Effectiveness of Mindfulness-informed Intervention for Diabetes-related Outcomes Among Individuals With Type 2 Diabetes
Effectiveness of Mindfulness-informed Intervention for Diabetes-related Outcomes Among Individuals With Type 2 Diabetes
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.
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.
Inclusion Criteria:
Exclusion Criteria: