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Completed

NCT Number: NCT05762315

Transformative Audio Storytelling

Pilot testing the feasibility of the Transformative Audio Storytelling approach for informal caregivers, as an innovative method for delivering potentially empowering mental health narratives.

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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, Lombardy, 20145, Italy

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Informal caregiver (family members or significant other person who provides primary care for the patients visiting or being hospitalized in the Rehabilitation Ward)
  • Age ≥18 years
  • Native speaker of the Italian language
  • Having voluntarily agreed to participate in the study and having signed the informed consent in all its points.

Exclusion criteria

  • Informal caregiver for children
  • Informal caregiver who does not personally play this role (primary caregiver)
  • Informal caregiver of adults with a tumor pathological condition

Treatment and study plan

Audio Storytelling

Behavioral

The audio session is designed to deliver audio narrative developed following the Transformative Storytelling Technique and provide re-structurization of internal caregiver self-stories.

Primary outcomes

  1. Perceived Stress Scale

    Time frame: pre-post (15 minutes) intervention

    The PSS is a questionnaire consisting of 10 items, on a 5-step Likert scale, ranging from 0, "Never" to 4, "Very Often". A total score of the 10 items provides a general measure of perceived stress. PPS items rate thoughts and feelings about the past month.

  2. Sense of Coherence Scale revised (SOC-R)

    Time frame: pre-post (15 minutes) intervention

    The SOC-R is a tool composed of 13 items on a 5-point Likert scale ranging from 1 - "Not at all true" to 5 - "Extremely true".

  3. Meaning in Life (MLQ)

    Time frame: pre-post (15 minutes) intervention

    The MLQ is a questionnaire composed of 10 items to evaluate meaning of life. The MLQ uses 7-step Likert scales from 1 "Absolutely true" to "Absolutely not true".

  4. Cognitive Emotion Regulation Questionnaire (CERQ)

    Time frame: pre-post (15 minutes) intervention

    The CERQ is a questionnaire composed of 27 items, consisting of 5-step Likert scales, from 1 - "almost never" to 5 "almost always"

  5. Facial expressions responses (Noldus FaceReader)

    Time frame: during 15 minutes intervention session

    this facial expression recognition software includes the evaluation of six basic expressions and then calculates the drive, valence, arousal, gaze direction, head orientation and other additional characteristics such as age and the sex

  6. Burden Scale for Family Caregivers - Short Form (BSFC-s)

    Time frame: pre-post (15 minutes) intervention

    The BSFC-s is a 10-item 4-step Likert scale ranging from (0) "Strongly disagree" to (4) Strongly agree.

Secondary outcomes

  1. Feedback on the perceived value of audio storytelling

    Time frame: after 15 minutes intervention sessions

    this facial expression recognition software includes the evaluation of six basic expressions and then calculates the drive, valence, arousal, gaze direction, head orientation and other additional characteristics such as age and the sex

Sponsors and collaborators

Lead sponsor

Istituto Auxologico Italiano

Other

Collaborators

  • European Union

Registry information

Official study title

Un Protocollo di Studio Per l'Assessment Dell'Efficacia Dello Storytelling Audio Trasformativo Per Caregiver Informale (A Protocol for Assessing the Feasibility of Transformative Audio Storytelling for Informal Caregivers)

Acronym: HealingStories

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 9, 2023
Registry last updated
Mar 13, 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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