NCT01823120

Brief Summary

Between 6% and 30% of people who harm themselves repeat this self-harm within the following 12 months. The investigators know that people who harm themselves are much more likely to commit suicide, but the investigators have no clear evidence about the best way to reduce the likelihood of someone harming themselves again. Text messaging is now a common form of communication. Previous research has shown us that the investigators can use text messages for different types of health care interventions. Examples of this include reminding patients of medical appointments, delivering test results, to check patient side effects following treatment and to reduce depressive symptoms in patients with depression and alcohol problems. The Samaritans have introduced interactive text messages (where you can have a conversation by text with their service) and have noted an increasing use of this contact with their service. This research study is taking place to find out if using supportive and interactive text messages can reduce further episodes of self-harm in patients who present to the Emergency Department (ED) with self-harm. The investigators hypothesize that supportive, informative and interactive text messages delivered to patients discharged from an ED after an episode of self-harm will significantly reduce the frequency and intensity of thoughts of self-harm and self-harming behaviour in patients compared with those receiving only follow-up treatment as usual. A secondary hypothesis is that patients receiving the text messages will report a favourable experience and an overall satisfaction with the system.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 4, 2013

Completed
1.9 years until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 11, 2014

Status Verified

September 1, 2014

Enrollment Period

9 months

First QC Date

March 26, 2013

Last Update Submit

September 9, 2014

Conditions

Keywords

Self harmEmergency DepartmentRepetitionSupportive Text messagesInteractive

Outcome Measures

Primary Outcomes (2)

  • Repetition of self-harm

    Proportion of patients repeating self-harm

    Three months

  • Change scores on the Suicide Behaviors Questionnaire from baseline

    The change scores on the Suicide Behaviors Questionnaire from baseline

    Baseline and three months

Secondary Outcomes (5)

  • Repeat episodes of self-harm per person

    Three months

  • Change scores in the Modified Scale for Suicide Ideation from baseline

    Baseline anf three months

  • Change scores on the Positive and Negative Suicide Ideation Inventory from baseline

    Baseline and three months

  • Change scores on the Beck Hopelessness Scale from baseline

    Baseline and three months

  • Change scores on the Global Assessment of Functioning Scale from baseline

    Baseline and three months

Other Outcomes (3)

  • Utilisation of the services provided by the Samaritans Ireland

    Three months

  • Patient satisfaction with treatment

    Three months

  • Feedback about patients' experiences, expectations and satisfaction with the communication system

    Three months

Study Arms (2)

No text messages

NO INTERVENTION

Patients in the non-intervention group will not receive any text messages. However, they will also receive the routine outpatient follow-up arrangements associated with attendance at an ED with self-harm including the provision of a contact phone number for the Samaritans.

Supportive and interactive text messages

EXPERIMENTAL

We will deliver daily supportive and informative text messages for one month followed by one supportive and informative text message every other day the second month and then one weekly text message the third month to patients in the intervention group after they have been discharged from the ED following an episode of self-harm. Supportive text messages will mainly target relieving the patients of mood symptoms and providing them with strategies for dealing with suicidal thoughts while the informative ones will provide patients with a dedicated mobile phone number through which they can receive interactive support from the Samaritans. The text messages will encourage participants to text the Samaritans in times of crisis. Please see appendix I for examples of the relevant text messages.

Other: Supportive and interactive text messages

Interventions

Supportive and interactive text messages

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients 18 years and over, presenting to the ED with self-harm.
  • All patients should have a mobile phone, be familiar with text messaging technology and be willing to take part in the study.

You may not qualify if:

  • Patients who do not consent to take part in the study.
  • Patients who do not have a mobile phone or are unable to use the mobile text message technology.
  • Patients who are admitted as a psychiatric inpatient following the assessment in the ED or those who require admission to a medical ward for longer than 48 hours.
  • Patients who would be unavailable for follow-up during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beaumont Hospital

Dublin, Co Dublin, Dublin 9, Ireland

Location

Related Publications (30)

  • Agyapong, V., J. Milnes, M. McLoughlin and C. Farren (2012).

    BACKGROUND
  • Agyapong, V. I. O., M. D. McLoughlin and C. K. Farren. Usefulness of Supportive Text Messages to Patients with Alcohol Use Disorder and Comorbid Depression-A Single-Blind Randomised Controlled Trial. J. Affect. Disord. Volume 141, Issues 2-3, 10 December 2012, Pages 168-176

    BACKGROUND
  • Australian Bureau of Statistics (2003). Household Use of Information Technology Canberra, Australia. B., P. (2003).

    BACKGROUND
  • Bateman, A. and P. Fonagy (1999).

    BACKGROUND
  • Brianna S., Fjeldsoe B.A. and Alison L. (2009).

    BACKGROUND
  • Carter, G. L., K. Clover, I. M. Whyte, A. H. Dawson and C. D'Este (2005).

    BACKGROUND
  • Cohen, J. (1988). Statistical power analysis for the behavioral sciences, Academic Press. New York. Downer, S., J. Meara and A. Da Costa (2005).

    BACKGROUND
  • Guthrie E, Kapur N, Mackway-Jones K, Chew-Graham C, Moorey J, Mendel E, Marino-Francis F, Sanderson S, Turpin C, Boddy G, Tomenson B. Randomised controlled trial of brief psychological intervention after deliberate self poisoning. BMJ. 2001 Jul 21;323(7305):135-8. doi: 10.1136/bmj.323.7305.135.

    PMID: 11463679BACKGROUND
  • Hawton K, Arensman E, Townsend E, Bremner S, Feldman E, Goldney R, Gunnell D, Hazell P, van Heeringen K, House A, Owens D, Sakinofsky I, Traskman-Bendz L. Deliberate self harm: systematic review of efficacy of psychosocial and pharmacological treatments in preventing repetition. BMJ. 1998 Aug 15;317(7156):441-7. doi: 10.1136/bmj.317.7156.441.

    PMID: 9703526BACKGROUND
  • Haynes RB., S. D., Guyatt G., Tugwell, P., (2005). Clinical Epidemiology: How to do Clinical Practice Research. Philadelphia PA, Lippincott, Williams, Wilkins.

    BACKGROUND
  • House A, Owens D, Patchett L. Deliberate self harm. Qual Health Care. 1999 Jun;8(2):137-43. doi: 10.1136/qshc.8.2.137. No abstract available.

    PMID: 10557677BACKGROUND
  • Jeffery RW, Drewnowski A, Epstein LH, Stunkard AJ, Wilson GT, Wing RR, Hill DR. Long-term maintenance of weight loss: current status. Health Psychol. 2000 Jan;19(1S):5-16. doi: 10.1037/0278-6133.19.suppl1.5.

    PMID: 10709944BACKGROUND
  • Leong KC, Chen WS, Leong KW, Mastura I, Mimi O, Sheikh MA, Zailinawati AH, Ng CJ, Phua KL, Teng CL. The use of text messaging to improve attendance in primary care: a randomized controlled trial. Fam Pract. 2006 Dec;23(6):699-705. doi: 10.1093/fampra/cml044. Epub 2006 Aug 17.

    PMID: 16916871BACKGROUND
  • Linehan MM, Armstrong HE, Suarez A, Allmon D, Heard HL. Cognitive-behavioral treatment of chronically parasuicidal borderline patients. Arch Gen Psychiatry. 1991 Dec;48(12):1060-4. doi: 10.1001/archpsyc.1991.01810360024003.

    PMID: 1845222BACKGROUND
  • Luborsky, L. (1962).

    BACKGROUND
  • Menon-Johansson AS, McNaught F, Mandalia S, Sullivan AK. Texting decreases the time to treatment for genital Chlamydia trachomatis infection. Sex Transm Infect. 2006 Feb;82(1):49-51. doi: 10.1136/sti.2004.014381.

    PMID: 16461603BACKGROUND
  • Molenberghs G, K. M., Ed. (2007). Missing data in clinical studies. Chichester, John Wiley & Sons. Owens, C., P. Farrand, R. Darvill, T. Emmens, E. Hewis and P. Aitken (2011).

    BACKGROUND
  • Patrick K, Raab F, Adams MA, Dillon L, Zabinski M, Rock CL, Griswold WG, Norman GJ. A text message-based intervention for weight loss: randomized controlled trial. J Med Internet Res. 2009 Jan 13;11(1):e1. doi: 10.2196/jmir.1100.

    PMID: 19141433BACKGROUND
  • Rice R. and K. J. (2003).

    BACKGROUND
  • Rickards L., Fox K., Roberts C., Flectcher L. and G. E. (2004). Living in Britain-The 2002 General Household Survey. London: Office for National Statistics. London, Office for National Statistics.

    BACKGROUND
  • Sherry E, C. B., Warnke P. (2002).

    BACKGROUND
  • Stross, R. (2008). What carriers aren't eager to tell you about texting. New York Times. New York.

    BACKGROUND
  • Tomnay JE, P. M., Fairley CK. (2005).

    BACKGROUND
  • van der Sande R, Buskens E, Allart E, van der Graaf Y, van Engeland H. Psychosocial intervention following suicide attempt: a systematic review of treatment interventions. Acta Psychiatr Scand. 1997 Jul;96(1):43-50. doi: 10.1111/j.1600-0447.1997.tb09903.x.

    PMID: 9259223BACKGROUND
  • Weaver A, Young AM, Rowntree J, Townsend N, Pearson S, Smith J, Gibson O, Cobern W, Larsen M, Tarassenko L. Application of mobile phone technology for managing chemotherapy-associated side-effects. Ann Oncol. 2007 Nov;18(11):1887-92. doi: 10.1093/annonc/mdm354. Epub 2007 Oct 5.

    PMID: 17921245BACKGROUND
  • Wei, J., I. Hollin and S. Kachnowski (2011).

    BACKGROUND
  • Whittaker, R., R. Borland, C. Bullen, R. Lin, H. McRobbie and A. Rodgers (2009).

    BACKGROUND
  • Suffoletto , B., C. Callaway, J. Kristan, K. Kraemer and D. B. Clark (2011 Dec 14).

    BACKGROUND
  • Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

  • Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.

MeSH Terms

Conditions

Self-Injurious BehaviorEmergencies

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Vincent IO Agyapong, MRCPsych MD

    University of Dublin, Trinity College Dublin

    PRINCIPAL INVESTIGATOR
  • Siobhan MacHale, FRCPsych

    Beaumont Hospital Dublin

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 26, 2013

First Posted

April 4, 2013

Study Start

March 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 11, 2014

Record last verified: 2014-09

Locations