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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 Intervention
Prof. Dr. Gabriele Wilz
Humboldtstraße 11
07743 Jena
Germany
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 Intervention
Prof. Dr. Gabriele Wilz
Humboldtstraße 11
07743 Jena
Germany
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 Intervention
Prof. Dr. Gabriele Wilz
Humboldtstraße 11
07743 Jena
Germany
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 Intervention
Prof. Dr. Gabriele Wilz
Humboldtstraße 11
07743 Jena
Germany
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 Gesundheit
Rochusstr. 1
53123 Bonn
Germany
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 Fakultät
Bachstr. 18 Gebäude 1
07740 Jena
Germany
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
UTN (Universal Trial Number):
No Entry
EUDAMED 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