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Internet-based psychotherapy for family-caregivers of people with dementia

Organizational Data

DRKS-ID:
DRKS00006743
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2014-09-25
Last update in DRKS:
2019-02-14
Registration type:
Prospective

Acronym/abbreviation of the study

Tele.TAnDem.Online

URL of the study

http://www.teletandem.uni-jena.de/

Brief summary in lay language

Caregivers are faced with high demands which often leads to a need for professional support. At the same time, the high burden of care can also complicate the utilization of support services available to caregivers. Internet-based resources are a solution because they offer a much needed flexibility. Against this background, we want to investigate if an internet-based psychotherapy can help dementia caregivers to manage demands of the caregiving situation and enhance their quality of life. To assess this, family caregivers are interviewed three or four times, depending on group allocation: The intervention group receives 8 contacts with a cognitive-behavioral psychotherapist via the internet directly after enrollment, participants of the waiting control group recieve the same support after a waiting time of 5 months. All participants receive information material about care and dementia. The results of the study will be used to improve support services for caregivers.

Brief summary in scientific language

Caregivers are faced with high demands which often leads to a need for professional support. At the same time, the high burden of care can also complicate the utilization of support services available to caregivers. Internet-based resources are a solution because they offer a much needed flexibility. It is therefore the aim of this study to investigate application of the „Tele.TAnDem“ Manual as an internet-based intervention and to evaluate its applicability and effectiveness as well as acceptance by caregivers. To assess this, family caregivers are interviewed three times (pre-intervention, post-intervention, 6 month follow up). The baseline assessment is conducted after caregivers received extensive information about the project, a telephone-based screening that determines if caregivers meet the inclusion criteria and after consent is given. Post-intervention assessment is conducted after an eight-week period during the intervention group receives internet-based support. Follow-up assessment is conducted three months after the post-intervention assessment. After the baseline assessment participants are randomly allocated to one of two groups: 1) Caregivers in the intervention group receive 8 contacts with a cognitive-behavioral therapist over 2 months; i.e. one message per week. Therapists initiate all contacts and caregivers are asked to spend about 40 to 50 minutes on one message and reply within two to three days. They can expects their therapist’s answer within 1 to 2 days. 2) The waiting control group receives the same therapeutic support after a waiting time of five months. Participants are asked to complete a forth assessment after completion of the intervention. All therapeutic contacts are realized via messages that are exchanged via a secured website. Participants receive login data for their personal account. All participants receive information material on dementia.

Health condition or problem studied

ICD10:
F03 - Unspecified dementia
Free text:
caregiver burden
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Intervention group: internet-based psychotherapy via a website exclusively developed for this project. During the intervention time of 8 weeks, caregivers receive weekly messages from their therapists and are asked to answer and/or to complete therapeutic tasks and describe and reflect their experiences. At the beginning of the intervention, the main problem areas are explored and therapist and caregiver agree upon one to two therapy goals. The remaining messages are dedicated to reaching these goals with the use of cognitive-behavioral methods. The degree of goal attainment is rated in the last session and steps to maintain successful developments are agreed upon. This study is an add-on to the registered study Tele.TAnDem transfer with an approved amendment (Ethik-ID: 3453-05/12).
Arm 2:
waiting control group: receives intervention identical to intervention group after a waiting tome of 5 months. participates in 4 assessments (1-3 identical to intervention group, 4th assessment after completion of intervention)

Endpoints

Primary outcome:
Subjective health status (GBB-24 subscales) body discomfort (GBB-24) ability to solve problems relating to focused problem areas (Goal Attainment Scaling) All measured at all three assessments: pre-intervention, post-intervention, 6-month follow pp
Secondary outcome:
Quality of life (WHO-Quality of Life-Bref) depressive symptoms (Allgemeine Depressionsskala + thermometer scale) caregiver grief (newly developed German Caregiver Grief Scale; Meichsner, Schinköthe, & Wilz, in preparation) violence in caregiving (LEANDER subscale) seeking professional assistance & institutionalization rate (specific items assesing utilization of services) cost effectiveness (EQ5D) All measured at all three assessments: pre-intervention, post-intervention, 6-month follow pp

Study Design

Purpose:
Supportive care
Allocation:
Randomized controlled study
Control:
  • Other
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 complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • Other Friedrich-Schiller-Universität Jena, Institut für Psychologie, Abteilung Klinisch-psychologische Intervention Jena

Recruitment period and number of participants

Planned study start date:
2014-10-15
Actual study start date:
2014-11-05
Planned study completion date:
No Entry
Actual Study Completion Date:
2017-10-01
Target Sample Size:
40
Final Sample Size:
39

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

Friedrich-Schiller-Universität Jena, Institut für Psychologie, Abteilung Klinisch-psychologische Intervention
Prof. Dr. Gabriele Wilz
Humboldtsraße 11
07743 Jena
Germany
Telephone:
0049 3641 945170
Fax:
No Entry
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

Friedrich-Schiller-Universität Jena, Institut für Psychologie, Abteilung Klinisch-psychologische Intervention
Prof. Dr. Gabriele Wilz
Humboldtsraße 11
07743 Jena
Germany
Telephone:
0049 3641 945170
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uni-jena.de/Klinisch_Psychologische_Intervention.html

Contact for Public Queries

Friedrich-Schiller-Universität Jena, Institut für Psychologie, Abteilung Klinisch-psychologische Intervention
Dr. Franziska Meichsner
Humboldtstraße 11
07743 Jena
Germany
Telephone:
0049 3641 945175
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uni-jena.de/Klinisch_Psychologische_Intervention.html

Principal Investigator

Friedrich-Schiller-Universität Jena, Institut für Psychologie, Abteilung Klinisch-psychologische Intervention
Prof. Dr. Gabriele Wilz
Humboldtsraße 11
07743 Jena
Germany
Telephone:
0049 3641 945170
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uni-jena.de/Klinisch_Psychologische_Intervention.html

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Friedrich-Schiller-Universität Jena
Humboldtsraße 11
07743 Jena
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

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
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2014-07-02
Ethics committee number:
3453-05/12
Vote of the Ethics Committee:
Approved
Date of the vote:
2014-07-16

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
U1111-1161-6748
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:
Meichsner, F., Theurer, C., & Wilz, G. (2018). Acceptance and treatment effects of an internet-delivered cognitive-behavioral intervention for family caregivers of people with dementia: A randomized-controlled trial. Journal of Clinical Psychology, 1–20. doi: 10.1002/jclp.22739.
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