Personalized exposure and experience sampling method feedback versus exposure as usual for obsessive-compulsive disorder: a study protocol for a randomized controlled trial.
Cognitive behavorial therapy
Ecological momentary assessment
Ecological momentary interventions
Experience sampling
Exposure with response prevention
Mediation analysis
Obsessive–compulsive disorder
Personalized medicine
Randomized controlled trial
Video-calling CBT
Journal
Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253
Informations de publication
Date de publication:
12 Jan 2024
12 Jan 2024
Historique:
received:
20
03
2023
accepted:
06
11
2023
medline:
13
1
2024
pubmed:
13
1
2024
entrez:
12
1
2024
Statut:
epublish
Résumé
Patients with obsessive-compulsive disorder (OCD) suffer from repetitive fearful intrusions which they try to neutralize by performing compulsions. OCD is considered to be the most resistant anxiety disorder with a remission rate of only 53% after a year of an evidence-based treatment. Therefore, it remains an obligation to develop and investigate more effective treatment interventions. This study aims to compare personalized exposure with response prevention (ERP) using experience sampling methodology-based feedback to ERP as usual in patients with OCD. Personalized exposure will be provided screen-to-screen in an ecologically valid (real time and real place) context by means of a smartphone application. This app will also be used to collect both objective and subjective data by means of experience sampling methodology (ESM). This ESM data will be used to identify triggers and protective factors for symptom severity, provide personalized feedback and optimize the effect of ERP. The primary goal of this RCT is to compare the effectiveness of personalized ERP to ERP as usual in the traditional context of a therapist's room in patients with OCD in OCD symptom severity, as well as differences in quality of life, depressive symptoms and anxiety states. Since both self-efficacy and experiential avoidance are known to influence symptom severity in OCS, a secondary goal is to examine if a possible treatment effect is mediated by self-efficacy or experiential avoidance. This study involves a randomized controlled trial with 20 weekly sessions by 2 groups (ERP as usual versus personalized ERP), repeated measurements at baseline (T0), 5 weeks of treatment (T1), 10 weeks of treatment (T2), 15 weeks of treatment (T3), posttest at 20 weeks (T4), 6 weeks follow-up (T5), 3 months follow-up (T6), 6 months follow-up (T7) and a year follow-up (T8). A hundred and sixty patients with an OCD diagnosis according to DSM-5 criteria will participate. Half of the group will receive exposure with response prevention as usual, the other half will receive personalized exposure with response prevention with a smartphone application and personalized feedback sessions based on experience sampling data. Multilevel mixed modelling analysis will be used to investigate differences in treatment effect, as well as differences in quality of life, depressive symptoms and anxiety states. We will use the macro of Preacher and Hayes and apply bootstrapping methods to assess the possible mediating effect of changes in self-efficacy and experiential avoidance on subsequent treatment effects. This randomized controlled trial is the first to assess the influence of delivering ERP through video-calling and the use of an ESM intervention on the symptom severity of OCD. Since the global pandemic COVID-19, the use of video-calling to deliver psychological treatments has become more common, increasing the relevance of this study. ICTRP Trial NL8254. Registered on 2019-12-24.
Sections du résumé
BACKGROUND
BACKGROUND
Patients with obsessive-compulsive disorder (OCD) suffer from repetitive fearful intrusions which they try to neutralize by performing compulsions. OCD is considered to be the most resistant anxiety disorder with a remission rate of only 53% after a year of an evidence-based treatment. Therefore, it remains an obligation to develop and investigate more effective treatment interventions. This study aims to compare personalized exposure with response prevention (ERP) using experience sampling methodology-based feedback to ERP as usual in patients with OCD. Personalized exposure will be provided screen-to-screen in an ecologically valid (real time and real place) context by means of a smartphone application. This app will also be used to collect both objective and subjective data by means of experience sampling methodology (ESM). This ESM data will be used to identify triggers and protective factors for symptom severity, provide personalized feedback and optimize the effect of ERP. The primary goal of this RCT is to compare the effectiveness of personalized ERP to ERP as usual in the traditional context of a therapist's room in patients with OCD in OCD symptom severity, as well as differences in quality of life, depressive symptoms and anxiety states. Since both self-efficacy and experiential avoidance are known to influence symptom severity in OCS, a secondary goal is to examine if a possible treatment effect is mediated by self-efficacy or experiential avoidance.
