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

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ClinicalTrials.gov Identifier: NCT01531101
Recruitment Status : Recruiting
First Posted : February 10, 2012
Last Update Posted : October 10, 2017
Sponsor:
Collaborator:
University of Oslo
Information provided by (Responsible Party):
Randi Ulberg, Sykehuset i Vestfold HF

Tracking Information
First Submitted Date  ICMJE February 8, 2012
First Posted Date  ICMJE February 10, 2012
Last Update Posted Date October 10, 2017
Study Start Date  ICMJE January 2012
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2014)
  • 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
  • Inventory of Interpersonal Problems-Circumplex Version (IIP-C) [ Time Frame: Currentl ]
    64.items patient rated measure
Original Primary Outcome Measures  ICMJE
 (submitted: February 9, 2012)
  • Psychodynamic Functioning Scales (PFS)
  • Inventory of Interpersonal Problems-Circumplex Version (IIP-C)
Change History Complete list of historical versions of study NCT01531101 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2014)
  • Global Assessment of Functioning (GAF) [ Time Frame: One week ]
    Rated by experienced clinician raters
  • Symptom Checklist-90 (Global Severity Index; GSI) [ Time Frame: Current ]
    Patient-rated
  • Beck Depression Inventory (BDI) [ Time Frame: Current ]
    Patient rated
  • Montgomery Åsberg Rating Scale (MADRS) [ Time Frame: Current ]
    Rated by therapist and/or experienced clinician rater
Original Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2012)
  • Global Assessment of Functioning (GAF)
  • Symptom Checklist-90 (Global Severity Index; GSI)
  • Beck Depression Inventory (BDI)
  • Montgomery Åsberg Rating Scale (MADRS)
Current Other Pre-specified Outcome Measures
 (submitted: December 5, 2014)
Adolescent Relationship Scale (ARS) [ Time Frame: Current ]
Patient rated Visual-Analogues scales
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE First Experimental Study of Transference Work - In Teenagers (FEST-IT)
Official Title  ICMJE First Experimental Study of Transference Work - In Teenagers
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.

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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Individual PDT with TW
    Individual Psychodynamic psychotherapy with transference work (TW).
    Intervention: Behavioral: Individual psychodynamic psychotherapy
  • Active Comparator: Individual PDT without (TW)
    Individual Psychodynamic psychotherapy without focus on transference work (TW).
    Intervention: Behavioral: Individual psychodynamic psychotherapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 5, 2014)
100
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE September 2028
Estimated Primary Completion Date September 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Adolescents aged 16 - 18 years

Exclusion Criteria:

  • Pervasive developmental disorder,
  • psychosis, or substance abuse
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Randi Ulberg, PhD +47 22 02 99 61 Randi.Ulberg@siv.no
Contact: Anne Hersoug, Dr.Phil. aghersoug@gmail.com
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01531101
Other Study ID Numbers  ICMJE Sykehuset i Vestfold
REK: 2011/1424 FEST-IT ( Registry Identifier: The Central Norway Regional Ethics Health Committee )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Randi Ulberg, Sykehuset i Vestfold HF
Study Sponsor  ICMJE Randi Ulberg
Collaborators  ICMJE University of Oslo
Investigators  ICMJE
Principal Investigator: Randi Ulberg, PhD Vestfold Hospital Trust and University of Oslo
PRS Account Sykehuset i Vestfold HF
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP