Mental Health IssuePSP-T2DMNCT07456410
Development and Validation of Psycho-Social Program (PSP)
A study testing Psycho-Social Program in people with Mental Health Issue and Depression, run by Government College University Faisalabad at 1 site in Pakistan.
Trial summary
The study aims to determine the effectiveness of a structured psycho-social program (PSP) in improving mental health outcomes among patients with Type 2 diabetes mellitus (T2DM). Read more about this study
- Who is it for?
- Ages 30 to 40 years
- Conditions the study is for
- Mental Health Issue, Depression, Diabetes Distress
- What is being tested?
- Psycho-Social Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 25 Mar 2026to 28 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 40 years
- All sexes
- No healthy volunteers
- Adult
Inclusion Criteria: Participants must be adults aged 30-40 years with Type 2 diabetes, experiencing mild-to-moderate mental health problems related to diabetes will be eligible.
Exclusion Criteria: Participants will be excluded if they have severe psychiatric disorders, serious medical comorbidities, are taking psychiatric medications that may affect outcomes, or are unable to participate in the intervention sessions.
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Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qasir Abbas Dr Dr Qasir Abbas, PhD Clinical Psychology contact
Pakistan1 site
Government College University Faisalabad
Faisalabad, Punjab Province, 38000
About this study
Official title: Development and Validation of Psycho-Social Program (PSP) for Mental Health Problems Among Patients With Type 2 Diabetes Mellitus (T2DM): A Randomised Controlled Trial
The study aims to determine the effectiveness of a structured psycho-social program (PSP) in improving mental health outcomes among patients with Type 2 diabetes mellitus (T2DM). The intervention is designed to reduce symptoms of depression, anxiety, and diabetes-related distress (DD) by addressing maladaptive thoughts, emotional responses, and coping behaviors associated with chronic illness management. Through structured sessions incorporating cognitive restructuring, stress management techniques, behavioral activation, and adaptive coping strategies, participants will learn to manage emotional distress more effectively while improving treatment adherence and daily functioning. The intervention is expected to enhance psychological well-being, promote healthier coping mechanisms, and support better overall adjustment to living with T2DM.
Read the detailed description
This study aims to evaluate the effectiveness of a structured psycho-social program (PSP) in improving mental health outcomes among patients with Type 2 diabetes mellitus (T2DM.) A total of 80 participants, aged 30-40 years, will be recruited from academic and clinical settings in Faisalabad, Pakistan, using purposive sampling. Participants will be randomly assigned to two groups: the intervention group (n=40) will receive 6-8 sessions of the psycho-social program targeting depression, anxiety, diabetes-related distress, medication adherence and quality of life, while the control group (n=40) will receive standard care without the intervention.
Participants with mild-to-moderate psychological distress will be included, whereas those with severe psychiatric conditions, co-morbidities, or under psychiatric medication will be excluded. Pre- and post-intervention assessments using validated instruments will measure changes in mental health outcomes, coping skills, and overall quality of life. The study is expected to show that the psycho-social program reduces psychological distress, enhances adaptive coping, and improves well-being, providing evidence-based guidance for mental health support in Type 2 diabetes patients.
- Being tested
- Psycho-Social Program
- Keywords
- Type 2 Diabetes Mellitus, mental health problems
- Medical subject headings
- Depression, Medication Adherence, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psycho-Social ProgramBehavioural
Participants in the intervention group will receive 6-8 sessions of psycho-social program (PSP) designed to improve mental health outcomes in patients with Type 2 diabetes. The session-wise agenda includes: Session 1 - Psychoeducation about diabetes and mental health; Session 2 - Behavioral Activation to increase engagement in health-promoting activities; Session 3 - Cognitive Conceptualization and Restructuring to identify and challenge negative thoughts; Session 4 - Stress Management; Session 5 - Time and Lifestyle Management; Session 6 - Problem-Solving Skills; and Session 7 - Relapse Prevention and Follow-up Planning to maintain progress and adaptive coping
| Study group | Role | What they receive |
|---|---|---|
| Psycho-Social Program group | Experimental | Participants will receive Psycho-Social Program Receives: Behavioral: Psycho-Social Program |
| Waitlist Control Group | No intervention | The control group will not receive the intervention during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Distress Scale
The Diabetes Distress Scale (DDS) is a 17-item self-report questionnaire that measures emotional distress related to managing diabetes, including worries about treatment, support, and daily disease management. Items are rated on a 6-point Likert scale, with higher scores indicating greater distress. It is widely used to assess the effectiveness of interventions on diabetes-related emotional well-being
Measured: At pre-assessment, after five weeks at post assessment
Patient Health Questionnaire
The Patient Health Questionnaire (PHQ-9) is a 9-item self-report measure used to assess the presence and severity of depressive symptoms over the past two weeks. Each item is rated on a 4-point Likert scale from 0 ("not at all") to 3 ("nearly every day"), with higher scores indicating greater severity of depression. The PHQ-9 is widely used in research and clinical practice to screen, monitor, and evaluate treatment outcomes for depression.
