Clinical trial NCT03627663: DBT-SS for Cognitively Challenged Individuals With Deliberate Self-harm
Official title: Dialectic Behavior Treatment Skills System (DBT-SS) as Treatment for Cognitively Challenged Individuals With Deliberate Self-harm
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self Harm
Suicide, Attempted
Borderline Personality Disorder
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2018-08-13
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Deliberate self-harm
timeFrame: Baseline - 64 weeks
Secondary outcomes:
measure: Problem behaviors
timeFrame: Baseline - 64 weeks
measure: Out-of control behavior
timeFrame: Baseline - 64 weeks
measure: Upset
timeFrame: Baseline - 64 weeks
measure: Worried
timeFrame: Baseline - 64 weeks
measure: Medication on demand
timeFrame: Baseline - 64 weeks
measure: Visits to psychiatric emergency ward
timeFrame: Baseline - 64 weeks
measure: Admission to hospital
timeFrame: Baseline - 64 weeks
measure: Coercive care
timeFrame: Baseline - 64 weeks
measure: Coercive acts
timeFrame: Baseline - 64 weeks
measure: Psychotropic medications
timeFrame: Baseline - 64 weeks
measure: Level of risk
timeFrame: Baseline - 64 weeks
measure: Resilience
timeFrame: Baseline - 64 weeks
measure: Vulnerability
timeFrame: Baseline - 64 weeks
measure: Level of functioning
timeFrame: Baseline - 64 weeks
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Division of Psychiatry, Region Skåne
state: Skåne
Study officials:
affiliation: Lund University
name: Sofie Westling, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: