Self-Harm Clinical Trial
Official title:
Using Implementation Intentions to Reduce Self-harm
Verified date | January 2022 |
Source | University of Manchester |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 1040 |
Est. completion date | March 1, 2021 |
Est. primary completion date | March 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | The University of Manchester | Manchester |
Lead Sponsor | Collaborator |
---|---|
University of Manchester |
United Kingdom,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | Exposure to suicide and mental imagery about death | 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. | 6 months | |
Secondary | Capability, opportunity and motivation (based on Capability, Opportunity, Motivation-Behaviour model) | 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. | 6 months | |
Secondary | Habit | 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. | 6 months | |
Secondary | State self-regulation | 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. |
6 months | |
Secondary | Frequencies with which critical situations were encountered and appropriate responses were used | Frequencies | 6 months |
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