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

Caregiver Burden Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05301257
• Other study ID #: 01122021
• Status: Completed
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: July 15, 2023

Study information

• Verified date: August 2023
• Source: Bar-Ilan University, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 15, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years old or over and both gender;

2. spent at least the last couple of months providing care;

3. must have internet access and the ability to use a computer or any other compatible device;

4. 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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Related Conditions & MeSH terms

• Caregiver Burden

Intervention

Behavioral:
• Intervention group SOSteniamoci
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.

Locations

Country	Name	City	State
Italy	Istituto Auxologico Italiano	Milano

Sponsors (3)

Lead Sponsor	Collaborator
Bar-Ilan University, Israel	Istituto Auxologico Italiano, Linkoeping University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-treatment; Week 8; 12 months post-treatment
Secondary	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.	Pre-treatment; Week 8; 12 months post-treatment
Secondary	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.	Pre-treatment; Week 8; 12 months post-treatment
Secondary	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.	Pre-treatment; Week 8; 12 months post-treatment
Secondary	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.	Pre-treatment; Week 8; 12 months post-treatment
Secondary	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.	Pre-treatment; Week 8; 12 months post-treatment
Secondary	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).	Pre-treatment; Week 8; 12 months post-treatment