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

March 16, 2020 updated by: Randi Ulberg

First Experimental Study of Transference Work - In Teenagers

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.

Study Overview

Status

Completed

Conditions

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Oslo, Norway
        • Oslo University Hospital
      • Oslo, Norway
        • University of Oslo
      • Oslo, Norway
        • BUP vest, Diakonhjemmet sykehus
      • Oslo, Norway
        • Nic Walls Institutt, Lovisenberg Diakonale Sykehus
      • Oslo, Norway
        • Spcialist in psychiatry and clinical psychiatry
    • Vestfold
      • Tønsberg, Vestfold, Norway, 3103
        • Research Unit, Division of

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adolescents aged 16 - 18 years

Exclusion Criteria:

  • Pervasive developmental disorder,
  • psychosis, or substance abuse

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Individual PDT with TW
Individual Psychodynamic psychotherapy with transference work (TW).
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).
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months
Inventory of Interpersonal Problems-Circumplex Version (IIP-C)
Time Frame: Currentl
64.items patient rated measure
Currentl

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Assessment of Functioning (GAF)
Time Frame: One week
Rated by experienced clinician raters
One week
Symptom Checklist-90 (Global Severity Index; GSI)
Time Frame: Current
Patient-rated
Current
Beck Depression Inventory (BDI)
Time Frame: Current
Patient rated
Current
Montgomery Åsberg Rating Scale (MADRS)
Time Frame: Current
Rated by therapist and/or experienced clinician rater
Current

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adolescent Relationship Scale (ARS)
Time Frame: Current
Patient rated Visual-Analogues scales
Current

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Randi Ulberg, PhD, Vestfold Hospital Trust and University of Oslo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2012

Primary Completion (ACTUAL)

March 1, 2019

Study Completion (ACTUAL)

March 1, 2019

Study Registration Dates

First Submitted

February 8, 2012

First Submitted That Met QC Criteria

February 9, 2012

First Posted (ESTIMATE)

February 10, 2012

Study Record Updates

Last Update Posted (ACTUAL)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 16, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sykehuset i Vestfold
  • REK: 2011/1424 FEST-IT (REGISTRY: The Central Norway Regional Ethics Health Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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