Emotional InstabilityNCT02991586
Effectiveness Study of a Dialectical Behavioral Treatment for Adolescents With Emotional Instability and Their Families
A study testing Dialectical Behaviour Therapy in people with Emotional Instability, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
Emotional instability disorder (IE) is appreciable since adolescence, and crises (suicidal ideation, self-harm, impulsive acts and brief psychotic episodes) carry a high use of health resources, coupled with the suffering of families who feel helpless and difficulties in handling. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Emotional Instability
- What is being tested?
- Dialectical Behaviour Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteSpain
- Study dates
- May 2016to Apr 2022
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Parents of patients aged 12-17 years whose child is at least 3 criteria of borderline personality disorder ( Diagnostic and Statistical Manual of Mental Disorders 5 ) .
- Talk correctly Spanish correctly.
- Coexistence with son and willingness to participate in the groups.
- Informed consent.
Who cannot join
- Mental retardation.
- Being involved in some other structured DBT family intervention.
- Parents whose children are not receiving any treatment .
- Participated in Actions for Treatment of Personality in Adolescence (ATRAPA TAI)
Trial locations and contacts
1 site in 1 country.
Spain1 site
Instituto Provincial de Psiquiatria, Hospital General Universitario Gregorio Maranon. Calle Ibiza 43
Madrid, 28009
About this study
Official title: Effectiveness Study of a Dialectical Behavioral Treatment for Adolescents With Emotional Instability and Their Families. Comparison of Family Functioning and Cope Strategies in Adolescents With Emotional Instability and Their Families and a Control Group
Emotional instability disorder (IE) is appreciable since adolescence, and crises (suicidal ideation, self-harm, impulsive acts and brief psychotic episodes) carry a high use of health resources, coupled with the suffering of families who feel helpless and difficulties in handling.
this study is composed of three diferents studies:
Read more
. The first study's goal is to determine if there are diferences and, which ones, between family functioning and cope strategies between adolescents with IE and their families, and families of a control group.
- the purpose of the second study is to evaluate the effectivenes of a dialectical behavior therapy for adolescents with IE and their families who are in treatment in the Child Abd Adolescent Mental Heath Service of the Hospital sant Joan de Déu Terres de Lleida. This treatment consist on 2 preliminary sessions with parents and patients and 12 group sessions which purpose is to teach skilss to manage emotions based on dialectical Behavior Therapy.
- finally, the third study is designed to evaluate the effectiveness of a dialectical behavior therapy (DBT) for parents of adolescents with IE who are in treatment in the different network devices of Child and Adolescent Mental Health of the Community of Madrid. Treatment goals are the development of communication skills, validation and crisis management as well as increase understanding and competence of the pathology. The DBT intervention will begin with two individual sessions with parents of patients and 10 theoretical and practical seminars in group format (6-7 families) following the model proposed by Marsha Linehan. The DBT interventions will be added to "standard treatment" that a patient with IE receives in the investigative devices.
Read the detailed description
- In the first study, case group is composed by patients with IE and their families, both from Madrid and Lérida. The control group is composed by adolescents without mental pathologies, recruited from some high scholls from Madrid and Lérida.
- In the second study, the results will be measured a after the end of treatment and 6 months after the treatment ends.
In the third study, the results will be measured a after the end of treatment and 6 months after the treatment ends.
- Conditions
- Emotional Instability
- Being tested
- Dialectical Behaviour Therapy
- Keywords
- Emotional Instability, Family Therapy, BPD, DBT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialectical Behaviour TherapyBehavioural
Group of families
| Study group | Role | What they receive |
|---|---|---|
| Dialectical Behavior Therapy | Experimental | Dialectical Behavior Therapy (DBT) is a cognitive behavioral treatment that was originally developed to treat chronically suicidal individuals diagnosed with borderline personality disorder (BPD) and it is now recognized as the gold standard psychological treatment for this population. In addition, research has shown that it is effective in treating a wide range of other disorders such as substance dependence, depression, post-traumatic stress disorder (PTSD), and eating disorders. In this research DBT skills will be taught to parents of adolescents with high emotional instability Receives: Behavioral: Dialectical Behaviour Therapy |
| Control | No intervention | Control: The "No intervention arm" in this research is defined as follow:, sons and daughters are in their respective treatment but parents are nor receiving any DBT intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difficulties in Emotional Regulation Scale (DERS). (Hervás 2008)
Measured: one year
Automatic Anger and Hostility Thoughts Scale (IPRI) (Magán 2010)
Measured: one year
Coping Styles and Strategies Scale (COPE) (Crespo 1997)
Measured: one year
Secondary outcomes (1)
Children Relapses and Self harms Questionnaire (Ad Hoc)
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2022
- Study completionApr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emotional InstabilityStudies 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Mayoral, Hospital General Universitario Gregorio Marañon
- Investigators
- Maria Mayoral, PhD, Principal investigator, Gregorio Marañon Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02991586
- Sponsor's protocol ID
- FALGregorioMaranon
- Status last verified
- May 2022
- First submitted
- 10 Jun 2016
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
PubMed 32368793
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness Study of a Dialectical Behavioral Treatment for Adolescents With Emotional Instability and Their Families. Comparison of Family Functioning and Cope Strategies in Adolescents With Emotional Instability and Their Families and a Control Group
- ClinicalTrials.gov ID
- NCT02991586
- Acronym / sponsor ID
- FALGregorioMaranon
- Conditions
- Emotional Instability
- Keywords
- Emotional Instability, Family Therapy, BPD, DBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jan 2022 (actual)
- Study completion
- Apr 2022 (actual)
- First posted
- 13 Dec 2016 (estimated)
- 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.
