World Health Organization site
Skip Navigation Links

Main
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ISRCTN
Last refreshed on: 15 July 2019
Main ID:  ISRCTN12276176
Date of registration: 13/03/2018
Prospective Registration: No
Primary sponsor: The Eric M. Mindich Research Fund for the Foundation of Human Behavior.
Public title: Self-criticism and self-injury: Testing a novel diary-based treatment approach
Scientific title: Novel online daily diary interventions for non-suicidal self injury: A preliminary study
Date of first enrolment: 25/06/2015
Target sample size: 144
Recruitment status: Completed
URL:  http://isrctn.com/ISRCTN12276176
Study type:  Interventional
Study design:  Randomized parallel trial (Treatment)  
Phase:  Not Applicable
Countries of recruitment
Australia Canada Costa Rica Germany Hungary Ireland Japan Netherlands
Portugal Romania Russian Federation Sweden United Kingdom United States of America
Contacts
Name:    
Address: 
Telephone:
Email:
Affiliation: 
Name: Jill    Hooley
Address:  Department of Psychology, Harvard University 33 Kirkland Street 02138-2044 Cambridge United States of America
Telephone:
Email:
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria:
1. =2 NSSI episodes in previous month
2. Aged 18 years or over
3. Daily internet access
4. Fluent in English

Exclusion criteria: Inclusion criteria not met

Age minimum:
Age maximum:
Gender: Both
Health Condition(s) or Problem(s) studied
Non-suicidal self-injury
Mental and Behavioural Disorders
Intentional self-harm
Intervention(s)

Participants were recruited from online forums related to self-injury and severe psychopathology (e.g. reddit.com/r/depression). Forum members who met the inclusion criteria and were interested in participating completed an online consent form and a ~45-min baseline assessment. Participants were randomly assigned to one of three treatment groups (JNL, EW or ASET) using randomization software within Qualtrics. Each treatment was designed as a brief, daily diary treatment that could be completed from home or from a mobile device anywhere with internet access.
Participants assigned to ASET were asked to write for 5 min each day about something that happened that day that made them feel good about themselves as a person. Participants assigned to EW were asked to write for 5 min each day about something that bothered them or was on their mind that day. Participants in JNL were asked to write for 5 min each day about the events of the day in a general and factually descriptive way. For all groups, writing responses were monitored daily.
Participants were asked to complete daily writing assignments as well as four brief weekly follow-up assessments during the treatment month (i.e. 28 days). 4 weeks after the end of treatment, participants were contacted again (i.e. 1-month follow up/8 weeks after baseline to complete the first follow-up assessment. A final follow up assessment occurred 8 weeks later (i.e. 3-month follow-up/16 weeks after baseline).
Primary Outcome(s)
Primary outcomes were self-criticism, depression, self-cutting episodes, and overall NSSI episodes (including self-cutting). Self-criticism (using the Self-Rating Scale - self-report questionnaire) and depression (using the Beck Depression Inventory-II) were assessed at baseline, week 1, week 2, week 3, and week 4 of treatment, 4 weeks post-treatment and 12 weeks post-treatment.
Secondary Outcome(s)
Secondary outcomes were desire to discontinue NSSI, likelihood of future NSSI, days of active suicide ideation, and days of suicide plans. A self-report questionnaire version of the Self-Injurious Thoughts and Behaviors Interview was used to obtain measures of NSSI, suicide ideation, suicide plans, and suicidal behaviors. Each of these thoughts and behaviors were measured at baseline, week 1, week 2, week 3, and week 4 of treatment. These were also measured over two follow-up time points, at 8 and 12 weeks post treatment.
Secondary ID(s)
The Eric M. Mindich Research fund for the Foundation of Human Behavior 373676.801263.0017
Source(s) of Monetary Support
The Eric M. Mindich Research Fund for the Foundation of Human Behavior
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Harvard University Institutional Review Board, 06/07/2016, IRB15-3940.
Results
Results available: Yes
Date Posted:
Date Completed: 20/11/2018
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history