Mindfulness-informed Intervention for Improving Diabetes Outcomes in Type 2 Diabetes

NCT07130370 | Completed DMC

• 1 other identifier: NationalUModernLanguages
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if Acceptance and Commitment Therapy (ACT), a mindfulness-based psychological approach, can improve health and emotional well-being in adults with type 2 diabetes. The main questions it aims to answer are: Can ACT reduce diabetes-related distress? Can ACT improve self-care behaviors? Can ACT improve psychological flexibility? Researchers will compare people who receive ACT to those in a waitlist control group to see if ACT has better effects on diabetes-related outcomes. Participants will: Attend ACT sessions tailored for people with type 2 diabetes Complete questionnaires about their health, mood, and self-care.

Conditions

Type 2 Diabetes (T2DM)

Keywords

Mindfulness, Acceptance and commitment therapy, diabetes distress, psychological flexibility, diabetes self-care practice; Mindfulness; Acceptance and commitment Therapy; Type 2 Diabetes; Diabetes Distress; Diabetes Self-care Practice; Psychological Flexibility

Outcome Measures

Primary Outcomes (2)

• Diabetes Distress Assessment Scale

  It is a five point liker scale where "5" means there is a "serious problem" and 1 means "there is a not a problem". high score indicates greater level of diabetes distress.

  Before intervention and after six weeks of intervention

• Summary of Diabetes-Self-care activity

  It is 15 item scale to measure diabetes self-care practices. It is based on number of activities being performed the last week. Therefore response scale is from 0 till 7. where "0" means this particular self care activity has not been performed in the last week and "7" means it has been performed every day. Higher the score, higher the number of diabetes self-care practices performed last week. These include diet, blood glucose testing, Exercise, Foot care and Medications.

  Before intervention and after six weeks of intervention

Secondary Outcomes (1)

• Brief Coping Inventory

  Before intervention and after six weeks of intervention

Study Arms (2)

Mindfulness-informed Acceptance and commitment Therapy

EXPERIMENTAL

In this arm, culturally adapted acceptance and commitment therapy will be utilized to improve diabetes outcomes among individuals with type 2 diabetes

Behavioral: Acceptance and commitment therapy

Waitlist Control Group

NO INTERVENTION

This group would be receiving routine diabetes treatment by primary health care provider (Treatment as usual).

Interventions

Acceptance and commitment therapy BEHAVIORAL

Acceptance and Commitment Therapy (ACT) is a mindfulness-informed behavioral intervention that helps individuals accept difficult thoughts and feelings, clarify personal values, and commit to meaningful actions. It aims to improve psychological flexibility, enabling healthier coping with life's challenges.

Mindfulness-informed Acceptance and commitment Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• having diagnosis of type 2 diabetes at least since one year and having moderate to high diabetes distress.

You may not qualify if:

• Psychosis, Dementia, Terminal Renal failure or other life threatening condition

Sponsors & Collaborators

• National University of Modern Languages: lead

Study Sites (1)

University Counseling Centre

Islamabad, 44000, Pakistan

Location

Related Publications (1)

• Fisher L, Polonsky WH, Perez-Nieves M, Desai U, Strycker L, Hessler D. A new perspective on diabetes distress using the type 2 diabetes distress assessment system (T2-DDAS): Prevalence and change over time. J Diabetes Complications. 2022 Aug;36(8):108256. doi: 10.1016/j.jdiacomp.2022.108256. Epub 2022 Jul 5.

  PMID: 35810147 BACKGROUND

Related Links

• Publication of article on systemic review

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Anila Sadaf, PhD

  National University of Modern Languages, Islamabad

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 19, 2025
• Study Start: April 1, 2025
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)