NCT02175953

Brief Summary

This study is to test the feasibility (pilot part) and efficacy (phase IIa part) of a specifically on the needs of caregivers of people with dementia composed new short-term psychotherapeutical intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

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

June 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

October 26, 2016

Status Verified

October 1, 2016

Enrollment Period

1.4 years

First QC Date

June 24, 2014

Last Update Submit

October 25, 2016

Conditions

Caregiver Burden of People With Dementia

Keywords

caregiver burdenstressdepressiondementia

Outcome Measures

Primary Outcomes (1)

  • Change in perceived self-efficacy directly and 3 month after psychotherapeutical intervention and reduction of symptoms of depression

    SWE, a german self-efficacy self-rating scale, will be used for self-efficacy measurement AND ADS (German Version of the CES-D Scale) for measurement for symptoms of depression

    before intervention, 0 and 3 month after end of intervention

Secondary Outcomes (1)

  • reduction of perceived burden of care

    before intervention, 0 and 3 month after end of intervention

Study Arms (2)

Interventiongroup

EXPERIMENTAL

Psychotherapy

Behavioral: Psychotherapy

Waitling list group

NO INTERVENTION

waiting list

Interventions

PsychotherapyBEHAVIORAL

The program is designed for 10 participants and consists of two modules of caregiver education followed by ten psychotherapeutic group modules. The major overarching topics will be (i) caregiver´s emotional and physical limits, (ii) conscious and unconscious feelings and emotions towards the people with dementia and (iii) activation of caregivers´ social resources. Duration of each module is planned to be 90 minutes including a relaxation exercise at the end of each module.

Interventiongroup

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • caregiver of a person with dementia
  • willing to participate in all 12 modules of the program

You may not qualify if:

  • current psychotherapy or antidepressive medication for less than 6 month
  • major depression

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rostock

Rostock, Mecklenburg-Vorpommern, 18147, Germany

Location

Related Publications (3)

  • Bedard M, Molloy DW, Squire L, Dubois S, Lever JA, O'Donnell M. The Zarit Burden Interview: a new short version and screening version. Gerontologist. 2001 Oct;41(5):652-7. doi: 10.1093/geront/41.5.652.

    PMID: 11574710BACKGROUND

  • Schwarzer, R., & Jerusalem, M. (1995). Generalized Self-Efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs (pp. 35-37). Windsor, UK.

    BACKGROUND

  • Weissman MM, Sholomskas D, Pottenger M, Prusoff BA, Locke BZ. Assessing depressive symptoms in five psychiatric populations: a validation study. Am J Epidemiol. 1977 Sep;106(3):203-14. doi: 10.1093/oxfordjournals.aje.a112455.

    PMID: 900119BACKGROUND

MeSH Terms

Conditions

Caregiver BurdenDepressionDementia

Interventions

Psychotherapy

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Neurologist

Study Record Dates

First Submitted

June 24, 2014

First Posted

June 26, 2014

Study Start

June 1, 2014

Primary Completion

November 1, 2015

Study Completion

May 1, 2016

Last Updated

October 26, 2016

Record last verified: 2016-10

Locations

DE(1)