Trial document




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  DRKS00010573

Trial Description

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Title

Transactional Analysis Treatment of Depression in Outpatients

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Trial Acronym

TADEO

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URL of the Trial

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Brief Summary in Lay Language

The effectiveness of outpatient transactional-analytic psychotherapy with patients having the principal diagnosis, "depression," is to be evaluated. Furthermore, process characteristics (psychiatric findings, significant interactions of the patients and interventions of the therapists) are to be examined and be put into relationship with the outcome measurements.
The primary outcome criterion is the QIDS-SR16 (Quick Inventory of Depressive Symptomatology, self report, German Version). The BDI (Beck's Depression Inventory) version 2 is also used for exploration. This is a naturalistic study, in which approx. 20 psychotherapists participate in their outpatient practices. Consecutively admitted patients with the principal diagnosis depression are screened regarding the fulfilment of the inclusion and exclusion criteria and asked for their agreement to participation in the study. Data are collected at inclusion into the study, at the beginning of the therapy, after each 25th. meeting, at the end of therapy, as well as 6 and 12 months after completion (self and third-party assessments). The goal is to include a total of between 80 and 120 patients in the study. As a result of the usual waiting lists in the practices a natural waiting control group arises, with a waiting period of at least 3 weeks.
For details on the instruments see the study protocol. Instruments which are established in field of naturalistic psychotherapy research were selected, and thus allow result comparisons with other treatment studies of outpatient psychotherapy (Wittmann WW, Steffanowski A, Kriz D et al, 2011).

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Brief Summary in Scientific Language

The goal of the study: Prospective, naturalistic study in outpatient psychotherapeutic practices focused on the research questions:
1. How successful is the outpatient transactional-analytic psychotherapy at the time of completion, as well as 6 and 12 months afterwards?
2. Can definable groups of interaction and intervention process profiles be formed on the basis of standardised study protocols?
3. Which interaction and intervention processes make a forecast of therapy success possible, also in the follow-up reports?
4. Is there a connection between the process profile and the strength of therapy success?
Type of study: Prospective cohort study with waiting control group
Sample: Patients with the principal diagnosis of a depression ICD-10 F32.0-2, F33.0-2, F34.0 and QIDS Score > 9, who are being treated as outpatients in psychotherapeutic practices with transactional-analytic psychotherapy.
Sample size: Expected sample after drop-outs: 80 < N < 120
Data acquisition: All patients accepted consecutively in participating outpatient practices with the principal diagnosis of depression are screened regarding the fulfilment of the inclusion and exclusion criteria, informed about the study, and included after written consent until the desired number of 80 < N < 120 is reached. Times of measurement are at inclusion into the study (T0), at beginning of the therapy (T1), after therapy completion or after 25 meetings (T2), after therapy completion or after 50 meetings (T3), at 6 months (T4) and 12 months after completion (T5). The principal diagnosis is made with the ISR (ICD-10-Symptom-Rating), the PHQ-D (Patient Health Questionnaire, German Version) and depression-specific with the QIDS-SR16R16, the QIDS-CR16 as well as the BDI version 3. The securing of the diagnosis is done together with the determination of possible comorbidity via the participating therapists with the mini-DIPS.
Statistical analyses: The outcome criterion is the QIDS-SR16-Score (degree of the depression). The outcome is evaluated both as continuous variable (T0 to T5), and as categorical (no response, moderate response, partial remission, complete remission). Moderator and mediator analyses are conducted according to Fournier & DeRubeis (2009) as well as Kraemer, et al. (2002), using HLM with nested random effects for continuous variables (QIDS-SR16 score) and SPSS CatReg for the categorical outcome (remission classes). Four groups of predictor variables are to enter into the analyses (characteristics of the depression, comorbidity, socio-demographic variables, and interaction-intervention-profile type). Variables which are to be monitored: medication, number of hours of psychotherapy, initial value of the principal outcome criterion (QIDS-SR16 score). In addition the BDI version 3 is used for exploration.
Study duration: Beginning to end of recruiting: 30 months. Total duration of the study: 58 months (without conclusion 12-month follow-ups); preparation of the study/training courses: months 1-3; recruiting the patients 4-34, follow-up reports; treatment of patients: months 4-58; follow-up reports: months 21-70; data analysis and reporting starting from month 58.
Participating practices: (still to be acquired) practices of psychotherapists, who are certified or who have legal permission for the practice of medicine in the area of psychotherapy, and who are certified transactional analysts after completed training (Certified Transactional analyst for psychotherapy EATA/ITAA), or stand one year or less before the formal conclusion of their training.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00010573
  •   2016/08/04
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  •   yes
  •   Approved
  •   148/16, Ethik-Kommission der Universität Ulm
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Secondary IDs

