An Internet-based emotion regulation intervention versus no intervention for non-suicidal self-injury in adolescents: a statistical analysis plan for a feasibility randomised clinical trial

Markus Harboe Olsen, Britt Morthorst, Anne Katrine Pagsberg, Michella Heinrichsen, Bo Møhl, Lotte Rubæk, Johan Bjureberg, Olivia Simonsson, Jane Lindschou, Christian Gluud, Janus Christian Jakobsen, Markus Harboe Olsen, Britt Morthorst, Anne Katrine Pagsberg, Michella Heinrichsen, Bo Møhl, Lotte Rubæk, Johan Bjureberg, Olivia Simonsson, Jane Lindschou, Christian Gluud, Janus Christian Jakobsen

Abstract

Background: Non-suicidal self-injury (NSSI) has a lifetime prevalence of 17% in adolescents in the general population and up to 74% in adolescents with psychiatric disorders. NSSI is one of the most important predictors of later suicidal behaviour and death by suicide. The TEENS feasibility trial was initiated to assess the feasibility and safety of Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA) as an add-on to treatment as usual in 13-17-year-old patients with NSSI referred to the Child and Adolescent Mental Health Services.

Methods: The TEENS feasibility trial is a randomised clinical trial with a parallel-group design. The trial intervention is an 11-week online therapy which is tested as an add-on to treatment as usual versus treatment as usual. The primary feasibility outcomes are the fraction of participants who (1) completed 12 weeks of follow-up interview or assessment, (2) consented to inclusion and randomisation out of all eligible participants, and (3) were compliant with the experimental intervention, assessed as completion of at least six out of eleven modules in the programme. Since this is a feasibility trial, we did not predefine a required sample size. The exploratory clinical outcome, the frequency of NSSI episodes, assessed using Deliberate Self-Harm Inventory - Youth version (DSHI-Y), at the end of intervention, is planned to be the future primary outcome in a larger pragmatic definitive randomised clinical trial. After completion of the feasibility trial, blinded data will be analysed by two independent statisticians blinded to the intervention, where 'A' and 'B' refer to the two groups. A third party will compare these reports, and discrepancies will be discussed. The statistical report with the analyses chosen for the manuscript is being tracked using a version control system, and both statistical reports will be published as a supplementary material. Based on the final statistical report, two blinded conclusions will be drawn by the steering group.

Discussion: We present a pre-defined statistical analysis plan for the TEENS feasibility trial, which limits bias, p-hacking, data-driven interpretations. This statistical analysis plan is accompanied by a pre-programmed version-controlled statistical report with simulated data, which increases transparency and reproducibility.

Trial registration: ClinicalTrials.gov NCT04243603 . Registered on 28 January 2020.

Keywords: Emotion Regulation Individual Therapy for Adolescents (ERITA); Internet-based intervention; Non-suicidal self-injury; Randomised feasibility trial; Statistical analysis plan.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2021. The Author(s).

Figures

Fig. 1
Fig. 1
The presentation of the primary feasibility outcomes with colour-coding for every outcome, either feasible (green) or unfeasible (red). The lines presented in the figure are based on simulated data to exemplify the results presented in the final manuscript (supplemental material)
Fig. 2
Fig. 2
Graphical presentation of outcomes, which will be presented with either A median and IQR or B mean and 95% confidence interval

