Clinical trial NCT01153867: Schema Focused Therapy for Chronic Depression
Official title: Schema-Focused Therapy for Chronic Depression: Efficacy and Mechanisms of Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Major Depressive Disorder
Keywords: Schema Focused Therapy
Chronic Depression
Mechanisms of Change
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: Academic Community Mental Health Centre (RIAGG)
First posted: 2010-06-30
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Depressive symptom improvement
timeFrame: Weekly during baseline and intervention; Monthly during follow-up
Secondary outcomes:
measure: Depressive relapse/recurrence
timeFrame: Measured at 12 month follow-up
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Academic Community Mental Health Center, Riagg
state: Limburg
Study officials:
affiliation: Department of Clinical Psychological Science, Maastricht University
name: Fritz Renner, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Clinical Psychological Science, Maastricht University
name: Marcus Huibers, PhD
role: STUDY_DIRECTOR
References: