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Depressive SymptomsCareACTNCT03391596

Internet-based Intervention for Enhancing the Psychological Well-being of Elderly Caregivers

A study testing Internet-based ACT intervention, Standardized rehabilitation and Support by voluntary caregiver associations in people with Depressive Symptoms and Psychological Distress, run by The Gerocenter Foundation for Research and Development at 1 site in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
What is being tested?
Internet-based ACT intervention, Standardized rehabilitation and Support by voluntary caregiver associations
Could I receive a placebo?
No, everyone receives an active treatment
How many people
151 participants
Where
1 siteFinland
Study dates
1 Dec 2016to 31 Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • family caregiver
  • at least 60 years of age
  • Inclusion Criteria for the experimental and active comparator group - depressive symptoms and/or psychological distress

Who cannot join

  • parallel psychological treatment
  • severe mental disorder
  • Additional inclusion criteria for the experimental group:
  • computer and Internet connection or willingness to use a tablet provided by the study

Trial locations and contacts

1 site in 1 country.

Finland1 site
  • Gerocenter Foundation for Research and Development

    Jyväskylä, 40700

Other trials in Finland

About this study

Official title: CareACT - Internet-based Intervention for Enhancing the Psychological Well-being of Elderly Caregivers

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

Read the detailed description

It is well-known that stress, low quality of life and depression are relatively common problems among family caregivers. The proportion of elderly family caregivers is rapidly increasing which emphasizes the need for new support systems. Internet-delivered psychological interventions are one possible approach, offering benefits as they are more easily to achieve for family caregivers who often are home-bound with their relatives.

This study will examine whether an Internet-based Acceptance and Commitment Therapy intervention would be effective, firstly, on reducing depressive symptoms, and, secondly, on improving well-being of elderly family caregivers.The family caregivers' depressive symptoms, perceived burden, anxiety, quality of life, psychological flexibility, personality and physical performance will be studied by a quasi-experimental study design comparing three groups of family caregivers (Group 1, experimental: Internet-based ACT intervention; Group 2, active comparator: Standardized institutional rehabilitation in a rehabilitation center; Group 3, other: Support given by voluntary family caregiver associations). Data collection will be performed at three time points: pre, 4 months and post (10 months).

Secondly, we also aim to examine demographics and psychological variables that could predict change in depression and perceived burden over time (pre, 4 months and post (10 months). A further aim of the study is to examine potential mediators on the effect of the interventions including psychological flexibility and suppression of thoughts. Moreover, we aim to study user experiences and satisfaction of the Internet-based program, i.e., how the family caregivers experience and accept the web-based ACT intervention.

Being tested
Internet-based ACT intervention, Standardized rehabilitation, Support by voluntary caregiver associations
Keywords
Family caregivers, Depressive symptoms, Psychological wellbeing, Internet-based intervention, Acceptance and Commitment Therapy
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Internet-based ACT interventionBehavioural

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

  • Standardized rehabilitationBehavioural

    Standardized institutional rehabilitation in a rehabilitation center

  • Support by voluntary caregiver associationsBehavioural

    Support given by voluntary caregiver associations

Study groups in NCT03391596
Study groupRoleWhat they receive
Internet-based ACT interventionExperimentalGroup "Internet-based ACT intervention" will receive a 12-week Internet-based, acceptance and commitment therapy intervention
Receives: Behavioral: Internet-based ACT intervention
Standardized rehabilitationActive comparatorGroup "Standardized rehabilitation" will receive a standardized rehabilitation program in the rehabilitation center
Receives: Behavioral: Standardized rehabilitation
Support by caregiver associationsOtherGroup "Support by voluntary caregiver associations" will receive support given by caregiver associations
Receives: Behavioral: Support by voluntary caregiver associations

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: baseline, 4 months, post (10 months)

Secondary outcomes (9)
  1. Carers of Older People in Europe (COPE): change from baseline to 4 months and 10 months

    COPE is an assessment of carers' perceptions of their role as caregiver: negative impact, positive value and quality of support of caregiving in informal carers of older people. It was developed in collaboration with several European countries as a brief first-stage assessment tool to identify caregivers who may need supportive interventions of any kind.

    Measured: baseline, 4 months, post (10 months)

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

    The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials.

    Measured: baseline, 4 months, post (10 months)

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

    Generalized Anxiety Disorder 7 (GAD-7) is a self-reported questionnaire for screening and severity measuring of the four most common anxiety disorders (Generalized Anxiety Disorder, Panic Disorder, Social Phobia and Post Traumatic Stress Disorder). GAD-7 has seven items, which measure severity of various signs of GAD according to reported response categories with assigned points (Not at all: 0 points; Several days: 1 point; More than half the days: 2 points; and Nearly every day: 3 points). Assessment is indicated by the total score (min 0, max 21). Higher GAD-7 scores correlate with disability and functional impairment. 5-9 points indicate moderate anxiety, 10-14 moderate and >15 severe anxiety.

    Measured: baseline, 4 months, post (10 months)

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

    The SOC-13 is derived from the original 29-item scale measuring different aspects of sense coherence. Responses are made on a 7-point scale.The SOC-13 scale has three components: Comprehensibility (items 2, 6, 8, 9, 11; min 5, max 35), Manageability (items 3, 5, 10, 13; min 4, max 28) and Meaningfulness (items 1, 4, 7, 12; min 4, max 28) with higher scores indicating better outcomes. This scale is rated on a 7-point likert scale, a total score can also be used and the coding for items 1, 2, 3, 7 and 10 should be reversed. The subscales are combined to compute a total score. SOC scores range from 13 to 91 with higher scores indicating a better outcome: more sense of coherence.

    Measured: baseline, 4 months, post (10 months)

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

    The AAQ-II is a measure with seven questions to be answered on a scale of 1 (never true) to 7 (always true) participant's willingness to be in contact with negative private events, acceptance of these events, and whether they can live in accordance with their values. Summation of the scores results in a total mark ranging from 7 to 49, whereby a higher score indicates means a higher level of psychological flexibility, e.g. higher acceptance.

    Measured: baseline, 4 months, post (10 months)

  6. Experiential Avoidance in Caregiving Questionnaire (EACQ): change from baseline to 4 months and 10 months

    The EACQ is a scale measuring experiential avoidance in the caregiving context: 1. Active Avoidant Behaviors, 2) Intolerance of Negative Thoughts and Emotions Towards the Relative and 3) Apprehension Concerning Negative Internal Experiences Related to Caregiving. The questionnaire consists of 15 items rated on a 5-point Likert scale. Each statement can be answered by 1: not at all, 2: a little, 3: somewhat, 4: often and 5: a lot. Factor 1 is made up of 6 items that measure caregivers' behaviors for avoiding negative thoughts related to caregiving (min 5, max 25). Factor 2 include 4 items with content related to rigid verbal thinking about negative emotions/thoughts with regard to the care-recipient (min 4, max 20), the factor 3 composes of 5 items referring to reluctant attitudes towards negative thoughts regarding the relative (min 5, max 25). The subscales are summed to compute a total score. Higher values represent more avoidance, e.g. worse outcome.

    Measured: baseline, 4 months, post (10 months)

  7. White Bear Suppression Inventory (WBSI): change from baseline to 4 months and 10 months

    The WBSI is a 15-item questionnaire that is designed to measure thought suppression. Chronic thoughts suppression is related to obsessive thinking and negative affect associated with depression and anxiety. The scoring of the WBSI is based on a 5 point scale from Strongly disagree (1) to Strongly agree (5). The total score (range from 15 to 75) is obtained by summing up the responses that are provided by respondents. Higher scores on the WBSI indicate greater tendencies to suppress thoughts.

    Measured: baseline, 4 months, post (10 months)

  8. The 'Short Five' (S5): change from baseline to 4 months and 10 months

    The Short Five personality questionnaire is a 60-item questionnaire constructed for measuring 30 facets of the Five-Factor Model

    Measured: baseline, 4 months, post (10 months)

  9. Short Physical Performance Battery (SPPB): change from baseline to 4 months and 10 months

    The Short Physical Performance Battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests (Guralnik et al., 2000). It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. The scores range from 0 (worst performance) to 12 (best performance). The SPPB has been shown to have predictive validity showing a gradient of risk for mortality, nursing home admission, and disability.

    Measured: baseline, 4 months, post (10 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Jan 2018
  2. Study start1 Dec 2016
  3. Primary completion31 Oct 2018
  4. Study completion31 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
151 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03391596
Sponsor's protocol ID
3E/2016
Acronym
CareACT
Status last verified
Apr 2019
First submitted
12 Dec 2017
Last updated
19 Apr 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 30836951

Questions about this trial

What is this clinical trial studying?

A study testing Internet-based ACT intervention, Standardized rehabilitation and Support by voluntary caregiver associations in people with Depressive Symptoms and Psychological Distress, run by The Gerocenter Foundation for Research and Development at 1 site in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Beck Depression Inventory (BDI-II): change from baseline to 4 months and 10 months (time frame: baseline, 4 months, post (10 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03391596, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2019.

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