Feasibility of a randomised controlled trial of remotely delivered problem-solving cognitive behaviour therapy versus usual care for young people with depression and repeat self-harm: lessons learnt (e-DASH)

Kapil Sayal, James Roe, Harriet Ball, Christopher Atha, Catherine Kaylor-Hughes, Boliang Guo, Ellen Townsend, Richard Morriss, Kapil Sayal, James Roe, Harriet Ball, Christopher Atha, Catherine Kaylor-Hughes, Boliang Guo, Ellen Townsend, Richard Morriss

Abstract

Background: Self-harm and depression are strong risk factors for repeat self-harm and suicide. We aimed to investigate the feasibility of a randomised controlled trial (RCT) of remotely delivered problem-solving cognitive behaviour therapy (PSCBT) plus treatment as usual (TAU) versus TAU in young people with repeat self-harm and depression.

Methods: Single-blind multi-centre RCT with an internal pilot, pre-set stop-go criteria and qualitative semi-structured interviews. Eligible participants (aged 16-30 years) were recruited from 9 adult or child and adolescent self-harm and crisis services; had ≥ 2 lifetime self-harm episodes, one in the preceding 96 h; and Beck Depression Inventory-II (BDI-II) score ≥ 17. Participants were randomised (1:1) to either TAU or TAU and 10-12 sessions of PSCBT delivered by mobile phone or video-calling.

Results: Twenty-two participants were recruited (11 in each arm), 10 (46%) completed follow-up at 6 months, 9 (82%) started the PSCBT and 4 (36%) completed it. The study did not meet three of its four stop-go criteria, reflecting considerable barriers to recruitment and retention. Participants had severe depression symptoms: with mean BDI-II 38.9 in the PSCBT and 37.2 in TAU groups, respectively. Three (14%) unblindings occurred for immediate safety concerns. Barriers to recruitment and retention included lack of agency for participants, severity of depression, recency of crisis with burden for participants and clinicians who diagnosed depression according to pervasiveness.

Conclusions: RCTs of PSCBT for young people with depression and self-harm are not feasible using recruitment through mental health services that conduct assessments following self-harm presentations. Clinician assessment following self-harm presentation mainly identifies those with severe rather than mild-moderate depression.

Trial registration: ClinicalTrials.gov ( NCT02377011 ); Date of registration: March 3rd 2015. Retrospectively registered: within 21 days of recruitment of the first participant.

Keywords: Cognitive behaviour therapy; Depression; Problem-solving therapy; RCT; Self-harm.

Conflict of interest statement

Ethics approval and consent to participate

Ethics approval was obtained from the National Research Ethics Service (NRES) Committee East Midlands - Nottingham 1, UK on 24th September 2014 (REC reference: 14/EM/1084). All participants provided written informed consent. The consent included contact details of up to three family or close friend contacts that a participant was willing to give to the research team if there were safety concerns.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Consort flow diagram

References

    1. National Institute for Health and Clinical Excellence. Self-harm: longer-term management. National Clinical Guideline Number 133. National Institute for Health and Clinical Excellence: London, 2012.
    1. Knorr AC, Tull MT, Anestis MD, Dixon-Gordon KL, Bennett MF, Gratz KL. The interactive effect of major depression and non-suicidal self-injury on current suicide risk and lifetime suicide attempts. Arch Suicide Res. 2016;20:539–552. doi: 10.1080/13811118.2016.1158679.
    1. Olfson M, Wall M, Wang S, Crystal S, Gerhard T, Blanco C. Suicide following deliberate self-harm. Am J Psychiatry. 2017;174:765–774. doi: 10.1176/appi.ajp.2017.16111288.
    1. Moran P, Coffey C, Romaniuk H, Olsson C, Borschmann R, Carlin JB, et al. The natural history of self-harm from adolescence to young adulthood: a population-based cohort study. Lancet. 2012;379:236–243. doi: 10.1016/S0140-6736(11)61141-0.
    1. Rodway C, Tham SG, Ibrahim S, Turnbull P, Windfuhr K, Shaw J, et al. Suicide in children and young people in England: a consecutive case series. Lancet Psychiatry. 2016;3:751–759. doi: 10.1016/S2215-0366(16)30094-3.
    1. Gairin I, House A, Owens D. Attendance at the accident and emergency department in the year before suicide: retrospective study. Br J Psychiatry. 2003;183:28–33. doi: 10.1192/bjp.183.1.28.
    1. Hawton K, Townsend E, Arensman E, Gunnell D, House A, Van Heeringen C. Psychosocial versus pharmacological treatments for deliberate self-harm. Cochrane Database Syst Rev. 2000;2:CD001764.
    1. Hawton K, Witt KG, Taylor Salisbury TL, Arensman E, Gunnell D, Hazell P, et al. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2016;5:CD012189.
    1. Linde K, Sigterman K, Kriston L, Rucker G, Jamil S, Meissner K, et al. Effectiveness of psychological treatments for depressive disorders in primary care: systematic review and meta-analysis. Ann Fam Med. 2015;13:56–68. doi: 10.1370/afm.1719.
    1. Murphy E, Steeg S, Cooper J, Chang R, Turpin C, Guthrie E, et al. Assessment rates and compliance with assertive follow-up after self-harm: cohort study. Arch Suicide Res. 2010;14:120–134. doi: 10.1080/13811111003704662.
    1. Kapur N, Gunnell D, Hawton K, Nadeem S, Khalil S, Longson D, et al. Messages from Manchester: pilot randomised controlled trial following self-harm. Br J Psychiatry. 2013;203:73–74. doi: 10.1192/bjp.bp.113.126425.
    1. Hedman E, Ljótsson B, Lindefors N. Cognitive behavior therapy via the internet: a systematic review of applications, clinical efficacy and cost-effectiveness. Expert Rev Pharmacoecon Outcomes Res. 2012;12:745–764. doi: 10.1586/erp.12.67.
    1. Whittaker R, Merry S, Stasiak K, McDowell H, Doherty I, Shepherd M, et al. MEMO - a Mobile phone depression prevention intervention for adolescents: development process and Postprogram findings on acceptability from a randomized controlled trial. J Med Internet Res. 2012;14:e13. doi: 10.2196/jmir.1857.
    1. Wagner B, Horn AB, Maercker A. Internet-based versus face-to-face cognitive-behavioral intervention for depression: a randomized controlled non-inferiority trial. J Affect Disord. 2014;152-154:113–121. doi: 10.1016/j.jad.2013.06.032.
    1. Linde K, Rücker G, Sigterman K, Jamil S, Meissner K, Schneider A, et al. Comparative effectiveness of psychological treatments for depressive disorders in primary care: network meta-analysis. BMC Fam Pract. 2015;16:103. doi: 10.1186/s12875-015-0314-x.
    1. Olthuis JV, Watt MC, Bailey K, Hayden JA, Stewart SH. Therapist-supported internet cognitive behavioural therapy for anxiety disorders in adults. Cochrane Database Syst Rev. 2016;3:CD011565.
    1. Marasinghe RB, Edirippulige S, Kavanagh D, Smith A, Jiffry MT. Effect of mobile phone-based psychotherapy in suicide prevention: a randomized controlled trial in Sri Lanka. J Telemed Telecare. 2012;18:151–155. doi: 10.1258/jtt.2012.SFT107.
    1. Hawton K, Witt KG, Taylor Salisbury TL, Arensman E, Gunnell D, Townsend E. At al. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2015;12:CD012013.
    1. Beck AT, Steer RA, Brown GK. Manual for the Beck depression inventory-II. San Antonio, Texas: The Psychological Corporation; 1996.
    1. First MB, Spitzer RL, Gibbon M, Endicott J. Structured clinical interview for DSM-IV Axis 1 disorders. Washington, DC: American Psychiatric Press; 1997.
    1. Brown G, Ten Have T, Henriques GR, Xie SX, Hollander JE, Beck AT. Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial. JAMA. 2005;294:563–570. doi: 10.1001/jama.294.5.563.