METHODS
METHODS
This study involves a randomized controlled trial with 20 weekly sessions by 2 groups (ERP as usual versus personalized ERP), repeated measurements at baseline (T0), 5 weeks of treatment (T1), 10 weeks of treatment (T2), 15 weeks of treatment (T3), posttest at 20 weeks (T4), 6 weeks follow-up (T5), 3 months follow-up (T6), 6 months follow-up (T7) and a year follow-up (T8). A hundred and sixty patients with an OCD diagnosis according to DSM-5 criteria will participate. Half of the group will receive exposure with response prevention as usual, the other half will receive personalized exposure with response prevention with a smartphone application and personalized feedback sessions based on experience sampling data. Multilevel mixed modelling analysis will be used to investigate differences in treatment effect, as well as differences in quality of life, depressive symptoms and anxiety states. We will use the macro of Preacher and Hayes and apply bootstrapping methods to assess the possible mediating effect of changes in self-efficacy and experiential avoidance on subsequent treatment effects.
DISCUSSION
CONCLUSIONS
This randomized controlled trial is the first to assess the influence of delivering ERP through video-calling and the use of an ESM intervention on the symptom severity of OCD. Since the global pandemic COVID-19, the use of video-calling to deliver psychological treatments has become more common, increasing the relevance of this study.
TRIAL REGISTRATION
BACKGROUND
ICTRP Trial NL8254. Registered on 2019-12-24.
Identifiants
pubmed: 38217045
doi: 10.1186/s13063-023-07780-5
pii: 10.1186/s13063-023-07780-5
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
43Informations de copyright
© 2024. The Author(s).
Références
American Psychiatric Association. Diagnostic and statistical manual of mental disorders. American Psychiatric Association; 2013.
Ruscio AM, Stein DJ, Chiu WT, Kessler RC. The epidemiology of obsessive-compulsive disorder in the National Comorbidity Survey Replication. Mol Psychiatry. 2010;15:53–63.
pubmed: 18725912
doi: 10.1038/mp.2008.94
Steketee G, Eisen J, Dyck I, Warshaw M, Rasmussen S. Predictors of course in obsessive-compulsive disorder. Psychiatry Res. 1999;89:229–38.
pubmed: 10708269
doi: 10.1016/S0165-1781(99)00104-3
Veale D, Roberts A. Obsessive-compulsive disorder. BMJ. 2014;348:2183.
doi: 10.1136/bmj.g2183
Obsessive-compulsive disorder and body dysmorphic disorder: treatment | Guidance and guidelines | NICE.
Craske MG, Kircanski K, Zelikowsky M, Mystkowski J, Chowdhury N, Baker A. Optimizing inhibitory learning during exposure therapy. Behav Res Ther. 2008;46:5–27.
pubmed: 18005936
doi: 10.1016/j.brat.2007.10.003
Vervliet B, Depreeuw B, Craske MG. Exposuretherapie. Gedragstherapie. 2014;47:296–339.
Hofmann SG, Smits JAJ. Cognitive-behavioral therapy for adult anxiety disorders: a meta-analysis of randomized placebo-controlled trials. J Clin Psychiatry. 2008;69:621–32.
pubmed: 18363421
pmcid: 2409267
doi: 10.4088/JCP.v69n0415
Olatunji BO, Kauffman BY, Meltzer S, Davis ML, Smits JAJ, Powers MB. Cognitive-behavioral therapy for hypochondriasis/health anxiety: a meta-analysis of treatment outcome and moderators. Behav Res Ther. 2014;58:65–74.
pubmed: 24954212
doi: 10.1016/j.brat.2014.05.002
Sharma E, Thennarasu K, Reddy YCJ. Long-term outcome of obsessive-compulsive disorder in adults. J Clin Psychiatry. 2014;75:1019–27.
pubmed: 25295427
doi: 10.4088/JCP.13r08849
Andersson E, Enander J, Andrén P, Hedman E, Ljótsson B, Hursti T, et al. Internet-based cognitive behaviour therapy for obsessive-compulsive disorder: a randomized controlled trial. Psychol Med. 2012;42:2193–203.
pubmed: 22348650
pmcid: 3435873
doi: 10.1017/S0033291712000244
Feusner JD, Farrell NR, Kreyling J, McGrath PB, Rhode A, Faneuff T, et al. Online video teletherapy treatment of obsessive-compulsive disorder using exposure and response prevention: clinical outcomes from a retrospective longitudinal observational study. J Med Internet Res. 2022;24(5):e36431 ( https://www.jmir.org/2022/5/e36431 ).
pubmed: 35587365
pmcid: 9164091
doi: 10.2196/36431
Fletcher TL, Boykin DM, Helm A, Dawson DB, Ecker AH, Freshour J, et al. A pilot open trial of video telehealth-delivered exposure and response prevention for obsessive-compulsive disorder in rural Veterans. APA. 2021;34:83–90.
Ferreri F, Bourla A, Peretti CS, Segawa T, Jaafari N, Mouchabac S. How new technologies can improve prediction, assessment, and intervention in obsessive-compulsive disorder (e-ocd): Review. JMIR Ment Heal. 2019;6(12).
Abramowitz JS, Lackey GR, Wheaton MG. Obsessive–compulsive symptoms: the contribution of obsessional beliefs and experiential avoidance. J Anxiety Disord. 2009;23:160–6.
pubmed: 18657382
doi: 10.1016/j.janxdis.2008.06.003
Angelakis I, Gooding P. Obsessive–compulsive disorder and suicidal experiences: the role of experiential avoidance. Suicide Life-Threatening Behav. 2020;50:359–71.
doi: 10.1111/sltb.12593
Angelakis I, Pseftogianni F. Association between obsessive-compulsive and related disorders and experiential avoidance: a systematic review and meta-analysis. J Psychiatr Res. 2021;138:228–39.
pubmed: 33866051
doi: 10.1016/j.jpsychires.2021.03.062
Manos RC, Cahill SP, Wetterneck CT, Conelea CA, Ross AR, Riemann BC. The impact of experiential avoidance and obsessive beliefs on obsessive-compulsive symptoms in a severe clinical sample. J Anxiety Disord. 2010;24:700–8.
pubmed: 20627655
doi: 10.1016/j.janxdis.2010.05.001
Reuman L, Jacoby RJ, Abramowitz JS. Cognitive fusion, experiential avoidance, and obsessive beliefs as predictors of obsessive-compulsive symptom dimensions. Int J Cogn Ther. 2016;9:313–26.
doi: 10.1521/ijct_2016_09_13
Corchs F, Corregiari F, Ferrão YA, Takakura T, Mathis ME, Lopes AC, et al. Personality traits and treatment outcome in obsessive-compulsive disorder. Rev Bras Psiquiatr. 2008;30:246–50.
pubmed: 18833426
doi: 10.1590/S1516-44462008000300012
Cruz-Fuentes C, Blas C, Gonzalez L, Camarena B, Nicolini H. Severity of obsessive-compulsive symptoms is related to self-directedness character trait in obsessive-compulsive disorder. CNS Spectr. 2004;9:607–12.
pubmed: 15273653
doi: 10.1017/S1092852900002789
Voderholzer U, Hilbert S, Fischer A, Neumüller J, Schwartz C, Hessler-Kaufmann JB. Frequency and level of self-efficacy predict the effectiveness of therapist- and self-guided exposure in obsessive compulsive disorder. Behav Cogn Psychother. 2020;48:751–5.
