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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01531101
Other study ID # Sykehuset i Vestfold
Secondary ID REK: 2011/1424 F
Status Completed
Phase N/A
First received
Last updated
Start date January 2012
Est. completion date March 2019

Study information

Verified date March 2020
Source Sykehuset i Vestfold HF
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date March 2019
Est. primary completion date March 2019
Accepts healthy volunteers No
Gender All
Age group 16 Years to 18 Years
Eligibility Inclusion Criteria:

- Adolescents aged 16 - 18 years

Exclusion Criteria:

- Pervasive developmental disorder,

- psychosis, or substance abuse

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Norway 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 Research Unit, Division of Tønsberg Vestfold

Sponsors (2)

Lead Sponsor Collaborator
Randi Ulberg University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Other Adolescent Relationship Scale (ARS) Patient rated Visual-Analogues scales Current
Primary Psychodynamic Functioning Scales (PFS) Average of 5 subscales rated by experienced clinician raters; family relations, friendships, tolerance for affects, insight, problem solving and adaptive capacity 3 months
Primary Inventory of Interpersonal Problems-Circumplex Version (IIP-C) 64.items patient rated measure Currentl
Secondary Global Assessment of Functioning (GAF) Rated by experienced clinician raters One week
Secondary Symptom Checklist-90 (Global Severity Index; GSI) Patient-rated Current
Secondary Beck Depression Inventory (BDI) Patient rated Current
Secondary Montgomery Åsberg Rating Scale (MADRS) Rated by therapist and/or experienced clinician rater Current
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