Clinical trial NCT05301257: SOSteniamoci: An Internet-based Intervention to Support Informal Caregivers.
Official title: SOSteniamoci: An Internet-based Intervention to Support Informal Caregivers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver Burden
Keywords: informal caregiver
internet-based intervention
caregiver burden
culturally adapted
eHealth
Lead sponsor: Bar-Ilan University, Israel
Sponsor class: OTHER
Collaborators: name: Istituto Auxologico Italiano
name: Linkoeping University
First posted: 2022-03-29
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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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Primary outcomes:
measure: Cargiver Burden Inventory (CBI)
timeFrame: Pre-treatment; Week 8; 12 months post-treatment
Secondary outcomes:
measure: Perceived Stress Scale (PSS-10)
timeFrame: Pre-treatment; Week 8; 12 months post-treatment
measure: The Patient Health Questionnaire (PHQ-9)
timeFrame: Pre-treatment; Week 8; 12 months post-treatment
measure: Generalized Anxiety Disorder (GAD-7)
timeFrame: Pre-treatment; Week 8; 12 months post-treatment
measure: World Health Organization (WHO-5)
timeFrame: Pre-treatment; Week 8; 12 months post-treatment
measure: Couple Satisfaction Inventory (CSI-4)
timeFrame: Pre-treatment; Week 8; 12 months post-treatment
measure: The Inclusion of Illness in the Self Scale (IIS) - Caregiver version
timeFrame: Pre-treatment; Week 8; 12 months post-treatment
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Istituto Auxologico Italiano
Study officials:
References: