Skip to main content
OpenTrials
Completed

NCT Number: NCT01153867

Schema Focused Therapy for Chronic Depression

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Academic Community Mental Health Center, Riagg

Maastricht, Limburg, 6221BD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

Schema Focused Therapy

Behavioral

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.

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

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Academic Community Mental Health Centre (RIAGG)

Registry information

Official study title

Schema-Focused Therapy for Chronic Depression: Efficacy and Mechanisms of Change

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Jun 30, 2010
Registry last updated
Mar 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.