Major Depressive Disorder Clinical Trial
Official title:
Deficits in Emotion Regulation Skills as a Maintaining Factor in Major Depressive Disorder
NCT number | NCT01330485 |
Other study ID # | BE4510/3-1 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2010 |
Est. completion date | September 2014 |
Verified date | April 2019 |
Source | Friedrich-Alexander-Universität Erlange-Nürnberg |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary aim of the study is to evaluate the efficacy of a systematic training of general affect regulation skills (ART) on the reduction of depressive symptom in individuals meeting criteria for major depressive disorder (MDD).
Status | Completed |
Enrollment | 218 |
Est. completion date | September 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - diagnosis of MDD according to DSM-IV criteria as the primary diagnosis - age 18 and above - sufficient German language skills Exclusion Criteria: - high risk of suicide - indication of substantial secondary gain - currently in psychotherapeutic treatment with an institution/professional other than those involved in the study - co-occurring psychotic, bi-polar, and/or substance disorders - organic brain disorder(s), severe medical condition, and/or severe cognitive impairment that impedes ability to participate in the study or treatment |
Country | Name | City | State |
---|---|---|---|
Germany | Aus- und Weiterbildungszentrum für Klinische Verhaltenstherapie | Kassel | |
Germany | University of Mainz | Mainz | |
Germany | Philipps-University of Marburg | Marburg | Hessen |
Lead Sponsor | Collaborator |
---|---|
Friedrich-Alexander-Universität Erlange-Nürnberg | German Research Foundation |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | General psychopathological symptom load | General psychopathological symptom load as assessed with the Brief Symptom Inventory | Pre to post ART, CFC or WLC; hence covering the ten week time period from the first assessment point (prior to randomization) to the assessment point 10 weeks later | |
Other | Course of depressive symptoms during individual CBT after ART/CFC/WLC. | Course of depressive symptoms during individual CBT after ART/CFC/WLC. Testing the hypothesis that fostering emotion regulation skills may enhance the efficacy of subsequent individual cognitive behavioral therapy for depression | Pre to post individual CBT (estimated up to 2 years, depending upon the patient's specific needs) | |
Primary | Change in depressive symptoms | Change in depressive symptoms as assessed in Beck Depression Inventory (BDI-II) and Hamilton Rating Scale for Depression (HRSD) and aggregated to a composite score is possible | Pre to post ART, CFC or WLC; hence covering the ten week time period from the first assessment point (prior to randomization) to the assessment point 10 weeks later | |
Secondary | Emotion regulation skills | Emotion regulation skills as assessed with the Emotion Regulation Skills Questionnaire | Pre to post ART, CFC or WLC; hence covering the ten week time period from the first assessment point (prior to randomization) to the assessment point 10 weeks later |
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