Contrasting Group Therapy Methods for Psychosis

NCT01764568 | Terminated

• 2 other identifiers: H12-01968F11-02233
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 1

Brief Summary

Current Canadian Clinical Practice guidelines emphasize the need for effective psychosocial adjuncts to pharmacotherapy for schizophrenia (Canadian Psychiatric Association 2005). This randomized control trial seeks to contribute to the body of evidence supporting psychosocial treatments by assessing the effectiveness of metacognitive training (MCT) and cognitive remediation (CR) at treating the persistent positive and cognitive symptoms of schizophrenia. MCT is a therapy designed to improve patient awareness and insight into the cognitive biases that are frequently seen in schizophrenia; it has been associated with decreased psychopathology (specifically decreased positive symptoms) and improved psychosocial function. CR is a therapy designed to improve performance in a variety of neurocognitive functions such as attention, memory, and executive functioning; it has been associated with improved cognitive and psychosocial functioning. Both MCT and CR will be compared to treatment as usual (TAU) as done previously (Kumar er al., 2010; Moritz et al., 2011). Hypotheses:

1. 1.MCT will produce greater change in delusions (severity and conviction) than CR and TAU.
2. 2.CR and MCT will produce greater change in social/everyday functioning than TAU.
3. 3.CR will produce greater improvement in basic attention and memory measures relative to MCT and TAU.
4. 4.MCT will produce greater reduction on tasks measuring targeted reasoning biases relative to CR and TAU.
5. 5.CR will increase efficiency of functional networks on a working memory task relative to MCT and TAU.
6. 6.MCT will lead to a greater decrease in the neural response to evidence matches relative to CR and TAU.

Conditions

Psychosis; Schizophrenia; Schizoaffective Disorder; Schizophreniform Disorder

Keywords

Metacognitive training; Cognitive behavioral therapy; Clinical trial; Group intervention; Group therapy; Schizophrenia; Psychosis; Cognitive remediation

Outcome Measures

Primary Outcomes (1)

• Delusion Severity

  Delusion severity will be measured using the Delusions Scale of the Psychotic Symptom Rating Scales (PSYRATS; Haddock, McCarron, Tarrier, \& Faragher, 1999). The PSYRATS Delusion Scale measures more specific aspects of delusions such as conviction and impact on thinking.

  8-12 weeks (post-treatment) relative to baseline (pre-treatment)

Secondary Outcomes (12)

• Symptom Ratings

  4 weeks (midpoint of therapy) relative to baseline (pre-treatment)

• Symptom Ratings

  8-12 weeks (post-treatment) relative to baseline (pre-treatment)

• Cognitive Function

  Pre-treatment (prior to commencement of therapy)

• Cognitive Function

  4 weeks (midpoint of therapy) relative to baseline (pre-treatment)

• Cognitive Function

  8-12 weeks (post-treatment) relative to baseline (pre-treatment)

Study Arms (3)

Metacognitive Training for Psychosis

EXPERIMENTAL

Individuals with psychosis (Schizophrenia, Schizoaffective, Schizophreniform, etc.) who will receive Metacognitive Training twice weekly for 8 weeks (16 sessions).

Behavioral: Metacognitive Training (MCT)

Cognitive Remediation for Psychosis

EXPERIMENTAL

Individuals with psychosis (Schizophrenia, Schizoaffective, Schizophreniform, etc.) who will receive Cognitive Remediation treatment twice weekly for 8 weeks (16 sessions).

Behavioral: Cognitive Remediation (CR)

Treatment as Usual for Psychosis

NO INTERVENTION

Individuals with psychosis (Schizophrenia, Schizoaffective, Schizophreniform, etc.) who will continue to receive treatment as usual (TAU) as defined by their health care team (i.e., medication, other therapies) while still taking part in baseline, midpoint, and end-point assessments.

Interventions

Metacognitive Training (MCT) BEHAVIORAL

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) and can be obtained online at no cost (www.uke.de/mkt). This experimental intervention will consist of two 8-module cycles occurring twice a week for 8 weeks, for a total of 16 sessions. Each module will include a 45 to 60 minute instructor-led group session using PowerPoint slides and homework assignments to facilitate learning. Groups will consist of 4-10 subjects. Subjects will be able to attend the alternate (Cognitive Remediation) group after completion of the MCT group if they wish.

Metacognitive Training for Psychosis

Cognitive Remediation (CR) BEHAVIORAL

The CR group will use a computerized cognitive remediation program that has been used with schizophrenia patients, Scientific Brain Training Pro (SBT Pro; Vianin et al, 2010). Modules focus on attention, working memory, verbal memory, and planning and reasoning. Each session will incorporate psycho-educational group discussion of strategies, and individual work through exercises on personal tablet computers and personalized level of difficulty. The CR treatment will take place twice per week for 8 weeks, for a total of 16 sessions. Groups will consist of 4-10 subjects. Subjects will be able to attend MCT after completion of CR if they wish.

Cognitive Remediation for Psychosis

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Between the ages of 19 to 60 years
• Diagnosis of schizophrenia, schizoaffective disorder or schizophreniform disorder.
• Diagnosis of mood disorder with current psychosis.

You may not qualify if:

• 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.
• A history of severe neurological disorder and those with severe manifestations of hostility, megalomania, formal thought disorder and suspiciousness.
• Subjects who are obtaining ongoing electroconvulsive therapy (ECT)
• Subjects who are consistently disrupting the rest of the group might be asked to leave, this will be at the discretion of the group instructor.
• 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.
• Currently suffer from severe substance dependence.
• Surgery within the last 6 weeks.
• Surgery to the brain, heart or eyes.
• Metal implants
• Metal fragments in or near your eyes.
• Pregnant.
• Recent serious concussion, or loss of consciousness of more than 10 minutes.
• Colour blind
• History of brain damage or other medical problems that may affect comprehension (e.g., seizure disorders, stroke, aneurysm, brain tumor, etc.)

Sponsors & Collaborators

• University of British Columbia: lead
• Vancouver Coastal Health Research Institute: collaborator
• Vancouver General Hospital: collaborator
• Vancouver Coastal Health: collaborator
• VGH and UBC Hospital Foundation: collaborator

Study Sites (1)

UBC Hospital - Detwiller Pavilion

Vancouver, British Columbia, V6T 2A1, Canada

Location

Related Publications (23)

• Barrowclough C, Haddock G, Lobban F, Jones S, Siddle R, Roberts C, Gregg L. Group cognitive-behavioural therapy for schizophrenia. Randomised controlled trial. Br J Psychiatry. 2006 Dec;189:527-32. doi: 10.1192/bjp.bp.106.021386.

  PMID: 17139037 BACKGROUND

• Beck AT, Baruch E, Balter JM, Steer RA, Warman DM. A new instrument for measuring insight: the Beck Cognitive Insight Scale. Schizophr Res. 2004 Jun 1;68(2-3):319-29. doi: 10.1016/S0920-9964(03)00189-0.

  PMID: 15099613 BACKGROUND

• Bechdolf A, Knost B, Nelson B, Schneider N, Veith V, Yung AR, Pukrop R. Randomized comparison of group cognitive behaviour therapy and group psychoeducation in acute patients with schizophrenia: effects on subjective quality of life. Aust N Z J Psychiatry. 2010 Feb;44(2):144-50. doi: 10.3109/00048670903393571.

  PMID: 20113303 BACKGROUND

• Cohen J. A power primer. Psychol Bull. 1992 Jul;112(1):155-9. doi: 10.1037//0033-2909.112.1.155.

  PMID: 19565683 BACKGROUND

• Haddock G, McCarron J, Tarrier N, Faragher EB. Scales to measure dimensions of hallucinations and delusions: the psychotic symptom rating scales (PSYRATS). Psychol Med. 1999 Jul;29(4):879-89. doi: 10.1017/s0033291799008661.

  PMID: 10473315 BACKGROUND

• Lecomte T, Leclerc C, Corbiere M, Wykes T, Wallace CJ, Spidel A. Group cognitive behavior therapy or social skills training for individuals with a recent onset of psychosis? Results of a randomized controlled trial. J Nerv Ment Dis. 2008 Dec;196(12):866-75. doi: 10.1097/NMD.0b013e31818ee231.

  PMID: 19077853 BACKGROUND

• Liddle PF, Ngan ET, Duffield G, Kho K, Warren AJ. Signs and Symptoms of Psychotic Illness (SSPI): a rating scale. Br J Psychiatry. 2002 Jan;180:45-50. doi: 10.1192/bjp.180.1.45.

  PMID: 11772851 BACKGROUND

• Moritz S, Woodward TS. Jumping to conclusions in delusional and non-delusional schizophrenic patients. Br J Clin Psychol. 2005 Jun;44(Pt 2):193-207. doi: 10.1348/014466505X35678.

  PMID: 16004654 BACKGROUND

• Moritz S, Woodward TS. Metacognitive training in schizophrenia: from basic research to knowledge translation and intervention. Curr Opin Psychiatry. 2007 Nov;20(6):619-25. doi: 10.1097/YCO.0b013e3282f0b8ed.

  PMID: 17921766 BACKGROUND

• Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.

