NCT04420546

Brief Summary

The aim of the present research is to explore whether a brief intervention based on psychological theory can help people to avoid self-harming. The intervention is the Volitional Help Sheet (VHS), or "IF-THEN" plans, which will be tested in the context of trying to reduce self-harm. Each participant will be randomly allocated to one of two conditions. The two conditions are: (1) a control condition, and (2) intervention (form multiple implementation intentions from a drop-down menu). The main outcome measure will be reduction in self-harm, which will be self-reported

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,040

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

May 28, 2020

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

June 10, 2020

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
Last Updated

January 13, 2022

Status Verified

January 1, 2022

Enrollment Period

9 months

First QC Date

May 28, 2020

Last Update Submit

January 12, 2022

Conditions

Self-Harm

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 attempts

    '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 (2)

Control (volitional help sheet)

ACTIVE COMPARATOR

Participants read a brief statement designed to encourage them to be more physically active ("We want you to plan to increase your level of physical activity"). 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 not to be physically active 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

Intervention (volitional help sheet)

EXPERIMENTAL

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 from a drop down menu for each critical situation.

Behavioral: Volitional help sheet

Interventions

Volitional help sheetBEHAVIORAL

Participants are asked to choose from a list of strategies for increasing physical activity

Control (volitional help sheet)

Eligibility Criteria

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

You may qualify if:

  • Aged 18 and over
  • Have a history of self-harm
  • Good verbal and written understanding of English

You may not qualify if:

  • Aged under 18 years of age
  • No history of self-harm
  • Poor verbal and written understanding of English
  • Not currently resident of an inpatient facility for mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Manchester

Manchester, M13 9PL, United Kingdom

Location

Related Publications (11)

  • 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.

    PMID: 28434871BACKGROUND

  • Sekhon M, Cartwright M, Francis JJ. Acceptability of healthcare interventions: an overview of reviews and development of a theoretical framework. BMC Health Serv Res. 2017 Jan 26;17(1):88. doi: 10.1186/s12913-017-2031-8.

    PMID: 28126032BACKGROUND

  • Biddle L, Cooper J, Owen-Smith A, Klineberg E, Bennewith O, Hawton K, Kapur N, Donovan J, Gunnell D. Qualitative interviewing with vulnerable populations: individuals' experiences of participating in suicide and self-harm based research. J Affect Disord. 2013 Mar 5;145(3):356-62. doi: 10.1016/j.jad.2012.08.024. Epub 2012 Sep 25.

    PMID: 23021191BACKGROUND

  • Dhingra K, Boduszek D, O'Connor RC. Differentiating suicide attempters from suicide ideators using the Integrated Motivational-Volitional model of suicidal behaviour. J Affect Disord. 2015 Nov 1;186:211-8. doi: 10.1016/j.jad.2015.07.007. Epub 2015 Jul 29.

    PMID: 26247914BACKGROUND

  • O'Connor RC, Rasmussen S, Hawton K. Distinguishing adolescents who think about self-harm from those who engage in self-harm. Br J Psychiatry. 2012 Apr;200(4):330-5. doi: 10.1192/bjp.bp.111.097808. Epub 2012 Mar 8.

    PMID: 22403089BACKGROUND

  • 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: 32314500BACKGROUND

  • Patton JH, Stanford MS, Barratt ES. Factor structure of the Barratt impulsiveness scale. J Clin Psychol. 1995 Nov;51(6):768-74. doi: 10.1002/1097-4679(199511)51:63.0.co;2-1.

    PMID: 8778124BACKGROUND

  • Ahorsu DK, Lin CY, Imani V, Saffari M, Griffiths MD, Pakpour AH. The Fear of COVID-19 Scale: Development and Initial Validation. Int J Ment Health Addict. 2022;20(3):1537-1545. doi: 10.1007/s11469-020-00270-8. Epub 2020 Mar 27.

    PMID: 32226353BACKGROUND

  • Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

    PMID: 12900694BACKGROUND

  • Vanaken L, Scheveneels S, Belmans E, Hermans D. Validation of the Impact of Event Scale With Modifications for COVID-19 (IES-COVID19). Front Psychiatry. 2020 Jul 28;11:738. doi: 10.3389/fpsyt.2020.00738. eCollection 2020.

    PMID: 32848918BACKGROUND

  • 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.

    PMID: 33884617DERIVED

Related Links

MeSH Terms

Conditions

Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Fellow

Study Record Dates

First Submitted

May 28, 2020

First Posted

June 9, 2020

Study Start

June 10, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

January 13, 2022

Record last verified: 2022-01

Locations

GB(1)