Contrasting Group Therapy Methods for Psychosis (MCTpilot)
This study is currently recruiting participants.
Verified April 2013 by University of British Columbia
Sponsor:
University of British Columbia
Collaborators:
Vancouver Coastal Health Research Institute
Vancouver General Hospital
Vancouver Coastal Health
VGH and UBC Hospital Foundation
Information provided by (Responsible Party):
Todd Woodward, University of British Columbia
ClinicalTrials.gov Identifier:
NCT01764568
First received: November 28, 2012
Last updated: April 4, 2013
Last verified: April 2013
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Purpose
Current Canadian Clinical Practice guidelines emphasize the need for effective psychosocial adjuncts to pharmacotherapy for schizophrenia (Canadian Psychiatric Association 2005). The proposed study aims to contribute to the body of evidence supporting psychosocial treatments, in general; to the evidence supporting two promising group approaches, in specific; and to the research and development of a potentially superior combined intervention. This randomized control trial seeks to assess the effectiveness of metacognitive training (MCT), group cognitive‐behavioral therapy (CBT) and a combined condition at treating the persistent positive symptoms of schizophrenia in a stable patient population. Other features of interest, including insight and specific cognitive biases will also be examined using verified measures.
Hypotheses
- That MCT and CBT will each prove feasible, acceptable to patients and more effective than treatment as usual in reducing the positive symptoms of schizophrenia.
- That the MCT condition will offer benefits over the CBT condition in the areas of insight and measures of cognitive bias and will show greater sustained improvement of positive symptoms at 6 months post-treatment.
| Condition | Intervention |
|---|---|
|
Psychosis Schizophrenia Schizoaffective Disorder Schizophreniform Disorder |
Behavioral: Metacognitive training Behavioral: Cognitive behavioral therapy |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Functional Brain Networks Underlying Non-pharmaceutical Interventions for Psychosis. A Pilot Study. |
Resource links provided by NLM:
Further study details as provided by University of British Columbia:
Primary Outcome Measures:
- Symptom rating [ Time Frame: 4 months (end of therapy) ] [ Designated as safety issue: No ]General psychopathology will be assessed using the Signs and Symptoms of Psychotic Illness scale (SSPI; Liddle, Ngan, Duffield, Kho, & Warren, 2002). The psychotic symptom rating scales (PSYRATS; Haddock, McCarron, Tarrier, & Faragher, 1999) will be administered in order to measure more specific aspects of delusions such as conviction and impact on thinking.
- Symptom rating [ Time Frame: 6 months (post therapy) ] [ Designated as safety issue: No ]General psychopathology will be assessed using the Signs and Symptoms of Psychotic Illness scale (SSPI; Liddle, Ngan, Duffield, Kho, & Warren, 2002). The psychotic symptom rating scales (PSYRATS; Haddock, McCarron, Tarrier, & Faragher, 1999) will be administered in order to measure more specific aspects of delusions such as conviction and impact on thinking.
Secondary Outcome Measures:
- Cognitive Bias [ Time Frame: 4 months (end of therapy) ] [ Designated as safety issue: No ]The jumping to conclusions (JTC) bias and the bias against disconfirmatory evidence (BADE), will be evaluated in this study using tasks developed, in part, by the research supervisor and described in previous research (Lecomte & Woodward 2005; Moritz & Woodward 2005; Woodward 2009) and (Woodward 2006a; Woodward 2006b; Woodward 2007).
- Insight [ Time Frame: 4 months (end of therapy) ] [ Designated as safety issue: No ]The Beck Cognitive Insight Scale (BCIS; Beck, Baruch, Balter, Steer, & Warman 2004) will be administered to evaluate insight.
- Feasibility and acceptability [ Time Frame: 4 months (end of therapy) ] [ Designated as safety issue: No ]After the final session in active treatment conditions, patients will be asked to complete a questionnaire comprising 10 questions on acceptance and subjective efficacy (Moritz & Woodward 2007a). Data accumulated therein will be used together with frequency of unattended sessions to establish acceptability and feasibility of the various treatment conditions.
- Cognitive Bias [ Time Frame: 6 months (post therapy) ] [ Designated as safety issue: No ]The jumping to conclusions (JTC) bias and the bias against disconfirmatory evidence (BADE), will be evaluated in this study using tasks developed, in part, by the research supervisor and described in previous research (Lecomte & Woodward 2005; Moritz & Woodward 2005; Woodward 2009) and (Woodward 2006a; Woodward 2006b; Woodward 2007).
- Insight [ Time Frame: 6 months (post therapy) ] [ Designated as safety issue: No ]The Beck Cognitive Insight Scale (BCIS; Beck, Baruch, Balter, Steer, & Warman 2004) will be administered to evaluate insight.
| Estimated Enrollment: | 16 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Metacognitive training
The metacognitive group training program that will form the basis of the 16-session MCT intervention has been described in previous research (Moritz & Woodward 2007a; Moritz & Woodward 2007b; Moritz 2011). The experimental intervention will consist of two 8‐module cycles that are identical in terms of content, but use different examples. Each module will include a 45 to 60 minute instructor‐led group session using PowerPoint (Microsoft office) slides and homework assignments to facilitate learning. Groups will ideally consist of 8-¬10 subjects.
|
Behavioral: Metacognitive training
The metacognitive group training program that will form the basis of the 16-session MCT intervention has been described in previous research (Moritz & Woodward 2007a; Moritz & Woodward 2007b; Moritz 2011). The experimental intervention will consist of two 8‐module cycles that are identical in terms of content, but use different examples. Each module will include a 45 to 60 minute instructor‐led group session using PowerPoint (Microsoft office) slides and homework assignments to facilitate learning. Groups will ideally consist of 8 to 10 subjects.
|
|
Experimental: Cognitive behavioral therapy
The group CBT treatment will be based on a manualized treatment targeting cognitions and social functioning that has been previously validated in schizophrenia (Granholm et al, 2005, 2009 etc). Consistent with the MCT protocol, this involves an 8 week group treatment.
|
Behavioral: Cognitive behavioral therapy
The group CBT treatment will be based on a manualized treatment targeting cognitions and social functioning that has been previously validated in schizophrenia (Granholm et al, 2005, 2009 etc). Consistent with the MCT protocol, this involves an 8 week group treatment.
|
|
No Intervention: Treatment as usual
Treatment as usual
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 19 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Between the ages of 19 to 55 years
- Diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder.
Exclusion Criteria:
- An inability to read and write in English. Participants must be have used English on a daily basis for at least 5 years, and must be able to understand the consent form and give written consent.
- History of brain damage or other medical problems that may affect comprehension (e.g., seizure disorders, stroke, aneurysm, brain tumor, etc.)
- Psychosis that is a direct consequence of substance abuse
- Concurrent Axis I diagnosis not involving psychosis.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01764568
Contacts
| Contact: Emma M Davis, MSc | 604-822-7312 | emmamunrodavis@gmail.com |
| Contact: Todd Woodward, PhD | 604-875-2000 ext 4724 | todd.woodward@ubc.ca |
Locations
| Canada, British Columbia | |
| UBC Hospital - Detwiller Pavilion | Recruiting |
| Vancouver, British Columbia, Canada, V6T 2A1 | |
| Contact: Mahesh Menon, PhD 604-822-7312 dr.mahesh.menon@gmail.com | |
| Principal Investigator: Todd Woodward, PhD | |
| Sub-Investigator: Mahesh Menon, PhD | |
| Vancouver General Hospital | Recruiting |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Contact: Chris Flynn Chris.Flynn@vch.ca | |
| Sub-Investigator: Katy Harper | |
Sponsors and Collaborators
University of British Columbia
Vancouver Coastal Health Research Institute
Vancouver General Hospital
Vancouver Coastal Health
VGH and UBC Hospital Foundation
Investigators
| Principal Investigator: | Todd Woodward, PhD | University of British Columbia |
More Information
Publications:
| Responsible Party: | Todd Woodward, Associate Professor, University of British Columbia |
| ClinicalTrials.gov Identifier: | NCT01764568 History of Changes |
| Other Study ID Numbers: | F11-02233-pilot, F11-02233 |
| Study First Received: | November 28, 2012 |
| Last Updated: | April 4, 2013 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University of British Columbia:
|
Metacognitive training Cognitive behavioral therapy Clinical trial Group intervention |
Group therapy Schizophrenia Psychosis |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Schizophrenia Schizophrenia and Disorders with Psychotic Features |
ClinicalTrials.gov processed this record on June 18, 2013