Metacognitive Training for Negative Symptoms

NCT06127004 | Recruiting

• 2 other identifiers: Region SörmlandDepartment of Medical Sciences
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

There is a clear rationale for developing interventions targeting negative symptoms of schizophrenia as these are a stronger indicator of current and future functioning than positive symptoms and because they respond poorly to medication and existing psychological interventions. This is reflected in the NIMH-MATRICS consensus statement that emphasised that persistent negative symptoms represent an unmet therapeutic need for patients suffering from schizophrenia. The purpose of this study is to evaluate, in a scientific manner, the intervention developed by Swanson et al. 2021: Metacognitive Training (MCT) Minus. The MCT was adapted to target negative symptoms in psychotic disorders (e.g. schizophrenia, schizoaffective or non-affective functional psychosis) as the original version of the intervention focused exclusively on positive symptoms. The specific aim is to study whether MCT Minus is a promising treatment for the intended population in terms of reductions in negative symptoms, severity of defeatist attitudes, internalised stigma, and depression as well as improvements in reflective ability and overall functioning. The research will add to existing research by identifying and measuring potential mechanisms of change for negative symptoms (i.e., defeatist attitudes, reflective functioning, stigma and depression). It will also add to the existing evidence base by measuring whether the cognitive biases addressed in MCT lead to changes in the wider conceptualisation of metacognition used elsewhere and whether the promising results seen in the feasibility study of MCT Minus can be replicated in a randomised controlled trial (RCT) with a control group and a blinded assessor. The researchers also hope to replicate the findings of a previous study, where MCT was found to be related to the modulation of default-mode network (DMN) homogeneity in schizophrenia, an area thought to be involved in self- and other-reflectivity.

Conditions

Negative Symptoms in Schizophrenia

Outcome Measures

Primary Outcomes (3)

• The Clinical Assessment Interview for Negative Symptoms (CAINS) (Forbes et al., 2011)

  Clincial interview to assess negative symptoms. Minimum value is 0 = better outcome. Maximum value is 52 = worse outcome.

  15 minutes

• The Motivation and Pleasure Scale- Self-Report (MAP-SR) (Llerena et al., 2013)

  Self-rated questionnaire to assess negative symptoms Minimum value is 0 = better outcome. Maximum value is 90 = worse outcome.

  5 minutes

• The Positive and Negative Syndrome Scale (PANSS) (Kay et al., 1987)

  Clinical interview to assess negative symptoms (analysed with the five factor-model) Minimum value is 0 = better outcome. Maximum value is 210 = worse outcome.

  20 minutes

Secondary Outcomes (5)

• The Dysfunctional Attitudes Scale (DAS) (Weissman & Beck, 1978)

  5 minutes

• The Reflective Functioning Questionnaire (RFQ-8) (Fonagy et al., 2016)

  5 minutes

• The Internalized Stigma of Mental Illness Scale-9 (ISMI-9) (Hammer & Toland, 2017)

  5 minutes

• The Calgary Depression Scale for Schizophrenia (CDSS) (Addington, Addington, & Schissel, 1990)

  10 minutes

• The World Health Organization (WHO) Disability Assessment Schedule (WHODAS) 2.0 (WHO, 2010)

  10 minutes

Study Arms (2)

Metacognitive Training for Negative Symptoms

EXPERIMENTAL

The original MCT intervention was adapted to negative symptoms by incorporating psychoeducation and strategies to target the cognitions suggested by the cognitive model (Beck et al., 2009) to be implicated in the development and/or maintenance of negative symptoms. Although some of the strategies have traditionally been used to target positive symptoms, it is assumed that the same reasoning styles lead to negative symptoms through the dysfunctional cognitions discussed previously (e.g., jumping to conclusions in regard to social rejection and a dysfunctional attribution style reinforcing social withdrawal). Metacognitive training for negative symptoms consists of eight sessions, delivered individually as there is evidence indicating that this approach may lead to stronger effect sizes than delivery in a group format (Liu et al., 2018). The developer of MCT (Professor Steffen Moritz) approved the modification.

