NCT00285753

Brief Summary

This study aims at developing and evaluating a support group program for patients with mild cognitive impairment (MCI) and their partners. These patients have defective memory function but are not demented. However, there is an increased chance of developing dementia in the near future; 10-15% per year for MCI patients, in contrast to 1-2% per year for healthy elderly persons. For the patients and their caregivers this means that they are confronted with feelings of uncertainty and fear towards the future. They also have many questions about how to improve their memory problems and how to cope with other changes or consequences. The purpose of the support group program is to improve coping skills and facilitate adaptation to the impairments, in order to reduce anxiety or depression and strengthen feelings of competence in patients and their partners.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2003

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

May 21, 2008

Status Verified

May 1, 2008

Enrollment Period

3.9 years

First QC Date

February 1, 2006

Last Update Submit

May 20, 2008

Conditions

Mild Cognitive Impairment

Keywords

psychosocial interventionmild cognitive impairmentsupport groupcaregiversMild Cognitive Impairment (MCI)Cognitive Impairment No Dementia (CIND)

Outcome Measures

Primary Outcomes (2)

  • quality of life: RAND, GDS

    pre and post treatment

  • caregiver: sense of competence (SCQ), burden of the problems in the Revised Memory and Behavioral Problems (RMBP)

    pre- and post intervention

Secondary Outcomes (2)

  • Illness cognitions: Illness Cognitions Questionnaire (ICQ)

    pre and post treatment

  • marital satisfaction: Maudsley Marital Questionnaire (MMQ)

    pre and post treatment

Interventions

support groupsBEHAVIORAL

cognitive behavioral intervention with psychoeducation

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with MCI (MCI criteria, Petersen, 2001 and Grundman, 2004) and their primary caregivers.

You may not qualify if:

  • Mini-Mental State Examination (MMSE) \< 23
  • Severe mood disorder.
  • No motivation.
  • Severe language problems.
  • Premorbid relationship problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rijnstate Ziekenhuis

Arnhem, Gelderland, Netherlands

Location

UMC Sint Radboud

Nijmegen, Gelderland, 6500 HB, Netherlands

Location

Related Publications (2)

  • Banningh LW, Vernooij-Dassen MJ, Vullings M, Prins JB, Rikkert MG, Kessels RP. Learning to live with a loved one with mild cognitive impairment: effectiveness of a waiting list controlled trial of a group intervention on significant others' sense of competence and well-being. Am J Alzheimers Dis Other Demen. 2013 May;28(3):228-38. doi: 10.1177/1533317513481093. Epub 2013 Mar 25.

    PMID: 23528880DERIVED

  • Joosten-Weyn Banningh LW, Prins JB, Vernooij-Dassen MJ, Wijnen HH, Olde Rikkert MG, Kessels RP. Group therapy for patients with mild cognitive impairment and their significant others: results of a waiting-list controlled trial. Gerontology. 2011;57(5):444-54. doi: 10.1159/000315933. Epub 2010 Jul 20.

    PMID: 20664181DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Jan Pieter Teunisse, PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Floor Kraaimaat, Professor

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

  • Marcel Olde Rikkert, Professor

    Coordinator Alzheimer Centre UMC Nijmegen

    PRINCIPAL INVESTIGATOR

  • Myrra Vernooy, PhD

    Coordinator Alzheimer Centre UMC Nijmegen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 1, 2006

First Posted

February 2, 2006

Study Start

November 1, 2003

Primary Completion

October 1, 2007

Study Completion

October 1, 2007

Last Updated

May 21, 2008

Record last verified: 2008-05

Locations

NL(2)