Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
Trials
Published in: Trials 1/2010

Open Access 01-12-2010 | Study protocol

Cognitive behavioural therapy versus supportive therapy for persistent positive symptoms in psychotic disorders: The POSITIVE Study, a multicenter, prospective, single-blind, randomised controlled clinical trial

Authors: Stefan Klingberg, Andreas Wittorf, Christoph Meisner, Wolfgang Wölwer, Georg Wiedemann, Jutta Herrlich, Andreas Bechdolf, Bernhard W Müller, Gudrun Sartory, Michael Wagner, Tilo Kircher, Hans-Helmut König, Corinna Engel, Gerhard Buchkremer

Published in: Trials | Issue 1/2010

Login to get access

Abstract

Background

It has been demonstrated that cognitive behavioural therapy (CBT) has a moderate effect on symptom reduction and on general well being of patients suffering from psychosis. However, questions regarding the specific efficacy of CBT, the treatment safety, the cost-effectiveness, and the moderators and mediators of treatment effects are still a major issue. The major objective of this trial is to investigate whether CBT is specifically efficacious in reducing positive symptoms when compared with non-specific supportive therapy (ST) which does not implement CBT-techniques but provides comparable therapeutic attention.

Methods/Design

The POSITIVE study is a multicenter, prospective, single-blind, parallel group, randomised clinical trial, comparing CBT and ST with respect to the efficacy in reducing positive symptoms in psychotic disorders. CBT as well as ST consist of 20 sessions altogether, 165 participants receiving CBT and 165 participants receiving ST. Major methodological aspects of the study are systematic recruitment, explicit inclusion criteria, reliability checks of assessments with control for rater shift, analysis by intention to treat, data management using remote data entry, measures of quality assurance (e.g. on-site monitoring with source data verification, regular query process), advanced statistical analysis, manualized treatment, checks of adherence and competence of therapists.
Research relating the psychotherapy process with outcome, neurobiological research addressing basic questions of delusion formation using fMRI and neuropsychological assessment and treatment research investigating adaptations of CBT for adolescents is combined in this network. Problems of transfer into routine clinical care will be identified and addressed by a project focusing on cost efficiency.

Discussion

This clinical trial is part of efforts to intensify psychotherapy research in the field of psychosis in Germany, to contribute to the international discussion on psychotherapy in psychotic disorders, and to help implement psychotherapy in routine care. Furthermore, the study will allow drawing conclusions about the mediators of treatment effects of CBT of psychotic disorders.

Trial Registration

Current Controlled Trials ISRCTN29242879
Appendix
Available only for authorised users
Literature
1.
Leucht S, Corves C, Arbter D, Engel RR, Li C, Davis JM: Second-generation versus first-generation antipsychotic drugs for schizophrenia: a meta-analysis. Lancet. 2009, 373: 31-41. 10.1016/S0140-6736(08)61764-X.CrossRefPubMed
2.
Wykes T, Steel C, Everitt B, Tarrier N: Cognitive behavior therapy for schizophrenia: Effect sizes, clinical models, and methodological rigor. Schizophr Bull. 2008, 34: 523-537. 10.1093/schbul/sbm114.CrossRefPubMed
3.
Zimmermann G, Favrod J, Trieu VH, Pomini V: The effect of cognitive behavioral treatment on the positive symptoms of schizophrenia spectrum disorders: a meta-analysis. Schizophr Res. 2005, 77: 1-9. 10.1016/j.schres.2005.02.018.CrossRefPubMed
4.
Pilling S, Bebbington P, Kuipers E, Garety P, Geddes J, Orbach G, Morgan C: Psychological treatments in schizophrenia: I. Meta-analysis of family intervention and cognitive behaviour therapy. Psychol Med. 2002, 32: 763-782.PubMed
5.
Deutsche Gesellschaft für Psychiatrie PuNH:Behandlungsleitlinie Schizophrenie. 2006, Darmstadt: Steinkopf,
6.
Jones C, Cormac I, Silveira-da-Mota-Neto JI, Campbell C: Cognitive behaviour therapy for schizophrenia. Cochrane Database Syst Rev. 2005, CD000524-
7.
Tarrier N, Haddock G, Lewis S, Drake R, Gregg L: Suicide behaviour over 18 months in recent onset schizophrenic patients: the effects of CBT. Schizophr Res. 2006, 83: 15-27. 10.1016/j.schres.2005.12.846.CrossRefPubMed
8.
Bentall RP, Corcoran R, Howard R, Blackwood N, Kinderman P: Persecutory delusions: A review and theoretical integration. Clin Psychol Rev. 2001, 21: 1143-1192. 10.1016/S0272-7358(01)00106-4.CrossRefPubMed
9.
Bentall RP, Kaney S: Content specific information processing and persecutory delusions: an investigation using the emotional Stroop test. Br J Med Psychol. 1989, 62 (Pt 4): 355-364.CrossRefPubMed
10.
Kinderman P: Attentional bias, persecutory delusions and the self-concept. British Journal of Medical Psychology. 1994, 67: 53-66.CrossRefPubMed
11.
Pinkham AE, Penn DL, Perkins DO, Lieberman J: Implications for the neural basis of social cognition for the study of schizophrenia. Am J Psychiatry. 2003, 160: 815-824. 10.1176/appi.ajp.160.5.815.CrossRefPubMed
12.
Blackwood NJ, Howard RJ, Bentall RP, Murray RM: Cognitive neuropsychiatric models of persecutory delusions. Am J Psychiatry. 2001, 158: 527-539. 10.1176/appi.ajp.158.4.527.CrossRefPubMed
13.
Wykes T, Brammer M, Mellers J, Bray P, Reeder C, Williams C, Corner J: Effects on the brain of a psychological treatment: cognitive remediation therapy: functional magnetic resonance imaging in schizophrenia. Br J Psychiatry. 2002, 181: 144-152.PubMed
14.
Gilleen J, David AS: The cognitive neuropsychiatry of delusions: from psychopathology to neuropsychology and back again. Psychol Med. 2005, 35: 5-12. 10.1017/S0033291704003976.CrossRefPubMed
15.
Keshavan MS, Rabinowitz J, DeSmedt G, Harvey PD, Schooler N: Correlates of insight in first episode psychosis. Schizophr Res. 2004, 70: 187-194. 10.1016/j.schres.2003.11.007.CrossRefPubMed
16.
Orlinsky DE, Grawe K, Parks BK: Process and outcome in psychotherapy - noch einmal. Handbook of psychotherapy and behavior change. Edited by: Bergin AE, Garfield SL. 1994, New York: John Wiley, 270-376. 4
17.
Kuipers E, Garety P, Fowler D, Dunn G, Bebbington P, Freeman D, Hadley C: London-East Anglia randomised controlled trial of cognitive-behavioral therapy for psychosis. I. Effects of the treatment phase. Br J Psychiatry. 1997, 171: 319-327. 10.1192/bjp.171.4.319.CrossRefPubMed
18.
Tarrier N, Yusupoff L, McCarthy E, Kinney C, Wittkowski A: Some reasons why patients suffering from chronic schizophrenia fail to continue in psychological treatment. Behavioural and Cognitive Psychotherapy. 1998, 26: 177-181.
19.
Sensky T, Turkington D, Kingdon D, Scott JL, Scott J, Siddle R, O'Carroll M, Barnes TR: A randomized controlled trial of cognitive-behavioral therapy for persistent symptoms in schizophrenia resistant to medication. Arch Gen Psychiatry. 2000, 57: 165-172. 10.1001/archpsyc.57.2.165.CrossRefPubMed
20.
Lehrl S: Mehrfachwahl-Wortschatz-Intelligenztest (MWT-B) [A multiple choice vocabulary intelligence test (MWT-B)]. 1992, Nürnberg: Perimed-spitta
21.
Penn DL, Mueser KT, Tarrier N, Gloege A, Cather C, Serrano D, Otto MW: Supportive therapy for schizophrenia: possible mechanisms and implications for adjunctive psychosocial treatments. Schizophr Bull. 2004, 30: 101-112.CrossRefPubMed
22.
Kay SR, Fiszbein A, Opler LA: The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987, 13: 261-276.CrossRefPubMed
23.
Kay SR, Opler LA, Lindenmayer JP: Reliability and validity of the positive and negative syndrome scale for schizophrenics. Psychiatry Res. 1988, 23: 99-110. 10.1016/0165-1781(88)90038-8.CrossRefPubMed
24.
25.
Müller MJ, Rossbach W, Davids E, Wetzel H, Benkert O: Evaluation eines standardisierten Trainings für die "Positve and Negative Syndrome Scale" (PANSS). Nervenarzt. 2000, 71: 195-204.CrossRefPubMed
26.
Gaebel W, Moller HJ, Buchkremer G, Ohmann C, Riesbeck M, Wolwer W, Von Wilmsdorff M, Bottlender R, Klingberg S: Pharmacological long-term treatment strategies in first episode schizophrenia--study design and preliminary results of an ongoing RCT within the German Research Network on Schizophrenia. Eur Arch Psychiatry Clin Neurosci. 2004, 254: 129-140. 10.1007/s00406-004-0509-y.CrossRefPubMed
27.
Addington D, Addington J, Atkinson M: A psychometric comparison of the Calgary Depression Scale for Schizophrenia and the Hamilton Depression Rating Scale. Schizophr Res. 1996, 19: 205-212. 10.1016/0920-9964(95)00070-4.CrossRefPubMed
28.
Haddock G, Tarrier N, Morrison AP, Drake R, Lewis S: A pilot study evaluating the effectiveness of individual inpatient cognitive-behavioural therapy in early psychosis. Soc Psychiatry Psychiatr Epidemiol. 1999, 34: 254-258. 10.1007/s001270050141.CrossRefPubMed
29.
Arbeitsgemeinschaft für Methodik und Dokumentation in der Psychiatrie (AMDP): Das AMDP-System. Manual zur Dokumentation psychiatrischer Befunde. 1995, Berlin: Springer
30.
Amador XF, Strauss DH, Yale SA, Flaum MM, Endicott J, Gorman JM: Assessment of Insight in Psychosis. Am J Psychiatry. 1993, 150: 873-879.CrossRefPubMed
31.
Franke G:Die Symptom-Checkliste von Derogatis - Deutsche Version - (SCL-90-R). 1995, Göttingen: Beltz-Test GMBH,
32.
Gumley A, Karatzias A, Power K, Reilly J, McNay L, O'Grady M: Early intervention for relapse in schizophrenia: impact of cognitive behavioural therapy on negative beliefs about psychosis and self-esteem. Br J Clin Psychol. 2006, 45: 247-260. 10.1348/014466505X49925.CrossRefPubMed
33.
Deusinger IM: Die Frankfurter Selbstkonzeptskalen (FSKN). 1986, Göttingen: Hogrefe
34.
Fowler D, Freeman D, Smith B, Kuipers E, Bebbington P, Bashforth H, Coker S, Hodgekins J, Gracie A, Dunn G, Garety P: The Brief Core Schema Scales (BCSS): psychometric properties and associations with paranoia and grandiosity in non-clinical and psychosis samples. Psychol Med. 2006, 36: 749-759. 10.1017/S0033291706007355.CrossRefPubMed
35.
Singer JD, Willet JB: Applied longitudinal data analysis. Modelling change and event occurrence. 2003, New York: Oxford University PressCrossRef
36.
Tarrier N, Wykes T: Is there evidence that cognitive behaviour therapy is an effective treatment for schizophrenia? A cautious or cautionary tale?. Behav Res Ther. 2004, 42: 1377-1401. 10.1016/j.brat.2004.06.020.CrossRefPubMed
37.
Kuipers E, Fowler D, Garety P, Chisholm D, Freeman D, Dunn G, Bebbington P, Hadley C: London-east Anglia randomised controlled trial of cognitive-behavioural therapy for psychosis. III: Follow-up and economic evaluation at 18 months. Br J Psychiatry. 1998, 173: 61-68. 10.1192/bjp.173.1.61.CrossRefPubMed