Other: Metacognitive Training for Negative Symptoms (MCT)

Control group

ACTIVE COMPARATOR

Supportive Counselling (8 sessions) will be used as a control. Participants enrolled in this condition can then get the intervention if they request this.

Other: Supportive Counselling

Interventions

Metacognitive Training for Negative Symptoms (MCT) OTHER

See arm/group descriptions

Metacognitive Training for Negative Symptoms

Supportive Counselling OTHER

Se arm/group descriptions

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Over the age of 18
• Clinical diagnosis of schizophrenia, delusional disorder or non-affective psychosis
• Resident in Region Sörmland, Region Västmanland or Region Uppland

You may not qualify if:

• Evidence of severe organic brain dysfunction
• Learning disabilities
• Difficulty with the Swedish language
• Visual and/or hearing impairment
• Being unable or unwilling to provide written informed consent

Sponsors & Collaborators

• Sormland County Council, Sweden: lead
• Uppsala County Council, Sweden: collaborator
• Västmanland County Council, Sweden: collaborator

Study Sites (1)

Region Sörmland

Multiple Locations, Sweden

RECRUITING

Related Publications (67)

• Addington D, Addington J, Schissel B. A depression rating scale for schizophrenics. Schizophr Res. 1990 Jul-Aug;3(4):247-51. doi: 10.1016/0920-9964(90)90005-r.

  PMID: 2278986 BACKGROUND

• Aleman A, Lincoln TM, Bruggeman R, Melle I, Arends J, Arango C, Knegtering H. Treatment of negative symptoms: Where do we stand, and where do we go? Schizophr Res. 2017 Aug;186:55-62. doi: 10.1016/j.schres.2016.05.015. Epub 2016 Jun 9.

  PMID: 27293137 BACKGROUND

• American Psychiatric Association (APA). (1987). Diagnostic and statistical manual of mental disorders (3rd edition, revised) (DSM-III-TR). APA.

  BACKGROUND

• Austin, S. F., Lysaker, P. H., Jansen, J. E., Trauelsen, A. M., Nielsen, H.-G. L., Pedersen, M. B., Haahr, U. H., & Simonsen, E. (2019). Metacognitive capacity and negative symptoms in first episode psychosis: Evidence of a prospective relationship over a 3-year follow-up. Journal of Experimental Psychopathology, 10(1). doi: 10.1177/2043808718821572

  BACKGROUND

• Beck, A. T., Rector, N. A., Stolar, N., & Grant, P. (2009). Schizophrenia: cognitive theory, research and therapy. Guilford Press.

  BACKGROUND

• Beck AT, Himelstein R, Grant PM. In and out of schizophrenia: Activation and deactivation of the negative and positive schemas. Schizophr Res. 2019 Jan;203:55-61. doi: 10.1016/j.schres.2017.10.046. Epub 2017 Nov 21.

  PMID: 29169775 BACKGROUND

• Bentall, R. P., Simpson, P. W., Lee, D. A., Williams, S., Elves, S., Brabbins, C., & Morrison, A. P. (2010). Motivation and avolition in schizophrenia patients: The role of self-efficacy. Psychosis, 2(1), 12-22. doi: 10.1080/17522430903505966

  BACKGROUND

• Birules I, Lopez-Carrilero R, Cuadras D, Pousa E, Barrigon ML, Barajas A, Lorente-Rovira E, Gonzalez-Higueras F, Grasa E, Ruiz-Delgado I, Cid J, de Apraiz A, Montserrat R, Pelaez T, Moritz S, The Spanish Metacognition Study Group, Ochoa S. Cognitive Insight in First-Episode Psychosis: Changes during Metacognitive Training. J Pers Med. 2020 Nov 27;10(4):253. doi: 10.3390/jpm10040253.

  PMID: 33260823 BACKGROUND

• Braun, V., & Clarke, V. (2006). Using thematic analysis in psychology. Qualitative Research in Psychology, 3(2), 77-101. doi: 10.1191/1478088706qp063oa

  BACKGROUND

• Campellone TR, Sanchez AH, Kring AM. Defeatist Performance Beliefs, Negative Symptoms, and Functional Outcome in Schizophrenia: A Meta-analytic Review. Schizophr Bull. 2016 Nov;42(6):1343-1352. doi: 10.1093/schbul/sbw026. Epub 2016 Mar 15.

  PMID: 26980144 BACKGROUND

• Correll CU, Schooler NR. Negative Symptoms in Schizophrenia: A Review and Clinical Guide for Recognition, Assessment, and Treatment. Neuropsychiatr Dis Treat. 2020 Feb 21;16:519-534. doi: 10.2147/NDT.S225643. eCollection 2020.

  PMID: 32110026 BACKGROUND

• Cox C, Jolley S, Johns L. Understanding and treating amotivation in people with psychosis: An experimental study of the role of guided imagery. Psychiatry Res. 2016 Dec 30;246:387-391. doi: 10.1016/j.psychres.2016.09.047. Epub 2016 Sep 28.

  PMID: 27788457 BACKGROUND

• Faith LA, Lecomte T, Corbiere M, Francoeur A, Hache-Labelle C, Lysaker PH. Metacognition Is Uniquely Related to Concurrent and Prospective Assessments of Negative Symptoms Independent of Verbal Memory in Serious Mental Illness. J Nerv Ment Dis. 2020 Nov;208(11):837-842. doi: 10.1097/NMD.0000000000001219.

  PMID: 32740145 BACKGROUND

• Flavell, J. H. (1979). Metacognition and cognitive monitoring: A new area of cognitive-developmental inquiry. American Psychologist, 34(10), 906-911. doi: 10.1037/0003-066X.34.10.906

  BACKGROUND

• Fonagy P, Luyten P, Moulton-Perkins A, Lee YW, Warren F, Howard S, Ghinai R, Fearon P, Lowyck B. Development and Validation of a Self-Report Measure of Mentalizing: The Reflective Functioning Questionnaire. PLoS One. 2016 Jul 8;11(7):e0158678. doi: 10.1371/journal.pone.0158678. eCollection 2016.

  PMID: 27392018 BACKGROUND

• Forbes C, Blanchard JJ, Bennett M, Horan WP, Kring A, Gur R. Initial development and preliminary validation of a new negative symptom measure: the Clinical Assessment Interview for Negative Symptoms (CAINS). Schizophr Res. 2010 Dec;124(1-3):36-42. doi: 10.1016/j.schres.2010.08.039. Epub 2010 Sep 24.

  PMID: 20869848 BACKGROUND

• Fox-Wasylyshyn SM, El-Masri MM. Handling missing data in self-report measures. Res Nurs Health. 2005 Dec;28(6):488-95. doi: 10.1002/nur.20100.

  PMID: 16287052 BACKGROUND

• Fusar-Poli P, Papanastasiou E, Stahl D, Rocchetti M, Carpenter W, Shergill S, McGuire P. Treatments of Negative Symptoms in Schizophrenia: Meta-Analysis of 168 Randomized Placebo-Controlled Trials. Schizophr Bull. 2015 Jul;41(4):892-9. doi: 10.1093/schbul/sbu170. Epub 2014 Dec 20.

  PMID: 25528757 BACKGROUND

• Galderisi S, Mucci A, Buchanan RW, Arango C. Negative symptoms of schizophrenia: new developments and unanswered research questions. Lancet Psychiatry. 2018 Aug;5(8):664-677. doi: 10.1016/S2215-0366(18)30050-6. Epub 2018 Mar 27.

  PMID: 29602739 BACKGROUND

• Galderisi S, Mucci A, Dollfus S, Nordentoft M, Falkai P, Kaiser S, Giordano GM, Vandevelde A, Nielsen MO, Glenthoj LB, Sabe M, Pezzella P, Bitter I, Gaebel W. EPA guidance on assessment of negative symptoms in schizophrenia. Eur Psychiatry. 2021 Feb 18;64(1):e23. doi: 10.1192/j.eurpsy.2021.11.

  PMID: 33597064 BACKGROUND

• Garcia-Mieres H, Lundin NB, Minor KS, Dimaggio G, Popolo R, Cheli S, Lysaker PH. A cognitive model of diminished expression in schizophrenia: The interface of metacognition, cognitive symptoms and language disturbances. J Psychiatr Res. 2020 Dec;131:169-176. doi: 10.1016/j.jpsychires.2020.09.008. Epub 2020 Sep 14.

  PMID: 32979692 BACKGROUND

• Garcia-Mieres H, Nino-Robles N, Ochoa S, Feixas G. Exploring identity and personal meanings in psychosis using the repertory grid technique: A systematic review. Clin Psychol Psychother. 2019 Nov;26(6):717-733. doi: 10.1002/cpp.2394. Epub 2019 Aug 26.

  PMID: 31412423 BACKGROUND

• Granholm E, Holden J, Worley M. Improvement in Negative Symptoms and Functioning in Cognitive-Behavioral Social Skills Training for Schizophrenia: Mediation by Defeatist Performance Attitudes and Asocial Beliefs. Schizophr Bull. 2018 Apr 6;44(3):653-661. doi: 10.1093/schbul/sbx099.

  PMID: 29036391 BACKGROUND

• Grant PM, Beck AT. Defeatist beliefs as a mediator of cognitive impairment, negative symptoms, and functioning in schizophrenia. Schizophr Bull. 2009 Jul;35(4):798-806. doi: 10.1093/schbul/sbn008. Epub 2008 Feb 27.

  PMID: 18308717 BACKGROUND

• Griffiths, H., & McLeod, H. (2019). Promoting recovery from negative symptoms: An attachment theory perspective. In K. Berry, S. Bucci, & A. N. Danquah (Eds.), Attachment theory and psychosis: Current perspectives and future directions (pp. 62-83). Routledge/Taylor & Francis Group.

  BACKGROUND

• Gspandl S, Peirson RP, Nahhas RW, Skale TG, Lehrer DS. Comparing Global Assessment of Functioning (GAF) and World Health Organization Disability Assessment Schedule (WHODAS) 2.0 in schizophrenia. Psychiatry Res. 2018 Jan;259:251-253. doi: 10.1016/j.psychres.2017.10.033. Epub 2017 Nov 5.

  PMID: 29091824 BACKGROUND

• Gumley AI, Taylor HE, Schwannauer M, MacBeth A. A systematic review of attachment and psychosis: measurement, construct validity and outcomes. Acta Psychiatr Scand. 2014 Apr;129(4):257-74. doi: 10.1111/acps.12172. Epub 2013 Jul 3.

  PMID: 23834647 BACKGROUND

• Hammer, J. H., & Toland, M. D. (2017). Internal structure and reliability of the Internalized Stigma of Mental Illness Scale (ISMI-29) and Brief Versions (ISMI-10, ISMI-9) among Americans with depression. Stigma and Health, 2(3), 159-174. doi: 10.1037/sah0000049

  BACKGROUND

• Harder S. Attachment in schizophrenia--implications for research, prevention, and treatment. Schizophr Bull. 2014 Nov;40(6):1189-93. doi: 10.1093/schbul/sbu133. Epub 2014 Sep 16.

  PMID: 25232144 BACKGROUND

• Horsselenberg EM, van Busschbach JT, Aleman A, Pijnenborg GH. Self-Stigma and Its Relationship with Victimization, Psychotic Symptoms and Self-Esteem among People with Schizophrenia Spectrum Disorders. PLoS One. 2016 Oct 26;11(10):e0149763. doi: 10.1371/journal.pone.0149763. eCollection 2016.

  PMID: 27783677 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

• Kirkpatrick B, Strauss GP, Nguyen L, Fischer BA, Daniel DG, Cienfuegos A, Marder SR. The brief negative symptom scale: psychometric properties. Schizophr Bull. 2011 Mar;37(2):300-5. doi: 10.1093/schbul/sbq059. Epub 2010 Jun 17.

  PMID: 20558531 BACKGROUND

• Kumari S, Malik M, Florival C, Manalai P, Sonje S. An Assessment of Five (PANSS, SAPS, SANS, NSA-16, CGI-SCH) commonly used Symptoms Rating Scales in Schizophrenia and Comparison to Newer Scales (CAINS, BNSS). J Addict Res Ther. 2017;8(3):324. doi: 10.4172/2155-6105.1000324. Epub 2017 May 11.

  PMID: 29430333 BACKGROUND

• Lincoln TM, Mehl S, Kesting ML, Rief W. Negative symptoms and social cognition: identifying targets for psychological interventions. Schizophr Bull. 2011 Sep;37 Suppl 2(Suppl 2):S23-32. doi: 10.1093/schbul/sbr066.

  PMID: 21860044 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

• Llerena K, Park SG, McCarthy JM, Couture SM, Bennett ME, Blanchard JJ. The Motivation and Pleasure Scale-Self-Report (MAP-SR): reliability and validity of a self-report measure of negative symptoms. Compr Psychiatry. 2013 Jul;54(5):568-74. doi: 10.1016/j.comppsych.2012.12.001. Epub 2013 Jan 22.

  PMID: 23351831 BACKGROUND

• Lopez-Morinigo JD, Ajnakina O, Martinez AS, Escobedo-Aedo PJ, Ruiz-Ruano VG, Sanchez-Alonso S, Mata-Iturralde L, Munoz-Lorenzo L, Ochoa S, Baca-Garcia E, David AS. Can metacognitive interventions improve insight in schizophrenia spectrum disorders? A systematic review and meta-analysis. Psychol Med. 2020 Oct;50(14):2289-2301. doi: 10.1017/S0033291720003384. Epub 2020 Oct 14.

  PMID: 33050956 BACKGROUND

• Lutgens D, Gariepy G, Malla A. Psychological and psychosocial interventions for negative symptoms in psychosis: systematic review and meta-analysis. Br J Psychiatry. 2017 May;210(5):324-332. doi: 10.1192/bjp.bp.116.197103. Epub 2017 Mar 16.

  PMID: 28302699 BACKGROUND

• Luther L, Fukui S, Firmin RL, McGuire AB, White DA, Minor KS, Salyers MP. Expectancies of success as a predictor of negative symptoms reduction over 18 months in individuals with schizophrenia. Psychiatry Res. 2015 Sep 30;229(1-2):505-10. doi: 10.1016/j.psychres.2015.06.022. Epub 2015 Jun 28.

  PMID: 26162662 BACKGROUND

• Lysaker PH, Chernov N, Moiseeva T, Sozinova M, Dmitryeva N, Alyoshin V, Faith LA, Karpenko O, Kostyuk G. Contrasting metacognitive profiles and their association with negative symptoms in groups with schizophrenia, early psychosis and depression in a Russian sample. Psychiatry Res. 2020 Sep;291:113177. doi: 10.1016/j.psychres.2020.113177. Epub 2020 Jun 7.

  PMID: 32615314 BACKGROUND

• Lysaker PH, Gagen E, Klion R, Zalzala A, Vohs J, Faith LA, Leonhardt B, Hamm J, Hasson-Ohayon I. Metacognitive Reflection and Insight Therapy: A Recovery-Oriented Treatment Approach for Psychosis. Psychol Res Behav Manag. 2020 Apr 2;13:331-341. doi: 10.2147/PRBM.S198628. eCollection 2020.

  PMID: 32308511 BACKGROUND

• Lysaker, P. H., & Klion, R. E. (2017). Recovery, meaning-making, and severe mental illness: A comprehensive guide to metacognitive reflection and insight therapy. Routledge.

  BACKGROUND

• Lysaker PH, Kukla M, Dubreucq J, Gumley A, McLeod H, Vohs JL, Buck KD, Minor KS, Luther L, Leonhardt BL, Belanger EA, Popolo R, Dimaggio G. Metacognitive deficits predict future levels of negative symptoms in schizophrenia controlling for neurocognition, affect recognition, and self-expectation of goal attainment. Schizophr Res. 2015 Oct;168(1-2):267-72. doi: 10.1016/j.schres.2015.06.015. Epub 2015 Jul 9.

  PMID: 26164820 BACKGROUND

• Mairs H, Lovell K, Campbell M, Keeley P. Development and pilot investigation of behavioral activation for negative symptoms. Behav Modif. 2011 Sep;35(5):486-506. doi: 10.1177/0145445511411706. Epub 2011 Jul 11.

  PMID: 21746764 BACKGROUND

• Marcellusi A, Fabiano G, Viti R, Francesa Morel PC, Nicolo G, Siracusano A, Mennini FS. Economic burden of schizophrenia in Italy: a probabilistic cost of illness analysis. BMJ Open. 2018 Feb 8;8(2):e018359. doi: 10.1136/bmjopen-2017-018359.

  PMID: 29439067 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

• Moritz S, Berna F, Jaeger S, Westermann S, Nagel M. The customer is always right? Subjective target symptoms and treatment preferences in patients with psychosis. Eur Arch Psychiatry Clin Neurosci. 2017 Jun;267(4):335-339. doi: 10.1007/s00406-016-0694-5. Epub 2016 May 18.

  PMID: 27194554 BACKGROUND

• Moritz S, Klein JP, Lysaker PH, Mehl S. Metacognitive and cognitive-behavioral interventions for psychosis: new developments . Dialogues Clin Neurosci. 2019 Sep;21(3):309-317. doi: 10.31887/DCNS.2019.21.3/smoritz.

  PMID: 31749655 BACKGROUND

• Moritz S, Lysaker PH. Metacognition - What did James H. Flavell really say and the implications for the conceptualization and design of metacognitive interventions. Schizophr Res. 2018 Nov;201:20-26. doi: 10.1016/j.schres.2018.06.001. Epub 2018 Jun 12.

  PMID: 29903626 BACKGROUND

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

  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

• Pos K, Meijer CJ, Verkerk O, Ackema O, Krabbendam L, de Haan L. Metacognitive training in patients recovering from a first psychosis: an experience sampling study testing treatment effects. Eur Arch Psychiatry Clin Neurosci. 2018 Feb;268(1):57-64. doi: 10.1007/s00406-017-0833-7. Epub 2017 Aug 21.

  PMID: 28828697 BACKGROUND

• Rector NA, Beck AT, Stolar N. The negative symptoms of schizophrenia: a cognitive perspective. Can J Psychiatry. 2005 Apr;50(5):247-57. doi: 10.1177/070674370505000503.

  PMID: 15968839 BACKGROUND

• Sarkar S, Hillner K, Velligan DI. Conceptualization and treatment of negative symptoms in schizophrenia. World J Psychiatry. 2015 Dec 22;5(4):352-61. doi: 10.5498/wjp.v5.i4.352. eCollection 2015 Dec 22.

  PMID: 26740926 BACKGROUND

• Sauve G, Lavigne KM, Pochiet G, Brodeur MB, Lepage M. Efficacy of psychological interventions targeting cognitive biases in schizophrenia: A systematic review and meta-analysis. Clin Psychol Rev. 2020 Jun;78:101854. doi: 10.1016/j.cpr.2020.101854. Epub 2020 Apr 24.

  PMID: 32361339 BACKGROUND

• Schneider, B. C., & Andreou, C. (2014). A critical review of metacognitive training (MCT) for psychosis: Efficacy, proposed mechanisms of action and significance for functional outcomes. OA Behavioral Medicine, 1.

  BACKGROUND

• Shan X, Liao R, Ou Y, Ding Y, Liu F, Chen J, Zhao J, Guo W, He Y. Metacognitive Training Modulates Default-Mode Network Homogeneity During 8-Week Olanzapine Treatment in Patients With Schizophrenia. Front Psychiatry. 2020 Mar 27;11:234. doi: 10.3389/fpsyt.2020.00234. eCollection 2020.

  PMID: 32292360 BACKGROUND

• Strauss GP, Keller WR, Buchanan RW, Gold JM, Fischer BA, McMahon RP, Catalano LT, Culbreth AJ, Carpenter WT, Kirkpatrick B. Next-generation negative symptom assessment for clinical trials: validation of the Brief Negative Symptom Scale. Schizophr Res. 2012 Dec;142(1-3):88-92. doi: 10.1016/j.schres.2012.10.012. Epub 2012 Nov 3.

  PMID: 23127378 BACKGROUND

• Swanson L, Griffiths H, Moritz S, Cervenka S. Metacognitive training for negative symptoms: Support for the cognitive model. Clin Psychol Psychother. 2023 Mar;30(2):486-490. doi: 10.1002/cpp.2809. Epub 2022 Dec 17.

  PMID: 36494180 BACKGROUND

• Swanson L, Schwannauer M, Bird T, Eliasson E, Millar A, Moritz S, Griffiths H. Metacognitive training modified for negative symptoms: A feasibility study. Clin Psychol Psychother. 2022 May;29(3):1068-1079. doi: 10.1002/cpp.2692. Epub 2021 Dec 17.

  PMID: 34792834 BACKGROUND

• Thomas EC, Luther L, Zullo L, Beck AT, Grant PM. From neurocognition to community participation in serious mental illness: the intermediary role of dysfunctional attitudes and motivation. Psychol Med. 2017 Apr;47(5):822-836. doi: 10.1017/S0033291716003019. Epub 2016 Nov 25.

  PMID: 27884217 BACKGROUND

• Üstün, T. B., Kostanjsek, N., Chatterji, S., & Rehm, J. (Eds.). (2010). Measuring health and disability: Manual for WHO disability assessment schedule WHODAS 2.0. World Health Organization.

  BACKGROUND

• Veerman SRT, Schulte PFJ, de Haan L. Treatment for Negative Symptoms in Schizophrenia: A Comprehensive Review. Drugs. 2017 Sep;77(13):1423-1459. doi: 10.1007/s40265-017-0789-y.

  PMID: 28776162 BACKGROUND

• Velligan DI, Roberts D, Mintz J, Maples N, Li X, Medellin E, Brown M. A randomized pilot study of MOtiVation and Enhancement (MOVE) Training for negative symptoms in schizophrenia. Schizophr Res. 2015 Jul;165(2-3):175-80. doi: 10.1016/j.schres.2015.04.008. Epub 2015 May 1.

  PMID: 25937461 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

• Weijers, J. G., ten Kate, C., Debbané, M., Bateman, A. W., de Jong, S., Selten, J.-P. C. J., & Eurelings-Bontekoe, E. H. M. (2020). Mentalization and psychosis: A rationale for the use of mentalization theory to understand and treat non-affective psychotic disorder. Journal of Contemporary Psychotherapy: On the Cutting Edge of Modern Developments in Psychotherapy, 50(3), 223-232. doi: 10.1007/s10879-019-09449-0

  BACKGROUND

• Weissman, A.; Beck, AT. Development and validation of the Dysfunctional Attitude Scale: A preliminary Investigation. Paper presented at the Education Research Association; Toronto, Ontario, Canada. 1978

  BACKGROUND

Study Officials

• Linda Swanson, Dr

  Region Sörmland/ Uppsala University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Linda Swanson, Dr

CONTACT

0046-720 843 708; linda.swanson@regionsormland.se

Simon Cervenka, Prof

CONTACT

simon.cervenka@neuro.uu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised Controlled Trial

Study Record Dates

• First Submitted: July 22, 2023
• First Posted: November 13, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2032
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)