CClinicalTrials.gg
Sign In
CompletedNCT01153867Updated Mar 16, 2016

Schema Focused Therapy for Chronic Depression

An interventional study of Schema Focused Therapy in Chronic Major Depressive Disorder, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-03-16.

Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Major Depressive Disorder

Keywords

  • Schema Focused Therapy
  • Chronic Depression
  • Mechanisms of Change
03

In context

Depression

8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 25 is below the median of 84 across 6,720 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
25 participants (actual)

Study arms

  • Experimental
    Schema Focused Therapy

    Participants will receive Schema Focused Therapy

    Behavioral: Schema Focused Therapy

Interventions

  • BehavioralSchema Focused Therapy

    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.

06

What researchers measure

Primary outcomes

  1. Depressive symptom improvement

    Time frame: Weekly during baseline and intervention; Monthly during follow-up

Secondary outcomes

  1. Depressive relapse/recurrence

    Time frame: Measured at 12 month follow-up

07

Study locations

1 site
  • Academic Community Mental Health Center, Riagg
    Maastricht, Limburg 6221BD, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 16, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01153867
Lead sponsor
Maastricht University Medical Center
Collaborators
Academic Community Mental Health Centre (RIAGG)
Responsible party
Fritz Renner (Dr, Maastricht University Medical Center) — Principal investigator
First posted
Jun 30, 2010
Start date
Jan 2011
Primary completion
Jan 2016
Completion
Jan 2016
Last update
Mar 16, 2016

Study contacts

Fritz Renner, PhD
principal investigator · Department of Clinical Psychological Science, Maastricht University
Marcus Huibers, PhD
study director · Department of Clinical Psychological Science, Maastricht University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Depression→

Other studies from this sponsor

Maastricht University Medical Center

Start the discussion