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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Sykehuset i Vestfold HF
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Randi Ulberg, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier:
NCT01531101
First received: February 8, 2012
Last updated: December 5, 2014
Last verified: December 2014
  Purpose

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 Intervention Phase
Depression
Behavioral: Individual psychodynamic psychotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: First Experimental Study of Transference Work - In Teenagers

Further study details as provided by Sykehuset i Vestfold HF:

Primary Outcome Measures:
  • Psychodynamic Functioning Scales (PFS) [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Average of 5 subscales rated by experienced clinician raters; family relations, friendships, tolerance for affects, insight, problem solving and adaptive capacity

  • Inventory of Interpersonal Problems-Circumplex Version (IIP-C) [ Time Frame: Currentl ] [ Designated as safety issue: No ]
    64.items patient rated measure


Secondary Outcome Measures:
  • Global Assessment of Functioning (GAF) [ Time Frame: One week ] [ Designated as safety issue: No ]
    Rated by experienced clinician raters

  • Symptom Checklist-90 (Global Severity Index; GSI) [ Time Frame: Current ] [ Designated as safety issue: No ]
    Patient-rated

  • Beck Depression Inventory (BDI) [ Time Frame: Current ] [ Designated as safety issue: No ]
    Patient rated

  • Montgomery Åsberg Rating Scale (MADRS) [ Time Frame: Current ] [ Designated as safety issue: No ]
    Rated by therapist and/or experienced clinician rater


Other Outcome Measures:
  • Adolescent Relationship Scale (ARS) [ Time Frame: Current ] [ Designated as safety issue: No ]
    Patient rated Visual-Analogues scales


Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: September 2028
Estimated Primary Completion Date: September 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   16 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adolescents aged 16 - 18 years

Exclusion Criteria:

  • Pervasive developmental disorder,
  • psychosis, or substance abuse
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01531101

Contacts
Contact: Randi Ulberg, PhD +47 22 02 99 61 Randi.Ulberg@siv.no
Contact: Anne Hersoug, Dr.Phil. A.G.Hersoug@medisin.uio.no

Locations
Norway
Research Unit, Division of Recruiting
Tønsberg, Vestfold, Norway, 3103
Contact: Randi Ulberg, PhD       Randi.Ulberg@medisin.uio.no   
Contact: Hanne-Sofie J. Dahl, PhD       h.s.dahl@medisin.uio.no   
Principal Investigator: Randi Ulberg, PhD         
Sub-Investigator: Anne Hersoug, Dr.Phil         
Sub-Investigator: Per Høglend, Dr.med         
Sub-Investigator: Hanne-Sofie J. Dahl, PhD.         
BUP vest, Diakonhjemmet sykehus Recruiting
Oslo, Norway
Contact: Magne O Gudmestad, Dr.Psy.       MagneOlav.Gudmestad@diakonsyk.no   
Nic Walls Institutt, Lovisenberg Diakonale Sykehus Recruiting
Oslo, Norway
Contact: Han O Korsgaard, MD       HansOle.Korsgaard@lds.no   
Oslo University Hospital Recruiting
Oslo, Norway
Contact: Øystein Sørbye, MD       OYSSOR@ous-hf.no   
Spcialist in psychiatry and clinical psychiatry Recruiting
Oslo, Norway
Contact: Randi Ulberg, PhD       Randi.Ulberg@medisin.uio.no   
University of Oslo Recruiting
Oslo, Norway
Contact: Randi Ulberg, PhD       Randi.Ulberg@medisin.uio.no   
Contact: Per Høglend, Dr.med.       p.a.hoglend@medisin.uio.no   
Sub-Investigator: Anne G Hersoug, Dr.Phil.         
Sponsors and Collaborators
Randi Ulberg
University of Oslo
Investigators
Principal Investigator: Randi Ulberg, PhD Vestfold Hospital Trust and University of Oslo
  More Information

Additional Information:
No publications provided by Sykehuset i Vestfold HF

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Randi Ulberg, Researcher, Sykehuset i Vestfold HF
ClinicalTrials.gov Identifier: NCT01531101     History of Changes
Other Study ID Numbers: Sykehuset i Vestfold, REK: 2011/1424 FEST-IT
Study First Received: February 8, 2012
Last Updated: December 5, 2014
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by Sykehuset i Vestfold HF:
Transference work
Psychodynamic
Depression
Treatment
Adolescent

ClinicalTrials.gov processed this record on May 21, 2015