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Completed

NCT Number: NCT03627663

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Psychiatry, Region Skåne

Lund, Skåne County, 22185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dialectic Behavior Therapy - Skills System

Behavioral

Treatment with Dialectical Behavior therapy adapted for cognitively challenged individuals

Primary outcomes

  1. Deliberate self-harm

    Time frame: Baseline - 64 weeks

    Frequency of deliberate self-harm

Secondary outcomes

  1. Problem behaviors

    Time frame: Baseline - 64 weeks

    Frequency of problem behaviors

  2. Out-of control behavior

    Time frame: Baseline - 64 weeks

    Number of hours per week with out-of control behavior

  3. Upset

    Time frame: Baseline - 64 weeks

    Number of hours per week when the individual is upset

  4. Worried

    Time frame: Baseline - 64 weeks

    Number of hours per week when the individual is worried

  5. Medication on demand

    Time frame: Baseline - 64 weeks

    Frequency of occasions with medication on demand

  6. Visits to psychiatric emergency ward

    Time frame: Baseline - 64 weeks

    Frequency of visits to psychiatric emergency ward

  7. Admission to hospital

    Time frame: Baseline - 64 weeks

    Number of days admitted to hospital

  8. Coercive care

    Time frame: Baseline - 64 weeks

    Number of days with coercive care

  9. Coercive acts

    Time frame: Baseline - 64 weeks

    Number of coercive acts

  10. Psychotropic medications

    Time frame: Baseline - 64 weeks

    Number of psychotropic medications

  11. Level of risk

    Time frame: Baseline - 64 weeks

    Measurement with Short-Term Assessment of Risk and Treatability

  12. Resilience

    Time frame: Baseline - 64 weeks

    Measurement with Short-Term Assessment of Risk and Treatability

  13. Vulnerability

    Time frame: Baseline - 64 weeks

    Measurement with Short-Term Assessment of Risk and Treatability

  14. Level of functioning

    Time frame: Baseline - 64 weeks

    Self-rated by interview level of functioning in daily life with WHODAS 2.0

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 13, 2018
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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