The effectiveness of acceptance and commitment therapy (ACT) on emotional overeating, emotion regulation and psychological well-being in women with diabetes
The effectiveness of Acceptance and Commitment Therapy on emotional overeating, emotion regulation, and psychological well-being in women with type 2 diabetes.
Design
This study is a quasi-experimental pretest–posttest study with a control group on 40 women with type 2 diabetes. Participants will be selected by convenience sampling and then randomly assigned by simple randomization into two groups of 20. The intervention group will receive 8 ACT sessions, while the control group will receive no intervention. This is not a drug trial and has no trial phase.
Settings and conduct
This study will be conducted in Rasht among women with type 2 diabetes using a pretest–posttest design with a control group. The intervention group will receive 8 ACT sessions, and no blinding will be performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
a) A diagnosis of diabetes confirmed by a specialist physician.
b) Ability to attend eight group sessions.
c) Written informed consent to participate in the study.
d) Age range between 20 and 50 years.
Exclusion criteria:
a) Severe active psychiatric disorders, including clinical depression or anxiety requiring immediate treatment.
b) Absence from at least two ACT sessions.
c) Unwillingness to continue attending the sessions.
Intervention groups
This study will be conducted as a quasi-experimental study with a control group. Participants will be randomly assigned to two groups. The intervention group will receive 8 ACT sessions, while the control group will receive no intervention. Emotional eating, emotion regulation, and psychological well-being will be assessed at pretest and posttest.
Main outcome variables
Emotional eating, emotion regulation, and psychological well-being.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260503069247N1
Registration date:2026-06-25, 1405/04/04
Registration timing:registered_while_recruiting
Last update:2026-06-25, 1405/04/04
Update count:0
Registration date
2026-06-25, 1405/04/04
Registrant information
Name
Avishan Aghaeipour
Name of organization / entity
The university of tonekabon
Country
Iran (Islamic Republic of)
Phone
+98 13 4242 3280
Email address
avishan.aghaeipour@iau.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-06-23, 1405/04/02
Expected recruitment end date
2026-08-21, 1405/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of acceptance and commitment therapy (ACT) on emotional overeating, emotion regulation and psychological well-being in women with diabetes
Public title
The effectiveness of acceptance and commitment therapy (ACT) on emotional overeating, emotion regulation and psychological
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
a) Diagnosis of diabetes confirmed by a specialist physician.b) Ability to attend 8 group sessions.c) Written informed consent for participation in the study.d) Age range between 20 and 50 years.
Exclusion criteria:
a) Severe active mental disorders (clinical depression or anxiety requiring immediate treatment).b) Absence from at least two ACT sessions.c) Lack of willingness to continue attending the sessions.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Islamic Azad University, Tonekabon Branch
Street address
Km 3, Chalous Road, Valiabad, Islamic Azad University Tonekabon Complex
City
Tonekabon
Province
Mazandaran
Postal code
۴۶۸۴۱۶۱۱۶۷
Approval date
2026-04-15, 1405/01/26
Ethics committee reference number
IR.IAU.TON.REC.1405.018
Health conditions studied
1
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11.0
ICD-10 code description
Type 2 diabetes mellitus with hyperosmolarity
Primary outcomes
1
Description
Score of emotional eating based on the Eating Behavior Questionnaire.
Timepoint
Assessment of variables at baseline (pretest) and one week after the intervention sessions (posttest).
Method of measurement
The study variables will be measured using the following instruments: Van Strien’s Eating Behavior Questionnaire for emotional eating.
Secondary outcomes
1
Description
Emotion regulation score based on the 16‑item short form of the Emotion Regulation Questionnaire (ERQ).
Timepoint
At the beginning of the study (pretest) and one week after the completion of the intervention sessions (posttest)
Method of measurement
Sixteen‑item short form of the Emotion Regulation Questionnaire for measuring emotion regulation.
2
Description
Psychological well‑being score based on Ryff’s Psychological Well‑Being Questionnaire.
Timepoint
At the beginning of the study (pretest) and one week after the completion of the intervention sessions (posttest)
Method of measurement
Ryff Psychological Well‑Being Questionnaire for measuring psychological well‑being.
Intervention groups
1
Description
Intervention group: The intervention group will receive 8 sessions of group-based Acceptance and Commitment Therapy. Each session will last 60 minutes and will be conducted by a trained psychologist. The content of the sessions includes training and practice on concepts such as acceptance, cognitive defusion, mindfulness, value clarification, and committed action, with the aim of improving emotional eating and emotion regulation.
Category
Lifestyle
2
Description
Control group: Participants in this group will not receive any psychological intervention during the study period and will continue to receive routine medical care related to type 2 diabetes according to standard clinical practice. After the completion of data collection, and if they are willing, the educational content of Acceptance and Commitment Therapy (ACT) will be provided to this group in a condensed format.
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results, tables, and the treatment protocol.
When the data will become available and for how long
The access period will begin 6 months after the publication of the results
To whom data/document is available
Access to the anonymized study data is restricted to researchers affiliated with academic universities, scientific institutions, and research centers holding valid ethical approval, subject to the review of their request and approval by the Ethics Committee.
Under which criteria data/document could be used
Access to the documentation of this clinical trial is restricted to academic and scientific researchers and is permitted only upon obtaining authorization from the principal investigator.
From where data/document is obtainable
Correspondence via email: Aveshen Aghaeipour. avishan_376@yahoo.com
What processes are involved for a request to access data/document
Any request for access to the data or documentation of this study must be submitted through a formal written request to the principal investigator or the academic supervisor. The request should include the applicant’s identification information, the purpose of using the data, the type of data requested, and the method for ensuring confidentiality of the information. After receiving the request, the following aspects will be reviewed: the applicant’s academic identity and institutional affiliation, evaluation of the research purpose and its alignment with the ethical principles of the study, and final approval by the principal investigator and, if necessary, the university ethics committee. If approved, the data will be provided in an anonymized form and limited to the requested items, in a format suitable for scientific use. Use of the data is permitted only with proper citation of the source and strict adherence to the confidentiality of participants’ information