Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03627663
Other study ID # 2017/827
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 10, 2017
Est. completion date April 1, 2020

Study information

Verified date June 2020
Source Region Skane
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 6
Est. completion date April 1, 2020
Est. primary completion date April 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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 Design


Intervention

Behavioral:
Dialectic Behavior Therapy - Skills System
Treatment with Dialectical Behavior therapy adapted for cognitively challenged individuals

Locations

Country Name City State
Sweden Division of Psychiatry, Region Skåne Lund Skåne

Sponsors (1)

Lead Sponsor Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Deliberate self-harm Frequency of deliberate self-harm Baseline - 64 weeks
Secondary Problem behaviors Frequency of problem behaviors Baseline - 64 weeks
Secondary Out-of control behavior Number of hours per week with out-of control behavior Baseline - 64 weeks
Secondary Upset Number of hours per week when the individual is upset Baseline - 64 weeks
Secondary Worried Number of hours per week when the individual is worried Baseline - 64 weeks
Secondary Medication on demand Frequency of occasions with medication on demand Baseline - 64 weeks
Secondary Visits to psychiatric emergency ward Frequency of visits to psychiatric emergency ward Baseline - 64 weeks
Secondary Admission to hospital Number of days admitted to hospital Baseline - 64 weeks
Secondary Coercive care Number of days with coercive care Baseline - 64 weeks
Secondary Coercive acts Number of coercive acts Baseline - 64 weeks
Secondary Psychotropic medications Number of psychotropic medications Baseline - 64 weeks
Secondary Level of risk Measurement with Short-Term Assessment of Risk and Treatability Baseline - 64 weeks
Secondary Resilience Measurement with Short-Term Assessment of Risk and Treatability Baseline - 64 weeks
Secondary Vulnerability Measurement with Short-Term Assessment of Risk and Treatability Baseline - 64 weeks
Secondary Level of functioning Self-rated by interview level of functioning in daily life with WHODAS 2.0 Baseline - 64 weeks
See also
  Status Clinical Trial Phase
Recruiting NCT04856449 - DBT Skills Plus EMDR for BPD and Trauma N/A
Active, not recruiting NCT04587518 - Five Factor Model Treatment for Borderline Personality Disorder N/A
Recruiting NCT05651295 - A Precision Medicine Approach to Target Engagement for Emotion Regulation N/A
Completed NCT03677037 - The Short-Term MBT Project Phase 3
Not yet recruiting NCT05989529 - Delving Into Borderline Personality Disorder Clinical Trial Experiences
Completed NCT02068326 - MBT in Groups for Adolescents With BPD or Subthreshold BPD Versus TAU - the M-GAB Randomized Controlled Trial N/A
Completed NCT02518906 - Evaluation of AIT Study N/A
Recruiting NCT04296604 - Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations N/A
Terminated NCT02149823 - Examining Dose-Related Effects of Oxytocin on Social Cognition Across Populations Phase 1
Completed NCT02108990 - Acetaminophen and Social Processes Phase 2
Completed NCT01635556 - Evaluation of a Modified Dialectical Behavior Therapy Program N/A
Not yet recruiting NCT01683136 - Evaluation of the HBDL Coil Transcranial Magnetic Stimulation (TMS) Device - Feasibility Study for the Treatment of Borderline Personality Disorder N/A
Completed NCT02988037 - Adapted Dialectical Behaviour Therapy for Adolescents With Deliberate Self-Harm: A Pre-post Observational Study N/A
Completed NCT02397031 - Mindfulness and Interpersonal Effectiveness Skills in Borderline Personality Disorder N/A
Terminated NCT01212588 - Preliminary Trial of the Effect of Glucocorticoid Receptor Antagonist on Borderline Personality Disorder (BPD) Phase 2
Terminated NCT01103180 - Selective Serotonin Reuptake Inhibitors (SSRIs) in Borderline Personality Disorder Phase 2
Terminated NCT00539188 - N-Acetylcysteine in Adjunct to DBT for the Treatment of Self-Injurious Behavior in BPD Phase 2
Recruiting NCT05398627 - Neurofeedback for Borderline Personality Disorder N/A
Recruiting NCT03994510 - SHame prOpensity in bOrderline Personality Disorder N/A
Recruiting NCT06005129 - Personality Change Study for Borderline Personality Disorder N/A