Text Message Intervention to Reduce Repeat Self-harm

This study has been terminated.
(Resignation of critical volunteer staff and lack of funding)
Sponsor:
Collaborators:
Beaumont Hospital
Royal College of Surgeons, Ireland
Information provided by (Responsible Party):
Vincent Agyapong, University of Dublin, Trinity College
ClinicalTrials.gov Identifier:
NCT01823120
First received: March 26, 2013
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Self-Injurious Behavior
Other: Supportive and interactive text messages

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Text Message Intervention to Reduce Repeat Self-harm in Patients Presenting to the Emergency Department

Resource links provided by NLM:


Further study details as provided by University of Dublin, Trinity College:

Primary Outcome Measures:
  • Repetition of self-harm [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
    Proportion of patients repeating self-harm

  • Change scores on the Suicide Behaviors Questionnaire from baseline [ Time Frame: Baseline and three months ] [ Designated as safety issue: Yes ]
    The change scores on the Suicide Behaviors Questionnaire from baseline


Secondary Outcome Measures:
  • Repeat episodes of self-harm per person [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
    Number of repeat episodes of self-harm per person

  • Change scores in the Modified Scale for Suicide Ideation from baseline [ Time Frame: Baseline anf three months ] [ Designated as safety issue: Yes ]
    The change scores on the Modified Scale for Suicide Ideation from baseline

  • Change scores on the Positive and Negative Suicide Ideation Inventory from baseline [ Time Frame: Baseline and three months ] [ Designated as safety issue: Yes ]
    The change scores on the Positive and Negative Suicide Ideation Inventory from baseline

  • Change scores on the Beck Hopelessness Scale from baseline [ Time Frame: Baseline and three months ] [ Designated as safety issue: Yes ]
    The change scores on the Beck Hopelessness Scale from baseline

  • Change scores on the Global Assessment of Functioning Scale from baseline [ Time Frame: Baseline and three months ] [ Designated as safety issue: Yes ]
    The change scores on the Global Assessment of Functioning Scale from baseline


Other Outcome Measures:
  • Utilisation of the services provided by the Samaritans Ireland [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
    The range and frequency of utilisation of the services provided by the Samaritans Ireland

  • Patient satisfaction with treatment [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
    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.

  • Feedback about patients' experiences, expectations and satisfaction with the communication system [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
    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


Enrollment: 10
Study Start Date: March 2015
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No text messages
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.
Experimental: Supportive and interactive text messages
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01823120

Locations
Ireland
Beaumont Hospital
Dublin, Co Dublin, Ireland, Dublin 9
Sponsors and Collaborators
University of Dublin, Trinity College
Beaumont Hospital
Royal College of Surgeons, Ireland
Investigators
Principal Investigator: Vincent IO Agyapong, MRCPsych MD University of Dublin, Trinity College Dublin
Study Chair: Siobhan MacHale, FRCPsych Beaumont Hospital Dublin
  More Information

No publications provided

Responsible Party: Vincent Agyapong, Dr, University of Dublin, Trinity College
ClinicalTrials.gov Identifier: NCT01823120     History of Changes
Other Study ID Numbers: 13/18
Study First Received: March 26, 2013
Last Updated: September 9, 2014
Health Authority: Ireland: Research Ethics Committee

Keywords provided by University of Dublin, Trinity College:
Self harm
Emergency Department
Repetition
Supportive Text messages
Interactive

Additional relevant MeSH terms:
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 16, 2014