Transformative Audio Storytelling

Study Overview
=================
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.

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)

Conditions
-----------------
Caregiver Burden

Intervention / Treatment
-----------------
* Behavioral: Audio Storytelling


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Interventional Model Description: pre-post
Masking: None (Open Label)


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
audio storytelling, informal caregivers, digital narratives