Long Term Efficacy of DBT-A in Adolescents With Repetitive Self-harming and Suicidal Behaviours

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lars Mehlum, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01593202
First received: April 16, 2012
Last updated: April 28, 2015
Last verified: April 2015
  Purpose

The purpose of the study is to evaluate the long-term efficacy of dialectical behavior therapy (DBT) in treatment of adolescents with deliberate self harm compared to enhanced usual care (EUC). This study follows-up 77 patients in the ages of 12-18 yrs who have been included in an RCT of DBT-A vs EUC. The main inclusion criterion for this study was repetitive self-harm behaviour. The patients were randomly allocated to receive 16 weeks of outpatient DBT or EUC in child and adolescent psychiatric clinics in Oslo. Participants have been assessed so far on five different time-points: baseline (before starting treatment), 9 weeks, 15 weeks, 19 weeks and 71 weeks after start of the treatment. In the current project patients will be assessed a 6th time 2 years after treatment completion.

The main study hypotheses are:

  • DBT will be significantly more efficacious in reducing the number of self-harm episodes with or without intent to die, as well as reducing the number of emergency room visits for self-harm or suicidal behaviour, compared to EUC.
  • DBT will be significantly more efficacious in reducing the level of suicidal ideation and depressive symptoms compared to EUC.

Condition Intervention Phase
Intentional Self Harm
Behavioral: Dialectical behavior therapy
Behavioral: Enhanced usual care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Long Term Efficacy of Dialectical Behaviour Therapy vs Enhanced Usual Care for Adolescents With Self-Harming and Suicidal Behaviours

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • Frequency of subsequent episodes of deliberate self harm and time elapsed to future episodes of deliberate self harm [ Time Frame: 2 years after end of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Severity of suicidal ideation, level of depressive symptoms [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • Frequency of subsequent emergency room visits, hospitalizations and use of additional treatments due to risk of deliberate self-harm behavior [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 77
Study Start Date: January 2012
Estimated Study Completion Date: September 2022
Estimated Primary Completion Date: September 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dialectical behavior therapy
Dialectical Behavior Therapy, delivered for 19 weeks, consisted of 1 weekly session of individual therapy (60 minutes), 1 weekly session of multifamily skills training (120 minutes), and family therapy sessions and Telephone coaching with individual therapists outside therapy sessions as needed.
Behavioral: Dialectical behavior therapy

16 weeks of Dialectical behavior therapy with one weekly session of individual therapy, one weekly session of multifamily skills training group, telephone coaching and ancillary family therapy and/or pharmacological treatment as needed.

The treatment has been developed by Marsha Linehan (Linehan, 1993a; 1993b)and adapted for adolescents by Alec Miller (Miller, Rathus & Linehan, 2007). Individual DBT therapists have been trained by drs Alec L Miller and Sarah K Reynolds and have a minimum of one year clinical practise as DBT therapists. The therapists are organised in two consultation teams supervised on a bimonthly basis throughout the entire study by drs Miller and Reynolds respectively.

Active Comparator: Enhanced usual care
Enhanced usual care was 19 weeks of standard care (enhanced for the purpose of the study by requiring that EUC therapists agree to provide on average no less than 1 weekly treatment session per patient throughout the trial) delivered by therapists (4 psychiatrists, 16 clinical psychologists, 6 clinical social workers, 2 clinical pedagogues, 1 specialist nurse, and 1 psychology graduate student) not trained in or practicing DBT.
Behavioral: Enhanced usual care
16 weeks of outpatient treatment in child and adolescent psychiatric clinics in Oslo, on average one weekly session of individual therapy and ancillary supportive. family and/or pharmacological treatment as needed.

Detailed Description:

The study is a long-term follow-up of a randomized trial comparing DBT-A with enhanced usual care (EUC). Participants were randomly allocated to receive either treatment at 1 of the participating child and adolescent psychiatric outpatient clinics in a 1:1 ratio stratified according to gender, presence of major depression, and presence of suicide intent during the most serious episode of self-harm behavior within the 16 weeks before enrollment. Treatment allocation of participants after baseline assessments was based on a permuted block randomization procedure with an undisclosed and variable blocking factor, and daily management of the randomization procedures was performed by an external group. Patients received either DBT or EUC by therapists working at and funded by the 10 child and adolescent psychiatric outpatient clinics participating in the study. They were assessed during treatment (9 and 15 weeks), at treatment completion 19 weeks, and at 71 weeks. In this study they are assessed at 2 years after treatment completion.

The assessment of outcomes include: number of self-reported self-harm episodes (suicide attempts and non-suicidal self-harm episodes combined, measured by Lifetime Parasucide Count); the severity of suicidal ideation as measured by the 15-item self-report Suicidal Ideation Questionnaire (SIQ-JR; and level of depressive symptoms as measured by the 13-item version of the self-report Short Mood and Feelings Questionnaire (SMFQ) and through the interviewer rated 10-item Montgomery-_Asberg Depression Rating Scale (MADRS). Other outcomes are hopelessness, measured by the 20-item self-report Beck Hopelessness Scale (BHS);borderline symptoms, assessed through the 23-itemself-report Borderline Symptom List (BSL); Borderline Personality Disorder as measured by SCID-II; and hospital admissions and emergency department visits because of self-harm.

  Eligibility

Ages Eligible for Study:   13 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients included in the initial RCT 'Treatment for Adolescents With Deliberate Self Harm' (ClinicalTrials ID NCT00675129). Inclusion criteria for this study were:

  • History of repeated deliberate self harm (last episode within last months)
  • Satisfies at least 2 criteria of DSM-IV Borderline Personality Disorder (as measured by SCID-II) in addition to the self-destructive criterion.

Or: Satisfies at least 1 criterion + 2 criteria scored below threshold (score 2) of DSM-IV Borderline Personality Disorder (as measured by SCID-II) in addition to the self-destructive criterion.

Exclusion Criteria:

  • Psychotic disorders
  • Anorexia Nervosa
  • Substance dependence disorder
  • Mental retardation (IQ less than 70)
  • Asperger syndrome/autism
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593202

Locations
Norway
National Centre for Suicide Research and Prevention Unit/University of Oslo
Oslo, Norway, 0372
Sponsors and Collaborators
Oslo University Hospital
Investigators
Principal Investigator: Lars Mehlum, Professor National Centre for Suicide Research and Prevention
  More Information

Additional Information:
No publications provided

Responsible Party: Lars Mehlum, Professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT01593202     History of Changes
Other Study ID Numbers: ES4894
Study First Received: April 16, 2012
Last Updated: April 28, 2015
Health Authority: Norway: Norwegian Social Science Data Services

ClinicalTrials.gov processed this record on May 26, 2015