Metacognitive Training and Insight in Schizophrenia

NCT04104347 | Unknown

• 1 other identifier: EC044-19_FJD-HRJC
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

Although insight in schizophrenia spectrum disorders (SSD) has been associated with positive outcomes, the effect size of previous treatments on insight has been relatively small to date. The metacognitive basis of insight suggests that metacognitive training (MCT) may improve insight and clinical outcomes in SSD, although this remains to be established. This single-center, assessor-blind, parallel-group, randomised clinical trial (RCT) aims to investigate the efficacy of MCT for improving insight (primary outcome), including clinical and cognitive insight, which will be measured by the Schedule for Assessment of Insight (Expanded version) (SAI-E) and the Beck Cognitive Insight Scale (BCIS), respectively, in (at least) n=126 outpatients with SSD at three points in time: i) at baseline (Time 0); ii) after treatment (Time 1) and iii) at 1-year follow-up (Time 2). SSD patients receiving MCT and controls attending a non-intervention support group will be compared on insight level changes and several clinical and cognitive secondary outcomes after treatment and at follow-up, whilst adjusting for baseline data. Ecological momentary assessment (EMA) will be piloted to assess functioning in a subsample of participants. This will be the first RCT testing the effect of group MCT on multiple insight dimensions (as primary outcome) in a sample of unselected patients with SSD, including several secondary clinically relevant outcomes, namely symptom severity, functioning, which will also be evaluated with EMA, hospitalizations and suicidal behaviour.

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Keywords

schizophrenia spectrum disorders; metacognitive training; insight; ecological momentary assessment

Outcome Measures

Primary Outcomes (2)

• Change in cognitive insight

  The Spanish version of the Beck Cognitive Insight Scale (BCIS), which is a 15-item self-administered scale which evaluates self-reflectiveness (9 items) and self-certainty (6 items). Each item is rated within a Likert scale ranging from 0 ("I disagree") to 4 ("I totally agree") so they can be summed up to create two subtotal scores, namely self-reflectiveness (ranging from 0 to 36, i.e., higher scores, better insight) and self-certainty (ranging from 0 to 24, where higher scores indicate worse insight). A composite index (CI) can also be calculated by subtracting self-certainty from self-reflectiveness so CI higher scores indicate better insight. Internal consistency was found to be acceptable (Cronbach's α=0.60-0.68).

  Change in cognitive insight will be evaluated after treatment at 2 months (Month 2) and at 12 months (Month 12). Changes from baseline (Day 0) score to Month 2 (Month 2 - Day 0) and from baseline to Month 12 (Month 12 - Day 0) will be calculated.

• Change in clinical insight

  The Spanish version of the Schedule for Assessment of Insight (expanded version) (SAI-E) will assess clinical insight. The SAI-E takes the form of a semi-structured interview which enquires about different aspects of insight by means of items ranging from 0 to 3, 4 ,5, or 7. The SAI-E provides scores on three insight dimensions in line with David's model - illness recognition (scores ranging from 0 to 10), symptom relabeling (scores ranging from 0 to 12), treatment compliance (range: 0-6) - and a total insight score (ranging from 0 to 28). Higher scores indicate better insight.

  Change in clinical insight will be assessed after-treatment at 2 months (Month 2) and at 12 months or follow-up (Month 12). Changes from baseline (Day 0) scores to Month 2 (Month 2-Day0) and from baseline to 12 months (Month 12-Day 0) will be calculated.

Secondary Outcomes (8)

• Change in psychotic symptoms severity

  Change in psychotic symptoms severity will be assessed at 2 months (Month 2) and at 12 months (Month 12). Changes from baseline (Day 0) scores to 2 months (Month 2 - Day 0) and from baseline to 12 months (Month 12 - Day 0) will be calculated.

• Change in depressive symptoms severity

  Change in depressive symptoms severity will be assessed at 2 months (Month 2) and at 12 months (Month 12). Changes from baseline (Day 0) scores to 2 months (Month 2 - Day 0) and from baseline to 12 months (Month 12 - Day 0) will be calculated.

• Hospitalizations

  Number of hospitalizations and length of stay will be considered over the 1-year follow-up trial period.

• Time to first suicidal event

  Data on suicidal behaviour will be collected at 12-month follow-up, which is the trial period.