38.
Gould RA, Mueser KT, Bolton E, Mays V, Goff D: Cognitive therapy for psychosis in schizophrenia: an effect size analysis. Schizophr Res. 2001, 48: 335-342. 10.1016/S0920-9964(00)00145-6.CrossRefPubMed
39.
Pinto A, La Pia S, Mennella R, Giorgio D, DeSimone L: Cognitive-behavioral therapy and clozapine for clients with treatment-refractory schizophrenia. Psychiatr Serv. 1999, 50: 901-904.CrossRefPubMed
40.
Lewis DA, Levitt P: Schizophrenia as a disorder of neurodevelopment. Annu Rev Neurosci. 2002, 25: 409-432. 10.1146/annurev.neuro.25.112701.142754.CrossRefPubMed
41.
Durham RC, Guthrie M, Morton RV, Reid DA, Treliving LR, Fowler D, Macdonald RR: Tayside-Fife clinical trial of cognitive-behavioural therapy for medication-resistant psychotic symptoms. Results to 3-month follow-up. Br J Psychiatry. 2003, 182: 303-311. 10.1192/bjp.182.4.303.CrossRefPubMed
42.
Singer JD, Willet JB: Applied longitudinal data analysis. Modelling change and event occurrence. 2003, New York: Oxford University PressCrossRef
43.
44.
Gelso CJ, Carter JA: The relationship in counseling and psychotherapy: components, consequences, and theoretical antecedents. The Couseling Psychologist. 1985, 13: 155-243. 10.1177/0011000085132001.CrossRef
45.
Horvath AO, Symonds BD: Relation between working alliance and outcome in psychotherapy: a meta-analysis. Journal of Counseling Psychology. 1991, 38: 139-149. 10.1037/0022-0167.38.2.139.CrossRef
46.
Martin DJ, Garske JP, Davis MK: Relation of the therapeutic alliance with outcome and other variables: A meta-analytic review. Journal of Consulting and Clinical Psychology. 2000, 68: 438-450. 10.1037/0022-006X.68.3.438.CrossRefPubMed
47.
Flückiger C, Regli D, Zwahlen D, Hostettler S, Caspar F: The Bern Post Session Report 2000, patient and therapist versions: Measuring psychotherapeutic processes. Z Klin Psychol Psychother. 2010, 39: 71-79.CrossRef
48.
Haddock G, Devane S, Bradshaw WH, McGovern J, Tarrier N, Kinderman P, Baguley I, Lancashire S, Harris N: An investigation into the psychometric properties of the Cognitive Therapy Scale For Psychoses (CTS-Psy). Behavioural and Cognitive Psychotherapy. 2001, 29: 221-233. 10.1017/S1352465801002089.CrossRef
49.
Pharoah FM, Mari JJ, Streiner DL:Family intervention for schizophrenia (Cochrane Review). Update Software. 2003, Oxford: The Cochrane Library, 1,
50.
Cormac I, Jones C, Campbell C, Silveira da Mota Neto J:Cognitive behaviour therapy for schizophrenia (cochrane-Review). Update Software. 2003, Oxford: The Cochrane Library, 1,
51.
Hayes RL, McGrath J:Cognitive rehabilitation for people with schizophrenia and related conditions (Cochrane Review). Update Software. 2003, Oxford: The Cochrane Library, 1,
52.
Pekkala E, Merinder L: Psychoeducation for schizophrenia (Cochrane Review). Update Software. 2003, Oxford: The Cochrane Library, 1
53.
Häfner H, Maurer K, Ruhrmann S, Bechdolf A, Klosterktter J, Wagner M, Maier W, Bottlender R, Mller HJ, Gaebel W, Wlwer W: Early detection and secondary prevention of psychosis: facts and visions. Eur Arch Psychiatry Clin Neurosci. 2004, 254: 117-128.CrossRefPubMed
54.
Wölwer W, Brinkmeyer J, Riesbeck M, Freimller L, Klimke A, Wagner M, Mller HJ, Klingberg S, Gaebel W, Gaebel W: Neuropsychological impairments predict the clinical course in schizophrenia. Eur Arch Psychiatry Clin Neurosci. 2008, 258 (Suppl 5): 28-34.CrossRefPubMed
55.
Woodward TS, Mizrahi R, Menon M, Christensen BK: Correspondences between theory of mind, jumping to conclusions, neuropsychological measures and the symptoms of schizophrenia. Psychiatry Res. 2009, 170: 119-123. 10.1016/j.psychres.2008.10.018.CrossRefPubMed
56.
Cohen AS, Nienow TM, Dinzeo TJ, Docherty NM: Attribution biases in schizophrenia: relationship to clinical and functional impairments. Psychopathology. 2009, 42: 40-46. 10.1159/000173702.CrossRefPubMed
