SOSteniamoci: An Internet-based Intervention to Support Informal Caregivers.
August 9, 2023 updated by: Noa Vilchinsky, Bar-Ilan University, Israel
The purpose of this study is to evaluate efficacy of internet intervention for informal caregivers in Italy in reducing their care-giving burden.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This intervention is going to take a form of an Internet-based Intervention (IBI) consisting of eight therapeutic modules. These are the themes, as listed chronologically: Introduction, Thoughts and Acceptance, Problem Solving, Stress and relaxation, Communication, Behavioural Activation, Worry and Anxiety, Maintenance. These themes were chosen after considering topics which might be the most useful for someone in a role of an informal caregiver, considering the trans-diagnostic nature of the intervention.
Effect of the intervention will be compared against a wait-list control group. Intervention is in Italian.
Study Type
Interventional
Enrollment (Actual)
105
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Milano, Italy, 20149
- Istituto Auxologico Italiano
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18 years old or over and both gender;
- spent at least the last couple of months providing care;
- must have internet access and the ability to use a computer or any other compatible device;
- must be able to complete a phone interview -
Exclusion Criteria:
1) having severe physical or mental impairments, psychiatric conditions or neurological disorders; 2) the person in need of care has a life expectancy below or approximately around 6 months; 3) not able to use a computer or an electronic device; 4) not able to complete a phone interview;
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group SOSteniamoci
Trans-diagnostic, 8 module, 8 week long internet intervention for reducing informal caregiver burden
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Intervention based on cognitive behavioural therapy principles and culturally adapted to Italian population.
Intervention's main purpose is to reduce caregiver burden and increase quality of life.
Intervention contains psycho-educational elements as well as examples and exercises.
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No Intervention: Control Group SOSteniamoci
Participants in the control group will be instructed to wait.
Once intervention group will be finished, participants in control group will be able to access the same intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cargiver Burden Inventory (CBI)
Time Frame: Pre-treatment; Week 8; 12 months post-treatment
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This measure is used to evaluate caregiver burden.
CBI contains 24 questions that are distributed within 5 facets - Time Dependency, Emotional Health, Development, Physical Health and Social Relationships.
Answer options are presented on a 5-item Likert scale and ranges from from 0 ('Never') to 4 ('Nearly Always').
Total score on CBI is summed up and ranges from 0 to 96, higher score indicating higher levels of burden experienced.
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Pre-treatment; Week 8; 12 months post-treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Patient Health Questionnaire (PHQ-9)
Time Frame: Pre-treatment; Week 8; 12 months post-treatment
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Measure will be used to evaluate depressive symptoms.
It contains 9 questions that must be responded to by choosing an answer from 4-item Likert scale, where number 0 indicates 'Not at all' and 3 - 'Nearly every day'.
Higher score indicates more severe symptoms.
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Pre-treatment; Week 8; 12 months post-treatment
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Generalized Anxiety Disorder (GAD-7)
Time Frame: Pre-treatment; Week 8; 12 months post-treatment
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Measure will be used to evaluate caregiver anxiety.
GAD-7 contains 7 questions that must be responded to by choosing an answer from 4-item Likert scale, where number 0 indicates 'Not at all' and 3 - 'Nearly every day'.
Higher score indicates more severe symptoms.
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Pre-treatment; Week 8; 12 months post-treatment
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World Health Organization (WHO-5)
Time Frame: Pre-treatment; Week 8; 12 months post-treatment
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This questionnaire contains 5 statements regarding individual's well-being.
Each of the statements must be evaluated using 6-item Likert scale with a score of 0 indicating 'At no time' while a score of 5 - 'All the time'.
Higher score indicates higher well-being.
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Pre-treatment; Week 8; 12 months post-treatment
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Couple Satisfaction Inventory (CSI-4)
Time Frame: Pre-treatment; Week 8; 12 months post-treatment
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This questionnaire contains 4 statements regarding couple satisfaction.
Each of the statements must be evaluated using a 6-item Likert scale.
A higher score indicates higher couple satisfaction.
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Pre-treatment; Week 8; 12 months post-treatment
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Perceived Stress Scale (PSS-10)
Time Frame: Pre-treatment; Week 8; 12 months post-treatment
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Measure will be used to evaluate levels of experienced stress.
It contains 10 questions on a Likert scale ranging from 0 ('Never') to 4 ('Very Often').
Higher score indicates more severe symptoms.
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Pre-treatment; Week 8; 12 months post-treatment
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The Inclusion of Illness in the Self Scale (IIS) - Caregiver version
Time Frame: Pre-treatment; Week 8; 12 months post-treatment
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This scale included a set of 7 pairs of concentric circles (one labeled 'Self' and one labeled 'Other's Illness') that vary in their degree of overlap from 1 (two separate circles) to 7 (almost completely overlapping circles).
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Pre-treatment; Week 8; 12 months post-treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2022
Primary Completion (Actual)
July 15, 2023
Study Completion (Actual)
July 15, 2023
Study Registration Dates
First Submitted
March 18, 2022
First Submitted That Met QC Criteria
March 18, 2022
First Posted (Actual)
March 29, 2022
Study Record Updates
Last Update Posted (Actual)
August 14, 2023
Last Update Submitted That Met QC Criteria
August 9, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01122021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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