Improve effects of psychological interventions for depressed and anxious cardiac inpatients by implementing sensory stimulation techniques with bifocal mindfulness? A cluster randomised control group trial.
Organizational Data
- DRKS-ID:
- DRKS00007850
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2015-03-26
- Last update in DRKS:
- 2015-03-26
- Registration type:
- Retrospective
Acronym/abbreviation of the study
SESBA
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
Using a prospective, cluster-randomized controlled trial, the effects of a new behavioral group intervention program for anxious or depressed cardiac inpatients will be evaluated. Patients who will be taught techniques of sensory stimulation with bifocal mindfulness (WHEE or Quick REMAP) are compared with patients who received conventional training with progressive muscle relaxation (PMR).
Health condition or problem studied
- ICD10:
- I21 - Acute myocardial infarction
- ICD10:
- I25 - Chronic ischaemic heart disease
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Techniques of sensory stimulation with bifocal mindfulness based on Wholistic Hybrid derived from EMDR and EFT (WHEE), 4 sessions within 2 weeks. The sessions comprises a total of 60 minutes, with one half of the time is reserved for information and discussions (coping) and the other half is for learning the techniques.
- Arm 2:
- Techniques of sensory stimulation with bifocal mindfulness based on Reed Eye Movement Psychotherapy Acupressure (Quick REMAP), 4 sessions within 2 weeks. The sessions comprises a total of 60 minutes, with one half of the time is reserved for information and discussions (coping) and the other half is for learning the techniques.
- Arm 3:
- Progressive Muscle Relaxation (PMR), 4 sessions within 2 weeks. The sessions comprises a total of 60 minutes, with one half of the time is reserved for information and discussions (coping) and the other half is for learning the techniques.
Endpoints
- Primary outcome:
- Reduction of the HADS-values from baseline to the end of the rehabilitation and 6 months after rehabilitation. The HADS is a self-report scale designed to measure current anxiety and depressive symptomatology in non-psychiatric hospital patients.
- Secondary outcome:
- Generalized anxiety and depression (PHQ-4) Self-efficacy (ASKU) from baseline to the end of the rehabilitation and 6 months after rehabilitation.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- No
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- Medical center Klinik Königsfeld Ennepetal
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2015-03-23
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 208
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 80 Years
- Additional Inclusion Criteria:
- Cardiac rehabilitation patients with depression and / or anxiety (HADS-values > 7).
Exclusion Criteria
Problems of language understanding
Addresses
Primary Sponsor
- Address:
- Verein zur Förderung der Rehabilitationsforschung, NorderneyFranz-Josef MuhmannGartenstraße 19448147 MünsterGermany
- Telephone:
- +492512383187
- 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:
- Institut für Rehabilitationsforschung, Norderney, Abteilung KönigsfeldDr. rer. medic. Dipl.-Psych. Jörg KittelHolthauser Talstraße 258256 EnnepetalGermany
- Telephone:
- +49 2333 9888 480
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Institut für Rehabilitationsforschung, Norderney, Abteilung KönigsfeldBrigitte WiesnerHolthauser Talstraße 258256 EnnepetalGermany
- Telephone:
- +4923339888481
- Fax:
- +4923339888482
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Institut für Rehabilitationsforschung, Norderney, Abteilung KönigsfeldDr. rer. medic. Dipl.-Psych. Jörg KittelHolthauser Talstraße 258256 EnnepetalGermany
- Telephone:
- +49 2333 9888 480
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Private sponsorship (foundations, study societies, etc.)
- Address:
- Verein zur Förderung der Rehabilitationsforschung e.V., NorderneyKaiserstraße 2626548 NorderneyGermany
- Telephone:
- +492512383187
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Universität Witten/HerdeckeAlfred-Herrhausen-Str. 5058448 WittenGermany
- Telephone:
- +49-2302-926740
- Fax:
- +49-2302-926739
- 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:
- 2015-02-26
- Ethics committee number:
- 25/2015
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2015-03-18
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