Trial document




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  DRKS00006743

Trial Description

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Title

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

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Trial Acronym

Tele.TAnDem.Online

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URL of the Trial

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

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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.

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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.

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Organizational Data

  •   DRKS00006743
  •   2014/09/25
  •   [---]*
  •   yes
  •   Approved
  •   3453-05/12, Ethikkommission der Friedrich-Schiller-Universität Jena an der Medizinischen Fakultät
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Secondary IDs

  •   U1111-1161-6748 
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Health Condition or Problem studied

  •   F03 -  Unspecified dementia
  •   caregiver burden
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Interventions/Observational Groups

  •   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).
  •   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)

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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Supportive care
  •   Parallel
  •   N/A
  •   N/A
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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

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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

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2014/11/05
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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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

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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

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Addresses

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    • Friedrich-Schiller-Universität Jena, Institut für Psychologie, Abteilung Klinisch-psychologische Intervention
    • Ms.  Prof. Dr.  Gabriele  Wilz 
    • Humboldtsraße 11
    • 07743  Jena
    • Germany
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    • Friedrich-Schiller-Universität Jena, Institut für Psychologie, Abteilung Klinisch-psychologische Intervention
    • Ms.  Prof. Dr.  Gabriele  Wilz 
    • Humboldtsraße 11
    • 07743  Jena
    • Germany
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    • Friedrich-Schiller-Universität Jena, Institut für Psychologie, Abteilung Klinisch-psychologische Intervention
    • Ms.  Dr.  Franziska  Meichsner 
    • Humboldtstraße 11
    • 07743  Jena
    • Germany
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Sources of Monetary or Material Support

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    • Friedrich-Schiller-Universität Jena
    • Ms.  Prof. Dr.  Gabriele  Wilz 
    • Humboldtsraße 11
    • 07743  Jena
    • Germany
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    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2017/10/01
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Trial Publications, Results and other Documents

  •   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.
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* This entry means the parameter is not applicable or has not been set.