DBT-SS for Cognitively Challenged Individuals With Deliberate Self-harm

Borderline Personality Disorder Clinical Trial

Official title:

Dialectic Behavior Treatment Skills System (DBT-SS) as Treatment for Cognitively Challenged Individuals With Deliberate Self-harm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03627663
• Other study ID #: 2017/827
• Status: Completed
• Phase: N/A
• Start date: December 10, 2017
• Est. completion date: April 1, 2020

Study information

• Verified date: June 2020
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Schizophrenia or Bipolar illness type 1

• Substance abuse

• Non-psychiatric disorder significantly contributing to symptoms.

Related Conditions & MeSH terms

• Borderline Personality Disorder
• Personality Disorders
• Self Harm
• Self Mutilation
• Self-Injurious Behavior
• Suicide
• Suicide, Attempted

Intervention

Behavioral:
• Dialectic Behavior Therapy - Skills System
Treatment with Dialectical Behavior therapy adapted for cognitively challenged individuals

Locations

Country	Name	City	State
Sweden	Division of Psychiatry, Region Skåne	Lund	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Deliberate self-harm	Frequency of deliberate self-harm	Baseline - 64 weeks
Secondary	Problem behaviors	Frequency of problem behaviors	Baseline - 64 weeks
Secondary	Out-of control behavior	Number of hours per week with out-of control behavior	Baseline - 64 weeks
Secondary	Upset	Number of hours per week when the individual is upset	Baseline - 64 weeks
Secondary	Worried	Number of hours per week when the individual is worried	Baseline - 64 weeks
Secondary	Medication on demand	Frequency of occasions with medication on demand	Baseline - 64 weeks
Secondary	Visits to psychiatric emergency ward	Frequency of visits to psychiatric emergency ward	Baseline - 64 weeks
Secondary	Admission to hospital	Number of days admitted to hospital	Baseline - 64 weeks
Secondary	Coercive care	Number of days with coercive care	Baseline - 64 weeks
Secondary	Coercive acts	Number of coercive acts	Baseline - 64 weeks
Secondary	Psychotropic medications	Number of psychotropic medications	Baseline - 64 weeks
Secondary	Level of risk	Measurement with Short-Term Assessment of Risk and Treatability	Baseline - 64 weeks
Secondary	Resilience	Measurement with Short-Term Assessment of Risk and Treatability	Baseline - 64 weeks
Secondary	Vulnerability	Measurement with Short-Term Assessment of Risk and Treatability	Baseline - 64 weeks
Secondary	Level of functioning	Self-rated by interview level of functioning in daily life with WHODAS 2.0	Baseline - 64 weeks