Predictors of Clinical Course and Treatment Response in DBT Programmes
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|ClinicalTrials.gov Identifier: NCT04318899|
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : March 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|Self Harm Borderline Personality Disorder||Behavioral: Dialectical Behaviour Therapy adapted for adolescents (DBT-A) Behavioral: Dialectical Behaviour Therapy - Standard version (DBT)||Not Applicable|
The aim of the project is to collect data from systematic and uniform clinical assessments to study predictors of the clinical course and treatment response in patients admitted to and treated in clinical units delivering Dialectical Behaviour Therapy in Norway.
Aims and research questions:
The study will address the following main research questions:
- Which patient characteristics (sociodemographic variables, psychiatric diagnoses/comorbidities, previous suicidal and self-harming behaviour, previous treatment history), predict a favourable clinical course and treatment response?
- Which factors mediate the clinical change in key outcomes such as a) target symptom levels (depression, hopelessness, suicidal ideation, borderline symptoms etc.), b) function levels (emotion regulation capacity, use of coping skills, social functioning, occupational / academic performance level etc.), c) problem behaviours (suicide attempts, non-suicidal self-harm, substance abuse, eating disorder symptoms etc.), d) global functioning and e) the use of emergency treatment services.
- What are significant moderators of treatment response with respect to key clinical outcomes (mentioned above)?
- Which of the treatment modalities are evaluated as the most salient and helpful by patients who receive the treatment according to their age, gender, psychiatric diagnoses and previous treatment history?
A uniform protocol for psychiatric diagnostics and clinical assessment of patients who receive treatment at the participating clinical units will be used. Since some participating clinical units will treat adult patients and some will treat children and adolescents, the protocol will offer assessment instrument suitable for the specific age group whenever this is relevant. The evaluation system includes assessments at baseline before treatment starts, evaluation at several time points during the treatment period, at termination of treatment and at follow-up. Assessments will be made both through interviews and ratings made by therapists and through self-report from patients.
Self-reports will be filled out electronically by patients, on tablets stationed at each participating clinical unit. At intervals patients will also provide self-rated information on dimensions such as emotions, cognitions and impulsive behaviour several times per day through a mobile app developed specifically for the purpose, so-called Ecological Momentary Assessment (EMA). Interview data and ratings will be entered into the database by each clinician to tablets in a similar fashion as self-report data from patients.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||250 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Predictors of Clinical Course and Treatment Response in Patients Having Received Dialectical Behaviour Therapy Delivered by Clinical Units in the Norwegian Network for Clinical Evaluation and Quality in DBT Programmes|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Experimental: Dialectical Behaviour Therapy
Dialectical Behavior Therapy, delivered for 20 weeks for adolescents (DBT-A) or 52 weeks for adults (standard DBT.
Behavioral: Dialectical Behaviour Therapy adapted for adolescents (DBT-A)
DBT developed by Marsha Linehan (Linehan 1993a; 1993b) and adapted for adolescents (DBT-A) by Miller, Rathus & Linehan, 2007 consisting of 20 weeks of weekly individual therapy (60 minutes), multifamily skills training (120 minutes), family therapy sessions as needed and telephone coaching outside therapy sessions.
Behavioral: Dialectical Behaviour Therapy - Standard version (DBT)
DBT developed by Marsha Linehan (Linehan 1993a, 1993 b) consisting of 1 weekly session of individual therapy (60 minutes), 1 weekly session of skills training (120 minutes), and telephone coaching with individual therapists outside therapy sessions as needed.
- Self-harm behaviour [ Time Frame: 4 weeks ]Number of self-harm episodes (split on suicide attempts and non-suicidal self-harm)
- Suicidal Ideation (adolescents) [ Time Frame: 2 weeks ]Suicidal Ideation Questionnaire (SIQ-Jr). Min=0, Max=90. Higher scores indicate worse outcome
- Depressive symptoms [ Time Frame: 1 week ]MADRS (Montgomery Asberg Depression Rating Scale).Min=0, Max=60. Higher scores indicate worse outcome
- Suicidal Ideation (adults) [ Time Frame: 4 weeks ]Beck Scale for Suicidal Ideation (BSS). MIn=0, Max=38. Higher scores indicate worse outcome
- Depressive symptoms (adolescents) [ Time Frame: 1 week ]Moods and Feelings Questionnaire (MFQ). Min=0, Max=26. Higher scores indicate worse outcome
- Depressive symptoms (adults) [ Time Frame: 1 week ]Beck Depression Inventory (BDI). Min=0, Max=63. Higher scores indicate worse outcome
- Borderline Symptoms [ Time Frame: 1 week ]Borderline Symptom List (BSL-23). Min=0, Max=92. Higher scores indicate more symptoms.
- Hopelessness [ Time Frame: 1 week ]Beck Hopelessness Scale (BHS). Min=0, Max=20. Higher scores indicate more hopelessness.
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): NCT04318899
|Contact: Egil Haga, PhDfirstname.lastname@example.org|
|Contact: Lars Mehlum, MD PhDemail@example.com|
|Moss DPS/Østfold sykehus HF||Recruiting|
|Moss, Norway, 1535|
|Contact: Eva Utne Haldorsen Kalla, MD firstname.lastname@example.org|
|Søndre Oslo DPS/Oslo Universitetssykehus HF||Recruiting|
|Oslo, Norway, 1281|
|Contact: Tone Enge Berthelsen, MA UXBETG@ous-hf.no|
|Psykiatrisk senter ytre Helgeland/Helgelandssykehuset HF||Recruiting|
|Sandnessjøen, Norway, 8800|
|Contact: Gry E Konradsen, Psych Nurse Gry.Elin.Konradsen@Helgelandssykehuset.no|
|Bjerketun behandlingshjem/Vestreviken HF||Recruiting|
|Sandvika, Norway, 1341|
|Contact: Kristoffer Ødegård, MA email@example.com|
|BUP Lian/St Olavs Hospital HF||Recruiting|
|Trondheim, Norway, 7024|
|Contact: Marthe Stornes, MA firstname.lastname@example.org|
|Principal Investigator:||Lars Mehlum, MD PhD||University of Oslo|