NCT03391596

Brief Summary

This study will examine whether an Internet-based Acceptance and Commitment Therapy (ACT) intervention is effective, firstly, on reducing depressive symptoms, and, secondly, on improving well-being of elderly family caregivers. In our study, we will compare 1) the experimental Internet-based ACT group to 2) standardized institutional rehabilitation carried out in rehabilitation centers and to 3) support provided by voluntary family caregiver associations

Trial Health

87
On Track

Trial Health Score

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

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

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

December 1, 2016

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

December 12, 2017

Completed
24 days until next milestone

First Posted

Study publicly available on registry

January 5, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

1.9 years

First QC Date

December 12, 2017

Last Update Submit

April 18, 2019

Conditions

Depressive SymptomsPsychological DistressQuality of Life

Keywords

Family caregiversDepressive symptomsPsychological wellbeingInternet-based interventionAcceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (1)

  • The Beck Depression Inventory (BDI-II): change from baseline to 4 months and 10 months

    The BDI-II contains 21 questions about depressive symptoms and their severity. The scale ranges from 0 to 63 and the items are summed (0 to 13 indicates no or very few depressive symptoms, 14 to 19 indicates mild depression, 20 to 28 moderate depression, and 29 to 63 severe depression).

    baseline, 4 months, post (10 months)

Secondary Outcomes (9)

  • Carers of Older People in Europe (COPE): change from baseline to 4 months and 10 months

    baseline, 4 months, post (10 months)

  • WHO Quality of Life-BREF (WHOQOL-BREF): change from baseline to 4 months and 10 months

    baseline, 4 months, post (10 months)

  • Generalized Anxiety Disorder 7-item (GAD-7) scale: change from baseline to 4 months and 10 months

    baseline, 4 months, post (10 months)

  • Sense of Coherence (SOC-13): change from baseline to 4 months and 10 months

    baseline, 4 months, post (10 months)

  • Acceptance and Action Questionnaire (AAQ-II): change from baseline to 4 months and 10 months

    baseline, 4 months, post (10 months)

  • +4 more secondary outcomes

Other Outcomes (2)

  • User experiences questionnaire (developed by the research group)

    4 months (only experimental group)

  • Closing interview (developed by the research group) questions

    4 months (only experimental group)

Study Arms (3)

Internet-based ACT intervention

EXPERIMENTAL

Group "Internet-based ACT intervention" will receive a 12-week Internet-based, acceptance and commitment therapy intervention

Behavioral: Internet-based ACT intervention

Standardized rehabilitation

ACTIVE COMPARATOR

Group "Standardized rehabilitation" will receive a standardized rehabilitation program in the rehabilitation center

Behavioral: Standardized rehabilitation

Support by caregiver associations

OTHER

Group "Support by voluntary caregiver associations" will receive support given by caregiver associations

Behavioral: Support by voluntary caregiver associations

Interventions

Internet-based ACT interventionBEHAVIORAL

The Internet-based ACT intervention is a 12-week program based on the processes of Acceptance and Commitment Therapy.

Internet-based ACT intervention
Standardized rehabilitationBEHAVIORAL

Standardized institutional rehabilitation in a rehabilitation center

Standardized rehabilitation
Support by voluntary caregiver associationsBEHAVIORAL

Support given by voluntary caregiver associations

Support by caregiver associations

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • family caregiver
  • at least 60 years of age

You may not qualify if:

  • parallel psychological treatment
  • severe mental disorder
  • \- computer and Internet connection or willingness to use a tablet provided by the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gerocenter Foundation for Research and Development

Jyväskylä, 40700, Finland

Location

Related Publications (1)

  • Lappalainen P, Pakkala I, Nikander R. CareACT - internet-based intervention for enhancing the psychological well-being of elderly caregivers - a study protocol of a controlled trial. BMC Geriatr. 2019 Mar 5;19(1):72. doi: 10.1186/s12877-019-1071-9.

    PMID: 30836951DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Riku Nikander, Professor

    Gerocenter Foundation for Research and Development

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, professor

Study Record Dates

First Submitted

December 12, 2017

First Posted

January 5, 2018

Study Start

December 1, 2016

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

April 19, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)