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Clinical Trials/NCT05301257
NCT05301257
Completed
N/A

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

Bar-Ilan University, Israel1 site in 1 country105 target enrollmentJuly 15, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Caregiver Burden
Sponsor
Bar-Ilan University, Israel
Enrollment
105
Locations
1
Primary Endpoint
Cargiver Burden Inventory (CBI)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2022
End Date
July 15, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Bar-Ilan University, Israel
Responsible Party
Principal Investigator
Principal Investigator

Noa Vilchinsky

Principal Investigator

Bar-Ilan University, Israel

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

  • 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;

Outcomes

Primary Outcomes

Cargiver Burden Inventory (CBI)

Time Frame: 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 Outcomes

  • 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)
  • 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)
  • Generalized Anxiety Disorder (GAD-7)(Pre-treatment; Week 8; 12 months post-treatment)
  • The Inclusion of Illness in the Self Scale (IIS) - Caregiver version(Pre-treatment; Week 8; 12 months post-treatment)

Study Sites (1)

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