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

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: Caregiver Burden
• Intervention / Treatment: Behavioral: Intervention group SOSteniamoci

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

Study Locations

• Italy
  • Milano, Italy, 20149
    • Istituto Auxologico Italiano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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	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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Bar-Ilan University, Israel
• Collaborators: Linkoeping University; Istituto Auxologico Italiano

Study record dates

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

• Keywords: informal caregiver; caregiver burden; eHealth; internet-based intervention; culturally adapted
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Caregiver Burden
• 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