Measured: At pre-assessment, after five weeks at post assessment
Secondary outcomes (5)
Short Health Anxiety Inventory
The SHAI contains 18 items that assess health anxiety independently of physical health status. Items assess worry about health, awareness of bodily sensations or changes, and feared consequences of having an illness. The SHAI has demonstrated good reliability, criterion validity, and sensitivity to treatment
Measured: At pre-assessment, after five weeks at post assessment
Revised Version of Diabetes Quality of Life Questionnaire
Diabetes quality of life Questionnaire (RV-DQOL) instrument has been used to measure quality of life among diabetes patients. It consists of 13 items has three domains such as Satisfaction, Impact, Worry. Patients respond to all items on a 5-point Likert scale. A score of 1 indicates no impact, no worries, or always satisfied. A score of 5 represents always affected, always worried, or never satisfied. The reliability was 0.92 and 0.84, for worry, 0.98 and 0.60, for satisfaction and, for "impact", 0.99 and 0.57, respectively
Measured: At pre-assessment, after five weeks at post assessment
Multidimensional Scale of Perceived Social Support
We will measure perceived social support using MSPSS 12-item, 7-point Likert-type scale (1 = Very strongly disagree, 2 = Strongly disagree, 3 = Mildly disagree, 4 = neutral, 5 = Mildly agree, 6 = Strongly agree, and 7 = Very strongly agree). A composite score is obtained by adding the scores on all 12 items and dividing it by 12. Cronbach alpha for the scale is 0.72 for our sample
Measured: At pre-assessment, after five weeks at post assessment
Diabetes Stigma Assessment Scale
This scale assesses the perceived stigma experienced by individuals with diabetes across three dimensions: social rejection, self-stigma, and discrimination. The DSAS-2 consists of 19 items rated on a 6-point Likert scale, ranging from 1 (Strongly Disagree) to 6 (Strongly Agree). Higher scores indicate greater perceived stigma. The DSAS-2 has been widely used and validated in various populations with diabetes
Measured: At pre-assessment, after five weeks at post assessment
Hill-Bone Medication Adherence Scale (HB-MAS)
The Hill-Bone Medication Adherence Scale (HB-MAS) is a self-report instrument designed to assess patients' adherence to prescribed medication regimens, particularly in chronic conditions like diabetes and hypertension. It includes items on medication-taking behavior, missed doses, and barriers to adherence, rated on a Likert scale. Higher scores indicate better adherence, and the scale is widely used to evaluate the effectiveness of interventions aimed at improving medication management and treatment compliance.
Measured: At pre-assessment, after five weeks at post assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start25 Mar 2026 (estimated)
- Primary completion28 Jul 2026 (estimated)
- Study completion28 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled trial (RCT) will be conducted using a two-arm parallel group design. The study will include an intervention group receiving a structured psycho-social program and a wait-list control group receiving standard care. Equal allocation (1:1 ratio) will be maintained, with 40 participants in each group (n = 40 per group), for a total sample size of 80. Purposive sampling will be used to recruit participants aged 30 to 40 years diagnosed with Type 2 diabetes and experiencing mild-to-moderate psychological distress. The intervention group will participate in 6-8 psycho-social sessions delivered concurrently, focusing on improving mental health outcomes, reducing depression and anxiety, and enhancing coping strategies, while the control group will remain on a wait-list
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Government College University Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qasir Abbas, Government College University Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07456410
- Sponsor's protocol ID
- GCUF-PSPT2DM-2026
- Other IDs
- Ethical Review Committee GCUF
- Acronym
- PSP-T2DM
- Status last verified
- Feb 2026
- First submitted
- 25 Feb 2026
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of Psycho-Social Program (PSP) for Mental Health Problems Among Patients With Type 2 Diabetes Mellitus (T2DM): A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT07456410
- Acronym / sponsor ID
- PSP-T2DM / GCUF-PSPT2DM-2026
- Keywords
- Type 2 Diabetes Mellitus, mental health problems
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Government College University FaisalabadUniversity, hospital or other
- Study start
- 25 Mar 2026 (estimated)
- Primary completion
- 28 Jul 2026 (estimated)
- Study completion
- 28 Aug 2026 (estimated)
- First posted
- 6 Mar 2026 (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 study aims to determine the effectiveness of a structured psycho-social program (PSP) in improving mental health outcomes among patients with Type 2 diabetes mellitus (T2DM). The intervention is designed to reduce symptoms of depression, anxiety, and diabetes-related distress (DD) by addressing maladaptive thoughts, emotional responses, and coping behaviors associated with chronic illness management. Through structured sessions incorporating cognitive restructuring, stress management techniques, behavioral activation, and adaptive coping strategies, participants will learn to manage emotional distress more effectively while improving treatment adherence and daily functioning. The intervention is expected to enhance psychological well-being, promote healthier coping mechanisms, and support better overall adjustment to living with T2DM.