• Change in General Functioning

  Change in general functioning will be determined at 2 months (Month 2) and at 12 months (Month 12). Changes in scores from baseline (Day 0) to 2 months (MOnth 2 - Day 0) and from baseline to 12 months (Month 12 - Day 0) will be calculated.

Study Arms (2)

Metacognitive training (MCT)

EXPERIMENTAL

Other: Metacognitive training (MCT)

Support group

ACTIVE COMPARATOR

Other: Support group

Interventions

Metacognitive training (MCT) OTHER

Metacognitive Training (MCT) was first developed in Germany in 2007 by Steffen Moritz and Todd Woodward (Moritz \& Woodward, 2007) targeting positive psychotic symptoms of patients with schizophrenia. MCT aims to change cognitive biases leading to delusional beliefs and consists of ten group sessions focused on different topics (Modules) as follows: Attributional Style (Module 1), Jumping to Conclusions (Modules 2 and 7), Changing Beliefs (Module 3), Empathy (Modules 4 and 6), Memory (Modules 5), Depression and Self-Esteem (Module 8) and two additional modules, namely Self-Esteem (Module 9) and Stigma (Module 10). Modules 8 (Self-Esteem), 9 (Self-Esteem) and 10 (Stigma) can be delivered together as one session so the intervention totals eight weekly group (3-10 participants) sessions. The MCT manual is available at: http://www.uke.de/mkt and was directly supervised by Steffen Moritz.

Metacognitive training (MCT)

Support group OTHER

Controls will attend eight weekly support groups. Seven group sessions will focus on the following topics: 1) basic activities of daily living (BADL), 2) instrumental activities of daily living (IADL), 3) physical health, 4) press-based work, 5) psychoeducation on emotions, 6) psychoeducation on illness, 7) social and family relationships. One additional session will give participants some time to openly raise general issues and concerns which were not discussed during the above sessions. Controls will be encouraged to attend these group sessions from which they are likely to benefit. While not an intervention as such, this should turn into enough incentive to reach similar attendance rates in both arms of the RCT.

Support group

Eligibility Criteria

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

You may qualify if:

• Age: 18-64 years, both inclusive
• Diagnosis: schizophrenia spectrum disorder (F20-F29, ICD-10)
• Outpatient status

You may not qualify if:

• IQ≤70 as measured by the short form of the Wechsler Adults Intelligence Scale (WAIS) (Wechsler, 1981).
• History of head injury and/or a neurological condition.
• Having received a metacognitively oriented therapy within the previous 12 months.
• Low level of Spanish.
• Lack of cooperativeness with the assessment and/or "intervention".

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead
• Universidad Autonoma de Madrid: collaborator

Study Sites (1)

Hospital Universitario Fundación JIménez Díaz

Madrid, 28040, Spain

RECRUITING

Related Publications (60)

• Morgan C, Lappin J, Heslin M, Donoghue K, Lomas B, Reininghaus U, Onyejiaka A, Croudace T, Jones PB, Murray RM, Fearon P, Doody GA, Dazzan P. Reappraising the long-term course and outcome of psychotic disorders: the AESOP-10 study. Psychol Med. 2014 Oct;44(13):2713-26. doi: 10.1017/S0033291714000282. Epub 2014 Feb 26.

  PMID: 25066181 BACKGROUND

• Lysaker PH, Pattison ML, Leonhardt BL, Phelps S, Vohs JL. Insight in schizophrenia spectrum disorders: relationship with behavior, mood and perceived quality of life, underlying causes and emerging treatments. World Psychiatry. 2018 Feb;17(1):12-23. doi: 10.1002/wps.20508.

  PMID: 29352540 BACKGROUND

• Pijnenborg GH, van Donkersgoed RJ, David AS, Aleman A. Changes in insight during treatment for psychotic disorders: a meta-analysis. Schizophr Res. 2013 Mar;144(1-3):109-17. doi: 10.1016/j.schres.2012.11.018. Epub 2013 Jan 8.

  PMID: 23305612 BACKGROUND

• Pijnenborg GH, Timmerman ME, Derks EM, Fleischhacker WW, Kahn RS, Aleman A. Differential effects of antipsychotic drugs on insight in first episode schizophrenia: Data from the European First-Episode Schizophrenia Trial (EUFEST). Eur Neuropsychopharmacol. 2015 Jun;25(6):808-16. doi: 10.1016/j.euroneuro.2015.02.012. Epub 2015 Apr 20.

  PMID: 25907250 BACKGROUND

• Cooke MA, Peters ER, Kuipers E, Kumari V. Disease, deficit or denial? Models of poor insight in psychosis. Acta Psychiatr Scand. 2005 Jul;112(1):4-17. doi: 10.1111/j.1600-0447.2005.00537.x.

  PMID: 15952940 BACKGROUND

• Cuesta MJ, Peralta V, Campos MS, Garcia-Jalon E. Can insight be predicted in first-episode psychosis patients? A longitudinal and hierarchical analysis of predictors in a drug-naive sample. Schizophr Res. 2011 Aug;130(1-3):148-56. doi: 10.1016/j.schres.2011.04.032. Epub 2011 May 31.

  PMID: 21632216 BACKGROUND

• Aleman A, Agrawal N, Morgan KD, David AS. Insight in psychosis and neuropsychological function: meta-analysis. Br J Psychiatry. 2006 Sep;189:204-12. doi: 10.1192/bjp.189.3.204.

  PMID: 16946354 BACKGROUND

• Flavell JH. Metacognition and cognitive monitoring: a new area of cognitive-developmental inquiry. Am Psychol. 1979;34:906-911

  BACKGROUND

• Wells A, Purdon C. Metacognition and cognitive-behaviour therapy: A special issue. Clin Psychol Psychoter. 1999;6(2):71-2.

  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

• Dimaggio G, Lysaker, PH. Metacognition and Severe Adult Mental Disorders. From Research to Treatment. 1st ed. New York; Routledge; 2010.

  BACKGROUND

• Nair A, Palmer EC, Aleman A, David AS. Relationship between cognition, clinical and cognitive insight in psychotic disorders: a review and meta-analysis. Schizophr Res. 2014 Jan;152(1):191-200. doi: 10.1016/j.schres.2013.11.033. Epub 2013 Dec 16.

  PMID: 24355529 BACKGROUND

• Moritz S, Woodward T S. Metacognitive Training for schizophrenia patients (MCT): A pilot study on feasibility, treatment adherence, and subjective efficacy. German Journal of Psychiatry. 2007;10(3):69-78.

  BACKGROUND

• Moritz S, Andreou C, Schneider BC, Wittekind CE, Menon M, Balzan RP, Woodward TS. Sowing the seeds of doubt: a narrative review on metacognitive training in schizophrenia. Clin Psychol Rev. 2014 Jun;34(4):358-66. doi: 10.1016/j.cpr.2014.04.004. Epub 2014 May 6.

  PMID: 24866025 BACKGROUND

• Jiang J, Zhang L, Zhu Z, Li W, Li C. Metacognitive training for schizophrenia: a systematic review. Shanghai Arch Psychiatry. 2015 Jun 25;27(3):149-57. doi: 10.11919/j.issn.1002-0829.215065.

  PMID: 26300597 BACKGROUND

• Eichner C, Berna F. Acceptance and Efficacy of Metacognitive Training (MCT) on Positive Symptoms and Delusions in Patients With Schizophrenia: A Meta-analysis Taking Into Account Important Moderators. Schizophr Bull. 2016 Jul;42(4):952-62. doi: 10.1093/schbul/sbv225. Epub 2016 Jan 8.

  PMID: 26748396 BACKGROUND

• Liu YC, Tang CC, Hung TT, Tsai PC, Lin MF. The Efficacy of Metacognitive Training for Delusions in Patients With Schizophrenia: A Meta-Analysis of Randomized Controlled Trials Informs Evidence-Based Practice. Worldviews Evid Based Nurs. 2018 Apr;15(2):130-139. doi: 10.1111/wvn.12282. Epub 2018 Feb 28.

  PMID: 29489070 BACKGROUND

• Philipp R, Kriston L, Lanio J, Kuhne F, Harter M, Moritz S, Meister R. Effectiveness of metacognitive interventions for mental disorders in adults-A systematic review and meta-analysis (METACOG). Clin Psychol Psychother. 2019 Mar;26(2):227-240. doi: 10.1002/cpp.2345. Epub 2018 Dec 16.

