Social AnxietyPhase 1/2NCT01376596
Group Cognitive-behavioral Intervention for Social Anxiety in Schizophrenia
A Phase 1/2 study testing Cognitive-Behavioral Therapy based intervention immediately and Wait list in people with Social Anxiety and Schizophrenia, run by Douglas Mental Health University Institute at 1 site in Canada.
Trial summary
This study will explore the helpfulness of a short psychological group treatment called cognitive-behavioral therapy, or CBT. CBT is a form of therapy that is very structured and it aims to improve difficulties that are related to behaviors and emotions by first working on identifying and changing negative inaccurate… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Social Anxiety, Schizophrenia
- What is being tested?
- Cognitive-Behavioral Therapy based intervention immediately and Wait list
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2011to Jan 2013
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of a schizophrenia spectrum disorder; aged 18-50; be able to read and write at an intermediate level (Education > 8 years or more); social anxiety scores above 34 for the SIAS, above 19 for the SPIN and above 20 for the BSPS; and the the presence of observable clinical symptoms supporting the diagnosis of a social anxiety disorder on Axis I.
Who cannot join
- Diagnosis of affective psychosis; currently clinically stable [score of 3 or less of the SAPS ratings; Global Assessment Scale score (Endicott, et al., 1976) of ≥ 50]; have no significant presence of social anxiety (score on scales below cut-off); hospitalized or hospitalized at the time of recruitment; and a change medication within the past 6 weeks.
Trial locations and contacts
1 site in 1 country.
Canada1 site
RUIS McGill CBT Teaching & Research Program
Montreal, Quebec, H3A 1A1
About this study
Official title: Manualized Group Cognitive-behavioral Intervention for Social Anxiety in Schizophrenia: An Efficacy Pilot Study.
This study will explore the helpfulness of a short psychological group treatment called cognitive-behavioral therapy, or CBT. CBT is a form of therapy that is very structured and it aims to improve difficulties that are related to behaviors and emotions by first working on identifying and changing negative inaccurate thoughts. The main goal of this intervention is to see if group CBT reduces the symptoms of social anxiety in people with schizophrenia so that they can improve their social functioning and help their psychotic symptoms. The study compares the usefulness of adding CBT to standard services.
Read the detailed description
Social anxiety is highly prevalent in people with schizophrenia and represents a major obstacle to positive functional outcomes. Social anxiety is a treatable condition but has, in the context of psychosis, received only scant attention thus far. Current existing manualized treatment for social anxiety may not be optimal for people with schizophrenia for a number of reasons described above. An adapted CBT intervention for schizophrenia must target the stigma attached to the illness, the presence of poor social skills, the presence of delusional and persecutory ideas, possible limited reading abilities, and associated cognitive deficits. The investigators propose to develop and test an adapted group CBT for social anxiety. The main objective of this research proposal is to contrast the impact of a CBT intervention for the treatment of social anxiety in schizophrenia with standard care (care as usual) on reducing symptoms of social anxiety. Considering the relationship between certain characteristics of social anxiety (e.g. social withdrawal) with diminished quality of life and poor functional outcome, a secondary objective is to examine the impact of reduced social anxiety on functional outcome.
- Conditions
- Social Anxiety, Schizophrenia
- Being tested
- Cognitive-Behavioral Therapy based intervention immediately, Wait list
- Keywords
- Remission, Psychosocial Functioning, Symptoms reduction
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive-Behavioral Therapy based intervention immediatelyBehavioural
This intervention will include: i) Psychoeducation on social anxiety disorder; ii) Cognitive Restructuring: Identify negative thoughts that occur before, during, or after anxiety-provoking situations; Evaluate the accuracy of their thoughts in the light of data derived from Socratic questioning or as a result of so-called behavioral experiments; and derive rational alternative thoughts based on the acquired information; iii) Exposure component, which focuses on the collection of information that will allow patients to revise their judgments about the degree of risk to which they are exposed in feared situations, challenge their dysfunctional beliefs about the self relative to the illness and their self-efficacy (social status related), and 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.
Wait listBehavioural
The group receiving treatment as usual (TAU) will be put on a wait list to receive the CBT intervention at the end of the experimental group, the one receiving the intervention immediately
| Study group | Role | What they receive |
|---|---|---|
| CBT-based Intervention | Experimental | Contrast the impact of a CBT intervention for the treatment of social anxiety in schizophrenia with standard care (care as usual) Receives: Behavioral: Cognitive-Behavioral Therapy based intervention immediately |
| Treatment as usual | Active comparator | Usual care received by patients at clinic/hospital - randomized to a wait list to receive the CBT intervention at the end of the group that received the intervention immediately Receives: Behavioral: Wait list |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social anxiety symptom reduction
To compare the effectiveness in social anxiety symptom reduction of a 13-week group CBT for social anxiety adapted for people with schizophrenia relative to a control condition involving participants who will be receiving standard care only, followed by the proposed intervention on a wait-list basis
Measured: 13-week intervention program
Secondary outcomes (1)
Positive and negative symptoms of schizophrenia reduction
To measure the effect of a group CBT intervention for social anxiety on positive and negative symptoms of schizophrenia.
