Trial document





This trial has been registered retrospectively.
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  DRKS00006554

Trial Description

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Title

Effects of Interpersonal Psychotherapy for depressed adolescents (IPT-A) in an outpatient therapy setting

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Trial Acronym

IPT-A

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URL of the Trial

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Brief Summary in Lay Language

We know from scientific research that by the age of 18, about 25% of young people have experienced a major depressive episode. Due to the severity of the disorder with low mood, loss of interest, reduced driving and frequent suicidal young people often miss critical development tasks without treatment and have experienced significant losses in the social, academic or occupational functioning. It can be in children and adolescents in recent years, a trend towards more frequent and earlier incipient depressive illness notice. Therefore, methods for treating depression are also explored in adolescence for some years. The interpersonal psychotherapy for adolescents (IPT-A) is supposed to be very effective. The contents of the therapy have been published in an English Manual 2004. Now a treatment guide has been prepared in the German language for ambulatory care. Our study examines the effectiveness and acceptance of psychotheraputic methods in adolescents in Germany.

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Brief Summary in Scientific Language

At the age between 13 and 18 years there is a 12-months prevalence of 3% for girls and 1% for boys for the occurrence of a Major Depressive Disorder (MDD) (Angold & Costello, 2001). Lifetime prevalence is about 15-25% (Kessler et al., 2003; Birmaher et al., 1996). On the basis of the clinical experience there additionally is a trend towards more frequent and earlier onset of depressive episodes in the last years (Colloshaw et al., 2004). Because of the severity of the disorder together with low mood, loss of interest, diminished drives and frequent suicidal tendency the patients without treatment often miss fundamental developmental tasks and have to accept important factors missing concerning the social, educational or job-related functional abilities.
Up to now there are little evaluated, alternative therapeutic approaches except the cognitive behavioral therapy that are specific to these groups of patients. After there have been numerous successful studies about the effectiveness of the Interpersonal Psychotherapy for depressive adult patients (IPT) the Interpersonal Psychotherapy for adolescents (IPT-A) has been adapted by PhD Laura Mufson and published in an English version. The evidences in the English area have shown the effectiveness of IPT-A with the treatment of depression also in adolescence.
As studies for IPT-A in Germany are missing up to now and especially in the ambulant setting of a German standard care clinic for child and adolescent psychiatry the objective of the present pilot study is to explore in what extent the treatment of depression for adolescents (between 12 and 20 years) is realizable, which results may be achieved and how many dropouts are registered. Objective of the present pilot study furthermore is to examine the effectiveness of IPT-A in the treatment of this group of patients.
Inclusion criteria are the following diagnoses: ICD-10: F32/F33.
Further inclusion criteria: Age 12-20 years, IQ > 85 and minimum secondary school, following values at the questionnaires: DCRS-R > 36 and BDI-II > 14. Patients cannot be included if a bipolar disorder is existing or the German language is not known in an adequate way.
If the patients are interested and meet the inclusion criteria, 6 participants per semester are included in the study. The total sample contains of 18 adolescents who are treated with IPT-A in 16 sessions over a period of 6-7 months each. The total psychotherapeutic intervention is planned to last 18 months. Subsequently, 6 months after treatment, there will be a follow-up examination. The procedure of the intervention and the accompanying data collection is explained by dialogue and by information for parents and patients. Informed consent is confirmed by signature. Data capture will take place at a pre and a post measurement date as well as 6 months after termination as a follow-up with the help of self-assessment and third-party assessment.

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Organizational Data

  •   DRKS00006554
  •   2015/07/03
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  •   yes
  •   Approved
  •   8/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   F32.0 -  Mild depressive episode
  •   F33.0 -  Recurrent depressive disorder, current episode mild
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Interventions/Observational Groups

  •   Interpersonal Psychotherapy for depressed adolescents (IPT-A) in an outpatient therapy setting. It is planned, 6 participants per semester to be included in the study. The total sample includes 18 young people who are treated in 16 sessions IPT -A over a period of 6-7 months each, so that an overall period of 18 months is planned for psychotherapeutic intervention. 6 months after the treatment was carried out a follow-up will occur.
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Change of Strength of depressive symptoms is measured by Children’s Depression Rating Scale – Revised (CDRS-R).

Data are collected each on three dates. Once before starting treatment, once after the end of therapy and again 6 months after cessation of treatment (catamnesis).

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Secondary Outcome

Improvement of Functioning is measured by Global Assessment of Functioning (GAF). Changes of Psychopathology is measured by Clinical Global Impression Scale (CGI). Improvement of interpersonal problems is measured by Conflict Behavior Questionnaire (CBQ-20). Improvement of social functioning is measured by Social Adjustment Scale (SAS-SR).

Data are collected each on three dates. Once before starting treatment, once after the end of therapy and again 6 months after cessation of treatment (catamnesis).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/05/22
  •   18
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   12   Years
  •   20   Years
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Additional Inclusion Criteria

ICD-10: F32 / F33.
Other inclusion criteria are : IQ ≥ 85 and at least visit the secondary school as well as values ​​for the questionnaires CDRS - R ≥ 36 and the BDI - II ≥ 14th

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Exclusion Criteria

acute psychosis, drug abuse, acute suicidality, severe OCD, severe
Anxiety disorder, severe Tourette syndrome, severe eating disorders, social disorders and mental retardation, bipolar disorder, insufficient knowledge of the german language.
Medication is in principle not a criterion for exclusion, however, requires that the medication for 3 weeks is kept stable. Dyslexia is also not an exclusion criterion.

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Addresses

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    • Universitätsklinikum Freiburg, Zentrum für psychische Erkrankungen Klinik für Psychiatrie, Psychotherapie und Psychosomatik im Kindes- und Jugendalter
    • Hauptstraße 8
    • 79104  Freiburg
    • Germany
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    • Zentrum für psychische Erkrankungen, Klinik für Psychiatrie, Psychotherapie und Psychosomatik im Kindes- und Jugendalter
    • Mr.  Prof. Dr.   Christian  Fleischhaker 
    • Hauptstraße 8
    • 79104  Freiburg
    • Germany
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    • Zentrum für psychische Erkrankungen, Klinik für Psychiatrie, Psychotherapie und Psychosomatik im Kindes- und Jugendalter,
    • Mr.  Prof. Dr.  Christian  Fleischhaker, 
    • Hauptstraße 8
    • 79104  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg, Zentrum für psychische Erkrankungen Klinik für Psychiatrie, Psychotherapie und Psychosomatik im Kindes- und Jugendalter,
    • Hauptstrasse 8
    • 79104  Freiburg,
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.