Text Message Intervention to Reduce Repeat Self-harm

Self-Injurious Behavior Clinical Trial

Official title:

Text Message Intervention to Reduce Repeat Self-harm in Patients Presenting to the Emergency Department

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01823120
• Other study ID #: 13/18
• Status: Terminated
• Phase: N/A
• First received: March 26, 2013
• Last updated: September 9, 2014
• Start date: March 2015
• Est. completion date: December 2015

Study information

• Verified date: September 2014
• Source: University of Dublin, Trinity College
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Description:

Repetition of self-harm is common, ranging from 6% to 30% in 12 months. Repetition is strongly associated with subsequent suicide and has important implications for healthcare resources. In every country including Ireland, fatal suicide attempts rank among the top ten causes of death for individual of all ages and one of the three leading causes of death in the 15 -35 years age group.

Previous studies of interventions to reduce the repetition of self-harm in unselected patient groups have been unsuccessful in reducing the proportion of repeaters. These interventions have included the use of antidepressants, problem solving, intensive care with outreach, an emergency card, psychosocial crisis intervention, and guaranteed inpatient shelter in cases of emergency. In a study involving the use of low cost postcards after an episode of self-poisoning, although no significant difference in the proportion of individual patients who repeated self-harm were detected, there was a clinically and statistically significant reduction in the number of events per individual by about 50%.

Only a few non-pharmacological interventions have been reported to be effective in reducing repetition in selected subsets of populations with self-harm including; partial hospitalization, dialectical behaviour therapy and psychodynamic interpersonal therapy. These interventions are all resource intensive and therefore may only be applicable to carefully selected patients.

Given the recent global financial crisis with consequent diminution of health care resources, interventions are needed that could be delivered economically to entire populations of patients who self-harm. In light of the growing interest in using text messages as an intervention in healthcare, the investigators will focus in this study on exploring the potential for using text messages to reduce repeat self-harm in patients presenting to the Emergency Department (ED).

There is established research evidence for using text messages to remind patients of scheduled medical appointments, to coordinate medical staff,to deliver medical test results and to monitor patient side effects following treatment.

In a review of the literature on the use of text messaging for clinical and healthy behaviour interventions, Wei et al. (2011) found that among 16 randomized controlled trials, 10 reported significant improvement with interventions and six reported differences suggesting positive trends. In one meta-analysis of four randomised trials of mobile phone-based interventions for smoking cessation, it was reported that text message interventions resulted in a significant increase in short-term self-reported quitting (RR of 2.18, 95% CI 1.80 to 2.65). In the same review, when data from an internet and a mobile phone programme were pooled and meta-analysed, they found significant increases in both short-, and long-term, self-reported quitting (RR of 2.03, 95% Conficence Intervals (CI)= 1.40 to 2.94).

In a study of text message services based on qualitative interviews with 12 young people, the aim of which was to provide young people with information on cannabis and help them to reduce their consumption of the drug, participants reported that they saw the messages as flexible and discrete, and as being personally meant for them. They paid more attention to the messages than they did to mass approaches such as public information broadcasts on TV. Along with other factors, the participants reported feeling motivated to decrease their level of cannabis abuse and to maintain a reduced level. .

In another study, young adults in 3 urban EDs (n= 45; aged 18 to 24 years, 54% women) who were identified as hazardous drinkers by the Alcohol Use Disorders Identification Test-Consumption Score were randomly assigned by the researchers to weekly text message-based feedback with goal setting (Intervention), weekly text message-based drinking assessments without feedback (Assessment), or to a control who received no text messages. At 3 months, they found that participants who were exposed to the text message-based intervention had 3.4 (Standard Deviation (SD)= 5.4) fewer heavy drinking days in the last month and 2.1 (SD 1.5) fewer drinks per drinking day when compared to baseline.

In a recent randomised trial in Ireland of supportive text messages for patients with depression and comorbid alcohol use disorder, there was a trend towards finding a greater cumulative abstinence duration in the group that received twice daily supportive text messages compared to the control group who only received fortnightly tank you text messages: 88.3 (SD=6.2) vs. 79.3 (SD=24.1), t=1.78, df=48, p=0.08. In this trial, after adjusting for baseline scores, patients in the supportive text message group also had significantly lower Beck's Depression Inventory Scores compared to the control groups; 8.5 (SD=8.0) vs. 16.7 (SD=10.3) respectively, F (1, 49) = 9.54, p=0.003, ƞp2=0.17.

In a study by Owens et al. (2010) to engage a group of self-harmers in the development of a text-messaging intervention to reduce repetition of self-harm, three broad categories of message emerged, namely, those that affirmed or validated emotions (e.g. "it's ok to feel angry"), those that prescribed actions, distractions or cognitive strategies (e.g. "call Samaritans," "have a warm bath"," take it a minute at a time") and those that were interrogative or designed to initiate dialogue (e.g. "do you want to talk?"). They also found that the group were unable to reach an agreement on a set of messages that might work in all circumstances to reduce the urge to self-harm or to enable people to feel cared for, concluding instead that text messages may need to be individualised. A major limitation of this study was its small sample size of only 8 people. Furthermore, participants in this study only reported how they envisaged they would respond to text messages rather than how they actually responded to text messages which could vary significantly from what is reported. In the recent randomised trial in Ireland of generic supportive text messages for patients with depression and comorbid alcohol use disorder, 20 of the 24 patients (83%) reported that the intervention had played a useful role in helping to improve their mental health.

Recently, the Samaritans in Ireland introduce a limited interactive text message programme for patients who experience suicidal ideation. This service allows clients to receive support when in crisis via an interactive text messaging programme from a trained volunteer.

After an extensive review of the literature using Google Scholar, MEDLINE, Pub Med, ERIC, Web of Science, Science Direct and PsychINFO, no published randomised trial was found on the use of text messages delivered via mobile phone as an intervention to address suicidal ideation and repeat self-harm in patients presenting with self-harm to the ED. Thus, the investigators seek to determine if text messaging is a useful and effective strategy to help reduce the frequency and intensity of thoughts of self-harm and depressive symptoms after patients are discharged from an ED following a presentation 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Self-Injurious Behavior

Intervention

Other:
• Supportive and interactive text messages

Locations

Country	Name	City	State
Ireland	Beaumont Hospital	Dublin	Co Dublin

Sponsors (3)

Lead Sponsor	Collaborator
University of Dublin, Trinity College	Beaumont Hospital, Royal College of Surgeons, Ireland

Country where clinical trial is conducted

Ireland, 

References & Publications (27)

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

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

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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, Träskman-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. Review. — View Citation

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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. — View Citation

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).

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. — View Citation

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.

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Tomnay JE, Pitts MK, Fairley CK. New technology and partner notification--why aren't we using them? Int J STD AIDS. 2005 Jan;16(1):19-22. Review. — View Citation

van der Sande R, van Rooijen L, Buskens E, Allart E, Hawton K, van der Graaf Y, van Engeland H. Intensive in-patient and community intervention versus routine care after attempted suicide. A randomised controlled intervention study. Br J Psychiatry. 1997 Jul;171:35-41. — View Citation

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. Epub 2007 Oct 5. — View Citation

Wei, J., I. Hollin and S. Kachnowski (2011).

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

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Utilisation of the services provided by the Samaritans Ireland	The range and frequency of utilisation of the services provided by the Samaritans Ireland	Three months	Yes
Other	Patient satisfaction with treatment	Patient satisfaction (for both groups) with their overall follow-up treatment at three months following discharge from the ED would be measured using a self-designed likert scale.	Three months	Yes
Other	Feedback about patients' experiences, expectations and satisfaction with the communication system	Feedback about patients' experiences, expectations and satisfaction with the communication system and its perceived impact on their mood, suicidal thoughts and potential to repeat self-harm. These aspects would be measured using semi-structured questionnaires which include likert scales at 3 months	Three months	Yes
Primary	Repetition of self-harm	Proportion of patients repeating self-harm	Three months	Yes
Primary	Change scores on the Suicide Behaviors Questionnaire from baseline	The change scores on the Suicide Behaviors Questionnaire from baseline	Baseline and three months	Yes
Secondary	Repeat episodes of self-harm per person	Number of repeat episodes of self-harm per person	Three months	Yes
Secondary	Change scores in the Modified Scale for Suicide Ideation from baseline	The change scores on the Modified Scale for Suicide Ideation from baseline	Baseline anf three months	Yes
Secondary	Change scores on the Positive and Negative Suicide Ideation Inventory from baseline	The change scores on the Positive and Negative Suicide Ideation Inventory from baseline	Baseline and three months	Yes
Secondary	Change scores on the Beck Hopelessness Scale from baseline	The change scores on the Beck Hopelessness Scale from baseline	Baseline and three months	Yes
Secondary	Change scores on the Global Assessment of Functioning Scale from baseline	The change scores on the Global Assessment of Functioning Scale from baseline	Baseline and three months	Yes