Self HarmNCT03627663
DBT-SS for Cognitively Challenged Individuals With Deliberate Self-harm
A study testing Dialectic Behavior Therapy - Skills System in people with Self Harm and Suicide, Attempted, run by Region Skane at 1 site in Sweden.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Self Harm, Suicide, Attempted, Borderline Personality Disorder
- What is being tested?
- Dialectic Behavior Therapy - Skills System
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSweden
- Study dates
- 10 Dec 2017to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Schizophrenia or Bipolar illness type 1
- Substance abuse
- Non-psychiatric disorder significantly contributing to symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Dialectic Behavior Therapy - Skills System
- Medical subject headings
- Self-Injurious Behavior, Suicide, Attempted, Borderline Personality Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectic Behavior Therapy - Skills SystemBehavioural
Treatment with Dialectical Behavior therapy adapted for cognitively challenged individuals
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Receiving treatment with Dialectic Behavior Therapy - Skills System + Treatment As Usual Receives: Behavioral: Dialectic Behavior Therapy - Skills System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deliberate self-harm
Frequency of deliberate self-harm
Measured: Baseline - 64 weeks
Secondary outcomes (14)
Problem behaviors
Frequency of problem behaviors
Measured: Baseline - 64 weeks
Out-of control behavior
Number of hours per week with out-of control behavior
Measured: Baseline - 64 weeks
Upset
Number of hours per week when the individual is upset
Measured: Baseline - 64 weeks
Worried
Number of hours per week when the individual is worried
Measured: Baseline - 64 weeks
Medication on demand
Frequency of occasions with medication on demand
Measured: Baseline - 64 weeks
Visits to psychiatric emergency ward
Frequency of visits to psychiatric emergency ward
Measured: Baseline - 64 weeks
Admission to hospital
Number of days admitted to hospital
Measured: Baseline - 64 weeks
Coercive care
Number of days with coercive care
Measured: Baseline - 64 weeks
Coercive acts
Number of coercive acts
Measured: Baseline - 64 weeks
Psychotropic medications
Number of psychotropic medications
Measured: Baseline - 64 weeks
Level of risk
Measurement with Short-Term Assessment of Risk and Treatability
Measured: Baseline - 64 weeks
Resilience
Measurement with Short-Term Assessment of Risk and Treatability
Measured: Baseline - 64 weeks
Vulnerability
Measurement with Short-Term Assessment of Risk and Treatability
Measured: Baseline - 64 weeks
Level of functioning
Self-rated by interview level of functioning in daily life with WHODAS 2.0
Measured: Baseline - 64 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2018
- Study start10 Dec 2017
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Self HarmStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sofie Westling, Region Skane
- Investigators
- Sofie Westling, MD, PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03627663
- Sponsor's protocol ID
- 2017/827
- Status last verified
- Jun 2020
- First submitted
- 21 Dec 2017
- Last updated
- 2 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialectic Behavior Treatment Skills System (DBT-SS) as Treatment for Cognitively Challenged Individuals With Deliberate Self-harm
- ClinicalTrials.gov ID
- NCT03627663
- Acronym / sponsor ID
- 2017/827
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 10 Dec 2017 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 13 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Dialectic Behavior Therapy - Skills SystemReceiving treatment with Dialectic Behavior Therapy - Skills System + Treatment As Usual |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Schizophrenia or Bipolar illness type 1
- Substance abuse
- Non-psychiatric disorder significantly contributing to symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialectic Behavior Therapy - Skills SystemTreatment with Dialectical Behavior therapy adapted for cognitively challenged individuals | Behavioural | Intervention |
Primary outcome
Deliberate self-harm
Time frame: Baseline - 64 weeks
Frequency of deliberate self-harm
14 secondary outcomes
Problem behaviors
Time frame: Baseline - 64 weeks
Out-of control behavior
Time frame: Baseline - 64 weeks
Upset
Time frame: Baseline - 64 weeks
Worried
Time frame: Baseline - 64 weeks
Medication on demand
Time frame: Baseline - 64 weeks
Visits to psychiatric emergency ward
Time frame: Baseline - 64 weeks
Admission to hospital
Time frame: Baseline - 64 weeks
Coercive care
Time frame: Baseline - 64 weeks
Coercive acts
Time frame: Baseline - 64 weeks
Psychotropic medications
Time frame: Baseline - 64 weeks
Level of risk
Time frame: Baseline - 64 weeks
Resilience
Time frame: Baseline - 64 weeks
Vulnerability
Time frame: Baseline - 64 weeks
Level of functioning
Time frame: Baseline - 64 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Self Harm
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Low Amplitude Pulse Seizure Therapy Versus Standard Ultra-Brief Right Unilateral Electroconvulsive Therapy
Suicidal Ideation, Major Depressive Disorder
Recruiting
Efficacy of Triple-daily 15mA tACS on Adolescent NSSI
Non-suicidal Self-injury (NSSI)
Recruiting
Risk and Resilience to Suicide Following Late-Life Spousal Bereavement
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Not yet recruitingPhase 2
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sofie Westling, MD, PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectic Behavior Therapy - Skills System in people with Self Harm and Suicide, Attempted, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deliberate self-harm (time frame: Baseline - 64 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2020.