Chronic Major Depressive DisorderNCT01153867
Schema Focused Therapy for Chronic Depression
A study testing Schema Focused Therapy in people with Chronic Major Depressive Disorder, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Schema focused therapy (SFT) is an innovative treatment approach to chronic, lifelong problems that incorporates cognitive, behavioral, experiential and psychodynamic elements and techniques. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Major Depressive Disorder
- What is being tested?
- Schema Focused Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2011to Jan 2016
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic MDD as defined by the DSM-IV (meeting full criteria of MDD for at least 2 years).
- Beck Depression Inventory II (BDI-II) score at screening >=20 (moderate to severe depression)
- Can understand and speak the Dutch language
- Has internet access at home
Who cannot join
- Acute suicide risk
- Substance induced mood disorder
- Medical condition causes depression directly or through medication intake
- MDD with psychotic features
- DSM-IV Bipolar disorder (current or past)
- DSM-IV Psychotic disorder (current or past)
Show all 11Show fewer
- DSM-IV alcohol or drug dependence
- Autism Spectrum Disorders (Autistic Disorder, Asperger Syndrome, Pervasive developmental disorder NOS, Rett syndrome, Childhood disintegrative disorder)
- Cluster A and Cluster B personality disorders
- Started with antidepressant medication within three months prior to initial screening. Patients who receive antidepressant medication for more than 3 months prior to the start of the study can keep taking their medication and will not be excluded from participation.
- MRI contra-indications, such as claustrophobia, metal parts in the body and, for women, current pregnancy or breastfeeding.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Community Mental Health Center, Riagg
Maastricht, Limburg, 6221BD
About this study
Official title: Schema-Focused Therapy for Chronic Depression: Efficacy and Mechanisms of Change
Schema focused therapy (SFT) is an innovative treatment approach to chronic, lifelong problems that incorporates cognitive, behavioral, experiential and psychodynamic elements and techniques. This study will determine whether SFT is a suitable and effective treatment for chronic depression in terms of acute effects and the prevention of relapse/recurrence. The secondary aim of this study is to identify the underlying mechanisms of change in SFT that lead to recovery from depression and the prevention of future relapse/recurrence.
Read the detailed description
A single-case series design with multiple randomized baselines across participants will be used in this study. The study will last approximately 36 months and comprises three phases. The first phase is a 6-12 weeks waiting list/baseline phase during which participants will be repeatedly assessed with the main outcome measures and putative mediators. In the second phase participants will receive up to 75 individual sessions of SFT for chronic depression depending on the individual progress in therapy. Upon completion of the intervention phase, participants will have monthly follow-up assessments for the next 12 months.
- Conditions
- Chronic Major Depressive Disorder
- Being tested
- Schema Focused Therapy
- Keywords
- Schema Focused Therapy, Chronic Depression, Mechanisms of Change
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schema Focused TherapyBehavioural
SFT is a novel treatment approach to chronic, lifelong problems that incorporates cognitive, behavioral, experiential and psychodynamic elements and techniques. In the present study participants will receive up to 75 individual sessions of SFT depending on the individual progress in therapy.
| Study group | Role | What they receive |
|---|---|---|
| Schema Focused Therapy | Experimental | Participants will receive Schema Focused Therapy Receives: Behavioral: Schema Focused Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptom improvement
Measured: Weekly during baseline and intervention; Monthly during follow-up
Secondary outcomes (1)
Depressive relapse/recurrence
Measured: Measured at 12 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2010 (estimated)
- Study startJan 2011
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Major Depressive DisorderStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Academic Community Mental Health Centre (RIAGG)
- Responsible party
- Principal investigator, Fritz Renner, Maastricht University Medical Center
- Investigators
- Fritz Renner, PhD, Principal investigator, Department of Clinical Psychological Science, Maastricht UniversityMarcus Huibers, PhD, Study director, Department of Clinical Psychological Science, Maastricht University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01153867
- Sponsor's protocol ID
- MEC 10-3-048
- Status last verified
- Mar 2016
- First submitted
- 29 Jun 2010
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Schema-Focused Therapy for Chronic Depression: Efficacy and Mechanisms of Change
- ClinicalTrials.gov ID
- NCT01153867
- Acronym / sponsor ID
- MEC 10-3-048
- Conditions
- Chronic Major Depressive Disorder
- Keywords
- Schema Focused Therapy, Chronic Depression, Mechanisms of Change
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Academic Community Mental Health Centre (RIAGG)
- Study start
- Jan 2011
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 30 Jun 2010 (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.
Schema focused therapy (SFT) is an innovative treatment approach to chronic, lifelong problems that incorporates cognitive, behavioral, experiential and psychodynamic elements and techniques. This study will determine whether SFT is a suitable and effective treatment for chronic depression in terms of acute effects and the prevention of relapse/recurrence. The secondary aim of this study is to identify the underlying mechanisms of change in SFT that lead to recovery from depression and the prevention of future relapse/recurrence.
Detailed description
A single-case series design with multiple randomized baselines across participants will be used in this study. The study will last approximately 36 months and comprises three phases. The first phase is a 6-12 weeks waiting list/baseline phase during which participants will be repeatedly assessed with the main outcome measures and putative mediators. In the second phase participants will receive up to 75 individual sessions of SFT for chronic depression depending on the individual progress in therapy. Upon completion of the intervention phase, participants will have monthly follow-up assessments for the next 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Schema Focused Therapy | Experimental | Behavioral: Schema Focused TherapyParticipants will receive Schema Focused Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic MDD as defined by the DSM-IV (meeting full criteria of MDD for at least 2 years).
- Beck Depression Inventory II (BDI-II) score at screening >=20 (moderate to severe depression)
- Can understand and speak the Dutch language
- Has internet access at home
Key exclusion criteria (11 listed)
- Acute suicide risk
- Substance induced mood disorder
- Medical condition causes depression directly or through medication intake
- MDD with psychotic features
- DSM-IV Bipolar disorder (current or past)
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 Focused TherapySFT is a novel treatment approach to chronic, lifelong problems that incorporates cognitive, behavioral, experiential and psychodynamic elements and techniques. In the present study participants will receive up to 75 individual sessions of SFT depending on the individual progress in therapy. | Behavioural | Schema Focused Therapy |
Primary outcome
Depressive symptom improvement
Time frame: Weekly during baseline and intervention; Monthly during follow-up
1 secondary outcome
Depressive relapse/recurrence
Time frame: Measured at 12 month follow-up
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 16 Mar 2016.
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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.
Fritz Renner, PhD principal investigator
Department of Clinical Psychological Science, Maastricht University
Marcus Huibers, PhD study director
Department of Clinical Psychological Science, Maastricht University
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 Focused Therapy in people with Chronic Major Depressive Disorder, run by Maastricht University Medical Center at 1 site in Netherlands.
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 11 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 16 Mar 2016. 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 Netherlands. 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?
Depressive symptom improvement (time frame: Weekly during baseline and intervention; Monthly during follow-up). 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 2016.