Transformative Audio Storytelling (HealingStories)

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)

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

Study Overview

• Status: Completed
• Conditions: Caregiver Burden
• Intervention / Treatment: Behavioral: Audio Storytelling

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lombardia
    • Milan, Lombardia, Italy, 20145
      • Istituto Auxologico Italiano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Audio Storytelling; 15 minutes transformative audio storytelling session	Behavioral: Audio Storytelling; The audio session is designed to deliver audio narrative developed following the Transformative Storytelling Technique and provide re-structurization of internal caregiver self-stories.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress Scale	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.	pre-post (15 minutes) intervention
Sense of Coherence Scale revised (SOC-R)	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".	pre-post (15 minutes) intervention
Meaning in Life (MLQ)	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".	pre-post (15 minutes) intervention
Cognitive Emotion Regulation Questionnaire (CERQ)	The CERQ is a questionnaire composed of 27 items, consisting of 5-step Likert scales, from 1 - "almost never" to 5 "almost always"	pre-post (15 minutes) intervention
Facial expressions responses (Noldus FaceReader)	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	during 15 minutes intervention session
Burden Scale for Family Caregivers - Short Form (BSFC-s)	The BSFC-s is a 10-item 4-step Likert scale ranging from (0) "Strongly disagree" to (4) Strongly agree.	pre-post (15 minutes) intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feedback on the perceived value of audio storytelling	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	after 15 minutes intervention sessions

Collaborators and Investigators

• Sponsor: Istituto Auxologico Italiano
• Collaborators: European Union

Study record dates

Study Major Dates

• Study Start (Actual): November 26, 2021
• Primary Completion (Actual): June 10, 2022
• Study Completion (Actual): September 25, 2022

Study Registration Dates

• First Submitted: February 28, 2023
• First Submitted That Met QC Criteria: February 28, 2023
• First Posted (Actual): March 9, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: informal caregivers; audio storytelling; digital narratives
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Caregiver Burden
• Other Study ID Numbers: 39C101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No