  PMID: 9881538 BACKGROUND

• Tarrier N, Yusupoff L, Kinney C, McCarthy E, Gledhill A, Haddock G, Morris J. Randomised controlled trial of intensive cognitive behaviour therapy for patients with chronic schizophrenia. BMJ. 1998 Aug 1;317(7154):303-7. doi: 10.1136/bmj.317.7154.303.

  PMID: 9685273 BACKGROUND

• Woodward TS, Moritz S, Chen EY. The contribution of a cognitive bias against disconfirmatory evidence (BADE) to delusions: a study in an Asian sample with first episode schizophrenia spectrum disorders. Schizophr Res. 2006 Apr;83(2-3):297-8. doi: 10.1016/j.schres.2006.01.015. Epub 2006 Mar 2. No abstract available.

  PMID: 16513331 BACKGROUND

• Woodward TS, Moritz S, Cuttler C, Whitman JC. The contribution of a cognitive bias against disconfirmatory evidence (BADE) to delusions in schizophrenia. J Clin Exp Neuropsychol. 2006 May;28(4):605-17. doi: 10.1080/13803390590949511.

  PMID: 16624787 BACKGROUND

• Woodward TS, Buchy L, Moritz S, Liotti M. A bias against disconfirmatory evidence is associated with delusion proneness in a nonclinical sample. Schizophr Bull. 2007 Jul;33(4):1023-8. doi: 10.1093/schbul/sbm013. Epub 2007 Mar 8.

  PMID: 17347526 BACKGROUND

• Woodward TS, Munz M, LeClerc C, Lecomte T. Change in delusions is associated with change in "jumping to conclusions". Psychiatry Res. 2009 Dec 30;170(2-3):124-7. doi: 10.1016/j.psychres.2008.10.020. Epub 2009 Nov 10.

  PMID: 19906443 BACKGROUND

• Wykes T, Parr AM, Landau S. Group treatment of auditory hallucinations. Exploratory study of effectiveness. Br J Psychiatry. 1999 Aug;175:180-5. doi: 10.1192/bjp.175.2.180.

  PMID: 10627803 BACKGROUND

• Canadian Psychiatric Association. Clinical practice guidelines. Treatment of schizophrenia. Can J Psychiatry. 2005 Nov;50(13 Suppl 1):7S-57S. No abstract available.

  PMID: 16529334 BACKGROUND

• Lecomte, T., Woodward, T. S., & Leclerc, C. (2005). Changes in the jumping-to-conclusions bias are associated with changes in delusions: A longitudinal study involving cognitive behavioural therapy [abstract]. Schizophrenia Research, 31, 365.

  BACKGROUND

• Moritz, S., & Woodward, T. S. (2007a). Metacognitive training for schizophrenia patients (MCT): A pilot study on feasibility, treatment adherence, and subjective efficacy. German Journal of Psychiatry, 10, 69-78.

  BACKGROUND

• Moritz S, Veckenstedt R, Randjbar S, Vitzthum F, Woodward TS. Antipsychotic treatment beyond antipsychotics: metacognitive intervention for schizophrenia patients improves delusional symptoms. Psychol Med. 2011 Sep;41(9):1823-32. doi: 10.1017/S0033291710002618. Epub 2011 Jan 28.

  PMID: 21275083 BACKGROUND

• Bartholomeusz CF, Allott K. Neurocognitive and social cognitive approaches for improving functional outcome in early psychosis: theoretical considerations and current state of evidence. Schizophr Res Treatment. 2012;2012:815315. doi: 10.1155/2012/815315. Epub 2012 Apr 5.

  PMID: 22966447 BACKGROUND

• Wykes T, Huddy V, Cellard C, McGurk SR, Czobor P. A meta-analysis of cognitive remediation for schizophrenia: methodology and effect sizes. Am J Psychiatry. 2011 May;168(5):472-85. doi: 10.1176/appi.ajp.2010.10060855. Epub 2011 Mar 15.

  PMID: 21406461 BACKGROUND

• McGurk SR, Twamley EW, Sitzer DI, McHugo GJ, Mueser KT. A meta-analysis of cognitive remediation in schizophrenia. Am J Psychiatry. 2007 Dec;164(12):1791-802. doi: 10.1176/appi.ajp.2007.07060906.

  PMID: 18056233 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Interventions

Cognitive Remediation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Todd Woodward, PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Mahesh Menon, PhD, RPsych

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 28, 2012
• First Posted: January 9, 2013
• Study Start: January 1, 2013
• Primary Completion: June 1, 2022
• Study Completion: June 1, 2022
• Last Updated: April 11, 2024

Record last verified: 2024-04

Locations

CA (1)