Treatment 1:Dialectical Behavior Therapy (DBT)NCT04309045
Assessment of Cost-effectiveness in Two Empirically-based Psychotherapies for Borderline Personality Disorder: A Randomized Controlled Trial
A study testing DBT and DDP in people with Treatment 1:Dialectical Behavior Therapy (DBT) and Treatment 2:Dynamic Deconstructive Psychotherapy (DDP), run by Shalvata Mental Health Center.
Trial summary
Patients suffering from borderline personality disorder (BPD) are considered frequent utilizers of psychiatric emergency rooms and of psychiatric hospitalizations. Nonetheless, recent studies challenge the effectiveness of psychiatric hospitalizations in reducing BPD symptoms, and some have even indicated potentially… Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Treatment 1:Dialectical Behavior Therapy (DBT), Treatment 2:Dynamic Deconstructive Psychotherapy (DDP), Placebo
- What is being tested?
- DBT and DDP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 22 Oct 2024
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- between 18 and 45 years old
- diagnosis of BPD,
- history of a suicide attempt within the prior year with presence of current suicidal ideation,
- agrees to participate in psychotherapy
- signed informed consent,
Who cannot join
- meet diagnostic criteria for schizophrenia, schizoaffective disorders, or have severe intellectual impairment.
About this study
Patients suffering from borderline personality disorder (BPD) are considered frequent utilizers of psychiatric emergency rooms and of psychiatric hospitalizations. Nonetheless, recent studies challenge the effectiveness of psychiatric hospitalizations in reducing BPD symptoms, and some have even indicated potentially harmful effects such as increasing suicide risk post-discharge. These findings highlight the importance of effective outpatient treatments for BPD patients in public psychiatric hospital settings. In this study we aim to assess the effectiveness and cost-effectiveness of two empirically-based treatments for BPD: dialectical behavior therapy (DBT) and dynamic deconstructive psychotherapy (DDP).
Read the detailed description
In this study we aim to assess the effectiveness and cost-effectiveness of two empirically-based treatments for BPD: dialectical behavior therapy (DBT) and dynamic deconstructive psychotherapy (DDP). Sixty-eight participants with BPD will be randomized to each of two treatment groups. Participants and therapists will be recruited from the Shalvata MHC, a 139-bed psychiatric institution with outpatient units serving a population of more than 600,000 people in Israel. A blinded research assistant will administer primary and secondary outcome measures every 3 months during the 12 months of treatment and at the end of the 6-month naturalistic follow-up period after ending treatment with DDP or DBT. Therapist adherence will be systematically assessed in both treatments for 10% of sessions. Primary outcome measure will be comprised of the Incremental cost-effectiveness ratio (ICER), as assessed by estimating the healthcare utilization costs per incremental improvement in suicide severity. Secondary outcome measures will include BPD and depression symptom severity and quality of life. This study was submitted to the institutional review board of the Shalvata MHC in November 2019, and is expected to be approved by late Janury 2020.
- Conditions
- Treatment 1:Dialectical Behavior Therapy (DBT), Treatment 2:Dynamic Deconstructive Psychotherapy (DDP), Placebo
- Being tested
- DBT, DDP, control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBTBehavioural
Today, the most well-known and established treatment for borderline personality disorder is Dialectical Behavior Therapy (DBT) that developed by Marsha Linhan in the 1990s. DBT is currently used in other disorders such as: eating disorders, addictions, impulse control problems and bipolar disorder. Various studies have found a beneficial effect for this treatment in various areas: decreased suicidal thoughts and attempts and self-harm behaviors, improvements in suicide attempts, anger levels, impulsive behaviors, depressive symptoms, The use of drugs, the percentage of dropouts from treatment, number Hospitalization and general function.
DDPBehavioural
DDP treatment is part of a trend of dynamic therapies to treat borderline personality disorder. The DDP focuses on deficiencies in the emotional experience processing and is performed in the form of weekly, individual sessions with a trained therapist over a 12-18 month period. Treatment is based on the need to correct three neurocognitive functions responsible for adaptive processing of emotional experiences: association (the ability to recognize, understand their existence, and experience a sequence of emotional experiences), attribution (the ability to make complex attributions about the self and others), and the ability to make realistic attribution, about the self and the other. Interventions that activate these three functions are the basis for DDP treatment.
control groupOther
Patients on the waiting list for treatment, or patients in the hospital under routine care.
| Study group | Role | What they receive |
|---|---|---|
| DBT | Experimental | Standard DBT treatment Receives: Behavioral: DBT |
| DDP | Active comparator | dynamic deconstructive psychotherapy (DDP) treatment, is part of a trend of dynamic therapies to treat borderline personality disorder. DDP is a treatment specifically developed for a population with more severe symptoms those dealing with borderline personality disorder. Receives: Behavioral: DDP |
| control group | Placebo comparator | patients on the waiting list for treatment, or patients in the hospital under routine care. Which will form the control group. Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incremental cost-effectiveness ratio (ICER)
The measure will be assessed by comparing health care use costs in ratio to improvement on the Columbia hardware rating scale.
