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Open Access 01-12-2021 | Delusional Disorder | Study protocol

Virtual reality cognitive-behavioural therapy versus cognitive-behavioural therapy for paranoid delusions: a study protocol for a single-blind multi-Centre randomised controlled superiority trial

Authors: M. Berkhof, E. C. D. van der Stouwe, B. Lestestuiver, E. van’t Hag, R. van Grunsven, J. de Jager, E. Kooijmans, C. E. R. Zandee, A. B. P. Staring, R. M. C. A. Pot-Kolder, M. Vos, W. Veling

Published in: BMC Psychiatry | Issue 1/2021

Abstract

Background

Seventy per cent of patients with psychotic disorders has paranoid delusions. Paranoid delusions are associated with significant distress, hospital admission and social isolation. Cognitive-behavioural therapy for psychosis (CBTp) is the primary psychological treatment, but the median effect size is only small to medium. Virtual reality (VR) has a great potential to improve the effectiveness of CBTp. In a previous study, we found that VR based CBT (VRcbt) for paranoid delusions is superior to waiting list. As a next step, a direct comparison with CBTp is needed. The present study aims to investigate whether VRcbt is more effective and cost-effective than regular CBTp in treating paranoid delusions and improving daily life social functioning of patients with psychotic disorders.

Methods

A total of 106 patients with DSM-5 diagnosis of psychotic disorder and at least moderate level of paranoid ideations will be recruited for this multicentre randomized controlled trial (RCT). Patients will be randomized to either VRcbt or standard CBTp for paranoid delusions. VRcbt consists of maximum 16 sessions in virtual social situations that trigger paranoid ideations and distress, delivered in an 8–12 week time frame. Standard CBTp also consists of maximum 16 sessions including exposure and behavioural experiments, delivered in an 8–12 week time frame.

The two groups will be compared at baseline, post-treatment and six months follow-up. Primary outcome is the level of paranoid ideations in daily life social situations, measured with ecological momentary assessments (EMA) at semi-random moments ten times a day during seven days, before and after treatment. Every session, participants and therapists will rate the level of paranoid ideation and global clinical impression.

Discussion

Comparison of VRcbt and CBTp will provide information about the relative (cost-) effectiveness of VRcbt for this population. VRcbt may become a preferred psychological treatment for paranoid delusions and social anxiety in patients with psychotic disorder.

Trial registration

Netherlands Trial Register, NL7758. Registered on 23 May 2019.

Available only for authorised users

Freeman D, Garety P. Advances in understanding and treating persecutory delusions: a review. Soc Psychiatry Psychiatr Epidemiol. 2014;49(8):1179–89. https://doi.org/10.1007/s00127-014-0928-7.CrossRefPubMedPubMedCentral

Freeman D. Persecutory delusions: a cognitive perspective on understanding and treatment. Lancet Psychiatry. 2016;3(7):685–92. https://doi.org/10.1016/S2215-0366(16)00066-3.CrossRefPubMed

Koyanagi A, Stickley A, Haro JM. Subclinical psychosis and suicidal behavior in England: findings from the 2007 adult psychiatric morbidity survey. Schizophr Res. 2015;168(1–2):62–7. https://doi.org/10.1016/j.schres.2015.07.041.CrossRefPubMed

Couture SM, Penn DL, Roberts DL. The functional significance of social cognition in schizophrenia: a review. Schizophr Bull. 2006;32(SUPPL.1):44–63. https://doi.org/10.1093/schbul/sbl029.CrossRef

Gayer-Anderson C, Morgan C. Social networks, support and early psychosis: a systematic review. Epidemiol Psychiatr Sci. 2013;22(2):131–46. https://doi.org/10.1017/S2045796012000406.CrossRefPubMed

Leucht S, Cipriani A, Spineli L, Mavridis D, Örey D, Richter F, et al. Comparative efficacy and tolerability of 15 antipsychotic drugs in schizophrenia: a multiple-treatments meta-analysis. Lancet. 2013;382(9896):951–62. https://doi.org/10.1016/S0140-6736(13)60733-3.CrossRefPubMed

Turner DT, Van Der Gaag M, Karyotaki E, Cuijpers P. Psychological interventions for psychosis: a meta-analysis of comparative outcome studies. Am J Psychiatry. 2014;171(5):523–38. https://doi.org/10.1176/appi.ajp.2013.13081159.CrossRefPubMed

Haddock G, Eisner E, Boone C, Davies G, Coogan C, Barrowclough C. An investigation of the implementation of NICE-recommended CBT interventions for people with schizophrenia. J Ment Health. 2014;23(4):162–5. https://doi.org/10.3109/09638237.2013.869571.CrossRefPubMed

Van der Gaag M, Valmaggia LR, Smit F. The effects of individually tailored formulation-based cognitive behavioural therapy in auditory hallucinations and delusions: a meta-analysis. Schizophr Res. 2014;156(1):30–7. https://doi.org/10.1016/j.schres.2014.03.016.CrossRefPubMed

10.

