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SOSteniamoci: An Internet-based Intervention to Support Informal Caregivers.

Primary Purpose

Caregiver Burden

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Intervention group SOSteniamoci
Sponsored by
Bar-Ilan University, Israel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Caregiver Burden focused on measuring informal caregiver, internet-based intervention, caregiver burden, culturally adapted, eHealth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 18 years old or over and both gender;
  2. score 24 or more points on the Caregiver Burden Inventory;
  3. spent at least the last couple of months providing care;
  4. must have internet access and the ability to use a computer or any other compatible device;
  5. must be able to complete a phone interview -

Exclusion Criteria:

  1. having severe physical or mental impairments, psychiatric condition or neurological disorder;
  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;
  5. score 23 or fewer points on the Caregiver Burden Inventory -

Sites / Locations

  • Istituto Auxologico Italiano

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group SOSteniamoci

Control Group SOSteniamoci

Arm Description

Trans-diagnostic, 8 module, 8 week long internet intervention for reducing informal caregiver burden

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

Outcomes

Primary Outcome Measures

Cargiver Burden Inventory (CBI)
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.

Secondary Outcome Measures

Perceived Stress Scale (PSS-10)
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.
The Patient Health Questionnaire (PHQ-9)
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.
Generalized Anxiety Disorder (GAD-7)
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.
World Health Organization (WHO-5)
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.
Couple Satisfaction Inventory (CSI-4)
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.
The Inclusion of Illness in the Self Scale (IIS) - Caregiver version
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).

Full Information

First Posted
March 18, 2022
Last Updated
August 9, 2023
Sponsor
Bar-Ilan University, Israel
Collaborators
Istituto Auxologico Italiano, Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT05301257
Brief Title
SOSteniamoci: An Internet-based Intervention to Support Informal Caregivers.
Official Title
SOSteniamoci: An Internet-based Intervention to Support Informal Caregivers.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
July 15, 2023 (Actual)
Study Completion Date
July 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bar-Ilan University, Israel
Collaborators
Istituto Auxologico Italiano, Linkoeping University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate efficacy of internet intervention for informal caregivers in Italy in reducing their care-giving burden.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burden
Keywords
informal caregiver, internet-based intervention, caregiver burden, culturally adapted, eHealth

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly allocated to either control or intervention group. Participants in the control group will receive the same treatment once the intervention group is finished with the treatment.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group SOSteniamoci
Arm Type
Experimental
Arm Description
Trans-diagnostic, 8 module, 8 week long internet intervention for reducing informal caregiver burden
Arm Title
Control Group SOSteniamoci
Arm Type
No Intervention
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Intervention group SOSteniamoci
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cargiver Burden Inventory (CBI)
Description
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.
Time Frame
Pre-treatment; Week 8; 12 months post-treatment
Secondary Outcome Measure Information:
Title
Perceived Stress Scale (PSS-10)
Description
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.
Time Frame
Pre-treatment; Week 8; 12 months post-treatment
Title
The Patient Health Questionnaire (PHQ-9)
Description
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.
Time Frame
Pre-treatment; Week 8; 12 months post-treatment
Title
Generalized Anxiety Disorder (GAD-7)
Description
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.
Time Frame
Pre-treatment; Week 8; 12 months post-treatment
Title
World Health Organization (WHO-5)
Description
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.
Time Frame
Pre-treatment; Week 8; 12 months post-treatment
Title
Couple Satisfaction Inventory (CSI-4)
Description
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.
Time Frame
Pre-treatment; Week 8; 12 months post-treatment
Title
The Inclusion of Illness in the Self Scale (IIS) - Caregiver version
Description
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).
Time Frame
Pre-treatment; Week 8; 12 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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; -
Facility Information:
Facility Name
Istituto Auxologico Italiano
City
Milano
ZIP/Postal Code
20149
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

SOSteniamoci: An Internet-based Intervention to Support Informal Caregivers.

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