Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

First Experimental Study of Transference Work - In Teenagers (FEST-IT) (FEST-IT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01531101
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : March 17, 2020
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Randi Ulberg, Sykehuset i Vestfold HF

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

The First Experimental Study on Transference work - In Teenagers (FEST-IT) will be a randomized clinical trial, which will be designed to explore effects of transference work in dynamic psychotherapy in adolescents with major depressive disorder (MDD). The design of the study is a so-called dismantling design, in which a single component is added and/or varied to an existent treatment method (psychodynamic psychotherapy). Thus, the efficiency of a specific technique (transference interventions) can be identified.

The primary hypothesis is that the transference group may have a more favorable course over time than will the comparison group.

The second hypothesis is that patients with a history of low Quality of Object Relations score and/or personality disorders—might benefit more from therapy with transference work than from therapy without.

The third hypothesis is that female adolescents may have better treatment effect of transference work than male adolescents.


Condition or disease Intervention/treatment Phase
Depression Behavioral: Individual psychodynamic psychotherapy Not Applicable

Detailed Description:

The effect of transference interventions in depressed adolescents and the moderator moderating effect of quality of object relations, personality disorder and gender will be explored. Methods and study design: The First Experimental Study of Transference Work-In Teenagers (FEST-IT) will be a randomized clinical trial with a dismantling design. The study is aimed to explore the effects of transference work in psychodynamic psychotherapy for adolescents with depression. One hundred patients ages 16 to 18 years old will be randomized to one of two treatment groups, in both of which general psychodynamic techniques will be used. The quality of adolescents' relationships will be a central focus of the study.The patients will be treated over 28 weeks with either a moderate level of transference intervention or no transference intervention. Follow-up will be at 1 year after treatment termination.

Gender personality disorder (PD) and quality of object relations (QOR) will be the preselected moderators.

The object of this clinical trial is to explore the effect of transference interventions in psychodynamic psychotherapy in adolescents with a major depressive disorder. Using a randomized and dismantling design, we hope that the study will add more specific knowledge to the evidence base.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: First Experimental Study of Transference Work - In Teenagers
Actual Study Start Date : January 2012
Actual Primary Completion Date : March 2019
Actual Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Individual PDT with TW
Individual Psychodynamic psychotherapy with transference work (TW).
 Behavioral: Individual psychodynamic psychotherapy
Individual psychodynamic psychotherapy with or without transference work. I.e. with or without relational therapist interventions focusing on the patient-therapist relationship.
Other Names:
  • Individual PDT
  • Short-term psychodynamic psychotherapy
  • Short-term dynamic psychotherapy
  • Short-term psychoanalytic psychotherapy
Active Comparator: Individual PDT without (TW)
Individual Psychodynamic psychotherapy without focus on transference work (TW).
 Behavioral: Individual psychodynamic psychotherapy
Individual psychodynamic psychotherapy with or without transference work. I.e. with or without relational therapist interventions focusing on the patient-therapist relationship.
Other Names:
  • Individual PDT
  • Short-term psychodynamic psychotherapy
  • Short-term dynamic psychotherapy
  • Short-term psychoanalytic psychotherapy


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Psychodynamic Functioning Scales (PFS) [ Time Frame: 3 months ]
    Average of 5 subscales rated by experienced clinician raters; family relations, friendships, tolerance for affects, insight, problem solving and adaptive capacity

  2. Inventory of Interpersonal Problems-Circumplex Version (IIP-C) [ Time Frame: Currentl ]
    64.items patient rated measure


Secondary Outcome Measures :
  1. Global Assessment of Functioning (GAF) [ Time Frame: One week ]
    Rated by experienced clinician raters

  2. Symptom Checklist-90 (Global Severity Index; GSI) [ Time Frame: Current ]
    Patient-rated

  3. Beck Depression Inventory (BDI) [ Time Frame: Current ]
    Patient rated

  4. Montgomery Åsberg Rating Scale (MADRS) [ Time Frame: Current ]
    Rated by therapist and/or experienced clinician rater


Other Outcome Measures:
  1. Adolescent Relationship Scale (ARS) [ Time Frame: Current ]
    Patient rated Visual-Analogues scales


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adolescents aged 16 - 18 years

Exclusion Criteria:

  • Pervasive developmental disorder,
  • psychosis, or substance abuse
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531101


Locations
Layout table for location information
Norway
Research Unit, Division of
Tønsberg, Vestfold, Norway, 3103
BUP vest, Diakonhjemmet sykehus
Oslo, Norway
Nic Walls Institutt, Lovisenberg Diakonale Sykehus
Oslo, Norway
Oslo University Hospital
Oslo, Norway
Spcialist in psychiatry and clinical psychiatry
Oslo, Norway
University of Oslo
Oslo, Norway
Sponsors and Collaborators
Randi Ulberg
University of Oslo
Investigators
Layout table for investigator information
Principal Investigator: Randi Ulberg, PhD Vestfold Hospital Trust and University of Oslo
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Randi Ulberg, Researcher, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier: NCT01531101    
Other Study ID Numbers: Sykehuset i Vestfold
REK: 2011/1424 FEST-IT ( Registry Identifier: The Central Norway Regional Ethics Health Committee )
First Posted: February 10, 2012    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Randi Ulberg, Sykehuset i Vestfold HF:
Transference work
Psychodynamic
Depression
Treatment
Adolescent
Additional relevant MeSH terms:
Layout table for MeSH terms
Depression
Behavioral Symptoms