Valmaggia LR, Latif L, Kempton MJ, Rus-Calafell M. Virtual reality in the psychological treatment for mental health problems: an systematic review of recent evidence. Psychiatry Res. 2016;236:189–95. https://doi.org/10.1016/j.psychres.2016.01.015.CrossRefPubMed

11.

Rus-Calafell M, Garety P, Sason E, Craig TJK, Valmaggia LR. Virtual reality in the assessment and treatment of psychosis: a systematic review of its utility, acceptability and effectiveness. Psychol Med. 2018;48(3):362–91. https://doi.org/10.1017/S0033291717001945.CrossRefPubMed

12.

Carl E, Stein AT, Levihn-Coon A, Pogue JR, Rothbaum B, Emmelkamp P, et al. Virtual reality exposure therapy for anxiety and related disorders: a meta-analysis of randomized controlled trials. J Anxiety Disord. 2019;61(July 2018):27–36. https://doi.org/10.1016/j.janxdis.2018.08.003.CrossRefPubMed

13.

Freeman D, Reeve S, Robinson A, Ehlers A, Clark D, Spanlang B, et al. Virtual reality in the assessment, understanding, and treatment of mental health disorders. Psychol Med. 2017;47(14):2393–400. https://doi.org/10.1017/S003329171700040X.CrossRefPubMedPubMedCentral

14.

Freeman D, Bradley J, Antley A, Bourke E, DeWeever N, Evans N, et al. Virtual reality in the treatment of persecutory delusions: randomised controlled experimental study testing how to reduce delusional conviction. Br J Psychiatry. 2016;209(1):62–7. https://doi.org/10.1192/bjp.bp.115.176438.CrossRefPubMedPubMedCentral

15.

Pot-Kolder RMCA, Geraets CNW, Veling W, van Beilen M, Staring ABP, Gijsman HJ, et al. Virtual-reality-based cognitive behavioural therapy versus waiting list control for paranoid ideation and social avoidance in patients with psychotic disorders: a single-blind randomised controlled trial. Lancet Psychiatry. 2018;5(3):217–26. https://doi.org/10.1016/S2215-0366(18)30053-1.CrossRefPubMed

16.

Turner DT, Reijnders M, van der Gaag M, Karyotaki E, Valmaggia LR, Moritz S, et al. Efficacy and moderators of cognitive Behavioural therapy for psychosis versus other psychological interventions: an individual-participant data Meta-analysis. Front Psychiatry. 2020;11(May):1–12. https://doi.org/10.3389/fpsyt.2020.00402.CrossRef

17.

Schizophrenia Commission. The Abandoned Illness. 2012;(November):88.

18.

Staring T, van den Berg D, Schuurmans H, van der Vleugel B. Praten naast pillen: Krijgt de patient met psychose dat wel? 2019:1–20.

19.

Green CEL, Freeman D, Kuipers E, Bebbington P, Fowler D, Dunn G, et al. Paranoid Thought Scales (GPTS). Psychol Med. 2008;38(1):101–11. https://doi.org/10.1017/S0033291707001638.CrossRefPubMed

20.

Stawski RS. Multilevel analysis: an introduction to basic and advanced multilevel modeling (2nd edition). Struct Equ Model A Multidiscip J. 2013;20(3):541–50. https://doi.org/10.1080/10705511.2013.797841.CrossRef

21.

Vallis TM, Shaw BF, Dobson KS. The cognitive therapy scale. Psychometric Properties. J Consult Clin Psychol. 1986;54(3):381–5. https://doi.org/10.1037/0022-006X.54.3.381.CrossRefPubMed

22.

