Personality Disorder, BorderlineNCT00247234
Effectiveness of Group Based Schema Therapy in the Treatment of Personality Disorders
A study testing Schema Therapy in people with Personality Disorder, Borderline and Avoidant Personality Disorder, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
This study intends to compare the effectiveness of schema therapy with standard psychiatric outpatient care for patients with borderline or avoidant personality disorder. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Personality Disorder, Borderline, Avoidant Personality Disorder
- What is being tested?
- Schema Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2004to Jan 2015
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Avoidant or Borderline personality disorders
Who cannot join
- Do not speak Scandinavian languages
- Antisocial personality disorder
- Narcissistic personality disorder
- Affective bipolar disorder I
- Schizophrenia
- Mental impairment/organic brain disorder
Show all 10Show fewer
- Substance dependence
- Planned pregnancy
- Serious somatic illness
- Anorexia Nervosa
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Group Based Schema Therapy in the Treatment of Borderline Personality Disorder and Avoidant Personality Disorder
This study intends to compare the effectiveness of schema therapy with standard psychiatric outpatient care for patients with borderline or avoidant personality disorder.
- Being tested
- Schema Therapy, standard care
- Medical subject headings
- Borderline Personality Disorder, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schema TherapyBehavioural
group based schema therapy
standard careBehavioural
standard psychiatric out-patient care
| Study group | Role | What they receive |
|---|---|---|
| schema therapy | Experimental | Not described Receives: Behavioral: Schema Therapy |
| standard care | Active comparator | standard psychiatric out-patient care Receives: Behavioral: standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life
Self-report measures
Measured: 5 years
depression
Self-report measures
Measured: 5 years
anxiety
Self-report measures
Measured: 5 years
suicidal ideation
Self-report measures
Measured: 5 years
Secondary outcomes (1)
Use of psychotropic medication
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2005 (estimated)
- Study startSep 2004
- Primary completionJun 2011
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Personality Disorder, BorderlineStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Are Holen, M.D., Ph.D., Study chair, Department of Neuroscience, NTNU - Faculty of Medicine, MTFS, NO-7489 Trondheim, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00247234
- Sponsor's protocol ID
- ursula.falkmer+AEA-stolav.no
- Status last verified
- Sep 2017
- First submitted
- 31 Oct 2005
- Last updated
- 25 Sep 2017
- 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 25 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Group Based Schema Therapy in the Treatment of Borderline Personality Disorder and Avoidant Personality Disorder
- ClinicalTrials.gov ID
- NCT00247234
- Acronym / sponsor ID
- ursula.falkmer+AEA-stolav.no
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Sep 2004 (actual)
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 1 Nov 2005 (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.
This study intends to compare the effectiveness of schema therapy with standard psychiatric outpatient care for patients with borderline or avoidant personality disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| schema therapy | Experimental | Behavioral: Schema Therapy |
| standard care | Active comparator | Behavioral: standard carestandard psychiatric out-patient care |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Avoidant or Borderline personality disorders
Key exclusion criteria (10 listed)
- Do not speak Scandinavian languages
- Antisocial personality disorder
- Narcissistic personality disorder
- Affective bipolar disorder I
- Schizophrenia
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 |
|---|---|---|
| Schema Therapygroup based schema therapy | Behavioural | schema therapy |
| standard carestandard psychiatric out-patient care | Behavioural | standard care |
Primary outcome
quality of life
Time frame: 5 years
Self-report measures
depression
Time frame: 5 years
Self-report measures
anxiety
Time frame: 5 years
Self-report measures
suicidal ideation
Time frame: 5 years
Self-report measures
1 secondary outcome
Use of psychotropic medication
Time frame: 5 years
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 25 Sep 2017.
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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.
Are Holen, M.D., Ph.D. study chair
Department of Neuroscience, NTNU - Faculty of Medicine, MTFS, NO-7489 Trondheim, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Schema Therapy in people with Personality Disorder, Borderline and Avoidant Personality Disorder, run by Norwegian University of Science and Technology at 1 site in Norway.
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 1 inclusion and 10 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 25 Sep 2017. 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 Norway. 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?
quality of life (time frame: 5 years). The study lists 4 primary outcomes in all. 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 25 Sep 2017.