Telephone-based psychotherapy for family-caregivers of people with dementia - Practice transfer of a telephone-based psychotherapy for supporting family-caregivers
Organizational Data
- DRKS-ID:
- DRKS00006355
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2014-10-29
- Last update in DRKS:
- 2014-10-29
- Registration type:
- Retrospective
Acronym/abbreviation of the study
Tele.TAnDem.Tansfer
URL of the study
http://www.teletandem.uni-jena.de/
Brief summary in lay language
Caregivers are confronted with high demands. This leads to a need for professional support. Simultaneously, the high burden of care can also lead to a situation in which support services cannot be used. Telephone support can often be used more easily as it can be accessed from home. Against this background, we want to investigate (1) whether the implementation of a telephone-based therapy in established care structures is realisable, (2) whether the telephone-based therapy is more effective compared to conventional support services, and (3) whether the telephone-based therapy is as effective as face-to-face therapy. To assess this, family caregivers are interviewed three times 6 months apart. All participants receive information material about care and dementia. The telephone group receives 12 psychotherapy sessions on the phone, the personal-contact group receives 12 psychotherapy sessions in one of the participating treatment centers. Participants are asked whether they reside in the territory of a study center and could participate in the personal therapy. If this is the case, they are assigned to the face-to-face group. If this is not the case, they are randomly assigned to either the telephone group or the control group. The results of the study will be used to improve support services for caregivers.
Brief summary in scientific language
Family caregivers are confronted with high demands creating a need for professional support as well as creating barriers for its utilization. Telephone support allows easier access than face-to-face support. The objectives of this study were (1) to test the implementation of a telephone-based cognitive-behavioural therapy (TCT) in established care provision structures, (2) to assess whether TCT improves outcomes compared to usual care, and (3) whether TCT is as effective as face-to-face therapy (FCT). Family caregivers are interviewed at three measurement points each 6 months apart. All participants receive information materials on care and dementia. The telephone group receives 12 psychotherapy sessions on the phone, the face-to-face group receives 12 psychotherapy sessions in direct contact in one of the treatment centers. Participants are asked whether they reside in the area of a study center and could participate in the FCT. If this is the case, they are assigned to the face-to-face group. If this is not the case, they are randomly assigned to the TCT or the control group. The following questions are to be examined: (1) Is the TeleTAnDem intervention more effective than usual care regarding the improvement of subjective health complaints, quality of life and depressiveness? (2) Is a two-day training (8h) in Tele.TAnDem for trained behavioral therapists sufficient to achieve an adequate and effective implementation of the intervention in a counseling office of the Alzheimer Society? (3) Is the Tele.TAnDem intervention a cost-effective or possibly even cost-saving alternative compared to usual care? (4) Is the telephone therapy equally effective as the face-to-face intervention (similar in content and therapeutic procedures)? (5) Does Tele.TAnDem increase the use of professional support from family-caregivers of people with dementia? (6) Does Tele.TAnDem lead to delayed institutionalization of people with dementia and thus promote care at home? The results of the study will be used to improve support services for family-caregivers.
Health condition or problem studied
- ICD10:
- F03 - Unspecified dementia
- Free text:
- Burden of care
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Telephone-based psychotherapy: Twelve 50-minute sessions are conducted within six months. The first four sessions take place at weekly intervals, further six sessions follow at two-week intervals. The two last sessions are conducted at monthly intervals.
- Arm 2:
- Control group: The control group receives usual care and written information on care/dementia.
- Arm 3:
- Face-to-face psychotherapy: Twelve 50-minute sessions are conducted within six months. The first four sessions take place at weekly intervals, further six sessions follow at two-week intervals. The two last sessions are conducted at monthly intervals.
Endpoints
- Primary outcome:
- Depressiveness is assessed at all three time points (T0: baseline; T1: 6 months after baseline (control group) or after the end of the 6-month therapy (intervention groups); T2: 6 months after T1) using a self-developed thermometer scale and the Allgemeine Depressionsskala (ADS). Burden of care is assessed at all three time points using a self-developed thermometer scale. Health complaints are assessed at all three time points using the Giessener Beschwerdebogen (GBB-24). Ability to solve problems relating to the focused problem areas is measured through goal attainment scaling (GAS) in the course of the therapy sessions.
- Secondary outcome:
- Anxiety is assessed at all three time points (T0: baseline; T1: 6 months after baseline (control group) or after the end of the 6-month therapy (intervention groups); T2: 6 months after T1) with the anxiety subscale of the Hospital Anxiety and Depression Scale (HADS-D). Quality of life is assessed at all three time points with the WHOQOL-Bref. Violence in caregiving is assessed at all three time points with the LEANDER questionnaire. Utilization of professional assistance is assessed at all three time points with an instrument developed in collaboration with the Alzheimer Society Thuringia.
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Control group receives no treatment
- 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 complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
- No Entry
Recruitment period and number of participants
- Planned study start date:
- No Entry
- Actual study start date:
- 2012-07-08
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 270
- Final Sample Size:
- 322
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- no minimum age
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- a) Caregiving relative: key responsibility in the care of the person with dementia b) Person with dementia: diagnosed dementia at least with low grade according to medical diagnosis
Exclusion Criteria
a) Caregiving relative: ongoing psychotherapeutic treatment; severe physical illness; medically diagnosed psychotic disorder b) Person with dementia: institutionalised or institutionalisation planned in the next 6 months
Addresses
Primary Sponsor
- Address:
- Friedrich-Schiller-Universität Jena, Institut für Psychologie, Abteilung Klinisch-psychologische InterventionProf. Dr. Gabriele WilzHumboldtstraße 1107743 JenaGermany
- Telephone:
- +49 3641 945170
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uni-jena.de/Klinisch_Psychologische_Intervention.html
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Friedrich-Schiller-Universität Jena, Institut für Psychologie, Abteilung Klinisch-psychologische InterventionProf. Dr. Gabriele WilzHumboldtstraße 1107743 JenaGermany
- Telephone:
- +49 3641 945170
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uni-jena.de/Klinisch_Psychologische_Intervention.html
Contact for Public Queries
- Address:
- Friedrich-Schiller-Universität Jena, Institut für Psychologie, Abteilung Klinisch-psychologische InterventionProf. Dr. Gabriele WilzHumboldtstraße 1107743 JenaGermany
- Telephone:
- +49 3641 945170
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uni-jena.de/Klinisch_Psychologische_Intervention.html
Principal Investigator
- Address:
- Friedrich-Schiller-Universität Jena, Institut für Psychologie, Abteilung Klinisch-psychologische InterventionProf. Dr. Gabriele WilzHumboldtstraße 1107743 JenaGermany
- Telephone:
- +49 3641 945170
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uni-jena.de/Klinisch_Psychologische_Intervention.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:
- Bundesministerium für GesundheitRochusstr. 153123 BonnGermany
- Telephone:
- 030 18441-0
- Fax:
- 030 18441-4900
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- https://www.bundesgesundheitsministerium.de
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Friedrich-Schiller-Universität Jena an der Medizinischen FakultätBachstr. 18 Gebäude 107740 JenaGermany
- Telephone:
- +49-3641-9391191
- Fax:
- +49-3641-9391192
- 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:
- 2012-05-08
- Ethics committee number:
- 3453-05/12
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2012-05-29
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