pubmed: 32814601
doi: 10.1017/S1352465820000582
Reid JE, Laws KR, Drummond L, Vismara M, Grancini B, Mpavaenda D, et al. Cognitive behavioural therapy with exposure and response prevention in the treatment of obsessive-compulsive disorder: a systematic review and meta-analysis of randomised controlled trials. Compr Psychiatry. 2021;106:152223.
pubmed: 33618297
doi: 10.1016/j.comppsych.2021.152223
Craske MG, Treanor M, Conway CC, Zbozinek T, Vervliet B. Maximizing exposure therapy: an inhibitory learning approach. Behav Res Ther. 2014;58:10–23.
pubmed: 24864005
pmcid: 4114726
doi: 10.1016/j.brat.2014.04.006
Van Balkom ALJM, Van Vliet IM, Emmelkamp PMG, Bockting CLH, Spijker J, Hermens MLM, et al. Multidisciplinaire richtlijn angststoornissen. Multidiciplinaire Richtlijn Angststoornissen (3e revisie, 2013). 2013:155–84.
Hartmann JA, Wichers M, Menne-Lothmann C, Kramer I, Viechtbauer W, Peeters F, et al. Experience sampling-based personalized feedback and positive affect: a randomized controlled trial in depressed patients. PLoS ONE. 2015;10:1–16.
doi: 10.1371/journal.pone.0128095
Kramer I, Simons CJP, Hartmann JA, Menne-Lothmann C, Viechtbauer W, Peeters F, et al. A therapeutic application of the experience sampling method in the treatment of depression: a randomized controlled trial. World Psychiatry. 2014;13:68–77.
pubmed: 24497255
pmcid: 3918026
doi: 10.1002/wps.20090
Simons CJP, Hartmann JA, Kramer I, Menne-Lothmann C, Höhn P, van Bemmel AL, et al. Effects of momentary self-monitoring on empowerment in a randomized controlled trial in patients with depression. Eur Psychiatry. 2015;30:900–6.
pubmed: 26647864
doi: 10.1016/j.eurpsy.2015.09.004
van Os J, Verhagen S, Marsman A, Peeters F, Bak M, Marcelis M, et al. The experience sampling method as an mHealth tool to support self-monitoring, self-insight, and personalized health care in clinical practice. Depress Anxiety. 2017;34:481–93.
pubmed: 28544391
doi: 10.1002/da.22647
Arrindell W, de Vlaming IH, Eisenhardt BM, van Berkum DE, Kwee MG. Cross-cultural validity of the Yale-Brown obsessive compulsive scale. J Behav Ther Exp Psychiatry. 2002;33:159–76.
pubmed: 12628634
doi: 10.1016/S0005-7916(02)00047-2
Trompenaars FJ, Masthoff ED, Van Heck GL, Hodiamont PP, De Vries J. Content validity, construct validity, and reliability of the WHOQOL-Bref in a population of Dutch adult psychiatric outpatients. Qual Life Res. 2005;14:151–60.
pubmed: 15789949
doi: 10.1007/s11136-004-0787-x
Rush AJ, Trivedi MH, Ibrahim HM, Carmody TJ, Arnow B, Klein DN, et al. The 16-item quick inventory of depressive symptomatology (QIDS), clinician rating (QIDS-C), and self-report (QIDS-SR): a psychometric evaluation in patients with chronic major depression. Biol Psychiatry. 2003;54:573–83.
pubmed: 12946886
doi: 10.1016/S0006-3223(02)01866-8
Schulte-van Maaren YWM, Carlier IVE, Zitman FG, van Hemert AM, de Waal MWM, van der Does AJW, et al. Reference values for major depression questionnaires: the Leiden routine outcome monitoring study. J Affect Disord. 2013;149:342–9.
pubmed: 23541841
doi: 10.1016/j.jad.2013.02.009
Spielberger CD. Manual for the State-Trait Anxiety Inventory STAI (Form Y) ("Self-Evaluation Questionnaire"). 1983.
van der Ploeg HM. De Zelf-Beoordelings Vragenlijst angst. Tijdschr Psychiatr. 1982;24:576–88.
