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

NCT ID: NCT07130370

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2025-07-15

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.

Detailed Description

Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder that requires ongoing medical care and self-management to prevent acute complications and reduce the risk of long-term complications. In addition to physical health challenges, many individuals with T2DM experience high levels of diabetes distress (DD), decreased self-efficacy, and difficulties in sustaining recommended lifestyle behaviors. Psychological interventions targeting these factors may enhance both mental and physical health outcomes.

Acceptance and Commitment Therapy (ACT), a third-wave behavioral therapy, emphasizes mindfulness, acceptance of internal experiences, and commitment to value-driven action. ACT aims to increase psychological flexibility - the ability to remain engaged in meaningful activities even when faced with difficult thoughts, emotions, or physical sensations. Although ACT has shown efficacy for various chronic illnesses, there is limited evidence from randomized controlled trials (RCTs) in Pakistan, and none to date for T2DM populations in this setting.

This randomized controlled trial will evaluate the effectiveness of a culturally adapted, group-based ACT program for adults diagnosed with T2DM. The primary objectives are:

To determine whether ACT reduces diabetes distress.

To assess whether ACT improve diabetes self-care behaviors, diabetes distress, diabetes self efficacy, psychological flexibility, self-compassion, coping and perceived social support

Study Design:

Type: Interventional, randomized, parallel-assignment clinical trial.

Participants: Adults (≥18 years) with a diagnosis of T2DM for at least 1 year, able to attend group sessions, moderate to high diabetes distress and providing informed consent.

Sample Size: 50 participants

Arms:

ACT Intervention Group: Participants will attend weekly, 60min group sessions for 6 weeks. The program will integrate mindfulness practices, acceptance-based coping strategies, and value clarification tailored for individuals with T2DM in Pakistan.

Waitlist Control Group: Participants will receive standard medical care during the study period and will be offered the ACT program after study completion.

Outcome Measures:

Primary Outcome: Change in diabetes distress, diabetes self-care practices and psychological flexibility from baseline to post-intervention.

Secondary Outcomes: changes in diabetes self-efficacy, self-compassion, perceived social support and coping.

Data Collection Timeline:

T1: Baseline assessment (questionnaires).

T2: Immediately post-intervention.

Significance:

This study will be the first RCT in Pakistan to examine the impact of ACT on diabetes-related outcomes in adults with T2DM. Findings will contribute to the global evidence base on ACT for chronic illness management and provide culturally relevant recommendations for integrating psychological care into diabetes management in low- and middle-income countries.

Conditions

Type 2 Diabetes (T2DM)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mindfulness-informed Acceptance and commitment Therapy

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

Group Type: EXPERIMENTAL

Acceptance and commitment therapy

Intervention Type: 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.

Waitlist Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Acceptance and commitment therapy

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University of Modern Languages

OTHER

Sponsor Role: lead

Responsible Party

Faiza Batool

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anila Sadaf, PhD

Role: STUDY_DIRECTOR

National University of Modern Languages, Islamabad

Locations

University Counseling Centre

Islamabad, , Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 35810147 (View on PubMed)

Study Documents

Document Type: Informed Consent Form

It is not applicable at this time.

View Document

Related Links

https://pakjmcr.com/index.php/1/article/view/67

Publication of article on systemic review

Other Identifiers

NationalUModernLanguages

Identifier Type: -

Identifier Source: org_study_id