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

Dialectic Behavior Treatment Skills System (DBT-SS) as Treatment 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.

Study Overview

• Status: Completed
• Conditions: Suicide, Attempted; Borderline Personality Disorder; Self Harm
• Intervention / Treatment: Behavioral: Dialectic Behavior Therapy - Skills System

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Skåne
    • Lund, Skåne, Sweden, 22185
      • Division of Psychiatry, Region Skåne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Deliberate self-harm	Frequency of deliberate self-harm	Baseline - 64 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Region Skane
• Investigators: Principal Investigator: Sofie Westling, MD, PhD, Lund University

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2017
• Primary Completion (Actual): April 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: August 10, 2018
• First Posted (Actual): August 13, 2018

Study Record Updates

• Last Update Posted (Actual): June 2, 2020
• Last Update Submitted That Met QC Criteria: June 1, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Wounds and Injuries; Personality Disorders; Suicide; Suicide, Attempted; Borderline Personality Disorder; Self-Injurious Behavior; Self Mutilation
• Other Study ID Numbers: 2017/827

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No