DBT-SS for Cognitively Challenged Individuals With Deliberate Self-harm
Dialectic Behavior Treatment Skills System (DBT-SS) as Treatment for Cognitively Challenged Individuals With Deliberate Self-harm
1 other identifier
interventional
6
1 country
1
Brief Summary
The study evaluates the effect of Dialectic Behavior Therapy Skills System (DBT-SS) in individuals with Intelligence Quotient 65-85 and recurrent self-harm. The study is primarily descriptive with 6 cases followed by repeated measurements (weekly; time series analysis). Primary outcome measure is frequency and severity of self-harming behavior, reported weekly 4 weeks before the start of the intervention, throughout the intervention and 12 weeks after the intervention has stopped.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 10, 2017
CompletedFirst Submitted
Initial submission to the registry
December 21, 2017
CompletedFirst Posted
Study publicly available on registry
August 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2020
CompletedJune 2, 2020
June 1, 2020
2.3 years
December 21, 2017
June 1, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Deliberate self-harm
Frequency of deliberate self-harm
Baseline - 64 weeks
Secondary Outcomes (14)
Problem behaviors
Baseline - 64 weeks
Out-of control behavior
Baseline - 64 weeks
Upset
Baseline - 64 weeks
Worried
Baseline - 64 weeks
Medication on demand
Baseline - 64 weeks
- +9 more secondary outcomes
Study Arms (1)
Intervention
EXPERIMENTALReceiving treatment with Dialectic Behavior Therapy - Skills System + Treatment As Usual
Interventions
Treatment with Dialectical Behavior therapy adapted for cognitively challenged individuals
Eligibility Criteria
You may qualify if:
- Ongoing contact with adult psychiatric clinic
- Intelligence Quotient 65-85
- Current self-harming behaviour at least twice the last six months
- Staff from residential care or near standing persons are able to participate in the treatment by participating in group sessions.
You may not qualify if:
- Schizophrenia or Bipolar illness type 1
- Substance abuse
- Non-psychiatric disorder significantly contributing to symptoms.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Region Skanelead
Study Sites (1)
Division of Psychiatry, Region Skåne
Lund, Skåne County, 22185, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sofie Westling, MD, PhD
Lund University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Psychiatrist, Doctor of Medicine
Study Record Dates
First Submitted
December 21, 2017
First Posted
August 13, 2018
Study Start
December 10, 2017
Primary Completion
April 1, 2020
Study Completion
April 1, 2020
Last Updated
June 2, 2020
Record last verified: 2020-06