Emotional instability disorder (IE) is appreciable since adolescence, and crises (suicidal ideation, self-harm, impulsive acts and brief psychotic episodes) carry a high use of health resources, coupled with the suffering of families who feel helpless and difficulties in handling.
this study is composed of three diferents studies:
. The first study's goal is to determine if there are diferences and, which ones, between family functioning and cope strategies between adolescents with IE and their families, and families of a control group.
- the purpose of the second study is to evaluate the effectivenes of a dialectical behavior therapy for adolescents with IE and their families who are in treatment in the Child Abd Adolescent Mental Heath Service of the Hospital sant Joan de Déu Terres de Lleida. This treatment consist on 2 preliminary sessions with parents and patients and 12 group sessions which purpose is to teach skilss to manage emotions based on dialectical Behavior Therapy.
- finally, the third study is designed to evaluate the effectiveness of a dialectical behavior therapy (DBT) for parents of adolescents with IE who are in treatment in the different network devices of Child and Adolescent Mental Health of the Community of Madrid. Treatment goals are the development of communication skills, validation and crisis management as well as increase understanding and competence of the pathology. The DBT intervention will begin with two individual sessions with parents of patients and 10 theoretical and practical seminars in group format (6-7 families) following the model proposed by Marsha Linehan. The DBT interventions will be added to "standard treatment" that a patient with IE receives in the investigative devices.
Detailed description
- In the first study, case group is composed by patients with IE and their families, both from Madrid and Lérida. The control group is composed by adolescents without mental pathologies, recruited from some high scholls from Madrid and Lérida.
- In the second study, the results will be measured a after the end of treatment and 6 months after the treatment ends.
In the third study, the results will be measured a after the end of treatment and 6 months after the treatment ends.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dialectical Behavior Therapy | Experimental | Behavioral: Dialectical Behaviour TherapyDialectical Behavior Therapy (DBT) is a cognitive behavioral treatment that was originally developed to treat chronically suicidal individuals diagnosed with borderline personality disorder (BPD) and it is now recognized as the gold standard psychological treatment for this population. In addition, research has shown that it is effective in treating a wide range of other disorders such as substance dependence, depression, post-traumatic stress disorder (PTSD), and eating disorders. In this research DBT skills will be taught to parents of adolescents with high emotional instability |
| Control | No intervention | –Control: The "No intervention arm" in this research is defined as follow:, sons and daughters are in their respective treatment but parents are nor receiving any DBT intervention |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Parents of patients aged 12-17 years whose child is at least 3 criteria of borderline personality disorder ( Diagnostic and Statistical Manual of Mental Disorders 5 ) .
- Talk correctly Spanish correctly.
- Coexistence with son and willingness to participate in the groups.
- Informed consent.
Key exclusion criteria (4 listed)
- Mental retardation.
- Being involved in some other structured DBT family intervention.
- Parents whose children are not receiving any treatment .
- Participated in Actions for Treatment of Personality in Adolescence (ATRAPA TAI)
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 |
|---|---|---|
| Dialectical Behaviour TherapyGroup of families | Behavioural | Dialectical Behavior Therapy |
Primary outcome
Difficulties in Emotional Regulation Scale (DERS). (Hervás 2008)
Time frame: one year
Automatic Anger and Hostility Thoughts Scale (IPRI) (Magán 2010)
Time frame: one year
Coping Styles and Strategies Scale (COPE) (Crespo 1997)
Time frame: one year
1 secondary outcome
Children Relapses and Self harms Questionnaire (Ad Hoc)
Time frame: one year
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 27 May 2022.
- Derived from this study: PubMed 32368793Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
- Individual participant dataSharing planned: No
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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.
Maria Mayoral, PhD principal investigator
Gregorio Marañon Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dialectical Behaviour Therapy in people with Emotional Instability, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
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 4 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 27 May 2022. 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 Spain. 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?
Difficulties in Emotional Regulation Scale (DERS). (Hervás 2008) (time frame: one year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02991586, which also lists 1 linked publication.
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 27 May 2022.