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Early intervention for people living with dementia and their relatives – a feasibility study on the biopsychological evaluation of a dyadic group therapy

Early intervention for people living with dementia and their relatives – a feasibility study on the biopsychological evaluation of a dyadic group therapy - FRIDA

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00037601
Enrollment
80
Registered
2025-09-24
Start date
2026-01-07
Completion date
Unknown
Last updated
2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

People with early-stage dementia and their caregivers F00 F01 F03

Interventions

Group 1: This study is designed as a single-arm, non-randomized, prospective intervention study with a pre-post follow-up design. There is no randomization and no assignment to intervention or control

Sponsors

Universität Konstanz
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Sufficient knowledge of German to understand information about the study and actively participate in group sessions and surveys • A diagnosis of dementia (e.g., Alzheimer's dementia or other diagnosed forms) • Ability to work in a group (the ability to integrate socially and actively participate in a structured group setting)

Exclusion criteria

Exclusion criteria: • Acute mental disorder that make participation unreasonable or impractical. These include in particular: o Severe depressive episodes with psychotic symptoms, o Acute suicidal tendencies or aggression towards others, o acute delusional disorders, • a Mini-Mental Status Test (MMST) score below 23 points, as in this case advanced cognitive impairment can be assumed, which significantly limits active and informed participation in the study.

Design outcomes

Primary

MeasureTime frame
Reduction in physiological stress markers (salivary cortisol and alpha-amylase) from the beginning to the end of the group therapy session (short-term effect)

Secondary

MeasureTime frame
- Reduction in physiological stress markers (salivary cortisol and alpha-amylase) over the course of the intervention, from baseline to post-treatment and follow-up - Reduction in chronic stress levels (hair cortisol concentration) - Synchronization of biopsychological stress markers (cortisol, alpha-amylase, heart rate variability) - Improvement in relationship quality - Maintenance or improvement of quality of life - Group psychotherapeutic mechanisms of change mediate the stress-reducing effect of the intervention

Countries

Germany

Contacts

Public ContactAnna Jäger

Universität Konstanz

officewuttke@uni-konstanz.de+49 7531 88 5705

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 7, 2026