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DepressionFEST-ITNCT01531101

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

A study testing Individual psychodynamic psychotherapy in people with Depression, run by Randi Ulberg at 6 sites in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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). Read more about this study

Who is it for?
Ages 16 to 18 years
Conditions the study is for
Depression
What is being tested?
Individual psychodynamic psychotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
6 sitesNorway
Study dates
Jan 2012to Mar 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Adolescents aged 16 - 18 years

Who cannot join

  • Pervasive developmental disorder,
  • psychosis, or substance abuse

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

Norway6 sites

  • BUP vest, Diakonhjemmet sykehus

    Oslo

  • Nic Walls Institutt, Lovisenberg Diakonale Sykehus

    Oslo

  • Oslo University Hospital

    Oslo

  • Spcialist in psychiatry and clinical psychiatry

    Oslo

  • University of Oslo

    Oslo

  • Research Unit, Division of

    Tønsberg, Vestfold, 3103

Other trials in Norway

About this study

Official title: 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.

Read more

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.

Read the 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.

Conditions
Depression
Being tested
Individual psychodynamic psychotherapy
Keywords
Transference work, Psychodynamic, Depression, Treatment, Adolescent
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individual psychodynamic psychotherapyBehavioural

    Also called Individual PDT, Short-term psychodynamic psychotherapy, Short-term dynamic psychotherapy, Short-term psychoanalytic psychotherapy

    Individual psychodynamic psychotherapy with or without transference work. I.e. with or without relational therapist interventions focusing on the patient-therapist relationship.

Study groups in NCT01531101
Study groupRoleWhat they receive
Individual PDT with TWExperimentalIndividual Psychodynamic psychotherapy with transference work (TW).
Receives: Behavioral: Individual psychodynamic psychotherapy
Individual PDT without (TW)Active comparatorIndividual Psychodynamic psychotherapy without focus on transference work (TW).
Receives: Behavioral: Individual psychodynamic psychotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 3 months

  2. Inventory of Interpersonal Problems-Circumplex Version (IIP-C)

    64.items patient rated measure

    Measured: Currentl

Secondary outcomes (4)

  1. Global Assessment of Functioning (GAF)

    Rated by experienced clinician raters

    Measured: One week

  2. Symptom Checklist-90 (Global Severity Index; GSI)

    Patient-rated

    Measured: Current

  3. Beck Depression Inventory (BDI)

    Patient rated

    Measured: Current

  4. Montgomery Åsberg Rating Scale (MADRS)

    Rated by therapist and/or experienced clinician rater

    Measured: Current

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionMar 2019
  4. Study completionMar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01531101
Sponsor's protocol ID
Sykehuset i Vestfold
Other IDs
REK: 2011/1424 FEST-IT
Acronym
FEST-IT
Status last verified
Mar 2020
First submitted
8 Feb 2012
Last updated
17 Mar 2020
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Calderon A, Storeide KAH, Elvejord C, Nissen-Lie HA, Ulberg R, Dahl HJ. Examining Psychotherapeutic Processes with Depressed Adolescents: A Comparative Study of Two Psychodynamic Therapies. Int J Environ Res Public Health. 2022 Dec 16;19(24):16939. doi: 10.3390/ijerph192416939.

    PubMed 36554820

  • 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.

    PubMed 35954850

  • 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.

    PubMed 34203924

  • 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.

    PubMed 33596856

  • 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.

    PubMed 30898111

  • 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.

    PubMed 30069230

  • 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.

    PubMed 22950546

Questions about this trial

What is this clinical trial studying?

A study testing Individual psychodynamic psychotherapy in people with Depression, run by Randi Ulberg at 6 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Psychodynamic Functioning Scales (PFS) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01531101, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.

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