Developing a Smartphone-based App to Reduce Self-harm for CAMHS-treated Adolescents

NCT05368701 | Unknown

• 1 other identifier: 313791
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of the present research is to explore whether a brief, smartphone app-based intervention based on psychological theory can help adolescents to avoid self-harming. The smartphone app will be piloted in a randomised controlled trial (RCT) with adolescents. 90 adolescents will be recruited and assigned to one of three conditions: (a) intervention group who will complete the smartphone-based VHS app for self-harm (n = 30), (b) control group (n = 30) who will complete paper-and-pencil modified VHS, without the app, and (c) control group who will complete measures via the app but not the VHS (n = 30).

Conditions

Self-harm

Keywords

self-harm; suicidal ideation; suicide attempt; smartphone app; volitional help sheet; implementation intentions; if-then plans

Outcome Measures

Primary Outcomes (3)

• Non-suicidal self-harm

  'Have you ever deliberately harmed yourself in any way but not with the intention of killing yourself? (i.e., self-harm)' (British Psychiatric Morbidity Survey) Response option is 'Yes' or 'No'. If respondents answer yes, timing of last episode and frequency will be asked.

  6 months

• Suicidal ideation

  'Have you ever seriously thought of taking your life, but not actually attempted to do so?' (British Psychiatric Morbidity Survey) Response option is 'Yes' or 'No'. If respondents answer yes, timing of last episode and frequency will be asked.

  6 months

• Suicide attempt

  'Have you ever made an attempt to take your life, by taking an overdose of tablets or in some other way?' (British Psychiatric Morbidity Survey) Response option is 'Yes' or 'No'. If respondents answer yes, timing of last episode and frequency will be asked.

  6 months

Secondary Outcomes (5)

• Exposure to suicide and mental imagery about death

  6 months

• Capability, opportunity and motivation (based on Capability, Opportunity, Motivation-Behaviour model)

  6 months

• Habit

  6 months

• State self-regulation

  6 months

• Frequencies with which critical situations were encountered and appropriate responses were used

  6 months

Study Arms (3)

App-based volitional help sheet (VHS) for self-harm

EXPERIMENTAL

A smartphone-based app version of the adapted VHS for self-harm. Participants read a brief statement designed to encourage them to avoid self-harming ("We want you to plan to avoid self-harming"). Participants are presented with ten 'high risk' situations (temptations). By selecting an appropriate situation, 10 appropriate responses (processes of change) are suggested (see Armitage, 2008). Participants are told that identifying situations in which they were tempted to self-harm and identifying ways to overcome those temptations had been shown to help people change their behaviour. Participants in this condition are asked to form implementation intentions by linking critical situations with appropriate responses by choosing an appropriate response from a drop down menu for each critical situation.

Behavioral: Volitional Help Sheet for self-harm

App-based pencil-and-paper VHS

ACTIVE COMPARATOR

The app will deliver a .pdf file (for printing) worksheet of the VHS for self-harm, with no integration into the app. Participants read a brief statement designed to encourage them to avoid self-harming ("We want you to plan to avoid self-harming"). Participants are presented with a table with two columns and ten rows. Ten 'high risk' situations (temptations) are presented in the left hand column and 10 appropriate responses (processes of change) are presented in the right hand column (see Armitage, 2008). Participants are told that identifying situations in which they were tempted to self-harm and identifying ways to overcome those temptations had been shown to help people change their behaviour. Participants in this condition are asked to form implementation intentions by linking critical situations with appropriate responses by choosing an appropriate response by drawing a line between the situation and response.

Behavioral: Volitional Help Sheet for self-harm

App with no VHS component

NO INTERVENTION

An app with no VHS component that collects questionnaire survey data. In this control condition, the app only contains the survey questions and links to helplines contained in the other two conditions. A free text entry box will ask participants to think of important situations where they might self-harm. A second box asks participants to think of alternative plans that they can do instead of self-harming. Participants are not guided to make links between the situations and responses.

Interventions

Volitional Help Sheet for self-harm BEHAVIORAL

The "volitional help sheet" (VHS) is a brief psychosocial intervention that significantly reduces thoughts and acts of self-harm in adults admitted to hospital following an initial episode of self-harm. It is based on IF-THEN statements that help people link critical situations to alternative appropriate responses. An example is: "If I feel the urge to self-harm when I want to get relief from a terrible state of mind, then I will do something else instead of self-harming". IF-THEN statements are intended to act as automatic coping responses, especially in cases where people may feel the urge to self-harm. The VHS has previously been successful in reducing self-harm in people recently admitted to hospital for self-harm. Recent data have also demonstrated that a web-based version of the VHS was acceptable among a large representative sample of UK adults with self-harm experiences. However, it is yet to be known whether this intervention is effective and acceptable among adolescents.

Also known as: If-Then Plans

App-based pencil-and-paper VHS; App-based volitional help sheet (VHS) for self-harm

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents aged between 12-18, who have been admitted to acute mental health in the past year or diagnosed with functional mental health problems

You may not qualify if:

• Individuals who cannot give informed consent, or whose parent/guardian cannot give informed consent.
• Individuals under the age of 12 years

Sponsors & Collaborators

• University of Manchester: lead

Related Publications (14)

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  PMID: 23021191 BACKGROUND

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  PMID: 30014862 BACKGROUND

• Dazzi T, Gribble R, Wessely S, Fear NT. Does asking about suicide and related behaviours induce suicidal ideation? What is the evidence? Psychol Med. 2014 Dec;44(16):3361-3. doi: 10.1017/S0033291714001299. Epub 2014 Jul 7.

  PMID: 24998511 BACKGROUND

• Keyworth C, Epton T, Goldthorpe J, Calam R, Armitage CJ. Acceptability, reliability, and validity of a brief measure of capabilities, opportunities, and motivations ("COM-B"). Br J Health Psychol. 2020 Sep;25(3):474-501. doi: 10.1111/bjhp.12417. Epub 2020 Apr 20.

  PMID: 32314500 BACKGROUND

• Keyworth C, O'Connor R, Quinlivan L, Armitage CJ. Acceptability of a Brief Web-Based Theory-Based Intervention to Prevent and Reduce Self-harm: Mixed Methods Evaluation. J Med Internet Res. 2021 Sep 14;23(9):e28349. doi: 10.2196/28349.

  PMID: 34518153 BACKGROUND

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  PMID: 31175059 BACKGROUND

• O'Connor RC, Ferguson E, Scott F, Smyth R, McDaid D, Park AL, Beautrais A, Armitage CJ. A brief psychological intervention to reduce repetition of self-harm in patients admitted to hospital following a suicide attempt: a randomised controlled trial. Lancet Psychiatry. 2017 Jun;4(6):451-460. doi: 10.1016/S2215-0366(17)30129-3. Epub 2017 Apr 20.

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Related Links

• Related Info

MeSH Terms

Conditions

Self-Injurious Behavior; Suicidal Ideation; Suicide, Attempted

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Suicide

Study Officials

• Christopher J Armitage

  University of Manchester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica Z Leather

CONTACT

+44 (0)161 275 1871; jessica.leather@manchester.ac.uk

Christopher J Armitage

CONTACT

chris.armitage@manchester.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The allocation sequence will be concealed from the researcher by using a centralised service (e.g., trial coordination centre) to ensure that selection remains unbiased. Thus, the trial will be double-blind.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate

Model Details: Participants will be randomly allocated to one of three conditions. Patients will be randomised to the control group or the interventions in a 1:1:1 using a computer-generated random allocation sequence with block sizes of 3, 6, and 9.

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 10, 2022
• Study Start: July 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share