Protocol summary
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Study aim
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This study aims to evaluate the effectiveness of group schema therapy in improving emotional awareness, cognitive flexibility, body image, and food craving in adults with type 2 diabetes mellitus (T2DM).
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Design
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Randomized controlled parallel-group trial with pre- and post-test assessments. Sample size: 50 participants across one center. Randomization was computer-generated and allocation was concealed.
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Settings and conduct
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This single-center trial will be conducted at Isfahan Endocrine and Metabolism Research Center (IEMRC). The procedure is as follows: Eligible participants will complete baseline assessments. They will then be randomly assigned to either the Schema Therapy group or the Standard Care control group using sequentially numbered, opaque, sealed envelopes (SNOSE). The intervention group will receive eight 90-minute weekly sessions of group Schema Therapy. The control group will receive eight 90-minute weekly sessions of structured diabetes education. Participants and outcome assessors are blinded to group allocation. All participants will be re-assessed on all outcomes immediately post-intervention.
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Participants/Inclusion and exclusion criteria
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Adults aged 30–60 years with T2DM and elevated food craving were included. Participants with current psychiatric disorders or using psychotropic medications were excluded.
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Intervention groups
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The intervention group will receive eight 90-minute sessions of schema-based group therapy. The control group will receive standard care.
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Main outcome variables
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Alexithymia, cognitive flexibility, body image, and food cravings will be measured with validated questionnaires.
General information
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Reason for update
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Updating the actual intervention start and end dates and recording the study completion date.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20251201068177N1
Registration date:
2025-12-31, 1404/10/10
Registration timing:
prospective
Last update:
2026-09-12, 1405/06/21
Update count:
1
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Registration date
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2025-12-31, 1404/10/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2025-10-12, 1404/07/20
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Expected recruitment end date
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2025-12-13, 1404/09/22
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Actual recruitment start date
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2026-01-17, 1404/10/27
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Actual recruitment end date
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2026-03-14, 1404/12/23
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Trial completion date
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2026-03-18, 1404/12/27
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Scientific title
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The Efficacy of Schema Therapy on Alexithymia, Cognitive Flexibility, Body Image and Food Craving Individuals with Type 2 Diabetes
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Public title
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The Efficacy of Schema Therapy in the treatment of diabetes
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Eligible individuals must be between 30 and 60 years old.
Have at least a high school diploma
Registration will only be done after participants provide written informed consent.
Patients with current psychiatric disorders or taking psychotropic medications are not eligible to participate in the study.
Exclusion criteria:
Unforeseen or unexpected events occur
Absence of more than 2 sessions
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Age
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From 30 years old to 60 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
50
Actual sample size reached:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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This study will be conducted as a randomized controlled clinical trial (RCT). Participants will be randomly allocated to either the intervention group (schema therapy) or the control group (standard care) using a computer-generated simple random sequence. Allocation concealment will be ensured through the use of sequentially numbered, sealed, and opaque envelopes, which will be opened only after each participant has been enrolled. The randomization sequence will be generated by an independent statistician and will remain concealed from the study implementer until the time of allocation, thereby minimizing selection bias. Data analysis will be performed using SPSS software version 26. Descriptive and appropriate inferential statistical methods will be applied to analyze the data, and a significance level of p < 0.05 will be considered statistically significant.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The interventions in both groups will be designed to be sufficiently similar in terms of implementation schedule and delivery format to allow participant-level blinding. Accordingly, this study will be conducted as a single-blind trial. Participants will not be informed of their group allocation and will be unaware of whether they receive schema therapy or standard care. Due to the nature of the interventions, the therapist delivering the sessions will not be blinded.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2025-07-15, 1404/04/24
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Ethics committee reference number
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IR.IAU.KHSH.REC.1404.095
Health conditions studied
1
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Description of health condition studied
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Type 2 diabetes mellitus
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ICD-10 code
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E11
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ICD-10 code description
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Type 2 diabetes mellitus
Primary outcomes
1
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Description
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The average score obtained from the alexithymia questionnaire in the study subjects is considered as the primary outcome of the study, the sample size is also calculated in the initial proposal based on this variable, and other variables are examined as secondary outcomes.
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Timepoint
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Baseline (pre-intervention) and immediately post-intervention (after 8 weeks of schema therapy).
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Method of measurement
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Valid Persian version of the Toronto Alexithymia Scale-20
Secondary outcomes
1
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Description
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Average score obtained from the Cognitive Flexibility Questionnaire in adults with type 2 diabetes after an 8-week schema therapy intervention.
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Timepoint
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Baseline (pre-intervention) and immediately post-intervention (after 8 weeks of schema therapy).
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Method of measurement
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Valid Persian version of Dennis and Vanderwaal's Cognitive Flexibility Questionnaire
2
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Description
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Average score obtained from the Body Image Concern Questionnaire in adults with type 2 diabetes after an 8-week schema therapy intervention.
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Timepoint
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Pre-test (before intervention) and immediate post-test after intervention (after 8 weeks of schema therapy).
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Method of measurement
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Valid Persian version of Littleton's body image concerns
3
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Description
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Average score obtained from the Food Craving Questionnaire in adults with type 2 diabetes after an 8-week schema therapy intervention.
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Timepoint
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Baseline (pre-intervention) and immediately post-intervention (after 8 weeks of schema therapy).
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Method of measurement
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Valid Persian version of the Sidabnitto Food Craving Trait Questionnaire (PFQ_T)
Intervention groups
1
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Description
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Intervention groups: Participants allocated to the intervention group will receive group-based schema therapy in addition to standard medical care. The intervention will consist of eight 90-minute sessions conducted according to Young’s schema therapy model. The sessions will focus on identification and modification of early maladaptive schemas, enhancement of emotional awareness, cognitive restructuring, experiential techniques (including imagery rescripting), and development of adaptive coping strategies. All sessions will be delivered by a trained therapist under professional supervision, and treatment fidelity will be maintained throughout the study period.
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Category
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Behavior
2
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Description
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Control group: Participants assigned to the control group will receive standard care only. Standard care will include routine diabetes education, general health counseling, and non-specific supportive group sessions routinely provided by the clinic. No structured psychological intervention or schema therapy–based techniques will be administered to this group during the study period. This control condition is designed to reflect usual clinical practice.
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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This study was will be conducted without any external financial support or sponsorship.
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Proportion provided by this source
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10
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Other
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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Sensitive personal data includes clinical information and psychological questionnaires, and there are currently no plans to share them publicly.
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available