Manualized Group Cognitive-behavioral Therapy for Social Anxiety in First Episode Psychosis
Condition: Social Phobia; Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders; Phobia, Social
Study type: Interventional

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.
    

Detailed description: 
      Preamble

      Social anxiety is highly prevalent in people with schizophrenia and related psychotic
      disorders, and represents a major obstacle to a positive functional outcome. The
      investigators have recently developed a psychosocial intervention for social anxiety that is
      specifically tailored to people with psychosis. An adapted Cognitive-Behavioural Therapy
      (CBT) intervention for psychosis must target the stigma attached to the illness, the possible
      presence of poor social skills, delusional and persecutory ideas, potential limited reading
      abilities, and associated cognitive deficits that are the hallmark of schizophrenia and
      related psychoses. Our preliminary data from an uncontrolled evaluation of our new
      intervention in first episode psychosis revealed a significant positive impact of this
      13-week group intervention for manifestations of social anxiety. Following these promising
      results, the investigators now propose to conduct a multi-center randomized controlled trial
      to test the efficacy of this intervention relative to an active control condition consisting
      of a cognitive remediation group. Their primary goal is to show the efficacy of this
      intervention on symptoms of social anxiety as determined by self-report measures and
      clinician-rated measures. Their secondary goal is to examine the impact of such an
      intervention on clinical and functional outcomes. The highly impairing nature of social
      anxiety in psychosis is well established and the proposed trial will ultimately show that
      treating this aspect of the condition is possible and will result in improved functioning.

      From 2010 to 2012, the investigators have offered their CBT intervention for social anxiety
      to several groups of patients at the Douglas Institute and now, more recently, at the McGill
      University Health Centre (MUHC). The investigators have employed an uncontrolled design
      recommended to evaluate the feasibility and potential benefits of a pilot psychosocial
      intervention. In their feasibility study, they offered this intervention to five groups of
      clients who were part of the Prevention and Early Intervention Program for Psychosis
      (PEPP-Montreal) and to two groups of clients with longer standing illness, from the Psychosis
      Program at the Douglas Institute and from the MUHC, respectively. All participants were
      referred by their treating team (e.g. psychiatrist, nurse, case manager, etc.) and were
      screened by our research team to evaluate the presence of significant social anxiety. They
      assessed the effects of this intervention using four scales: Social Interaction Anxiety Scale
      (SIAS), the Social Phobia Inventory (SPIN) and the Brief Social Phobia Scale (BSPS),
      Structured Clinical Diagnosis (SCID-I) for Diagnostic and Statistical Manual (DSM-IV).

      Focusing on their work in FEP at our program PEPP-Montreal, 25 out of 29 participants who
      were recruited for the feasibility study met diagnostic criteria for social phobia, whereas 4
      represented 'borderline' cases that were clearly reporting significant difficulties with
      social interactions and active avoidance of social situations. From the 29 clients who
      started the group intervention, 3 did not complete it (completion defined as attending more
      than 50% of the sessions). The overall attendance rate of completers of the weekly 13-week
      program was excellent, with an average of 11 sessions attended per participant (ranging from
      9-13), confirming that the intervention was well tolerated by the participants. For the 26
      patients who completed the intervention, a significant reduction in social anxiety was
      observed on all three measures (SPIN, SIAS, BSPS) at the end of the 13-week treatment. We
      observed effect sizes of 1.04 on the SIAS, 0.93 on the SPIN, and 0.95 on the BSPS, after
      correcting for within-subject dependence among means for the total sample of participants who
      completed the intervention. These effect sizes are quite large and represent a strong
      justification to pursue a larger-scale investigation of this novel intervention. Critically,
      from the 24 participants with a SCID-I based diagnosis of social phobia prior to the
      treatment, only two still met diagnostic criteria at the end of the study. Moreover, the
      investigators administered the Internalized Stigma of Mental Illness (ISMI) scale and
      observed a significant reduction in stigma following this intervention (p<.01), suggesting
      that our intervention does indeed target stigma in an efficient way.

      Having established the potential benefits of our new psychosocial intervention for social
      anxiety, the investigators devised a control condition to reproduce some of the aspects of
      our group intervention without the active ingredients of group CBT. An active control
      condition that could control for spontaneous changes in symptoms of social anxiety, the
      effect of being in a trial, and therapeutic commitment was chosen. In the selection of an
      active control condition, it is essential that this intervention does not target social
      anxiety while still controlling for the non-specific effects described above. As discussed by
      Everitt, a control intervention that does not target the symptoms of interest should
      potentially lead to a greater effect size between the experimental treatment and the control
      condition, and as such requires a smaller sample. Several researchers have attested to the
      appropriateness of cognitive remediation therapy (CRT) as a control condition for CBT
      intervention: two recent large multi-center trials involving a group CBT intervention to
      improve patients' insight into their illness or to improve negative symptoms have used CRT as
      their active control condition. CRT targetting cognitive performance can be offered in a
      group format and thus represents a very promising control condition for the proposed study.

      Several computer-assisted cognitive remediation therapies (CACRT) have been developed in the
      last few years. Many of these programs developed specifically for psychiatric patients follow
      a structured protocol and are given in small groups under supervision of a trained therapist.
      The goals of these programs are to improve performance on cognitive domains that have been
      determined to hinder functioning. The intervention aims to provide a positive experience for
      patients through the promotion of positive attitudes towards learning, and patients are
      encouraged to develop independent learning skills as well as a sense of competence and
      confidence. The intervention is also designed to increase awareness of the strengths and
      weaknesses of the patients' own learning styles. This particular method is advantageous
      because its goals match other psychiatric rehabilitation models and because it has
      theoretical bases in neuropsychology, learning, educational psychology, rehabilitation
      psychology, self-determination, and client-centered therapy. Furthermore, CRT has been shown
      to be effective at improving patients' cognitive abilities but has less impact on social
      functioning. Since fall 2011, the investigators have developed a group CRT program in
      collaboration with the Psychosis Program of the Douglas Institute and have presented their
      results at a recent scientific conference. The investigators propose to use Dr. Christopher
      Bowie's protocol in the current study. This psychosocial intervention represents an excellent
      control condition for their randomized controlled trial: it is conducted in a group format
      comparable to their proposed group CBT intervention, which controls for potential
      non-specific effects of simply participating in a group activity. Additionally, although this
      is a group activity, social interactions are limited as each participant spends most of the
      time working individually on a computer.

      Proposed study

      General aim: The goal of this research proposal is to evaluate the efficacy of a group CBT
      intervention (experimental condition) for social anxiety in first-episode psychosis in
      comparison to group-based cognitive remediation (control condition) on reducing symptoms of
      social anxiety.

      Primary objective: To compare the efficacy of a 13-week group CBT intervention adapted for
      people with psychosis for reducing symptoms of social anxiety to an active control condition
      comprised of a 13-week group cognitive remediation therapy.

      Primary hypothesis: Compared to the active control group, individuals receiving the brief
      manualized CBT intervention will show a reduction in symptoms associated with social anxiety,
      as determined with the Social Interaction Anxiety Scale (SIAS), the Social Phobia Inventory
      (SPIN) and the Brief Social Phobia Scale (BSPS) at the end of 13 weeks of intervention and at
      follow-up assessments (3- and 6-months). In addition, fewer participants receiving CBT will
      meet DSM-IV diagnostic criteria for social phobia at the end of the study.

      Secondary objective: To measure the effect of a group CBT intervention for social anxiety in
      first episode psychosis on clinical outcome and functional outcome.

      Secondary hypothesis: Following the treatment trial the CBT group will show better clinical
      outcome relative to the control group, defined as the length of symptomatic remission at
      follow-ups. For functional outcome, they will show significant improvement on a self-report
      measure of recovery (the Recovery Assessment Scale) and on a clinician-rated measure, the
      Social and Occupational Functioning Scale (SOFAS) at 3- and 6-month follow-ups.

      Methods

      Study design: A randomized controlled trial will be conducted comparing the experimental
      group, which will be receiving group CBT for social anxiety plus standard care, to the active
      control group who will be receiving CACRT and standard care. During the randomization process
      and repartition of participants, the two groups will be matched on the severity of social
      anxiety, level of functioning and gender (as described below) in order to avoid any initial
      group inequality. Participants will be assessed before and after treatment. They will also be
      asked to return for completion of two follow-up assessments (at 3- and 6-months) in order to
      measure the effect of treatment over time and verify whether the hypothesized therapeutic
      gains are maintained. As part of these follow-up evaluations, participants will complete
      various questionnaires and scales.

      Participants: This study will take place in Montreal and will involve five first-episode
      psychosis clinics affiliated with McGill University or Université de Montréal (UdeM). These
      include PEPP-Montréal, the Douglas Institute (Director Dr Ashok Malla, co-investigator), the
      First Episode Psychosis Program from the Jewish General Hospital (Director Dr. G. Eric
      Jarvis, co-investigator), and the First Episode Psychosis Program from the MUHC (Director Dr.
      Howard Margolese, co-investigator) from the McGill network, and The Clinique Jeunes Adultes
      Psychotiques from the Centre hospitalier de l'Université de Montréal (CHUM) (Director Dr.
      Amal Abdel-Baki, co-investigator) and the Programme des Premiers Épisodes Psychotiques from
      Institut Universitaire de Santé Mentale de Montréal (Director Dr. Luc Nicole,
      co-investigator) from UdeM. These related first episode psychosis programs all provide a
      complete range of services for adults suffering from psychosis, including evaluation,
      prevention, treatment, hospitalization, outpatient and family services, rehabilitation,
      modified assertive community case management, and variable community follow-ups. These
      programs provide follow-up for up to five years. Collectively, these five first-episode
      programs service the entire population of Montreal (2.2 million) and have more than 1000
      active patients in addition to accepting about 300 new clients per year.

      Screening of potential participants: Recruitment of participants will be facilitated by the
      co-investigators, who are clinical heads at the different services involved in this study,
      and by the culture of integration of clinical care and research that characterizes these
      different programs.

      Clinical assessment: After the screening is performed and informed consent is obtained, the
      participant will be administered a Structured Clinical Diagnosis (SCID) for DSM-IV to confirm
      the diagnosis of a psychotic disorder in collaboration with a research psychiatrist. If the
      diagnosis is confirmed and eligibility for the study is established, the participant will
      undergo a thorough clinical assessment at intake, 3-month and 6-month follow-ups, and at the
      end of therapy. Symptom evaluation will include the Scale for Assessment of Positive Symptoms
      (SAPS) and the Scale for Assessment of Negative Symptoms (SANS), as well as the Calgary
      Depression Scale. Social anxiety will be assessed via three scales: the SIAS is a 20-item
      scale which measures anxiety in interpersonal encounters; the SPIN is a 17-item scale
      assessing multiple dimensions of social anxiety including fear, avoidance and physiological
      discomfort; the Brief Social Phobia Scale (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. In
      addition, the social phobia module of the SCID-I will be used to confirm a diagnosis of
      social phobia. We have extensive experience in administering these instruments and our raters
      have achieved a high level of inter-rater reliability (ICC 0.79-.92). Finally, the Recovery
      Assessment Scale (RAS) and the Social and Occupational Functioning Scale (SOFAS) will be
      administered. The RAS is a 41-item self-report measure examining multiple dimensions of
      functional recovery as perceived by the patient him/herself. SOFAS is used to evaluate the
      individual's level of social and occupational functioning independent of the overall severity
      of psychiatric symptoms. The ratings are done first to allocate a category (1-10) based on
      the description of that category and how it applies to the individual, followed by a
      numerical score within that category.

      Neuropsychological assessment: Initial assessment of participants will include the Wechsler
      Abbreviated Scale of Intelligence (WASI), a pen and paper intelligence quotient (IQ) test
      consisting of 4 sub-scales (Vocabulary, Similarities, Block Design, Matrix Reasoning). It
      will only be administered once as part of initial assessment before treatment. Participants
      will also be evaluated using CogState, a computerized cognitive battery of 11 tasks that
      evaluate 7 cognitive domains (reasoning/problem solving, speed of processing,
      attention/vigilance, visual learning and memory, verbal learning and memory, working memory
      and social cognition). Both will be administered by a trained evaluator under the supervision
      of a neuropsychologist. The CogState is a repeatable neuropsychological battery that was
      specifically designed for schizophrenia and related psychoses. This assessment will be used
      to: confirm that participants present an IQ of at least 70; explore any impact of CACRT on
      neurocognitive performance; explore whether cognitive performance is predictive of treatment
      response in CBT, as some suggest.

      Procedure for participant recruitment and group randomization: Potential participants will be
      identified by clinical staff, in collaboration with the project coordinator, within the
      participating early psychosis programs. In all cases, only clients who will have indicated to
      their treating team a wish to learn more about the research study will be referred to the
      investigators. Once formal consent is obtained and an initial screening procedure completed,
      the research coordinator will assess the participant's overall functioning and eligibility
      for the current study by conducting the Global Assessment Scale (GAF), which has been shown
      in numerous studies to be a reliable and valid clinical measure of functioning. This measure
      will allow researchers to match participants not only on cognitive abilities (i.e.
      intermediate reading level) and language (i.e. informal participant-report of language
      proficiency) but also on their functionality. The score used for stratification will be a
      score of 50 or more, which will identify "high functional" versus "low functional"
      participants. In addition, participants will be asked to fill out the SIAS, SPIN and BSPS,
      and those with a score above the cut-off values described above will be approached for this
      study. A brief description of both psychosocial interventions (CBT and CACRT) will be offered
      by the referral source and the case will be referred to the research coordinator. During this
      initial session, the research staff will conduct a semi-structured interview, the Social
      Phobia / Anxiety sub-scale of the SCID-I. Random assignment will be carried out using a
      computer-run randomization protocol, which improves upon chance allocation to a given group
      by adjusting assignment probabilities based upon the frequency and characteristics of current
      group membership on key intake characteristics that could influence outcomes. A
      biostatistician (co-applicant Norbert Schmitz) not connected with treatment in any capacity
      and located away from the treatment site will carry out the randomization. Recruitment of
      participants and symptom assessments will be conducted, respectively, by a research
      coordinator and a research assistant, and the latter will be blind to treatment. After random
      assignment is complete, an appointment for the therapy session will be scheduled for those
      assigned to receive CBT and to those assigned to receive CACRT.

      We expect to take four years to complete the recruitment for this study.

      Treatment fidelity and quality control measures: To ensure that both interventions are being
      carried out in accordance with the detailed guidelines provided in the respective manuals, we
      will put in place quality control measures. For group CBT, we will use the approach developed
      by one of the co-investigator (T.L.) that is specific to group intervention in early
      psychosis. Briefly, all sessions will be audiotaped and the group adaptation of the
      Cognitive- Behavioral Therapy Scale will then be completed by two experienced CBT therapists.
      The audiotapes of the first 5 sessions of every group will be reviewed by two experienced CBT
      therapists and they will offer supervision to the therapists. Afterward, approximately 1 in
      every 3 sessions will be examined, or more if requested. For the active control condition
      involving cognitive remediation, Dr. Bowie (co-investigator), who has extensive experience in
      this field, will be responsible for quality control. Dr. Bowie has already conducted several
      randomized controlled trials using cognitive remediation interventions. Therapists will be
      trained by a registered clinical psychologist who is a senior clinician with over 12 years of
      experience with cognitive remediation.

      Medication: Medications will be monitored monthly using information from multiple sources
      (case managers, psychiatrists, and patients) to ensure that results are not due to changes in
      medication.

      Blinding the evaluations: While it is well acknowledged that conducting a classical double
      blind evaluation in a randomized controlled trial (RCT) of a psychosocial intervention is not
      feasible, we believe it is important to conduct blind evaluations of the study outcomes.
      Therefore, all evaluations will be conducted by a trained bilingual rater who will have no
      involvement in the conduct of the study, the delivery of the interventions or any involvement
      with any trial-related meetings.

      Clinical trial management: The steering committee will meet on a regular basis, about once
      every three months.
    

Intervention name(s): Manualized group Cognitive-behavioral therapy (CBT) for social anxiety in first episode psychosis; Group Computer assisted cognitive remediation therapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: social anxiety; psychosis; CBT; randomized; CRT