Caregiver BurdenNCT05301257
SOSteniamoci: An Internet-based Intervention to Support Informal Caregivers.
A study testing Intervention group SOSteniamoci in people with Caregiver Burden, run by Bar-Ilan University, Israel at 1 site in Italy.
Trial summary
The purpose of this study is to evaluate efficacy of internet intervention for informal caregivers in Italy in reducing their care-giving burden. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden
- What is being tested?
- Intervention group SOSteniamoci
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jul 2022to 15 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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;
- -
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate efficacy of internet intervention for informal caregivers in Italy in reducing their care-giving burden.
Read the 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.
- Conditions
- Caregiver Burden
- Being tested
- Intervention group SOSteniamoci
- Keywords
- informal caregiver, internet-based intervention, caregiver burden, culturally adapted, eHealth
- Medical subject headings
- Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group SOSteniamociBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group SOSteniamoci | Experimental | Trans-diagnostic, 8 module, 8 week long internet intervention for reducing informal caregiver burden Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-treatment; Week 8; 12 months post-treatment
Secondary outcomes (6)
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.
Measured: Pre-treatment; Week 8; 12 months post-treatment
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Pre-treatment; Week 8; 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start15 Jul 2022
- Primary completion15 Jul 2023
- Study completion15 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bar-Ilan University, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- Istituto Auxologico Italiano, Linkoeping University
- Responsible party
- Principal investigator, Noa Vilchinsky, Bar-Ilan University, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05301257
- Sponsor's protocol ID
- 01122021
- Status last verified
- Aug 2023
- First submitted
- 18 Mar 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOSteniamoci: An Internet-based Intervention to Support Informal Caregivers.
- ClinicalTrials.gov ID
- NCT05301257
- Acronym / sponsor ID
- 01122021
- Conditions
- Caregiver Burden
- Keywords
- informal caregiver, internet-based intervention, caregiver burden, culturally adapted, eHealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Bar-Ilan University, IsraelUniversity, hospital or other
- Collaborators
- Istituto Auxologico Italiano, Linkoeping University
- Study start
- 15 Jul 2022 (actual)
- Primary completion
- 15 Jul 2023 (actual)
- Study completion
- 15 Jul 2023 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group SOSteniamoci | Experimental | Behavioral: Intervention group SOSteniamociTrans-diagnostic, 8 module, 8 week long internet intervention for reducing informal caregiver burden |
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 -
Key exclusion criteria (2 listed)
- 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;
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention group SOSteniamociIntervention 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. | Behavioural | Experimental Group SOSteniamoci |
Primary outcome
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.
6 secondary outcomes
Perceived Stress Scale (PSS-10)
Time frame: Pre-treatment; Week 8; 12 months post-treatment
The Patient Health Questionnaire (PHQ-9)
Time frame: Pre-treatment; Week 8; 12 months post-treatment
Generalized Anxiety Disorder (GAD-7)
Time frame: Pre-treatment; Week 8; 12 months post-treatment
World Health Organization (WHO-5)
Time frame: Pre-treatment; Week 8; 12 months post-treatment
Couple Satisfaction Inventory (CSI-4)
Time frame: Pre-treatment; Week 8; 12 months post-treatment
The Inclusion of Illness in the Self Scale (IIS) - Caregiver version
Time frame: Pre-treatment; Week 8; 12 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group SOSteniamoci in people with Caregiver Burden, run by Bar-Ilan University, Israel at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cargiver Burden Inventory (CBI) (time frame: Pre-treatment; Week 8; 12 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.