Main
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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:
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ISRCTN |
Last refreshed on:
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15 July 2019 |
Main ID: |
ISRCTN12276176 |
Date of registration:
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13/03/2018 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Self-criticism and self-injury: Testing a novel diary-based treatment approach
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Scientific title:
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Novel online daily diary interventions for non-suicidal self injury: A preliminary study |
Date of first enrolment:
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25/06/2015 |
Target sample size:
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144 |
Recruitment status: |
Completed |
URL:
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http://isrctn.com/ISRCTN12276176 |
Study type:
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Interventional |
Study design:
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Randomized parallel trial
(Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Canada
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Costa Rica
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Germany
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Hungary
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Ireland
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Japan
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Netherlands
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Portugal
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Romania
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Russian Federation
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Sweden
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United Kingdom
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United States of America
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Jill
Hooley |
Address:
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Department of Psychology, Harvard University
33 Kirkland Street
02138-2044
Cambridge
United States of America |
Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Non-suicidal self-injury Mental and Behavioural Disorders Intentional self-harm
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Intervention(s)
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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).
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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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.
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Secondary ID(s)
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The Eric M. Mindich Research fund for the Foundation of Human Behavior 373676.801263.0017
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Source(s) of Monetary Support
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The Eric M. Mindich Research Fund for the Foundation of Human Behavior
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Ethics review
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Status:
Approval date:
Contact:
Harvard University Institutional Review Board, 06/07/2016, IRB15-3940.
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Results
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Results available:
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Yes |
Date Posted:
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Date Completed:
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20/11/2018 |
URL:
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