    1. Brown GK, Henriques GR, Ratto C, Beck AT. Cognitive therapy treatment manual for suicide attempters. Philadelphia: University of Pennsylvania; 2002.
    1. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001;16:606–613. doi: 10.1046/j.1525-1497.2001.016009606.x.
    1. Beck AT. Beck hopelessness scale. San Antonio, Texas: The Psychological Corporation; 1988.
    1. Spitzer RL, Kroenke K, Williams JB, Löwe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166:1092–1097. doi: 10.1001/archinte.166.10.1092.
    1. Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, et al. The Columbia- suicide severity rating scale (C-SSRS): initial validity and internal consistency findings from three multi-site studies with adolescents and adults. Am J Psychiatry. 2011;168:1266–1277. doi: 10.1176/appi.ajp.2011.10111704.
    1. Mundt JC, Marks IM, Shear MK, Greist JH. The work and social adjustment scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002;180:461–464. doi: 10.1192/bjp.180.5.461.
    1. Herdman M, Gudex C, Lloyd A, Janssen M, Kind P, Parkin D. At al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L) Qual Life Res. 2011;20:1727–1736. doi: 10.1007/s11136-011-9903-x.
    1. Whiteside SP, Lynam DR. The five factor model and impulsivity: using a structural model of personality to understand impulsivity. Personal Individ Differ. 2001;30:669–689. doi: 10.1016/S0191-8869(00)00064-7.
    1. Rawlings J, Shevlin M, Corcoran R, Morriss R, Taylor PJ. Out of the blue: untangling the association between impulsivity and planning in self-harm. J Affect Disord. 2015;184:29–35. doi: 10.1016/j.jad.2015.05.042.
    1. Slee N, Garnefski N, van der Leeden R, Arensman E, Spinhoven P. Cognitive-behavioural intervention for self-harm: randomised controlled trial. Br J Psychiatry. 2008;192:202–211. doi: 10.1192/bjp.bp.107.037564.
    1. Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Res Psychol. 2006;3:77–101. doi: 10.1191/1478088706qp063oa.
    1. Boyatzis RE. Transforming qualitative information: thematic analysis and code development. Thousand Oaks, CA: Sage; 1998.
    1. National Institute for Health and Clinical Excellence. Clinical Guideline 16. Self-harm: The short-term physical and psychological management and secondary prevention of self-harm in primary and secondary care. National Institute for Clinical Excellence, London, 2004.
    1. McManus S, Bebbington P, Jenkins R, Brugha T. (eds) Mental health and wellbeing in England: Adult Psychiatric Morbidity Survey 2014. Leeds, NHS Digital, 2016.
    1. American Psychiatric Association . Diagnostic and Statistical Manual of mental disorders, 5th edn (DSM-5) Washington DC: APA; 2013.
    1. Whiteside SP, Lynam DR, Miller JD, Reynolds SK. Validation of the UPPS impulsive behaviour scale: a four-factor model of impulsivity. Eur J Personal. 2005;19:559–574. doi: 10.1002/per.556.
    1. Cooper J, Hunter C, Owen-Smith A, Gunnell D, Donovan J, Hawton K, et al. “Well it’s like someone at the other end cares about you”. A qualitative study exploring the views of users and providers of care of contact-based interventions following self-harm. Gen Hosp Psychiatry. 2011;33:16–76. doi: 10.1016/j.genhosppsych.2011.01.009.
    1. Rowe SL, French RS, Henderson P, Ougrin D, Slade M, Moran P. Help-seeking behaviour and adolescent self-harm: a systematic review. Austr NZ J Psychiatry. 2014;48:1083–1095. doi: 10.1177/0004867414555718.
    1. Bergen H, Hawton K, Waters K, Cooper J, Kapur N. Epidemiology and trends in non-fatal self-harm in three centres in England: 2000-2007. Br J Psychiatry. 2010;197:493–498. doi: 10.1192/bjp.bp.110.077651.
    1. Hatcher S, Sharon C, Parag V, Collins N. Problem-solving therapy for people who present to hospital with self-harm: Zelen randomised controlled trial. Br J Psychiatry. 2011;199:310–316. doi: 10.1192/bjp.bp.110.090126.
    1. Cooper J, Steeg S, Gunnell D, Webb R, Hawton K, Bennewith O, et al. Variations in the hospital management of self-harm and patient outcome: a multi-site observational study in England. J Affect Disord. 2015;174:101–105. doi: 10.1016/j.jad.2014.11.037.
    1. Rossow I, Wichstrom L. Receipt of help after deliberate self-harm among adolescents: changes over an eight-year period. Psychiatr Serv. 2010;61:783–787. doi: 10.1176/ps.2010.61.8.783.

Source: PubMed

赞助者和合作者

医疗条件

药物干预

3
订阅