Measured: The expected duration of treatment is about one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2020
- Study start1 Apr 2020 (estimated)
- Primary completion22 Oct 2024 (estimated)
- Study completion22 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment 1:Dialectical Behavior Therapy (DBT)Studies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yuval Bloch, Shalvata Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04309045
- Sponsor's protocol ID
- 0011-19-SHA
- Status last verified
- Mar 2020
- First submitted
- 12 Mar 2020
- Last updated
- 16 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cost-effectiveness in Two Empirically-based Psychotherapies for Borderline Personality Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04309045
- Acronym / sponsor ID
- 0011-19-SHA
- Conditions
- Treatment 1:Dialectical Behavior Therapy (DBT), Treatment 2:Dynamic Deconstructive Psychotherapy (DDP), Placebo
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 22 Oct 2024 (estimated)
- Study completion
- 22 Oct 2024 (estimated)
- First posted
- 16 Mar 2020 (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.
Patients suffering from borderline personality disorder (BPD) are considered frequent utilizers of psychiatric emergency rooms and of psychiatric hospitalizations. Nonetheless, recent studies challenge the effectiveness of psychiatric hospitalizations in reducing BPD symptoms, and some have even indicated potentially harmful effects such as increasing suicide risk post-discharge. These findings highlight the importance of effective outpatient treatments for BPD patients in public psychiatric hospital settings. In this study we aim to assess the effectiveness and cost-effectiveness of two empirically-based treatments for BPD: dialectical behavior therapy (DBT) and dynamic deconstructive psychotherapy (DDP).
Detailed description
In this study we aim to assess the effectiveness and cost-effectiveness of two empirically-based treatments for BPD: dialectical behavior therapy (DBT) and dynamic deconstructive psychotherapy (DDP). Sixty-eight participants with BPD will be randomized to each of two treatment groups. Participants and therapists will be recruited from the Shalvata MHC, a 139-bed psychiatric institution with outpatient units serving a population of more than 600,000 people in Israel. A blinded research assistant will administer primary and secondary outcome measures every 3 months during the 12 months of treatment and at the end of the 6-month naturalistic follow-up period after ending treatment with DDP or DBT. Therapist adherence will be systematically assessed in both treatments for 10% of sessions. Primary outcome measure will be comprised of the Incremental cost-effectiveness ratio (ICER), as assessed by estimating the healthcare utilization costs per incremental improvement in suicide severity. Secondary outcome measures will include BPD and depression symptom severity and quality of life. This study was submitted to the institutional review board of the Shalvata MHC in November 2019, and is expected to be approved by late Janury 2020.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DBT | Experimental | Behavioral: DBTStandard DBT treatment |
| DDP | Active comparator | Behavioral: DDPdynamic deconstructive psychotherapy (DDP) treatment, is part of a trend of dynamic therapies to treat borderline personality disorder. DDP is a treatment specifically developed for a population with more severe symptoms those dealing with borderline personality disorder. |
| control group | Placebo comparator | Other: control grouppatients on the waiting list for treatment, or patients in the hospital under routine care. Which will form the control group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- between 18 and 45 years old
- diagnosis of BPD,
- history of a suicide attempt within the prior year with presence of current suicidal ideation,
- agrees to participate in psychotherapy
- signed informed consent,
Key exclusion criteria (1 listed)
- meet diagnostic criteria for schizophrenia, schizoaffective disorders, or have severe intellectual impairment.
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 |
|---|---|---|
| DBTToday, the most well-known and established treatment for borderline personality disorder is Dialectical Behavior Therapy (DBT) that developed by Marsha Linhan in the 1990s. DBT is currently used in other disorders such as: eating disorders, addictions, impulse control problems and bipolar disorder. Various studies have found a beneficial effect for this treatment in various areas: decreased suicidal thoughts and attempts and self-harm behaviors, improvements in suicide attempts, anger levels, impulsive behaviors, depressive symptoms, The use of drugs, the percentage of dropouts from treatment, number Hospitalization and general function. | Behavioural | DBT |
| DDPDDP treatment is part of a trend of dynamic therapies to treat borderline personality disorder. The DDP focuses on deficiencies in the emotional experience processing and is performed in the form of weekly, individual sessions with a trained therapist over a 12-18 month period. Treatment is based on the need to correct three neurocognitive functions responsible for adaptive processing of emotional experiences: association (the ability to recognize, understand their existence, and experience a sequence of emotional experiences), attribution (the ability to make complex attributions about the self and others), and the ability to make realistic attribution, about the self and the other. Interventions that activate these three functions are the basis for DDP treatment. | Behavioural | DDP |
| control groupPatients on the waiting list for treatment, or patients in the hospital under routine care. | Other | control group |
Primary outcome
Incremental cost-effectiveness ratio (ICER)
Time frame: The expected duration of treatment is about one year
The measure will be assessed by comparing health care use costs in ratio to improvement on the Columbia hardware rating scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing DBT and DDP in people with Treatment 1:Dialectical Behavior Therapy (DBT) and Treatment 2:Dynamic Deconstructive Psychotherapy (DDP), run by Shalvata Mental Health Center.
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 5 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
Incremental cost-effectiveness ratio (ICER) (time frame: The expected duration of treatment is about one year). 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 16 Mar 2020.