measures :
  1. Social anxiety symptoms as measured by the Social Interaction Anxiety Scale (SIAS) [ Time Frame: pre-treatment, 1 week, three and six-month follow-up ]

    Participants:

    120 participants receiving treatment for a FEP with social anxiety symptoms aged 18-35 will be recruited in Montreal from five FEP clinics affiliated with McGill University or Université de Montréal. Half of these participants will receive CBT, the other half CACRT.

    Assessment:

    As part of a thorough clinical assessment, symptoms of social anxiety will be assessed for each participant at intake, at the end of the therapy, and 3 and 6 months after the therapy. Change in symptom severity will be evaluated over time. Assessment will be conducted by a by a trained bilingual rater who will be blind to treatment.

    Unit of measure:

    The unit of measure used is the Social Interaction Anxiety Scale (SIAS). The SIAS is a 20-item scale which measures anxiety in interpersonal encounters.


  2. Social anxiety symptoms as measured by the Social Phobia Inventory (SPIN) [ Time Frame: pre-treatment, 1 week, three and six-month follow-up ]

    Participants:

    120 participants receiving treatment for a FEP with social anxiety symptoms aged 18-35 will be recruited in Montreal from five FEP clinics affiliated with McGill University or Université de Montréal. Half of these participants will receive CBT, the other half CACRT.

    Assessment:

    As part of a thorough clinical assessment, symptoms of social anxiety will be assessed for each participant at intake, at the end of the therapy, and 3 and 6 months after the therapy. Change in symptom severity will be evaluated over time. Assessment will be conducted by a by a trained bilingual rater who will be blind to treatment.

    The unit of measure used is the Social Phobia Inventory (SPIN). The SPIN is a 17-item scale assessing multiple dimensions of social anxiety including fear, avoidance and physiological discomfort.


  3. Social anxiety symptoms as measured by the the Brief Social Phobia Scale (BSPS) [ Time Frame: pre-treatment, 1 week, three and six-month follow-up ]

    Participants:

    120 participants receiving treatment for a FEP with social anxiety symptoms aged 18-35 will be recruited in Montreal from five FEP clinics affiliated with McGill University or Université de Montréal. Half of these participants will receive CBT, the other half CACRT.

    Assessment:

    As part of a thorough clinical assessment, symptoms of social anxiety will be assessed for each participant at intake, at the end of the therapy, and 3 and 6 months after the therapy. Change in symptom severity will be evaluated over time. Assessment will be conducted by a by a trained bilingual rater who will be blind to treatment.

    Unit of measure:

    The unit of measure used is the Brief Social Phobia Scale (BSPS). The BSPS is an 11-item clinician-rated assessment scale developed by Davidson which specifically measures fear, avoidance and autonomic physiological responses that are usually associated with most common social situations.



Secondary Outcome Measures :
  1. Psychosis Symptoms Remission as measured by the Scale for Assessment of Positive Symptoms (SAPS) and Negative Symptoms (SANS) [ Time Frame: pre-treatment, 1 week, three and six-month follow-up ]

    Participants:

    120 participants receiving treatment for a FEP with social anxiety symptoms aged 18-35 will be recruited in Montreal from five FEP clinics affiliated with McGill University or Université de Montréal. Half of these participants will receive CBT, the other half CACRT.

    Assessment:

    As part of a thorough clinical assessment, symptoms of social anxiety will be assessed for each participant at intake, at the end of the therapy, and 3 and 6 months after the therapy. Psychosis symptom remission will be evaluated over time. Assessment will be conducted by a by a trained bilingual rater who will be blind to treatment.

    Unit of measure:

    The unit of measure used is the Scale for Assessment of Positive Symptoms (SAPS) and Negative Symptoms (SANS). The SAPS and SANS is a 59-item scale assessing multiple categories of positive and negative symptoms.


  2. Functional outcome as measured by the Recovery Assessment Scale (RAS) [ Time Frame: pre-treatment, 1 week, three and six-month follow-up ]

    Participants:

    120 participants receiving treatment for a FEP with social anxiety symptoms aged 18-35 will be recruited in Montreal from five FEP clinics affiliated with McGill University or Université de Montréal. Half of these participants will receive CBT, the other half CACRT.

