Division of Psychiatry, Region Skåne
Lund, Skåne County, 22185, Sweden
NCT Number: NCT03627663
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Lund, Skåne County, 22185, Sweden
Not many psychotherapies are adapted to suit individuals with Intelligence Quotient(IQ) in the lower normal range. For individuals diagnosed with cognitive disability and self-harm, psychiatric treatment as usual often consists of only supportive meetings and sometimes heavy medication.
Dialectical Behavior therapy (DBT) is one of the evidence based treatments for individuals with self-harm and Borderline Personality Disorder. It is a comprehensive, multi component treatment, usually lasting a year or more. When offering DBT to individuals with cognitive disabilities or IQ in the lower normal range, it is necessary to alter the individual therapy procedures and skills group materials, while remaining adherent to DBT principles.
The Skills System is an adaptation of the standard DBT skills for individuals with cognitive challenges, well suited for IQ 65-85. When adapted DBT individual therapy integrates the Skills System as the skill group curriculum the treatment is called DBT-Skills System (DBT-SS). DBT-SS comprises weekly individual sessions, weekly group education and separate education for caregivers and/or near standing persons. The method is tested with positive effects on problem behaviors, however results need to be reproduced, and further tested in a randomized controlled trial. The handouts from Skills System has recently been translated to Swedish.
The current study aims to investigate the effect of Skills system on individuals with self-harm, IQ 65-85 and three or more symptoms of borderline personality disorder. A single-case time series design will be used with repeated, weekly measurements before, during and after the intervention is provided. 6 participants will be recruited in a pilot study, to investigate the feasibility of the method in a Swedish setting. Main outcome measures are frequency and severity of self-harming and aggressive behaviors, number of days with hospital admission and coercive care, number of medications, and self-rated level of daily functioning. Participation will last 64-70 weeks depending on when the group therapy starts in relation to enrollment.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Treatment with Dialectical Behavior therapy adapted for cognitively challenged individuals
Time frame: Baseline - 64 weeks
Frequency of deliberate self-harm
Time frame: Baseline - 64 weeks
Frequency of problem behaviors
Time frame: Baseline - 64 weeks
Number of hours per week with out-of control behavior
Time frame: Baseline - 64 weeks
Number of hours per week when the individual is upset
Time frame: Baseline - 64 weeks
Number of hours per week when the individual is worried
Time frame: Baseline - 64 weeks
Frequency of occasions with medication on demand
Time frame: Baseline - 64 weeks
Frequency of visits to psychiatric emergency ward
Time frame: Baseline - 64 weeks
Number of days admitted to hospital
Time frame: Baseline - 64 weeks
Number of days with coercive care
Time frame: Baseline - 64 weeks
Number of coercive acts
Time frame: Baseline - 64 weeks
Number of psychotropic medications
Time frame: Baseline - 64 weeks
Measurement with Short-Term Assessment of Risk and Treatability
Time frame: Baseline - 64 weeks
Measurement with Short-Term Assessment of Risk and Treatability
Time frame: Baseline - 64 weeks
Measurement with Short-Term Assessment of Risk and Treatability
Time frame: Baseline - 64 weeks
Self-rated by interview level of functioning in daily life with WHODAS 2.0
Region Skane
Other
Dialectic Behavior Treatment Skills System (DBT-SS) as Treatment for Cognitively Challenged Individuals With Deliberate Self-harm
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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