References

    1. Swannell SV, Martin GE, Page A, Hasking P, St John NJ. Prevalence of nonsuicidal self-injury in nonclinical samples: systematic review, meta-analysis and meta-regression. Suicide Life Threat Behav. 2014;44(3):273–303. doi: 10.1111/sltb.12070.
    1. Asarnow JR, Porta G, Spirito A, Emslie G, Clarke G, Wagner KD, Vitiello B, Keller M, Birmaher B, McCracken J, Mayes T, Berk M, Brent DA. Suicide attempts and nonsuicidal self-injury in the treatment of resistant depression in adolescents: findings from the TORDIA study. J Am Acad Child Adolesc Psychiatry. 2011;50(8):772–781. doi: 10.1016/j.jaac.2011.04.003.
    1. Whitlock J, Knox KL. The relationship between self-injurious behavior and suicide in a young adult population. Arch Pediatr Adolesc Med. 2007;161(7):634–640. doi: 10.1001/archpedi.161.7.634.
    1. Wilkinson P, Kelvin R, Roberts C, Dubicka B, Goodyer I. Clinical and psychosocial predictors of suicide attempts and nonsuicidal self-injury in the Adolescent Depression Antidepressants and Psychotherapy Trial (ADAPT) Am J Psychiatry. 2011;168(5):495–501. doi: 10.1176/appi.ajp.2010.10050718.
    1. Nock MK, Kessler RC. Prevalence of and risk factors for suicide attempts versus suicide gestures: analysis of the National Comorbidity Survey. J Abnorm Psychol. 2006;115(3):616–623. doi: 10.1037/0021-843X.115.3.616.
    1. Hawton K, Witt KG, Taylor Salisbury TL, Arensman E, Gunnell D, Townsend E, van Heeringen K, Hazell P. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2015;(12):CD012013. 10.1002/14651858.CD012013.
    1. Hawton K, Witt KG, Taylor Salisbury TL, Arensman E, Gunnell D, Hazell P, Townsend E, van Heeringen K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2016;(5):CD012189. 10.1002/14651858.CD012189.
    1. Turner BJ, Austin SB, Chapman AL. Treating nonsuicidal self-injury: a systematic review of psychological and pharmacological interventions. Can J Psychiatr. 2014;59(11):576–585. doi: 10.1177/070674371405901103.
    1. Ougrin D, Tranah T, Stahl D, Moran P, Asarnow JR. Therapeutic interventions for suicide attempts and self-harm in adolescents: systematic review and meta-analysis. J Am Acad Child Adolesc Psychiatry. 2015;54:97–107.e2. doi: 10.1016/j.jaac.2014.10.009.
    1. Bjureberg J, Sahlin H, Hedman-Lagerlöf E, Gratz KL, Tull MT, Jokinen J, Hellner C, Ljótsson B. Extending research on Emotion Regulation Individual Therapy for Adolescents (ERITA) with nonsuicidal self-injury disorder: open pilot trial and mediation analysis of a novel online version. BMC Psychiatry. 2018;18(1):326. doi: 10.1186/s12888-018-1885-6.
    1. Bjureberg J, Sahlin H, Hellner C, Hedman-Lagerlöf E, Gratz KL, Bjärehed J, Jokinen J, Tull MT, Ljótsson B. Emotion regulation individual therapy for adolescents with nonsuicidal self-injury disorder: a feasibility study. BMC Psychiatry. 2017;17(1):411. doi: 10.1186/s12888-017-1527-4.
    1. Gratz KL, Tull MT, Levy R. Randomized controlled trial and uncontrolled 9-month follow-up of an adjunctive emotion regulation group therapy for deliberate self-harm among women with borderline personality disorder. Psychol Med. 2014;44(10):2099–2112. doi: 10.1017/S0033291713002134.
    1. Miller AL. Introduction to a special issue dialectical behavior therapy: evolution and adaptations in the 21st century. Am J Psychother. 2015;69(2):91–95. doi: 10.1176/appi.psychotherapy.2015.69.2.91.
    1. Vigerland S, Lenhard F, Bonnert M, Lalouni M, Hedman E, Ahlen J, Olén O, Serlachius E, Ljótsson B. Internet-delivered cognitive behavior therapy for children and adolescents: a systematic review and meta-analysis. Clin Psychol Rev. 2016;50:1–10. doi: 10.1016/j.cpr.2016.09.005.
    1. Collins R, Bowman L, Landray M, Peto R. The magic of randomization versus the myth of real-world evidence. N Engl J Med. 2020;382(7):674–678. doi: 10.1056/NEJMsb1901642.
    1. Jakobsen J, Gluud C. The necessity of randomized clinical trials. Br J Med Med Res. 2013;3(4):1453–1468. doi: 10.9734/BJMMR/2013/3208.
    1. Arshad U, Farhat-Ul-Ain GJ, Husain N, Chaudhry N, Taylor PJ. A systematic review of the evidence supporting mobile- and Internet-based psychological interventions for self-harm. Suicide Life Threat Behav. 2020;50(1):151–179. doi: 10.1111/sltb.12583.
    1. Morthorst B, Rubæk L, Lindschou J, Jakobsen JC, Gluud C, Bjureberg J, et al. An Internet-based emotion regulation intervention versus no intervention for nonsuicidal self-injury in adolescents: study protocol for a feasibility trial. Pilot Feasibility Stud. 2021;7:1–10. doi: 10.1186/s40814-021-00785-4.
    1. Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, et al. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016;355:i5239. doi: 10.1136/bmj.i5239.
    1. Gamble C, Krishan A, Stocken D, Lewis S, Juszczak E, Doré C, Williamson PR, Altman DG, Montgomery A, Lim P, Berlin J, Senn S, Day S, Barbachano Y, Loder E. Guidelines for the content of statistical analysis plans in clinical trials. JAMA. 2017;318(23):2337–2343. doi: 10.1001/jama.2017.18556.
    1. Gratz KL. Measurement of deliberate self-harm: preliminary data on the deliberate self-harm inventory. J Psychopathol Behav Assess. 2001;23(4):253–263. doi: 10.1023/A:1012779403943.
    1. Ravens-Sieberer U, Erhart M, Rajmil L, Herdman M, Auquier P, Bruil J, et al. Reliability, construct and criterion validity of the KIDSCREEN-10 score: a short measure for children and adolescents’ well-being and health-related quality of life. Qual Life Res. 2010;19(10):1487–1500. doi: 10.1007/s11136-010-9706-5.
    1. Henry JD, Crawford JR. The short-form version of the Depression Anxiety Stress Scales (DASS-21): construct validity and normative data in a large non-clinical sample. Br J Clin Psychol. 2005;44(2):227–239. doi: 10.1348/014466505X29657.
    1. Bjureberg J, Ljótsson B, Tull MT, Hedman E, Sahlin H, Lundh L-G, Bjärehed J, DiLillo D, Messman-Moore T, Gumpert CH, Gratz KL. Development and validation of a brief version of the Difficulties in Emotion Regulation Scale: the DERS-16. J Psychopathol Behav Assess. 2016;38(2):284–296. doi: 10.1007/s10862-015-9514-x.
    1. Conway PM, Erlangsen A, Teasdale TW, Jakobsen IS, Larsen KJ. Predictive validity of the Columbia-Suicide Severity Rating Scale for Short-Term Suicidal Behavior: a Danish study of adolescents at a high risk of suicide. Arch Suicide Res. 2017;21(3):455–469. doi: 10.1080/13811118.2016.1222318.
    1. Fabes RA, Eisenberg N, Bernzweig J. The Coping with Children’s Negative Emotions Scale: procedures and scoring. Arizona State Univ. 1990; Available from: .
    1. Rozental A, Kottorp A, Boettcher J, Andersson G, Carlbring P. Negative effects of psychological treatments: an exploratory factor analysis of the negative effects questionnaire for monitoring and reporting adverse and unwanted events. PLoS One. 2016;11(6):e0157503. doi: 10.1371/journal.pone.0157503.
    1. Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharm Stat. 2005;4(4):287–291. doi: 10.1002/pst.185.
    1. Nørskov AK, Lange T, Nielsen EE, Gluud C, Winkel P, Beyersmann J, de Uña-Álvarez J, Torri V, Billot L, Putter H, Wetterslev J, Thabane L, Jakobsen JC. Assessment of assumptions of statistical analysis methods in randomised clinical trials: the what and how. BMJ Evid Based Med. 2021;26(3):121-126. 10.1136/bmjebm-2019-111268. Epub 2020 Jan 27.
    1. Visalakshi J, Jeyaseelan L. Confidence interval for skewed distribution in outcome of change or difference between methods. Clin Epidemiol Glob Heal. 2014;2(3):117–20. 10.1016/j.cegh.2013.07.006. Accessed 1 May 2021.
    1. Nielsen EE, Nørskov AK, Lange T, Thabane L, Wetterslev J, Beyersmann J, de Uña-Álvarez J, Torri V, Billot L, Putter H, Winkel P, Gluud C, Jakobsen JC. Assessing assumptions for statistical analyses in randomised clinical trials. BMJ Evid Based Med. 2019;24(5):185–189. doi: 10.1136/bmjebm-2019-111174.

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