Long Term Efficacy of DBT-A in Adolescents With Repetitive Self-harming and Suicidal Behaviours
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01593202|
Recruitment Status : Active, not recruiting
First Posted : May 8, 2012
Last Update Posted : May 2, 2018
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 or disease||Intervention/treatment||Phase|
|Intentional Self Harm||Behavioral: Dialectical behavior therapy Behavioral: Enhanced usual care||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||77 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Long Term Efficacy of Dialectical Behaviour Therapy vs Enhanced Usual Care for Adolescents With Self-Harming and Suicidal Behaviours|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||September 2022|
|Estimated Study Completion Date :||September 2022|
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.
- 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 ]Measured by the Linehan Parasuicide Count (LPC)
- Severity of suicidal ideation [ Time Frame: 2 years ]Measured by the Suicidal Ideation Questionnaire Jr (SIQ-Jr). Scale range: min= 0, max = 90. High values represent a worse outcome.
- Frequency of subsequent emergency room visits, hospitalizations and use of additional treatments due to risk of deliberate self-harm behavior [ Time Frame: 2 years ]Measured through and interview specifically developed for the purpose and through linkage with the Norwegian Patient Register
- Self reported level of depressive symptoms [ Time Frame: 2 years ]Measured by the Moods and feelings questionnaire (MFQ). Scale range: min = 0, max = 26. High levels represent a worse outcome
- Researcher rated level of depressive symptoms [ Time Frame: 2 years ]Measured through the Montgomery Asberg Depression Rating Scale (MADRS). Scale range: min = 0, max = 60. High levels represent a worse outcome.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01593202
|National Centre for Suicide Research and Prevention Unit/University of Oslo|
|Oslo, Norway, 0372|
|Principal Investigator:||Lars Mehlum, Professor||National Centre for Suicide Research and Prevention|