Shaw BF, Elkin I, Yamaguchi J, Olmsted M, Vallis TM, Dobson KS, et al. Therapist competence ratings in relation to clinical outcome in cognitive therapy of depression. J Consult Clin Psychol. 1999;67(6):837–46. https://doi.org/10.1037//0022-006x.67.6.837.CrossRefPubMed

23.

Oorschot M, Lataster T, Thewissen V, Lardinois M, van Os J, Delespaul PAEG, et al. Symptomatic remission in psychosis and real-life functioning. Br J Psychiatry. 2012;201(3):215–20. https://doi.org/10.1192/bjp.bp.111.104414.CrossRefPubMed

24.

Klippel A, Myin-Germeys I, Chavez-Baldini UY, Preacher KJ, Kempton M, Valmaggia L, et al. Modeling the interplay between psychological processes and adverse, stressful contexts and experiences in pathways to psychosis: an experience sampling study. Schizophr Bull. 2017;43(2):302–15. https://doi.org/10.1093/schbul/sbw185.CrossRefPubMedPubMedCentral

25.

Myin-Germeys I, Kasanova Z, Vaessen T, Vachon H, Kirtley O, Viechtbauer W, et al. Experience sampling methodology in mental health research: new insights and technical developments. World Psychiatry. 2018;17(2):123–32. https://doi.org/10.1002/wps.20513.CrossRefPubMedPubMedCentral

26.

Drake R, Haddock G, Tarrier N, Bentall R, Lewis S. The psychotic symptom rating scales (PSYRATS): their usefulness and properties in first episode psychosis. Schizophr Res. 2007;89(1–3):119–22. https://doi.org/10.1016/j.schres.2006.04.024.CrossRefPubMed

27.

Mattick RP, Clarke JC. Development and validation of measures of social phobia scrutiny fear and social interaction anxiety11Editor’s note: this article was written before the development of some contemporary measures of social phobia, such as the social phobia and anxiety Inve. Behav Res Ther. 1998;36(4):455–70. https://doi.org/10.1016/s0005-7967(97)10031-6.CrossRefPubMed

28.

Heidenreich T, Schermelleh-Engel K, Schramm E, Hofmann SG, Stangier U. The factor structure of the social interaction anxiety scale and the social phobia scale. J Anxiety Disord. 2011;25(4):579–83. https://doi.org/10.1016/j.janxdis.2011.01.006.CrossRefPubMed

29.

Rush AJ, Gullion CM, Basco MR, Jarrett RB, Trivedi MH. The inventory of depressive symptomatology (IDS): psychometric properties. Psychol Med. 1996;26(3):477–86. https://doi.org/10.1017/s0033291700035558.CrossRefPubMed

30.

Corruble E, Legrand JM, Duret C, Charles G, Guelfi JD. IDS-C and IDS-SR: psychometric properties in depressed in-patients. J Affect Disord. 1999;56(2–3):95–101. https://doi.org/10.1016/S0165-0327(99)00055-5.CrossRefPubMed

31.

Freeman D, Garety PA, Kuipers E. Persecutory delusions: developing the understanding of belief maintenance and emotional distress. Psychol Med. 2001;31(7):1293–306. https://doi.org/10.1017/S003329170100455X.CrossRefPubMed

32.

Brown TA, Antony MM, Barlow DH. Psychometric properties of the Penn state worry questionnaire in a clinical anxiety disorders sample. Behav Res Ther. 1992;30(1):33–7. https://doi.org/10.1016/0005-7967(92)90093-V.CrossRefPubMed

33.

Lecomte T, Corbière M, Laisné F. Investigating self-esteem in individuals with schizophrenia: relevance of the self-esteem rating scale-short form. Psychiatry Res. 2006;143(1):99–108. https://doi.org/10.1016/j.psychres.2005.08.019.CrossRefPubMed

34.

Boyce P, Parker G. Development of a scale to measure interpersonal sensitivity. Aust N Z J Psychiatry. 1989;23(3):369–72. https://doi.org/10.3109/00048678909068291.CrossRef

35.

Harb GC, Heimberg RG, Fresco DM, Schneier FR, Liebowitz MR. The psychometric properties of the interpersonal sensitivity measure in social anxiety disorder. Behav Res Ther. 2002;40(8):961–79. https://doi.org/10.1016/S0005-7967(01)00125-5.CrossRefPubMed

36.

