The Effectiveness of a Systemic Acceptance and Commitment Therapy (ACT) and Life Review therapy on Social Cognition, Emotional Adaptation, and Experiential Avoidance in Older Adults with Mild Cognitive Impairment
To evaluate the effectiveness of a systemic intervention based on Acceptance and Commitment Therapy (ACT) and life review provided by a family member on experiential avoidance, social cognition, and emotional adaptation in older adults with mild cognitive impairment at Yas Comprehensive Rehabilitation Center in Tehran.
Design
Design: Randomized controlled parallel-group clinical trial in older adults with mild cognitive impairment.
Allocation: 1:1 randomization to ACT + family Life Review or usual care.
Sample size: 30 participants (15 per group).
Randomization: Random number table.
Settings and conduct
The study will be conducted at Yas Comprehensive Rehabilitation Center in Tehran. After baseline assessment and obtaining informed consent, participants will be randomly allocated to two groups. The intervention group will receive ACT (10 group sessions) and family-provided Life Review (6 sessions). The control group will receive usual care provided by the center.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The inclusion criteria include being male or female, aged 60 years or older; having cognitive impairment diagnosed by a specialist physician; having the ability to read and write; and obtaining a score higher than 24 on the Mini-Mental State Examination (MMSE).
Exclusion criteria:
The exclusion criteria include the presence of severe cognitive, sensory-motor, or psychological problems; absence from more than two sessions; and failure to complete the assigned tasks.
Intervention groups
Intervention group: Receiving ACT (10 group sessions) and family-provided Life Review (6 sessions); caregivers trained through 2 online sessions and supervised by the researcher.
Control group: Receiving usual care from Yas Comprehensive Rehabilitation Center without ACT or Life Review.
Main outcome variables
Experiential avoidance; Social cognition; Emotional adaptation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260721070286N1
Registration date:2026-08-01, 1405/05/10
Registration timing:prospective
Last update:2026-08-01, 1405/05/10
Update count:0
Registration date
2026-08-01, 1405/05/10
Registrant information
Name
Delara Soleimani
Name of organization / entity
IAU Tehran Medical Branch
Country
Iran (Islamic Republic of)
Phone
+98 921 037 0414
Email address
delisoleimani76@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-08-03, 1405/05/12
Expected recruitment end date
2026-08-11, 1405/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of a Systemic Acceptance and Commitment Therapy (ACT) and Life Review therapy on Social Cognition, Emotional Adaptation, and Experiential Avoidance in Older Adults with Mild Cognitive Impairment
Public title
The Effectiveness of a Systemic Acceptance and Commitment Therapy (ACT) and Life Review therapy on Social Cognition, Emotional Adaptation, and Experiential Avoidance in Older Adults
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
men and women aged ≥60 years
A diagnosis of Mild Cognitive Impairment (MCI) confirmed by a specialist physician
the ability to read and write
a Mini-Mental State Examination (MMSE) score of 24 or above
Exclusion criteria:
severe cognitive problems, sensorimotor impairments, or psychological disorder
absence from more than two intervention sessions
failure to complete the assigned homework
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple randomization.
Unit of randomization: Individual participant.
Randomization tool: A random allocation sequence will be generated using a random numbers table.
Generation of the random allocation sequence: A unique identification code will be assigned to each participant, and based on the generated random allocation sequence, participants will be allocated to the intervention and control groups in a 1:1 ratio.
Allocation concealment: The allocation sequence will be maintained by an individual who is not involved in delivering the intervention or assessing the study outcomes. The allocation assignments will be placed in sequentially numbered, opaque, sealed envelopes. After completion of each participant's baseline assessment, the corresponding envelope will be opened in numerical order, and the participant's group allocation will be determined.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Participants in the intervention group will receive a combined intervention consisting of Acceptance and Commitment Therapy (ACT) and Life Review Therapy. The ACT sessions will be conducted by the therapist at Yas Comprehensive Rehabilitation Center in Tehran, in a group format, consisting of 10 sessions held twice weekly, with each session lasting one hour.The Life Review intervention will be conducted over 6 one-hour sessions. For participants who have a family caregiver, caregivers will initially receive two one-hour online training sessions on how to conduct the life review process. Subsequently, caregivers will implement the life review sessions at home with the older adults, and the implementation process will be monitored by the researcher.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Tehran Islamic Azad University Of Medical Sciences
Street address
Tehran Azad University of Medical Sciences, Headquarters Building, Corner of Gol Yakh Street, Ayeneh Boulevard, Amir Pabarja Street, Qolhak Junction, Dr. Shariati Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1949635881
Approval date
2026-06-15, 1405/03/25
Ethics committee reference number
IR.IAU.TMU.REC.1405.094
Health conditions studied
1
Description of health condition studied
Mild Cognitive disorder
ICD-10 code
F06.7
ICD-10 code description
A disorder characterized by impairment of memory, learning difficulties, and reduced ability to concentrate on a task for more than brief periods. There is often a marked feeling of mental fatigue when mental tasks are attempted, and new learning is found
Primary outcomes
1
Description
Social cognition
Timepoint
At baseline (pre-intervention), immediately after completion of the intervention (post-intervention), and at follow-up (1 months after the intervention).