Detailed description
This study aims to evaluate the effectiveness of a structured psycho-social program (PSP) in improving mental health outcomes among patients with Type 2 diabetes mellitus (T2DM.) A total of 80 participants, aged 30-40 years, will be recruited from academic and clinical settings in Faisalabad, Pakistan, using purposive sampling. Participants will be randomly assigned to two groups: the intervention group (n=40) will receive 6-8 sessions of the psycho-social program targeting depression, anxiety, diabetes-related distress, medication adherence and quality of life, while the control group (n=40) will receive standard care without the intervention.
Participants with mild-to-moderate psychological distress will be included, whereas those with severe psychiatric conditions, co-morbidities, or under psychiatric medication will be excluded. Pre- and post-intervention assessments using validated instruments will measure changes in mental health outcomes, coping skills, and overall quality of life. The study is expected to show that the psycho-social program reduces psychological distress, enhances adaptive coping, and improves well-being, providing evidence-based guidance for mental health support in Type 2 diabetes patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled trial (RCT) will be conducted using a two-arm parallel group design. The study will include an intervention group receiving a structured psycho-social program and a wait-list control group receiving standard care. Equal allocation (1:1 ratio) will be maintained, with 40 participants in each group (n = 40 per group), for a total sample size of 80. Purposive sampling will be used to recruit participants aged 30 to 40 years diagnosed with Type 2 diabetes and experiencing mild-to-moderate psychological distress. The intervention group will participate in 6-8 psycho-social sessions delivered concurrently, focusing on improving mental health outcomes, reducing depression and anxiety, and enhancing coping strategies, while the control group will remain on a wait-list
| Arm | Type | Receives |
|---|---|---|
| Psycho-Social Program group | Experimental | Behavioral: Psycho-Social ProgramParticipants will receive Psycho-Social Program |
| Waitlist Control Group | No intervention | –The control group will not receive the intervention during the study period. |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 |
|---|---|---|
| Psycho-Social ProgramParticipants in the intervention group will receive 6-8 sessions of psycho-social program (PSP) designed to improve mental health outcomes in patients with Type 2 diabetes. The session-wise agenda includes: Session 1 - Psychoeducation about diabetes and mental health; Session 2 - Behavioral Activation to increase engagement in health-promoting activities; Session 3 - Cognitive Conceptualization and Restructuring to identify and challenge negative thoughts; Session 4 - Stress Management; Session 5 - Time and Lifestyle Management; Session 6 - Problem-Solving Skills; and Session 7 - Relapse Prevention and Follow-up Planning to maintain progress and adaptive coping | Behavioural | Psycho-Social Program group |
Primary outcome
Diabetes Distress Scale
Time frame: At pre-assessment, after five weeks at post assessment
The Diabetes Distress Scale (DDS) is a 17-item self-report questionnaire that measures emotional distress related to managing diabetes, including worries about treatment, support, and daily disease management. Items are rated on a 6-point Likert scale, with higher scores indicating greater distress. It is widely used to assess the effectiveness of interventions on diabetes-related emotional well-being
Patient Health Questionnaire
Time frame: At pre-assessment, after five weeks at post assessment
The Patient Health Questionnaire (PHQ-9) is a 9-item self-report measure used to assess the presence and severity of depressive symptoms over the past two weeks. Each item is rated on a 4-point Likert scale from 0 ("not at all") to 3 ("nearly every day"), with higher scores indicating greater severity of depression. The PHQ-9 is widely used in research and clinical practice to screen, monitor, and evaluate treatment outcomes for depression.
5 secondary outcomes
Short Health Anxiety Inventory
Time frame: At pre-assessment, after five weeks at post assessment
Revised Version of Diabetes Quality of Life Questionnaire
Time frame: At pre-assessment, after five weeks at post assessment
Multidimensional Scale of Perceived Social Support
Time frame: At pre-assessment, after five weeks at post assessment
Diabetes Stigma Assessment Scale
Time frame: At pre-assessment, after five weeks at post assessment
Hill-Bone Medication Adherence Scale (HB-MAS)
Time frame: At pre-assessment, after five weeks at post assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Qasir Abbas Dr Dr Qasir Abbas, PhD Clinical Psychology contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psycho-Social Program in people with Mental Health Issue and Depression, run by Government College University Faisalabad 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?
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: opening soon, as of the sponsor's last update on 6 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qasir Abbas Dr Dr Qasir Abbas, PhD Clinical Psychology (+923337683133 ext. +10245, qasirabbas47@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Distress Scale (time frame: At pre-assessment, after five weeks at post assessment). 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?
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 6 Mar 2026.