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Health Condition or Problem studied

  •   F32.2 -  Severe depressive episode without psychotic symptoms
  •   F34.0 -  Cyclothymia
  •   F33.2 -  Recurrent depressive disorder, current episode severe without psychotic symptoms
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Interventions/Observational Groups

  •   Outpatient treatment with transactional analysis carried out by transactional analysts in outpatient practices according to the legal outpatient psychotherapy regulations in Germany. The therapists are examined and certified psychotherapeutic members of the European Assiciation of Transactional Analysis EATA, or they do psychotherapy under supervision in the last year before their examn. Diagnosis, assessment of the patient's psychodynamic process, treatment outline and the treatment itself are carried out according to the Transactional Analysis psychotherapy examination standards of the EATA.
  •   controlls wait for the beginning of the treatment, at least 3 weeks.
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Characteristics

  •   Interventional
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  •   Non-randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   Control group receives no treatment
  •   Treatment
  •   Other
  •   II
  •   N/A
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Primary Outcome

Therapy finished within 25 sessions (T2) or within 50 sessions (T3). Propabely most therapies will be finished within 50 sessions. Outcome measurement: QIDS-SR16 and QIDS-C. Additionally questionaires about treatment satisfaction and possible other treatments during the duration of the therapy.

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Secondary Outcome

6 months (T4) and 12 months(T5) after the treatment is finished. Outcome measures: QIDS-SR16, BDI2, QIDS-C. Additionally questionaires about treatment satisfaction and possible other treatments during the post treatment time.

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Countries of Recruitment

  •   Germany
  •   Switzerland
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Locations of Recruitment

  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2016/12/14
  •   100
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Depression with the diagnoses ICD-10 F32.0-2 depressive episode, F33.0-2 recurrent depressive disorder, F34.1 dysthymia, and a minimum of 9 points measured by the QIDS-SR16.

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Exclusion Criteria

depression not being the main diagnosis

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Addresses

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    • Psychotherapeutische Praxis
    • Mr.  Prof. Dr.  Ulrich  Elbing 
    • Steinäcker 10
    • 73527  Schwäbisch Gmünd
    • Germany
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    • Universitätsklinik Ulm, Klinik für Psychosomatische Medizin und Psychotherapie
    • Mr.  Prof. Dr.  Jörn  von Wietersheim 
    • Albert-Einstein-Allee 23
    • 89081  Ulm
    • Germany
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    • Psychotherapeutische Praxis
    • Mr.  Prof. Dr.  Ulrich  Elbing 
    • Steinäcker 10
    • 73527  Schwäbisch Gmünd
    • Germany
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    • TADEO-Studienassistenz
    • Mr.  Moritz  Seidenfus 
    • Bismarckstraße 26
    • 80803  München
    • Germany
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    •   +49 177 8537599
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    •   TADEO at dgta.de
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Sources of Monetary or Material Support

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    • Deutsche Gesellschaft für Transaktionsanalyse e. V. - Geschäftsstelle
    • Silvanerweg 8
    • 78464  Konstanz
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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