HealingStories: Transformative Audio Storytelling

Sponsor

Istituto Auxologico Italiano (Other)

Overall Status

Completed

CT.gov ID

NCT05762315

Collaborator

European Union (Other)

Enrollment

Location

Arm

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Caregiver Burden	Behavioral: Audio Storytelling	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

pre-postpre-post

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official 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)

Actual Study Start Date :

Nov 26, 2021

Actual Primary Completion Date :

Jun 10, 2022

Actual Study Completion Date :

Sep 25, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Perceived Stress Scale [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.
Sense of Coherence Scale revised (SOC-R) [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".
Meaning in Life (MLQ) [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".
Cognitive Emotion Regulation Questionnaire (CERQ) [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"
Facial expressions responses (Noldus FaceReader) [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
Burden Scale for Family Caregivers - Short Form (BSFC-s) [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 Outcome Measures

Feedback on the perceived value of audio storytelling [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istituto Auxologico Italiano	Milan	Lombardia	Italy	20145

Sponsors and Collaborators

Istituto Auxologico Italiano
European Union

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Istituto Auxologico Italiano

ClinicalTrials.gov Identifier:

NCT05762315

Other Study ID Numbers:

39C101

First Posted:

Mar 9, 2023

Last Update Posted:

Mar 13, 2023

Last Verified:

Mar 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Istituto Auxologico Italiano

audio storytelling

informal caregivers

digital narratives

Additional relevant MeSH terms:

Caregiver Burden

Study Results

No Results Posted as of Mar 13, 2023