Brief inpatient treatment continued by videoconference based psychotherapy for patients with chronic major depression
Organizational Data
- DRKS-ID:
- DRKS00009874
- Recruitment Status:
- Recruiting stopped (after recruiting started)
- Date of registration in DRKS:
- 2016-01-29
- Last update in DRKS:
- 2017-07-31
- Registration type:
- Retrospective
Acronym/abbreviation of the study
CBASP-VCP
URL of the study
No Entry
Brief summary in lay language
Aim of the project is to test the feasibility and acceptability of a combined treatment consisting of 3 week inpatient CBASP (Cognitive Behavioral Analysis System of Psychotherapy) -treatment and a 9 week outpatient CBASP-treatment using videoconference technology. During inpatient treatment patients undergo a medical and psychiatric examination and if necessary, medication is optimized according to the actual guide lines. Psychotherapeutic treatment starts and patients are introduced to the videoconference technique. After discharge the same therapist continues treatment via videoconference. A local ambulant psychiatrist will be involved in the treatment of the patient. Data collection will take place at four study centers at the same time. The pilot data sould provide the necessary data-base for the application of a larger randomized-controlled trial to conduct a cost-benefit-analysis in comparison to clinical routine treatment.
Brief summary in scientific language
Aim of the project is to test the feasibility and acceptability of a combined treatment consisting of 3 week inpatient CBASP (Cognitive Behavioral Analysis System of Psychotherapy) -treatment and a 9 week outpatient CBASP-treatment using videoconference technology.
Health condition or problem studied
- Free text:
- major chronic depression
- ICD10:
- F33 - Recurrent depressive disorder
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Intervetniongroup: 3 weeks inpatient CBASP treatment (2 single therapy sessions of 50 min per week) with following videoconference based outpatient CBASP treatment for 9 weeks (2 single therapy sessions of 50 min per week).
- Arm 2:
- Historical comparison group from existing data of patients who participated in a classical 12 weeks inpatient CBASP treatment (2 single therapy sessions of 50 min per week plus 2 h of CBASP-group therapy per week) .
Endpoints
- Primary outcome:
- - Questionnaire on feasibility and acceptance. Completed by patients and therapists - Hamilton Rating Scale for Depression (HAMD-24; Hamilton, 1960) T0, T1, T2, T3 (T0 : at admission to station , T1 : at discharge from station , T2 : at end of outpatient therapy , follow-up ( T3 ) : 3 months after completion of outpatient therapy (end of study)
- Secondary outcome:
- - Structured Clinical Interview for DSM-IV Disorders (T0). - Childhood Trauma Questionnaire (T0). - Beck Depression Inventory (T0-T3). - Clinical Global Impression Scale (T1-T2). - Global Assessment of Functioning Scale (T1-T2). - World Health Organization Quality of Life Instrument (T0-T3). - Impact Message Inventory-R (therapist-patient-relationship) (T1-T2).
Study Design
- Purpose:
- No Entry
- Allocation:
- Non-randomized controlled study
- Control:
-
- Historical
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Other
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting stopped (after recruiting started)
- Reason if recruiting stopped or withdrawn:
- Lack of funding
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Klinik für Psychiatrie und Psychotherapie Freiburg im Breisgau
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2015-10-06
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 30
- Final Sample Size:
- 6
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 70 Years
- Additional Inclusion Criteria:
- - diagnosis of Chronic Depression - Hamilton Rating Scale of Depression (HRSD-24) score>20 - in ongoing medical/psychiatric care - age 18-70 years - fluent in German language - technical requirements (Internet access) - informed consent - treatment resistance (no response to two or more adequate trials of antidepressants and/or no response to at least two health-insurance-reimbursed psychotherapies with at least 22 sessions each).
Exclusion Criteria
- history of bipolar disorder - substance addiction (less than 3 months clean) - antisocial or borderline personality disorder - severe autism - organic brain disorders - severe physical illness - acute risk of suicide or suicide attempt within the last 12 months
Addresses
Primary Sponsor
- Address:
- Klinik für Psychiatrie und Psychotherapie. Uniklinik FreiburgDr. Lars Hölzel79104 FreiburgGermany
- Telephone:
- 0761-270-69840
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum FreiburgKlinik für Psychiatrie und PsychotherapieDr. Nicole OwerHauptstr. 579104 FreiburgGermany
- Telephone:
- 0761-27069841
- Fax:
- 0761-27069890
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/psych.html
Contact for Public Queries
- Address:
- Universitätsklinikum FreiburgKlinik für Psychiatrie und PsychotherapieDr. Nicole OwerHauptstr. 579104 FreiburgGermany
- Telephone:
- 0761-27069841
- Fax:
- 0761-27069890
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/psych.html
Principal Investigator
- Address:
- Universitätsklinikum FreiburgKlinik für Psychiatrie und PsychotherapieDr. Nicole OwerHauptstr. 579104 FreiburgGermany
- Telephone:
- 0761-27069841
- Fax:
- 0761-27069890
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.uniklinik-freiburg.de/psych.html
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Ministerium für Wissenschaft, Fortschung und Kunst Baden-Württemberg70029 StuttgartGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum FreiburgKlinik für Psychiatrie und Psychotherapie79104 FreiburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2015-05-22
- Ethics committee number:
- 232/15
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2015-08-18
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry