ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03391596
Recruitment Status : Recruiting
First Posted : January 5, 2018
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):
Riku Nikander, The Gerocenter Foundation for Research and Development

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

Condition or disease Intervention/treatment Phase
Depressive Symptoms Psychological Distress Quality of Life Behavioral: Internet-based ACT intervention Behavioral: Standardized rehabilitation Behavioral: Support by voluntary caregiver associations Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CareACT - Internet-based Intervention for Enhancing the Psychological Well-being of Elderly Caregivers
Actual Study Start Date : December 1, 2016
Estimated Primary Completion Date : October 15, 2018
Estimated Study Completion Date : October 15, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Internet-based ACT intervention
Group "Internet-based ACT intervention" will receive a 12-week Internet-based, acceptance and commitment therapy intervention
Behavioral: Internet-based ACT intervention
The Internet-based ACT intervention is a 12-week program based on the processes of Acceptance and Commitment Therapy.

Active Comparator: Standardized rehabilitation
Group "Standardized rehabilitation" will receive a standardized rehabilitation program in the rehabilitation center
Behavioral: Standardized rehabilitation
Standardized institutional rehabilitation in a rehabilitation center

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




Primary Outcome Measures :
  1. The Beck Depression Inventory (BDI-II): change from baseline to 4 months and 10 months [ Time Frame: baseline, 4 months, post (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).


Secondary Outcome Measures :
  1. Carers of Older People in Europe (COPE): change from baseline to 4 months and 10 months [ Time Frame: baseline, 4 months, post (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.

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

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

  4. Sense of Coherence (SOC-13): change from baseline to 4 months and 10 months [ Time Frame: baseline, 4 months, post (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.

  5. Acceptance and Action Questionnaire (AAQ-II): change from baseline to 4 months and 10 months [ Time Frame: baseline, 4 months, post (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.

  6. Experiential Avoidance in Caregiving Questionnaire (EACQ): change from baseline to 4 months and 10 months [ Time Frame: baseline, 4 months, post (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.

  7. White Bear Suppression Inventory (WBSI): change from baseline to 4 months and 10 months [ Time Frame: baseline, 4 months, post (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.

  8. The 'Short Five' (S5): change from baseline to 4 months and 10 months [ Time Frame: baseline, 4 months, post (10 months) ]
    The Short Five personality questionnaire is a 60-item questionnaire constructed for measuring 30 facets of the Five-Factor Model

  9. Short Physical Performance Battery (SPPB): change from baseline to 4 months and 10 months [ Time Frame: baseline, 4 months, post (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.


Other Outcome Measures:
  1. User experiences questionnaire (developed by the research group) [ Time Frame: 4 months (only experimental group) ]
    The questionnaire developed by the research group includes 9 questions investigating experiences of the intervention as a whole and assessed its most beneficial aspects. The first five questions are using a scale from 1 to 10 with answer options such as 1 = very unsatisfied, 10 = very satisfied (question 1); 1 = not at all important, 10 = very important (question 2 and 4); 1 = very satisfied, 10 = not at all satisfied (question 3); 1 = has deteriorated,10 = has improved remarkably (question 5). Question 6 assesses the current well-being situation including 7 options. Question 7 assesses weekly time spent in the web program with 4 different options (less than 1 hour, between 1-2 hours, 2-3 hours and more than 3 hours). The 2 last questions are open-ended questions.

  2. Closing interview (developed by the research group) questions [ Time Frame: 4 months (only experimental group) ]
    The questionnaire includes 9 questions investigating caregiver experiences with the web-based program. 5 of the questions are open-ended questions, 3 questions are close-ended questions which can be answered with Yes or No. Examples for questions: Question 1: What kind of experience was it to participate in this program? Question 3:What have you learned from this program?. Question 4: Was the program easy to use? One question (Would you recommend the web-program to other family caregivers?) includes a scale from 1 (not at all) to 10 (very likely).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for all groups:

  • family caregiver
  • at least 60 years of age

Inclusion Criteria for the experimental and active comparator group - depressive symptoms and/or psychological distress

Exclusion Criteria for all groups:

  • 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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03391596


Contacts
Contact: Riku Nikander, Professor +358 400 304433 riku.p.nikander@jyu.fi
Contact: Inka Pakkala, PhD +358 44 3413690 inka.pakkala@gerocenter.fi

Locations
Finland
Gerocenter Foundation for Research and Development Recruiting
Jyväskylä, Finland, 40700
Contact: Riku Nikander, Professor    +358400304433    riku.p.nikander@jyu.fi   
Contact: Inka Pakkala, PhD    +358443413690    inka.pakkala@gerocenter.fi   
Sponsors and Collaborators
The Gerocenter Foundation for Research and Development
Investigators
Study Director: Riku Nikander, Professor Gerocenter Foundation for Research and Development

Responsible Party: Riku Nikander, PhD, professor, The Gerocenter Foundation for Research and Development
ClinicalTrials.gov Identifier: NCT03391596     History of Changes
Other Study ID Numbers: 3E/2016
First Posted: January 5, 2018    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Riku Nikander, The Gerocenter Foundation for Research and Development:
Family caregivers
Depressive symptoms
Psychological wellbeing
Internet-based intervention
Acceptance and Commitment Therapy

Additional relevant MeSH terms:
Depression
Behavioral Symptoms