57.
Kinderman P, Bentall RP: A new measure of causal locus: the internal, personal and situational attributions questionnaire. Pers Indiv Diff. 1996, 20: 261-264. 10.1016/0191-8869(95)00186-7.CrossRef
58.
Garety PA, Hemsley DR, Wessely S: Reasoning in deluded schizophrenic and paranoid patients. Biases in performance on a probabilistic inference task. J Nerv Ment Dis. 1991, 179: 194-201. 10.1097/00005053-199104000-00003.CrossRefPubMed
59.
Moritz S, Lincoln T: Wahn - Psychologie. In Neuropsychologie der Schizophrenie. Edited by: Kircher T, Gauggel S. 2008, Heidelberg: Springer, 456-467.CrossRef
60.
Ekman P, Friesen W: Facial action coding system: a technique for the measurement of facial movement. Palo Alto (California). 1978, Consulting Psychologists Press
61.
Chisholm D, Knapp MR, Knudsen HC, Amaddeo F, Gaite L, van Wijngaarden B: Client Socio-Demographic and Service Receipt Inventory--European Version: development of an instrument for international research. EPSILON Study 5. European Psychiatric Services: Inputs Linked to Outcome Domains and Needs. Br J Psychiatry Suppl. 2000, s28-s33. 10.1192/bjp.177.39.s28.
62.
EuroQol Group: EuroQol--a new facility for the measurement of health-related quality of life. The EuroQol Group. Health Policy. 1990, 16: 199-208. 10.1016/0168-8510(90)90421-9.CrossRef
63.
Dolan P: Modeling valuations for EuroQol health states. Med Care. 1997, 35: 1095-1108. 10.1097/00005650-199711000-00002.CrossRefPubMed
64.
Prieto L, Sacristn JA, Hormaechea JA, Casado A, Badia X, Gmez JC: Psychometric validation of a generic health-related quality of life measure (EQ-5D) in a sample of schizophrenic patients. Curr Med Res Opin. 2004, 20: 827-835. 10.1185/030079904125003674.CrossRefPubMed
65.
Lingjaerde O, Ahlfors UG, Bech P, Dencker SJ, Elgen K: The UKU side effect rating scale. A new comprehensive rating scale for psychotropic drugs and a cross-sectional study of side effects in neuroleptic-treated patients. Acta Psychiatr Scand Suppl. 1987, 334: 1-100. 10.1111/j.1600-0447.1987.tb10566.x.CrossRefPubMed
Metadata
Title
Cognitive behavioural therapy versus supportive therapy for persistent positive symptoms in psychotic disorders: The POSITIVE Study, a multicenter, prospective, single-blind, randomised controlled clinical trial
Authors
Stefan Klingberg
Andreas Wittorf
Christoph Meisner
Wolfgang Wölwer
Georg Wiedemann
Jutta Herrlich
Andreas Bechdolf
Bernhard W Müller
Gudrun Sartory
Michael Wagner
Tilo Kircher
Hans-Helmut König
Corinna Engel
Gerhard Buchkremer
Publication date
01-12-2010
Publisher
BioMed Central
Published in
Trials / Issue 1/2010
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-11-123

Other articles of this Issue 1/2010

Trials 1/2010 Go to the issue

Study protocol

The fitness for the Ageing Brain Study II (FABS II): protocol for a randomized controlled clinical trial evaluating the effect of physical activity on cognitive function in patients with Alzheimer's disease

Study protocol

Evidence-based interventions in dementia: A pragmatic cluster-randomised trial of an educational intervention to promote earlier recognition and response to dementia in primary care (EVIDEM-ED)

Study protocol

P3MC: A double blind parallel group randomised placebo controlled trial of Propranolol and Pizotifen in preventing migraine in children

Study protocol

Protocol for a randomised controlled trial investigating the effectiveness of an online e-health application compared to attention placebo or sertraline in the treatment of generalised anxiety disorder

Study protocol

Decision aid on radioactive iodine treatment for early stage papillary thyroid cancer - a randomized controlled trial

Study protocol

Study protocol: home-based telehealth stroke care: a randomized trial for veterans