Ignite Creation Date:
2025-12-25 @ 4:31 AM
Ignite Modification Date:
2026-03-06 @ 2:56 PM
Study NCT ID:
NCT02013518
Status:
UNKNOWN
Last Update Posted:
2013-12-17
First Post:
2013-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Behavioural Therapy for Persons With MCI or Mild Dementia
Sponsor:
Oslo University Hospital
Organization:
Study Overview
Official Title:
Cognitive Behavioural Therapy for Persons With Mild Cognitive Impairment or Dementia in the Early Stages
Status:
UNKNOWN
Status Verified Date:
2013-12
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A total of 200 home dwelling participants, who fulfil the inclusion criteria, Alzheimer's disease, will be recruited from three hospitals in Norway.
The intervention is based on a standardized manual, and consists of 11 weekly one-hour sessions, which are organized into six thematic modules.
The content of each session is specified by a treatment manual, which additionally consists of worksheets, suggestions for homework in between sessions and letters to the caregivers (the German manual: Werheid \& Thöne-Otto, 2010; the Norwegian manual: Ulstein, Gordner \& Tonga, not published). The treatment will be conducted by experienced health staff (nurses, psychologist, doctors) with formal training in Cognitive Behavioural Therapy, and knowledge about Alzheimer's Disease. Furthermore, the health staff will be familiarised with the manual before study inception, participate in a two-day training seminar and will regularly be supervised.
The control condition will be offered treatment as usual at the participating the memory clinics.
The hypothesis is that the participants in the intervention group will report less depression and increased self efficacy as compared with the control group.
We conducted a pilot study with 10 patients, 5 in each group, from March to June 2013 to examine the feasibility of the study protocol and do want to include these patients in the study population.
The intervention is based on a standardized manual, and consists of 11 weekly one-hour sessions, which are organized into six thematic modules.
The content of each session is specified by a treatment manual, which additionally consists of worksheets, suggestions for homework in between sessions and letters to the caregivers (the German manual: Werheid \& Thöne-Otto, 2010; the Norwegian manual: Ulstein, Gordner \& Tonga, not published). The treatment will be conducted by experienced health staff (nurses, psychologist, doctors) with formal training in Cognitive Behavioural Therapy, and knowledge about Alzheimer's Disease. Furthermore, the health staff will be familiarised with the manual before study inception, participate in a two-day training seminar and will regularly be supervised.
The control condition will be offered treatment as usual at the participating the memory clinics.
The hypothesis is that the participants in the intervention group will report less depression and increased self efficacy as compared with the control group.
We conducted a pilot study with 10 patients, 5 in each group, from March to June 2013 to examine the feasibility of the study protocol and do want to include these patients in the study population.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 12345 | OTHER | Nasjonalforeningen for folkehelse | View |