  PMID: 30456821 BACKGROUND

• van Oosterhout B, Smit F, Krabbendam L, Castelein S, Staring AB, van der Gaag M. Metacognitive training for schizophrenia spectrum patients: a meta-analysis on outcome studies. Psychol Med. 2016 Jan;46(1):47-57. doi: 10.1017/S0033291715001105. Epub 2015 Jul 20.

  PMID: 26190517 BACKGROUND

• Vohs JL, Leonhardt BL, James AV, Francis MM, Breier A, Mehdiyoun N, Visco AC, Lysaker PH. Metacognitive Reflection and Insight Therapy for Early Psychosis: A preliminary study of a novel integrative psychotherapy. Schizophr Res. 2018 May;195:428-433. doi: 10.1016/j.schres.2017.10.041. Epub 2017 Nov 3.

  PMID: 29108671 BACKGROUND

• de Jong S, van Donkersgoed RJM, Timmerman ME, Aan Het Rot M, Wunderink L, Arends J, van Der Gaag M, Aleman A, Lysaker PH, Pijnenborg GHM. Metacognitive reflection and insight therapy (MERIT) for patients with schizophrenia. Psychol Med. 2019 Jan;49(2):303-313. doi: 10.1017/S0033291718000855. Epub 2018 Apr 25.

  PMID: 29692285 BACKGROUND

• Pijnenborg GHM, de Vos AE, Timmerman ME, Van der Gaag M, Sportel BE, Arends J, Koopmans EM, Van der Meer L, Aleman A. Social cognitive group treatment for impaired insight in psychosis: A multicenter randomized controlled trial. Schizophr Res. 2019 Apr;206:362-369. doi: 10.1016/j.schres.2018.10.018. Epub 2018 Nov 12.

  PMID: 30429078 BACKGROUND

• David AS. Insight and psychosis. Br J Psychiatry. 1990 Jun;156:798-808. doi: 10.1192/bjp.156.6.798.

  PMID: 2207510 BACKGROUND

• Amador XF, David AS. Insight and Psychosis. Awareness of Illness in Schizophrenia and Related Disorders. 2nd ed. New York: Oxford University Press; 2004.

  BACKGROUND

• Amador XF, Strauss DH, Yale SA, Flaum MM, Endicott J, Gorman JM. Assessment of insight in psychosis. Am J Psychiatry. 1993 Jun;150(6):873-9. doi: 10.1176/ajp.150.6.873.

  PMID: 8494061 BACKGROUND

• . Kemp R, David AS. Insight and Compliance. In: Blackwell, B editor. Treatment Compliance and the Therapeutic Alliance in Serious Mental Illness. The Netherlands: Harwood Academic Publishers; 1997. p. 61-86

  BACKGROUND

• Barrigon ML, Berrouiguet S, Carballo JJ, Bonal-Gimenez C, Fernandez-Navarro P, Pfang B, Delgado-Gomez D, Courtet P, Aroca F, Lopez-Castroman J, Artes-Rodriguez A, Baca-Garcia E; MEmind study group. User profiles of an electronic mental health tool for ecological momentary assessment: MEmind. Int J Methods Psychiatr Res. 2017 Mar;26(1):e1554. doi: 10.1002/mpr.1554. Epub 2017 Mar 9.

  PMID: 28276176 BACKGROUND

• Berrouiguet S, Ramirez D, Barrigon ML, Moreno-Munoz P, Carmona Camacho R, Baca-Garcia E, Artes-Rodriguez A. Combining Continuous Smartphone Native Sensors Data Capture and Unsupervised Data Mining Techniques for Behavioral Changes Detection: A Case Series of the Evidence-Based Behavior (eB2) Study. JMIR Mhealth Uhealth. 2018 Dec 10;6(12):e197. doi: 10.2196/mhealth.9472.

  PMID: 30530465 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

• Wechsler D. The Wechsler Adult Intelligence Scale-Revised. New York: The Psychological Corporation; 1981.

  BACKGROUND

• Reitan R. Validity of the Trail Making Test as an indicator of organic brain damage. Perceptual and Motor Skills. 1958;8(3):271-6

  BACKGROUND

• Lopez-Morinigo JD, Di Forti M, Ajnakina O, Wiffen BD, Morgan K, Doody GA, Jones PB, Ayesa-Arriola R, Canal-Rivero M, Crespo-Facorro B, Murray RM, Dazzan P, Morgan C, Dutta R, David AS. Insight and risk of suicidal behaviour in two first-episode psychosis cohorts: Effects of previous suicide attempts and depression. Schizophr Res. 2019 Feb;204:80-89. doi: 10.1016/j.schres.2018.09.016. Epub 2018 Sep 22.

  PMID: 30253893 BACKGROUND

• Soriano-Barceló J, López-Moríñigo JD, Ramos-Ríos R, Rodríguez-Zanabria EA, David AS. Insight assessment in psychosis and psychopathological correlates: Validation of the Spanish version of the Schedule for Assessment of Insight - Expanded Version. Eur J Psychiat. 2016;30(1):55-65

  BACKGROUND

• Sanz M, Constable G, Lopez-Ibor I, Kemp R, David AS. A comparative study of insight scales and their relationship to psychopathological and clinical variables. Psychol Med. 1998 Mar;28(2):437-46. doi: 10.1017/s0033291797006296.

  PMID: 9572100 BACKGROUND

• Morgan KD, Dazzan P, Morgan C, Lappin J, Hutchinson G, Suckling J, Fearon P, Jones PB, Leff J, Murray RM, David AS. Insight, grey matter and cognitive function in first-onset psychosis. Br J Psychiatry. 2010 Aug;197(2):141-8. doi: 10.1192/bjp.bp.109.070888.

  PMID: 20679268 BACKGROUND

• Gutierrez-Zotes JA, Valero J, Cortes MJ, Labad A, Ochoa S, Ahuir M, Carlson J, Bernardo M, Canizares S, Escartin G, Canete J, Gallo P, Salamero M. Spanish adaptation of the Beck Cognitive Insight Scale (BCIS) for schizophrenia. Actas Esp Psiquiatr. 2012 Jan-Feb;40(1):2-9. Epub 2012 Jan 1.

  PMID: 22344490 BACKGROUND

• Ochoa S, Lopez-Carrilero R, Barrigon ML, Pousa E, Barajas A, Lorente-Rovira E, Gonzalez-Higueras F, Grasa E, Ruiz-Delgado I, Cid J, Birules I, Esteban-Pinos I, Casanas R, Luengo A, Torres-Hernandez P, Corripio I, Montes-Gamez M, Beltran M, De Apraiz A, Dominguez-Sanchez L, Sanchez E, Llacer B, Pelaez T, Bogas JL, Moritz S; Spanish Metacognition Study Group. Randomized control trial to assess the efficacy of metacognitive training compared with a psycho-educational group in people with a recent-onset psychosis. Psychol Med. 2017 Jul;47(9):1573-1584. doi: 10.1017/S0033291716003421. Epub 2017 Feb 7.

  PMID: 28166848 BACKGROUND

• Peralta V, Cuesta MJ. Psychometric properties of the positive and negative syndrome scale (PANSS) in schizophrenia. Psychiatry Res. 1994 Jul;53(1):31-40. doi: 10.1016/0165-1781(94)90093-0.

  PMID: 7991730 BACKGROUND

• Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.

  PMID: 3616518 BACKGROUND

• Wallwork RS, Fortgang R, Hashimoto R, Weinberger DR, Dickinson D. Searching for a consensus five-factor model of the Positive and Negative Syndrome Scale for schizophrenia. Schizophr Res. 2012 May;137(1-3):246-50. doi: 10.1016/j.schres.2012.01.031. Epub 2012 Feb 21.

  PMID: 22356801 BACKGROUND

• Addington D, Addington J, Maticka-Tyndale E, Joyce J. Reliability and validity of a depression rating scale for schizophrenics. Schizophr Res. 1992 Mar;6(3):201-8. doi: 10.1016/0920-9964(92)90003-n.

  PMID: 1571313 BACKGROUND

• Endicott J, Spitzer RL, Fleiss JL, Cohen J. The global assessment scale. A procedure for measuring overall severity of psychiatric disturbance. Arch Gen Psychiatry. 1976 Jun;33(6):766-71. doi: 10.1001/archpsyc.1976.01770060086012.

