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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627663
Recruitment Status : Completed
First Posted : August 13, 2018
Last Update Posted : June 2, 2020
Sponsor:
Information provided by (Responsible Party):
Sofie Westling, Region Skane

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.

Condition or disease Intervention/treatment Phase
Self Harm Suicide, Attempted Borderline Personality Disorder Behavioral: Dialectic Behavior Therapy - Skills System Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Dialectic Behavior Treatment Skills System (DBT-SS) as Treatment for Cognitively Challenged Individuals With Deliberate Self-harm
Actual Study Start Date : December 10, 2017
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Self-Harm

Arm Intervention/treatment
Experimental: Intervention
Receiving treatment with Dialectic Behavior Therapy - Skills System + Treatment As Usual
Behavioral: Dialectic Behavior Therapy - Skills System
Treatment with Dialectical Behavior therapy adapted for cognitively challenged individuals




Primary Outcome Measures :
  1. Deliberate self-harm [ Time Frame: Baseline - 64 weeks ]
    Frequency of deliberate self-harm


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03627663


Locations
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Sweden
Division of Psychiatry, Region Skåne
Lund, Skåne, Sweden, 22185
Sponsors and Collaborators
Region Skane
Investigators
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Principal Investigator: Sofie Westling, MD, PhD Lund University
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Responsible Party: Sofie Westling, Senior Psychiatrist, Doctor of Medicine, Region Skane
ClinicalTrials.gov Identifier: NCT03627663    
Other Study ID Numbers: 2017/827
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: June 2, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Self Mutilation
Suicide
Personality Disorders
Borderline Personality Disorder
Self-Injurious Behavior
Suicide, Attempted
Behavioral Symptoms
Mental Disorders
Wounds and Injuries