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

Not Applicable

Completed

• Conditions: Caregiver Burden
• Interventions: Behavioral: Intervention group SOSteniamoci

• Registration Number: NCT05301257
• Lead Sponsor: Bar-Ilan University, Israel

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.

Study Timeline

• Study First Submitted: 2022-03-18
• Study First Submitted QC: 2022-03-18
• Study First Posted: 2022-03-29
• Study Start: 2022-07-15
• Primary Completion: 2023-07-15
• Study Completion: 2023-07-15
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-09
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group SOSteniamoci	Intervention group SOSteniamoci	Trans-diagnostic, 8 module, 8 week long internet intervention for reducing informal caregiver burden

Primary Outcome Measures

Name	Time	Method
Cargiver Burden Inventory (CBI)	Pre-treatment; Week 8; 12 months post-treatment	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

Name	Time	Method
Perceived Stress Scale (PSS-10)	Pre-treatment; Week 8; 12 months post-treatment	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)	Pre-treatment; Week 8; 12 months post-treatment	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.
World Health Organization (WHO-5)	Pre-treatment; Week 8; 12 months post-treatment	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)	Pre-treatment; Week 8; 12 months post-treatment	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.
Generalized Anxiety Disorder (GAD-7)	Pre-treatment; Week 8; 12 months post-treatment	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.
The Inclusion of Illness in the Self Scale (IIS) - Caregiver version	Pre-treatment; Week 8; 12 months post-treatment	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).

Trial Locations

Locations (1)

Istituto Auxologico Italiano; 🇮🇹 Milano, Italy