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

NCT05301257 | Completed DMC

• 1 other identifier: 01122021
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver Burden

Keywords

informal caregiver; internet-based intervention; caregiver burden; culturally adapted; eHealth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Perceived Stress Scale (PSS-10)

  Pre-treatment; Week 8; 12 months post-treatment

• The Patient Health Questionnaire (PHQ-9)

  Pre-treatment; Week 8; 12 months post-treatment

• Generalized Anxiety Disorder (GAD-7)

  Pre-treatment; Week 8; 12 months post-treatment

• World Health Organization (WHO-5)

  Pre-treatment; Week 8; 12 months post-treatment

• Couple Satisfaction Inventory (CSI-4)

  Pre-treatment; Week 8; 12 months post-treatment

Study Arms (2)

Experimental Group SOSteniamoci

EXPERIMENTAL

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

Behavioral: Intervention group SOSteniamoci

Control Group SOSteniamoci

NO INTERVENTION

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

Interventions

Intervention group SOSteniamoci BEHAVIORAL

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.

Experimental Group SOSteniamoci

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• \) 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;

Sponsors & Collaborators

• Bar-Ilan University, Israel: lead
• Istituto Auxologico Italiano: collaborator
• Linkoeping University: collaborator

Study Sites (1)

Istituto Auxologico Italiano

Milan, 20149, Italy

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: March 29, 2022
• Study Start: July 15, 2022
• Primary Completion: July 15, 2023
• Study Completion: July 15, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)