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Using Implementation Intentions to Reduce Self-harm

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04420546
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Dr Chris Keyworth, University of Manchester

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


Condition or disease Intervention/treatment Phase
Self-Harm Behavioral: Volitional help sheet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Using Implementation Intentions to Reduce Self-harm
Actual Study Start Date : June 10, 2020
Estimated Primary Completion Date : March 1, 2021
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Self-Harm

Arm Intervention/treatment
Active Comparator: Control (volitional help sheet)

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

Experimental: Intervention (volitional help sheet)

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
Participants are asked to choose from a list of strategies for avoiding self-harm




Primary Outcome Measures :
  1. Non-suicidal self-harm [ Time Frame: 6 months ]
    '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.

  2. Suicidal ideation [ Time Frame: 6 months ]
    '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.

  3. suicide attempts [ Time Frame: 6 months ]
    '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.


Secondary Outcome Measures :
  1. Exposure to suicide and mental imagery about death [ Time Frame: 6 months ]
    Measured at baseline and follow-up using seven items adapted from those used in the literature previously (https://pubmed.ncbi.nlm.nih.gov/26247914/). Calculated as a binary variable ('yes' or 'no). Exposure to mental imagery will be calculated as a total score.

  2. Capability, opportunity and motivation (based on Capability, Opportunity, Motivation-Behaviour model) [ Time Frame: 6 months ]
    Measured using the Capability, Opportunity, Motivation questionnaire (https://pubmed.ncbi.nlm.nih.gov/32314500/). Each of the items (0-10 scale) will be analysed separately as these each measure a separate construct. Higher scores indicate higher agreement with statements.

  3. Habit [ Time Frame: 6 months ]
    Measured using the self-reported habit index (automaticity scale; https://ijbnpa.biomedcentral.com/articles/10.1186/1479-5868-9-102). This consists of four items (each from 1 to 7). Items are scored from 1 to 7, with a higher mean score indicating higher agreement with the statements.

  4. State self-regulation [ Time Frame: 6 months ]

    Items are adapted from those used previously (https://www.tandfonline.com/doi/abs/10.1080/08870440512331317670).

    Mean of the two items for each of three sub-constructs: awareness of standards, self-monitoring, and self-regulatory effort. Items are scored from 1 to 7, with higher scores indicating higher agreement with the statements.


  5. Frequencies with which critical situations were encountered and appropriate responses were used [ Time Frame: 6 months ]
    Frequencies



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04420546


Contacts
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Contact: Chris Keyworth, PhD 0161 275 2589 chris.keyworth@mnchester.ac.uk
Contact: Chris Armitage, PhD 01613066000 chris.armitage@manchester.ac.uk

Locations
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United Kingdom
The University of Manchester Recruiting
Manchester, United Kingdom, M13 9PL
Contact: Chris Keyworth, PhD    0161 275 2589    chris.keyworth@manchester.ac.uk   
Contact: Chris Armitage, PhD    01613066000    chris.armitage@manchester.ac.uk   
Sponsors and Collaborators
University of Manchester
Additional Information:
Publications:

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Responsible Party: Dr Chris Keyworth, Research Fellow, University of Manchester
ClinicalTrials.gov Identifier: NCT04420546    
Other Study ID Numbers: 2020-8446-15312
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Self-Injurious Behavior
Behavioral Symptoms