Type 2 Diabetes (T2DM)NCT07130370
Mindfulness-informed Intervention for Improving Diabetes Outcomes in Type 2 Diabetes
A study testing Acceptance and commitment therapy in people with Type 2 Diabetes (T2DM), run by National University of Modern Languages at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes (T2DM)
- What is being tested?
- Acceptance and commitment therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2025to 15 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- having diagnosis of type 2 diabetes at least since one year and having moderate to high diabetes distress.
Who cannot join
- Psychosis, Dementia, Terminal Renal failure or other life threatening condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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)
- Being tested
- Acceptance and commitment therapy
- 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
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and commitment therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Before intervention and after six weeks of intervention
Secondary outcomes (1)
Brief Coping Inventory
It is translated version of BRIEF Cope Scale (Brief Coping Inventory) in Urdu. It is a four point liker scale from 0-4. Where higher score indicates greater level of particular coping strategy is used by the individual. The subscales include emotion-focused coping, problem-focused coping and avoidance coping.
Measured: Before intervention and after six weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2025
- Study start1 Apr 2025
- Primary completion15 Jul 2025
- Study completion15 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Modern Languages
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Faiza Batool, National University of Modern Languages
- Investigators
- Anila Sadaf, PhD, Study director, National University of Modern Languages, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07130370
- Sponsor's protocol ID
- NationalUModernLanguages
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It will be shared upon request.
Publications
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.
PubMed 35810147
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mindfulness-informed Intervention for Diabetes-related Outcomes Among Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07130370
- Acronym / sponsor ID
- NationalUModernLanguages
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National University of Modern LanguagesUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 15 Jul 2025 (actual)
- Study completion
- 15 Jul 2025 (actual)
- First posted
- 19 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-informed Acceptance and commitment Therapy | Experimental | Behavioral: Acceptance and commitment therapyIn this arm, culturally adapted acceptance and commitment therapy will be utilized to improve diabetes outcomes among individuals with type 2 diabetes |
| Waitlist Control Group | No intervention | –This group would be receiving routine diabetes treatment by primary health care provider (Treatment as usual). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- having diagnosis of type 2 diabetes at least since one year and having moderate to high diabetes distress.
Key exclusion criteria (1 listed)
- Psychosis, Dementia, Terminal Renal failure or other life threatening condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acceptance and commitment therapyAcceptance 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. | Behavioural | Mindfulness-informed Acceptance and commitment Therapy |
Primary outcome
Diabetes Distress Assessment Scale
Time frame: Before intervention and after six weeks of intervention
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.
Summary of Diabetes-Self-care activity
Time frame: Before intervention and after six weeks of intervention
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.
1 secondary outcome
Brief Coping Inventory
Time frame: Before intervention and after six weeks of intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Background: PubMed 35810147Fisher 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.
- Publication of article on systemic reviewLink provided by the sponsor.
- Individual participant dataSharing planned: No. It will be shared upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anila Sadaf, PhD study director
National University of Modern Languages, Islamabad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and commitment therapy in people with Type 2 Diabetes (T2DM), run by National University of Modern Languages at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Distress Assessment Scale (time frame: Before intervention and after six weeks of intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07130370, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2025.