Protocol summary

Study aim
A comparative study of the impact of in-person and digital storytelling therapy on the cognitive performance of elderly individuals with mild cognitive impairment.
Design
This is a randomized clinical trial with a parallel design and control group. This randomized study will be conducted on 138 eligible elderly people with mild cognitive impairment. Randomized permutation blocks will be used for randomization and participants will be assigned to three groups (two intervention groups and one control group).
Settings and conduct
This study, which will be conducted at Farabi Hospital in Kermanshah, is not blinded. Registration and assessment of study inclusion criteria will be done by the student. Before the study begins, a questionnaire will be provided to the patients, and demographic information will be recorded in a checklist.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Informed consent; Full consciousness; Age at least 65 years; Mild cognitive impairment according to Peterson criteria; Diagnosis of mild cognitive impairment by a neuropsychiatrist; Minimum literacy. Exclusion criteria: Severe emergency conditions; Hearing and vision limitations; Participation in similar interventions
Intervention groups
In the first intervention group, story therapy sessions based on Milton Erickson's story therapy model will be held for 12 sessions (two one-hour in-person sessions per week). In the second intervention group, story therapy sessions based on Milton Erickson's story therapy model will be held for 12 sessions (two one-hour non-face-to-face sessions per week). For the control group, no intervention will be conducted.
Main outcome variables
Cognitive performance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20130812014333N269
Registration date: 2025-12-12, 1404/09/21
Registration timing: prospective

Last update: 2025-12-12, 1404/09/21
Update count: 0
Registration date
2025-12-12, 1404/09/21
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-12-26, 1404/10/05
Expected recruitment end date
2026-02-09, 1404/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the impact of in-person and digital storytelling therapy on the cognitive performance of elderly individuals with mild cognitive impairment.
Public title
Comparing the effects of face-to-face and digital storytelling on cognitive performance in the elderly
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed conset Full alertness At least 65 years old Having mild cognitive impairment according to Peterson criteria Diagnosis of mild cognitive impairment by a neuropsychiatrist Having at least basic reading and writing skills
Exclusion criteria:
Having a serious emergency condition Having hearing and vision limitations Participate in similar interventions
Age
From 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 138
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be assigned to three study groups using the random permutation block method (blocks of 6 consisting of the letters A, B, C). Randomization will be done using a random block of 6 that will be created using the website https://www.sealedenvelope.com and the following will be considered. a) A block of 6 will be considered b) A name will be assigned to each of the groups, for example, B and A are the two story therapy intervention groups and C is the control group c) A sequence will be created for a sample size of 132 d) For the allocation concealment process, 11 opaque envelopes and 11 cards will be prepared (separately for men and women), on each envelope the block number and on each card the name of the desired group in sequence will be written. In other words, four cards will be placed inside each envelope in the determined sequence. H) Blocks will be created according to the gender groups of the patients. I) Steps A to H will be performed by the statistical consultant and will be provided to the person who evaluates the patients in terms of entry and exit criteria and assigns them to groups. Registration and assessment of entry criteria for the study will be done by the student. The implementation of the intervention will also be done by the student. The person responsible for implementing the intervention will be in the flow of group codes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kermanshah University of Medical Sciences
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2025-10-29, 1404/08/07
Ethics committee reference number
IR.KUMS.REC.1404.448

Health conditions studied

1

Description of health condition studied
Mild cognitive impairment
ICD-10 code
F06.7
ICD-10 code description
Mild cognitive disorder

Primary outcomes

1

Description
Cognitive performance
Timepoint
Beginning of the study and end of the study
Method of measurement
Using the auditory-verbal learning test

Secondary outcomes

empty

Intervention groups

1

Description
In the first intervention group, story therapy sessions based on Milton Erickson's story therapy (Taken from the stories of the Masnavi) model will be held for 12 sessions (two one-hour in-person sessions per week). In-person storytelling is an art-based method that focuses attention on key information and emphasizes important concepts by building personal connections through real experiences and by drawing links among related topics.
Category
Treatment - Other

2

Description
In the second intervention group, story therapy sessions based on Milton Erickson's story therapy(Taken from the stories of the Masnavi) model will be held for 12 sessions (two one-hour non-face-to-face sessions per week).Digital storytelling is a narrative method that combines digital images, text, sound, and other interactive elements. It is increasingly used in social work and healthcare interventions to engage clients, illustrate lived experience, and support reflection and therapeutic change.
Category
Treatment - Other

3

Description
For the control group, no intervention will be conducted.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Hanie Shahdoost
Street address
Farabi Hospital, Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6719851151
Phone
+98 83 3826 1046
Email
haniehshahdoost1374@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Zohreh Rahimi
Street address
Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences, Building No.2, Shahid Beheshti Boulevard
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
Zrahimi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Hanie Shahdoost
Position
Master's Student in Psychiatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
haniehshahdoost1374@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Amir Jalali
Position
Faculty member, Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery Dolatabad Blvd, Isar Square
City
Keranshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
a_jalali@kums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Amir Jalali
Position
Faculty member, Kermanshah University of Medical Sciences
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery Dolatabad Blvd, Isar Square
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3826 6429
Email
a_jalali@kums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information available.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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