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Completed

NCT Number: NCT05301257

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.

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Key information

Conditions

Caregiver Burden Behavior Behavioral Symptoms Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituto Auxologico Italiano

Milan, 20149, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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;

-

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Perceived Stress Scale (PSS-10)

    Time frame: Pre-treatment; Week 8; 12 months post-treatment

    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.

  2. The Patient Health Questionnaire (PHQ-9)

    Time frame: Pre-treatment; Week 8; 12 months post-treatment

    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.

  3. Generalized Anxiety Disorder (GAD-7)

    Time frame: Pre-treatment; Week 8; 12 months post-treatment

    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.

  4. World Health Organization (WHO-5)

    Time frame: Pre-treatment; Week 8; 12 months post-treatment

    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.

  5. Couple Satisfaction Inventory (CSI-4)

    Time frame: Pre-treatment; Week 8; 12 months post-treatment

    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.

  6. The Inclusion of Illness in the Self Scale (IIS) - Caregiver version

    Time frame: Pre-treatment; Week 8; 12 months post-treatment

    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).

Sponsors and collaborators

Lead sponsor

Bar-Ilan University, Israel

Other

Collaborators

  • Istituto Auxologico Italiano
  • Linkoeping University

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 29, 2022
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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