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

Primary Purpose

Self Harm, Suicide, Attempted, Borderline Personality Disorder

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Dialectic Behavior Therapy - Skills System
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Self Harm

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Division of Psychiatry, Region Skåne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Receiving treatment with Dialectic Behavior Therapy - Skills System + Treatment As Usual

Outcomes

Primary Outcome Measures

Deliberate self-harm
Frequency of deliberate self-harm

Secondary Outcome Measures

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

Full Information

First Posted
December 21, 2017
Last Updated
June 1, 2020
Sponsor
Region Skane
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1. Study Identification

Unique Protocol Identification Number
NCT03627663
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
December 10, 2017 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Skane

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Self Harm, Suicide, Attempted, Borderline Personality Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Receiving treatment with Dialectic Behavior Therapy - Skills System + Treatment As Usual
Intervention Type
Behavioral
Intervention Name(s)
Dialectic Behavior Therapy - Skills System
Intervention Description
Treatment with Dialectical Behavior therapy adapted for cognitively challenged individuals
Primary Outcome Measure Information:
Title
Deliberate self-harm
Description
Frequency of deliberate self-harm
Time Frame
Baseline - 64 weeks
Secondary Outcome Measure Information:
Title
Problem behaviors
Description
Frequency of problem behaviors
Time Frame
Baseline - 64 weeks
Title
Out-of control behavior
Description
Number of hours per week with out-of control behavior
Time Frame
Baseline - 64 weeks
Title
Upset
Description
Number of hours per week when the individual is upset
Time Frame
Baseline - 64 weeks
Title
Worried
Description
Number of hours per week when the individual is worried
Time Frame
Baseline - 64 weeks
Title
Medication on demand
Description
Frequency of occasions with medication on demand
Time Frame
Baseline - 64 weeks
Title
Visits to psychiatric emergency ward
Description
Frequency of visits to psychiatric emergency ward
Time Frame
Baseline - 64 weeks
Title
Admission to hospital
Description
Number of days admitted to hospital
Time Frame
Baseline - 64 weeks
Title
Coercive care
Description
Number of days with coercive care
Time Frame
Baseline - 64 weeks
Title
Coercive acts
Description
Number of coercive acts
Time Frame
Baseline - 64 weeks
Title
Psychotropic medications
Description
Number of psychotropic medications
Time Frame
Baseline - 64 weeks
Title
Level of risk
Description
Measurement with Short-Term Assessment of Risk and Treatability
Time Frame
Baseline - 64 weeks
Title
Resilience
Description
Measurement with Short-Term Assessment of Risk and Treatability
Time Frame
Baseline - 64 weeks
Title
Vulnerability
Description
Measurement with Short-Term Assessment of Risk and Treatability
Time Frame
Baseline - 64 weeks
Title
Level of functioning
Description
Self-rated by interview level of functioning in daily life with WHODAS 2.0
Time Frame
Baseline - 64 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sofie Westling, MD, PhD
Organizational Affiliation
Lund University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Psychiatry, Region Skåne
City
Lund
State/Province
Skåne
ZIP/Postal Code
22185
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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