Fowler D, Freeman D, Smith B, et al. The brief Core Schema scales (BCSS): psychometric properties and associations with paranoia and grandiosity in non-clinical and psychosis samples. Psychol Med. 2006;36(6):749–59. https://doi.org/10.1017/S0033291706007355.CrossRefPubMed

37.

Van der Gaag M, Schütz C, ten Napel A, et al. Development of the Davos assessment of cognitive biases scale (DACOBS). Schizophr Res. 2013;144(1–3):63–71. https://doi.org/10.1016/j.schres.2012.12.010.CrossRefPubMed

38.

Bouwmans C, De Jong K, Timman R, et al. Feasibility, reliability and validity of a questionnaire on healthcare consumption and productivity loss in patients with a psychiatric disorder (TiC-P). BMC Health Serv Res. 2013;13:217. https://doi.org/10.1186/1472-6963-13-217

39.

Herdman M, Gudex C, Lloyd A, Janssen MF, Kind P, Parkin D, et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res. 2011;20(10):1727–36. https://doi.org/10.1007/s11136-011-9903-x.CrossRefPubMedPubMedCentral

40.

Janssen MF, Pickard AS, Golicki D, Gudex C, Niewada M, Scalone L, et al. Measurement properties of the EQ-5D-5L compared to the EQ-5D-3L across eight patient groups: a multi-country study. Qual Life Res. 2013;22(7):1717–27. https://doi.org/10.1007/s11136-012-0322-4.CrossRefPubMed

41.

Sheehan KH, Sheehan DV. Assessing treatment effects in clinical trials with the Discan metric of the Sheehan disability scale. Int Clin Psychopharmacol. 2008;23(2):70–83. https://doi.org/10.1097/YIC.0b013e3282f2b4d6.CrossRefPubMed

42.

Guy W. ECDEU assessment manual for psychopharmacology. Dept of Heal Educ Welfare, Public Heal Serv Alcohol, Drug Abus Ment Heal Adm Natl Inst Ment Heal Psychopharmacol Reasearch Branc Devision Extramur Res Programs. 1976.

43.

Haro JM, Kamath SA, Ochoa S, Novick D, Rele K, Fargas A, et al. The clinical global impression-schizophrenia scale: a simple instrument to measure the diversity of symptoms present in schizophrenia. Acta Psychiatr Scand Suppl. 2003;107(416):16–23. https://doi.org/10.1034/j.1600-0447.107.s416.5.x.CrossRef

44.

Schubert T, Friedmann F. The Experience of Presence: Factor Analytic Insights. 2001;10(3):266–81. https://doi.org/10.1162/105474601300343603.

45.

Kawata AK, Revicki DA. Psychometric properties of the personal and social performance scale (PSP) among individuals with schizophrenia living in the community. Qual Life Res. 2008;17(10):1247–56. https://doi.org/10.1007/s11136-008-9400-z.CrossRefPubMed

46.

Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)-a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009;42(2):377–81. https://doi.org/10.1016/j.jbi.2008.08.010.CrossRefPubMed

47.

Pot-Kolder R, Veling W, Geraets C, Lokkerbol J, Smit F, Jongeneel A, et al. Cost-effectiveness of virtual reality cognitive behavioral therapy for psychosis: health-economic evaluation within a randomized controlled trial. J Med Internet Res. 2020;22(5):1–13. https://doi.org/10.2196/17098.CrossRef

Title: Virtual reality cognitive-behavioural therapy versus cognitive-behavioural therapy for paranoid delusions: a study protocol for a single-blind multi-Centre randomised controlled superiority trial
Authors: M. Berkhof
E. C. D. van der Stouwe
B. Lestestuiver
E. van’t Hag
R. van Grunsven
J. de Jager
E. Kooijmans
C. E. R. Zandee
A. B. P. Staring
R. M. C. A. Pot-Kolder
M. Vos
W. Veling
Publication date: 01-12-2021
Publisher: BioMed Central
Keywords: Delusional Disorder
Behavioural Therapy
Published in: BMC Psychiatry / Issue 1/2021
Electronic ISSN: 1471-244X
DOI: https://doi.org/10.1186/s12888-021-03473-y

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Virtual reality cognitive-behavioural therapy versus cognitive-behavioural therapy for paranoid delusions: a study protocol for a single-blind multi-Centre randomised controlled superiority trial

Abstract

Background

Methods

Discussion

Trial registration

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Background

Methods

Discussion

Trial registration

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