Heyne D, King N, Tonge B, Rollings S, Pritchard M, Young D, et al. The self-efficacy questionnaire for school situations: development and psychometric evaluation. Behav Chang. 1998;15:31–40.
doi: 10.1017/S081348390000588X
Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, et al. Preliminary psychometric properties of the acceptance and action QUESTIONNAIRE–II: a revised measure of psychological inflexibility and experiential avoidance. Behav Ther. 2011;42:676–88.
pubmed: 22035996
doi: 10.1016/j.beth.2011.03.007
Jacobs N, Kleen M, De Groot F, A-Tjak J. Het meten van experiëntiële vermijding: De Nederlandstalige versie van de acceptance and action Ouestionnaire-II (AAO-II). PsycNET Tijdschr voor Gedragstherapie. 2008;41:349–61.
Venkatesh V, Morris MG, Davis GB, Davis FD. User acceptance of information technology: toward a unified view. MIS Q. 2003;27:425.
doi: 10.2307/30036540
van de Hei SJ, Poot CC, van den Berg LN, Meijer E, van Boven JFM, Flokstra-de Blok BMJ, et al. Effectiveness, usability and acceptability of a smart inhaler programme in patients with asthma: protocol of the multicentre, pragmatic, open-label, cluster randomised controlled ACCEPTANCE trial. BMJ Open Respir Res. 2022;9:e001400.
pubmed: 36522130
pmcid: 9756226
doi: 10.1136/bmjresp-2022-001400
Kayser L, Karnoe A, Furstrand D, Batterham R, Christensen KB, Elsworth G, et al. A multidimensional tool based on the eHealth literacy framework: development and initial validity testing of the eHealth literacy questionnaire (eHLQ). J Med Internet Res. 2018;20:e36.
pubmed: 29434011
pmcid: 5826975
doi: 10.2196/jmir.8371
Liu G, Liang K-Y. Sample size calculations for studies with correlated observations. Biometrics. 1997;53:937.
pubmed: 9290224
doi: 10.2307/2533554
Peter Diggle, Department of mathematics and statistics. Patrick J. Heagerty, Kung-Yee Liang SZ. Analysis of Longitudinal Data -. 2nd edition. Oxford; 2013.
Grant JE. Obsessive-compulsive disorder. N Engl J Med. 2014;371:646–53.
pubmed: 25119610
doi: 10.1056/NEJMcp1402176
Bogetto F, Venturello S, Albert U, Maina G, Ravizza L. Gender-related clinical differences in obsessive-compulsive disorder. Eur Psychiatry. 1999;14:434–41.
pubmed: 10683629
doi: 10.1016/S0924-9338(99)00224-2
de Mathis MA, de Alvarenga P, Funaro G, Torresan RC, Moraes I, Torres AR, et al. Gender differences in obsessive-compulsive disorder: a literature review. Rev Bras Psiquiatr. 2011;33:390–9.
pubmed: 22189930
doi: 10.1590/S1516-44462011000400014
Lochner C, Hemmings SMJ, Kinnear CJ, Moolman-Smook JC, Corfield VA, Knowles JA, et al. Gender in obsessive–compulsive disorder: clinical and genetic findings. Eur Neuropsychopharmacol. 2004;14:105–13.
pubmed: 15013025
doi: 10.1016/S0924-977X(03)00063-4
Clinical Trial Management System – ResearchManager. https://my-researchmanager.com/en/clinical-trial-management-system-en/ . Accessed 2 Nov 2023.
Jacobson, Truax. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991;59:12–9.
pubmed: 2002127
doi: 10.1037/0022-006X.59.1.12
Pittenger C, Bloch MH. Pharmacological treatment of obsessive-compulsive disorder. Psychiatr Clin North Am. 2014;37:375–91.
pubmed: 25150568
pmcid: 4143776
doi: 10.1016/j.psc.2014.05.006