    Assessment:

    As part of a thorough clinical assessment, symptoms of social anxiety will be assessed for each participant at intake, at the end of the therapy, and 3 and 6 months after the therapy. Functional recovery will be evaluated over time. Assessment will be conducted by a by a trained bilingual rater who will be blind to treatment.

    Unit of measure:

    The unit of measure used is the Recovery Assessment Scale (RAS). The RAS is a 41-item self-report measure examining multiple dimensions of functional recovery as perceived by the patient him/herself.


  3. Functional outcome as measured by the Social and Occupational Functioning Scale (SOFAS). [ Time Frame: pre-treatment, 1 week, three and six-month follow-up ]

    Participants:

    120 participants receiving treatment for a FEP with social anxiety symptoms aged 18-35 will be recruited in Montreal from five FEP clinics affiliated with McGill University or Université de Montréal. Half of these participants will receive CBT, the other half CACRT.

    Assessment:

    As part of a thorough clinical assessment, symptoms of social anxiety will be assessed for each participant at intake, at the end of the therapy, and 3 and 6 months after the therapy. Functional recovery will be evaluated over time. Assessment will be conducted by a by a trained bilingual rater who will be blind to treatment.

    Unit of measure:

    The unit of measure used is the the Social and Occupational Functioning Scale (SOFAS). The SOFAS is used to evaluate the individual's level of social and occupational functioning independent of the overall severity of psychiatric symptoms.




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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of a psychotic disorder (as determined by the SCID and consensus meeting between two research psychiatrists);
  • ability to read and write English or French at an intermediate level (Education > 8 years);
  • social anxiety scores above predetermined cut-offs on at least one of the three social anxiety measures (34 for the SIAS, above 19 for the SPIN and above 20 for the BSPS); and the presence of observable clinical symptoms supporting the diagnosis of a social anxiety disorder on Axis I and determined with the SCID social phobia module.

Exclusion Criteria:

  • currently clinically unstable, defined as the presence of positive symptoms that are moderate to severe on the SAPS rating scale;
  • IQ<70;
  • currently hospitalized or hospitalized at the time of recruitment;
  • a change in medication within the past 6 weeks; presence of a current episode of major depression (evidenced by Calgary Depression Scale (CDS) rating score of 8 or greater);
  • current diagnosis of substance dependence (but a diagnosis of substance abuse is not an exclusion criterion);
  • lifetime history of a neurological condition;
  • history of mental retardation or autism spectrum disorders.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02294409


Contacts
Contact: Martin M Lepage, Ph.D. 514-761-6131 ext 4393 martin.lepage@mcgill.ca
Contact: Karyne Anselmo, M.Sc. 514-761-6131 ext 3296 karyne.anselmo@douglas.mcgill.ca

Locations
Canada, Quebec
Douglas Mental Health University Institute Recruiting
Verdun, Quebec, Canada, H4H 1R3
Contact: Martin M Lepage, Ph.D    514-761-6131 ext 4393    martin.lepage@mcgill.ca   
Principal Investigator: Ashok K Malla, M.D.         
Sub-Investigator: Amal Abdel-Baki, M.D.         
Sub-Investigator: Christopher Bowie, Ph.D.         
Sub-Investigator: G. Eric Jarvis, M.D.         
Sub-Investigator: Ridha Joober, MD, PhD         
Sub-Investigator: Tania Lecomte, Ph.D.         
Sub-Investigator: Howard Margolese, M.D.         
Sub-Investigator: Tina Montreuil, Ph.D.         
Sub-Investigator: Gail Myhr, Ph.D.         
Sub-Investigator: Luc Nicole, M.D.         
Sub-Investigator: Norbert Schmitz, Ph.D.         
Sponsors and Collaborators
McGill University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Martin M Lepage, Ph.D. Douglas Mental Health University Institute

Responsible Party: Martin Lepage, James McGill Professor of Psychiatry, Researcher & Clinical Psychologist, McGill University
ClinicalTrials.gov Identifier: NCT02294409     History of Changes
Other Study ID Numbers: CBT_SA-FEP RCT
First Posted: November 19, 2014    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017

Keywords provided by Martin Lepage, McGill University:
social anxiety
psychosis
CBT
randomized
CRT

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Phobia, Social
Schizophrenia Spectrum and Other Psychotic Disorders
Phobic Disorders
Anxiety Disorders