Measured: 13-week intervention program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Douglas Mental Health University Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Martin Lepage, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376596
- Sponsor's protocol ID
- 10-273-PSY
- Status last verified
- Oct 2022
- First submitted
- 16 Jun 2011
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manualized Group Cognitive-behavioral Intervention for Social Anxiety in Schizophrenia: An Efficacy Pilot Study.
- ClinicalTrials.gov ID
- NCT01376596
- Acronym / sponsor ID
- 10-273-PSY
- Conditions
- Social Anxiety, Schizophrenia
- Keywords
- Remission, Psychosocial Functioning, Symptoms reduction
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Douglas Mental Health University InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Aug 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will explore the helpfulness of a short psychological group treatment called cognitive-behavioral therapy, or CBT. CBT is a form of therapy that is very structured and it aims to improve difficulties that are related to behaviors and emotions by first working on identifying and changing negative inaccurate thoughts. The main goal of this intervention is to see if group CBT reduces the symptoms of social anxiety in people with schizophrenia so that they can improve their social functioning and help their psychotic symptoms. The study compares the usefulness of adding CBT to standard services.
Detailed description
Social anxiety is highly prevalent in people with schizophrenia and represents a major obstacle to positive functional outcomes. Social anxiety is a treatable condition but has, in the context of psychosis, received only scant attention thus far. Current existing manualized treatment for social anxiety may not be optimal for people with schizophrenia for a number of reasons described above. An adapted CBT intervention for schizophrenia must target the stigma attached to the illness, the presence of poor social skills, the presence of delusional and persecutory ideas, possible limited reading abilities, and associated cognitive deficits. The investigators propose to develop and test an adapted group CBT for social anxiety. The main objective of this research proposal is to contrast the impact of a CBT intervention for the treatment of social anxiety in schizophrenia with standard care (care as usual) on reducing symptoms of social anxiety. Considering the relationship between certain characteristics of social anxiety (e.g. social withdrawal) with diminished quality of life and poor functional outcome, a secondary objective is to examine the impact of reduced social anxiety on functional outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-based Intervention | Experimental | Behavioral: Cognitive-Behavioral Therapy based intervention immediatelyContrast the impact of a CBT intervention for the treatment of social anxiety in schizophrenia with standard care (care as usual) |
| Treatment as usual | Active comparator | Behavioral: Wait listUsual care received by patients at clinic/hospital - randomized to a wait list to receive the CBT intervention at the end of the group that received the intervention immediately |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Diagnosis of a schizophrenia spectrum disorder; aged 18-50; be able to read and write at an intermediate level (Education > 8 years or more); social anxiety scores above 34 for the SIAS, above 19 for the SPIN and above 20 for the BSPS; and the the presence of observable clinical symptoms supporting the diagnosis of a social anxiety disorder on Axis I.
Key exclusion criteria (1 listed)
- Diagnosis of affective psychosis; currently clinically stable [score of 3 or less of the SAPS ratings; Global Assessment Scale score (Endicott, et al., 1976) of ≥ 50]; have no significant presence of social anxiety (score on scales below cut-off); hospitalized or hospitalized at the time of recruitment; and a change medication within the past 6 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive-Behavioral Therapy based intervention immediatelyThis intervention will include: i) Psychoeducation on social anxiety disorder; ii) Cognitive Restructuring: Identify negative thoughts that occur before, during, or after anxiety-provoking situations; Evaluate the accuracy of their thoughts in the light of data derived from Socratic questioning or as a result of so-called behavioral experiments; and derive rational alternative thoughts based on the acquired information; iii) Exposure component, which focuses on the collection of information that will allow patients to revise their judgments about the degree of risk to which they are exposed in feared situations, challenge their dysfunctional beliefs about the self relative to the illness and their self-efficacy (social status related), and 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. | Behavioural | CBT-based Intervention |
| Wait listThe group receiving treatment as usual (TAU) will be put on a wait list to receive the CBT intervention at the end of the experimental group, the one receiving the intervention immediately | Behavioural | Treatment as usual |
Primary outcome
Social anxiety symptom reduction
Time frame: 13-week intervention program
To compare the effectiveness in social anxiety symptom reduction of a 13-week group CBT for social anxiety adapted for people with schizophrenia relative to a control condition involving participants who will be receiving standard care only, followed by the proposed intervention on a wait-list basis
1 secondary outcome
Positive and negative symptoms of schizophrenia reduction
Time frame: 13-week intervention program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cognitive-Behavioral Therapy based intervention immediately and Wait list in people with Social Anxiety and Schizophrenia, run by Douglas Mental Health University Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Social anxiety symptom reduction (time frame: 13-week intervention program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.