Method of measurement
1- Social cognition score measured by the Bar-On/Cohen Empathy Quotient (EQ). 2- Theory of Mind score measured by the Revised Reading the Mind in the Eyes Test (RMET).
2
Description
Emotional adaptation
Timepoint
At baseline (pre-intervention), immediately after completion of the intervention (post-intervention), and at follow-up (1 months after the intervention).
Method of measurement
Emotional adaptation score measured by the Rabiu et al. Emotional Adaptation Scale
3
Description
Experiential avoidance
Timepoint
At baseline (pre-intervention), immediately after completion of the intervention (post-intervention), and at follow-up (1 months after the intervention).
Method of measurement
Experiential avoidance score measured by the Acceptance and Action Questionnaire-II (AAQ-II)
Secondary outcomes
empty
Intervention groups
1
Description
Participants will receive a combined intervention consisting of Acceptance and Commitment Therapy (ACT) and Butler's Life Review protocol delivered by a family member. ACT will be delivered by a therapist in 10 group sessions (60 minutes each, twice weekly) at Yas Comprehensive Rehabilitation Center, Tehran. Butler's Life Review will consist of six 60-minute sessions. Family members will first receive two online training sessions on Butler's Life Review protocol and will then conduct the Life Review sessions at home with the older adult. Intervention implementation will be regularly monitored by the researcher.
Category
Rehabilitation
2
Description
Control group: Participants in the control group will receive usual care provided by Yas Comprehensive Rehabilitation Center, Tehran, and will not receive the study interventions (Acceptance and Commitment Therapy [ACT] or Butler's Life Review protocol) during the study period.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Yas Comprehensive Rehabilitation Center
Full name of responsible person
Marzieh Shirazikhah
Street address
Second Street, Sattarkhan, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
02166500140
Phone
+98 21 6650 6012
Email
zendehbadazad@yahoo.com
Web page address
https://yasrehab.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Alireza khoshdel
Street address
Tehran Azad University of Medical Sciences, Headquarters Building, Corner of Gol Yakh Street, Ayeneh Boulevard, Amir Pabarja Street, Qolhak Junction, Dr. Shariati Street, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2200 6660
Email
Int.affairs@tms.iau.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
The Islamic Azad University, Tehran Medical Sciences Branch
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Delara Soleimani
Position
Master's Student in Clinical Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 3, Ayin Residential Complex, 63 Edalat Street, Nahar Khoran Boulevard, Gorgan, Iran
City
Tehran
Province
Tehran
Postal code
4917844436
Phone
+98 17 3253 1697
Email
delisoleimani76@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Delara Soleimani
Position
Master's Student in Clinical Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 3, Ayin Residential Complex, 63 Edalat Street, Nahar Khoran Boulevard, Gorgan, Iran.
City
Tehran
Province
Tehran
Postal code
4917844436
Phone
+98 17 3523 1697
Email
delisoleimani76@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Delara Soleimani
Position
Master's Student in Clinical Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 3, Ayin Residential Complex, 63 Edalat Street, Nahar Khoran Boulevard, Gorgan, Iran.
City
Tehran
Province
Tehran
Postal code
4917844436
Phone
+98 17 3523 1697
Email
delisoleimani76@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
فارسی English
عنوان و جزئیات بیشتر: پروتکل نهایی مطالعه؛ نسخه نهایی پروتکل پس از انتشار نتایج مطالعه، در صورت درخواست، قابل ارائه خواهد بود. Title and details: Final study protocol; the final version of the study protocol will be available upon reasonable request after publication of the study results.
When the data will become available and for how long
Availability period: From 6 months after publication of the study results for 5 years.
To whom data/document is available
Researchers and academic investigators affiliated with scientific or academic institutions
Under which criteria data/document could be used
For scientific research purposes only, upon submission of a reasonable request and approval by the principal investigator.
From where data/document is obtainable
By contacting the principal investigator via email
What processes are involved for a request to access data/document
Requests should be submitted to the principal investigator. After review and approval, the study protocol will be shared with the requester