- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01531101
First Experimental Study of Transference Work - In Teenagers (FEST-IT) (FEST-IT)
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
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Oslo, Norway
- Oslo University Hospital
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Oslo, Norway
- University of Oslo
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Oslo, Norway
- BUP vest, Diakonhjemmet sykehus
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Oslo, Norway
- Nic Walls Institutt, Lovisenberg Diakonale Sykehus
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Oslo, Norway
- Spcialist in psychiatry and clinical psychiatry
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Vestfold
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Tønsberg, Vestfold, Norway, 3103
- Research Unit, Division of
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adolescents aged 16 - 18 years
Exclusion Criteria:
- Pervasive developmental disorder,
- psychosis, or substance abuse
Study Plan
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:
|
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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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Psychodynamic Functioning Scales (PFS)
Time Frame: 3 months
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Average of 5 subscales rated by experienced clinician raters; family relations, friendships, tolerance for affects, insight, problem solving and adaptive capacity
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3 months
|
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Inventory of Interpersonal Problems-Circumplex Version (IIP-C)
Time Frame: Currentl
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64.items patient rated measure
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Currentl
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Global Assessment of Functioning (GAF)
Time Frame: One week
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Rated by experienced clinician raters
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One week
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Symptom Checklist-90 (Global Severity Index; GSI)
Time Frame: Current
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Patient-rated
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Current
|
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Beck Depression Inventory (BDI)
Time Frame: Current
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Patient rated
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Current
|
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Montgomery Åsberg Rating Scale (MADRS)
Time Frame: Current
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Rated by therapist and/or experienced clinician rater
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Current
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adolescent Relationship Scale (ARS)
Time Frame: Current
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Patient rated Visual-Analogues scales
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Current
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Randi Ulberg, PhD, Vestfold Hospital Trust and University of Oslo
Publications and helpful links
General Publications
- Brosholen P, Ulberg R, Dahl HJ, Thoren A. Therapists' Emotional Responses in Individual Therapy with Depressed Adolescents: An Evaluation of the Data Structure of the Feeling-Word Checklist-28. Int J Environ Res Public Health. 2022 Aug 2;19(15):9496. doi: 10.3390/ijerph19159496.
- Henriksen AK, Ulberg R, Tallberg BPU, Lovgren A, Johnsen Dahl HS. Conflicted Anger as a Central Dynamic in Depression in Adolescents-A Double Case Study. Int J Environ Res Public Health. 2021 Jun 15;18(12):6466. doi: 10.3390/ijerph18126466.
- Ulberg R, Hummelen B, Hersoug AG, Midgley N, Hoglend PA, Dahl HJ. The first experimental study of transference work-in teenagers (FEST-IT): a multicentre, observer- and patient-blind, randomised controlled component study. BMC Psychiatry. 2021 Feb 17;21(1):106. doi: 10.1186/s12888-021-03055-y.
- Lovgren A, Rossberg JI, Nilsen L, Engebretsen E, Ulberg R. How do adolescents with depression experience improvement in psychodynamic psychotherapy? A qualitative study. BMC Psychiatry. 2019 Mar 21;19(1):95. doi: 10.1186/s12888-019-2080-0.
- Ness E, Dahl HJ, Tallberg P, Amlo S, Hoglend P, Thoren A, Egeland J, Ulberg R. Assessment of dynamic change in psychotherapy with asdolescents. Child Adolesc Psychiatry Ment Health. 2018 Jul 30;12:39. doi: 10.1186/s13034-018-0246-z. eCollection 2018.
- Ulberg R, Hersoug AG, Hoglend P. Treatment of adolescents with depression: the effect of transference interventions in a randomized controlled study of dynamic psychotherapy. Trials. 2012 Sep 6;13:159. doi: 10.1186/1745-6215-13-159.
Helpful Links
- The Central Norway Regional Ethics Health Committee
- Sykehuset i Vesthold
- University of Oslo
- Ulberg R, Hersoug AG, Høglend P.(2012)Treatment of adolescents with depression: the effect of transference interventions in a randomized controlled study of dynamic psychotherapy.Trials. 2012 Sep 6;13:159. doi: 10.1186/1745-6215-13-159.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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