  PMID: 938196 BACKGROUND

• World Health Organization (WHO). WHO Disability Assessment Schedule 2.0 (WHODAS 2.0). 2010 [Available from: http://www.who.int/classifications/icf/whodasii/en/]. Accessed 22 May 2019.

  BACKGROUND

• Carlson J, Ochoa S, Haro JM, Escartin G, Ahuir M, Gutierrez-Zotes A, Salamero M, Valero J, Canizares S, Bernardo M, Canete J, Gallo P. Adaptation and validation of the quality-of-life scale: Satisfaction with Life Domains Scale by Baker and Intagliata. Compr Psychiatry. 2009 Jan-Feb;50(1):76-80. doi: 10.1016/j.comppsych.2008.05.008. Epub 2008 Aug 23.

  PMID: 19059518 BACKGROUND

• Insel TR. Digital Phenotyping: Technology for a New Science of Behavior. JAMA. 2017 Oct 3;318(13):1215-1216. doi: 10.1001/jama.2017.11295. No abstract available.

  PMID: 28973224 BACKGROUND

• Singh SP, Cooper JE, Fisher HL, Tarrant CJ, Lloyd T, Banjo J, Corfe S, Jones P. Determining the chronology and components of psychosis onset: The Nottingham Onset Schedule (NOS). Schizophr Res. 2005 Dec 1;80(1):117-30. doi: 10.1016/j.schres.2005.04.018. Epub 2005 Jun 22.

  PMID: 15978778 BACKGROUND

• Cannon-Spoor HE, Potkin SG, Wyatt RJ. Measurement of premorbid adjustment in chronic schizophrenia. Schizophr Bull. 1982;8(3):470-84. doi: 10.1093/schbul/8.3.470.

  PMID: 7134891 BACKGROUND

• Brett-Jones J, Garety P, Hemsley D. Measuring delusional experiences: a method and its application. Br J Clin Psychol. 1987 Nov;26(4):257-65. doi: 10.1111/j.2044-8260.1987.tb01359.x.

  PMID: 3427248 BACKGROUND

• Corcoran R, Mercer G, Frith CD. Schizophrenia, symptomatology and social inference: investigating "theory of mind" in people with schizophrenia. Schizophr Res. 1995 Sep;17(1):5-13. doi: 10.1016/0920-9964(95)00024-g.

  PMID: 8541250 BACKGROUND

• Gil D, Fernandez-Modamio M, Bengochea R, Arrieta M. [Adaptation of the Hinting Task theory of the mind test to Spanish]. Rev Psiquiatr Salud Ment. 2012 Apr-Jun;5(2):79-88. doi: 10.1016/j.rpsm.2011.11.004. Epub 2012 Jan 20. Spanish.

  PMID: 22854578 BACKGROUND

• Baron-Cohen S, Wheelwright S, Jolliffe T. Is There a

  BACKGROUND

• Cohen J. Statistical Power Analysis for the Behavioral Sciences. 2nd ed. New York: Routledge Academic; 1988.

  BACKGROUND

• Cox D. Regression models and life tables (with discussions). J R Stat Soc. 1972;34:187-220.

  BACKGROUND

• Lysaker PH, Roe D, Yanos PT. Toward understanding the insight paradox: internalized stigma moderates the association between insight and social functioning, hope, and self-esteem among people with schizophrenia spectrum disorders. Schizophr Bull. 2007 Jan;33(1):192-9. doi: 10.1093/schbul/sbl016. Epub 2006 Aug 7.

  PMID: 16894025 BACKGROUND

• National Institute for Health and Clinical Excellence (NICE). Clinical Guidance 178 Schizophrenia and psychosis. 2014 [Available from: http://www.nice.org.uk/Guidance/CG178]. Accessed 22 May 2019.

  BACKGROUND

• Drake RE, Gates C, Whitaker A, Cotton PG. Suicide among schizophrenics: a review. Compr Psychiatry. 1985 Jan-Feb;26(1):90-100. doi: 10.1016/0010-440x(85)90053-7. No abstract available.

  PMID: 3881217 BACKGROUND

• Restifo K, Harkavy-Friedman JM, Shrout PE. Suicidal behavior in schizophrenia: a test of the demoralization hypothesis. J Nerv Ment Dis. 2009 Mar;197(3):147-53. doi: 10.1097/NMD.0b013e318199f452.

  PMID: 19282679 BACKGROUND

• Schizophrenia Commission. The Abandoned Illness: A Report by the Schizophrenia Commission. Rethink Mental Illness, 2012.

  BACKGROUND

• Lopez-Morinigo JD, Barrigon ML, Porras-Segovia A, Ruiz-Ruano VG, Escribano Martinez AS, Escobedo-Aedo PJ, Sanchez Alonso S, Mata Iturralde L, Munoz Lorenzo L, Artes-Rodriguez A, David AS, Baca-Garcia E. Use of Ecological Momentary Assessment Through a Passive Smartphone-Based App (eB2) by Patients With Schizophrenia: Acceptability Study. J Med Internet Res. 2021 Jul 26;23(7):e26548. doi: 10.2196/26548.

  PMID: 34309576 DERIVED

• Lopez-Morinigo JD, Ruiz-Ruano VG, Martinez ASE, Estevez MLB, Mata-Iturralde L, Munoz-Lorenzo L, Sanchez-Alonso S, Artes-Rodriguez A, David AS, Baca-Garcia E. Study protocol of a randomised clinical trial testing whether metacognitive training can improve insight and clinical outcomes in schizophrenia. BMC Psychiatry. 2020 Jan 29;20(1):30. doi: 10.1186/s12888-020-2431-x.

  PMID: 31996174 DERIVED

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations

Study Officials

• Javier-David Lopez-Morinigo, MB BS, PhD

  Hospital Universitario Fundacion Jiménez Díaz. Universidad Autónoma de Madrid. Madrid (Spain)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier-David Lopez-Morinigo, MB BS, PhD

CONTACT

+34 627277126; javierd.lopez@uam.es

Enrique Baca-García, MB BS, PhD

CONTACT

+34 626932936; Ebaca@quironsalud.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: After the baseline (Time 0) assessment participants are randomised to either MCT or the control group through a computerized plan (no stratification factors) in blocks of 10 subjects (maximum number of each group) and assessor-patient blind. Only one co-principal investigator of the project (EBG) has access to the randomisation plan, but the assessor (JDLM) is not informed of the patient's allocation arm. Also, big efforts will be made on the ground to reduce the risk that the assessor (JDLM) may become accidentally unblinded and patients are reminded that they should not disclose their group assignment at any time. At the end of the baseline assessment, participants receive an envelope with the intervention assignment from an independent administrator who is not involved in the research team. Hence, assessor-blindness is guaranteed at all times throughout the study period since the assessor (JDLM) is not involved in the randomization plan or the active interventions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This single-center, assessor-blind, parallel-group, randomised clinical trial (RCT) aims to investigate the efficacy of MCT for improving insight (primary outcome), including clinical and cognitive insight, which will be measured by the Schedule for Assessment of Insight (Expanded version) (SAI-E) and the Beck Cognitive Insight Scale (BCIS), respectively, in (at least) n=126 outpatients with SSD at three points in time: i) at baseline (Time 0); ii) after treatment (Time 1) and iii) at 1-year follow-up (Time 2). SSD patients receiving MCT and controls attending a non-intervention support group will be compared on insight level changes and several clinical and cognitive secondary outcomes at Time 1 and at Time T2, whilst adjusting for baseline data. Ecological momentary assessment (EMA) will be piloted to assess functioning in a subsample of participants.

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: September 26, 2019
• Study Start: June 10, 2019
• Primary Completion: December 31, 2020
• Study Completion: January 15, 2021
• Last Updated: October 2, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: At the end of the baseline data collection, that is, by April 2020, baseline data will become available to other researchers, provided the access criteria below are complied with.
• Access Criteria: * An application needs to be made by an independent researcher which will have to specify: * Variables on which data are requested need to be listed. * Inclusion/exclusion criteria of participants. * Brief summary of the study protocol (e.g. specific outcome measures). * Statistical analysis plan * Results publication plan. Prior to submitting a manuscript for publication including findings from our dataset, this manuscript will have to be approved, including the relevant email, by the principal investigator of this project, (JDLM). * Ethical approval from the applicant's local Research Ethics Committee. * Ethical approval from our local Research Ethics Committee.

Locations

ES (1)