Development and Validation of Psycho-Social Program (PSP) for Mental Health Problems Among Patients With Type 2 Diabetes Mellitus (T2DM): A Randomised Controlled Trial
Phase: NA
Conditions: Mental Health Issue, Depression, Diabetes Distress, Quality of Life, Medication Adherence
Sponsor: Government College University Faisalabad

DEVELOPMENT AND VALIDATION OF PSYCHO-SOCIAL PROGRAM 
(PSP) FOR MENTAL HEALTH PROBLEMS AMONG PATIENTS WITH 
TYPE 2 DIABETES MELLITUS (T2DM): A RANDOMIZED CONTROL 
TRIAL 
 
Sana Latif 
2014-GCUF-0094 
Synopsis submitted in Partial Fulfillment of the requirements for the Degree of 
DOCTOR OF PHILOSOPHY 
 IN 
APPLIED PSYCHOLOGY 
 
DEPARTMENT OF APPLIED PSYCHOLOGY 
GOVERNMENT COLLEGE UNIVERSITY FAISALABAD 
PAKISTAN 
 (2023-2026) 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

DEVELOPMENT AND VALIDATION OF PSYCHO-SOCIAL PROGRAM 
(PSP) FOR MENTAL HEALTH PROBLEMS AMONG PATIENTS WITH 
TYPE 2 DIABETES MELLITUS (T2DM): A RANDOMIZED CONTROL 
TRIAL 
 
  Name: 
 
 
 
 Sana Latif 
Registration No:                                  2014-GCUF-0094 
Roll no.:                                              230403 
Date of admission:                             October 2023 
Date of initiation of research: 
February, 2025 
Probable duration of research: 
1.5 year 
 
Supervisor. 
 
 
Name:   
   Dr. Qasir Abbas  
                      Designation:      Associate Professor Clinical Psychology 
 
Supervisory Committee 
Member 1: 
                     Name:           Dr. Umer Khan 
                    Designation:   Assistant Professor 
               
Member 2: 
                    Name:           Dr. Arif Nadeem 
                    Designation:  Assistant Professor 
 
 
 
 
 
Department of Applied Psychology  
                             Government College University Faisalabad

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Trials structured Study Protocol template 
Title 
Trial’s guidance: 
 DEVELOPMENT AND VALIDATION OF PSYCHO-SOCIAL PROGRAM (PSP) FOR 
MENTAL HEALTH PROBLEMS AMONG PATIENTS WITH TYPE 2 DIABETES MELLITUS 
(T2DM): A RANDOMIZED CONTROL TRIAL 
 
Names protocol contributors 
Sana Latif 
Dr. Qasir Abbas 
Abstract 
Trials guidance:  
Background: Type 2 diabetes mellitus (T2DM) is a chronic condition that requires ongoing self-
management to prevent complications. However, psychosocial factors such as depression, diabetes-
related distress (DD) (Schmitt et al., 2021), health anxiety (HA), stigma and lack of social support 
can significantly hinder patients' ability to manage their quality of life (QOL) and treatment adherence 
(TA) effectively (Gonzalez Heredia et al., 2021). Despite the well-established impact of psychosocial 
factors on diabetes related mental health outcomes, few psychological structured programs (Hamdani 
et al., 2024) comprehensively address the need for psychosocial support for diabetes patients 
(Khowaja et al., 2023 & Saenz et al., 2022). This study aims to develop and validate Psycho-Social 
Program (PSP) for individuals with T2DM, addressing their emotional, behavioral, and social 
challenges to improve overall mental health outcomes.  
Methods: we will conduct randomized control trial with pre- and post- baselines using reliable and 
validated tools such as DDS, PHQ-9, SHAI, DSAS, MSPSS, DQOL and GMAS. Total N=80 diabetic 
patients would be divided into experimental n=40 and waitlist n=40 participants. Participants would 
be taken from different hospitals of the Faisalabad. Patient’s age range would be 30-40 years. Peoples 
with type-1 diabetes and patient with other medical illnesses such as heart disease, cancer patient 
would be excluded from our study. 
 
Discussion: The main purpose of this study is to evaluate the effectiveness of a PSP in improving 
mental health outcomes among patients with Type 2 diabetes mellitus (T2DM). The program aims to 
help participants manage depression, reduce diabetes-related distress, enhance social support, 
improve quality of life (QOL), and increase adherence to treatment. Participants will receive PSP as 
part of the intervention, and pre- and post-assessments will be conducted to measure changes in 
psychological well-being and behavioural functioning. This study is expected to provide evidence-
based guidance for mental health interventions in Type 2 diabetes patients and contribute to better 
treatment outcomes, supporting both patients and healthcare providers in improving overall well-
being. 
Trial registration: Trial would be register. 
Keywords 
Psycho-Social Program, Type 2 Diabetes Mellitus, Depression, Stigma, Social Support, Diabetes 
Quality of Life, Treatment Adherence, Diabetes Patients  
 
 
Administrative information 
Trials guidance: please include this text in your submitted protocol just above the Administrative information table: 
 
Note: the numbers in curly brackets in this protocol refer to SPIRIT checklist item numbers. The order of the items has 
been modified to group similar items (see http://www.equator-network.org/reporting-guidelines/spirit-2013-statement-
defining-standard-protocol-items-for-clinical-trials/). 

Page 4 of 18 
 
Title {1} 
Psycho-social program (PSP) for mental health problems 
among patients with type 2 diabetes mellitus (T2DM): a 
randomized control trial. 
Design. Randomized Control Design 
Population. Patients with Type II Diabetes 
Intervention. Psycho-Social Program 
Trial registration {2a and 2b}. 
Research proposal accepted from the ethical committee and reviews of 
institution then trial would be register. 
 
Protocol version {3} 
Trial would be register. 
Funding {4} 
 This research is not funded.  
Author details {5a} 
Ms Sana Latif 
Dr. Qasir Abbas. 
Name and contact information for the 
trial sponsor {5b} 
No one sponsor of this research. 
Role of sponsor {5c} 
We have no sponsor in our study. 
 
Introduction 
Background and rationale {6a} 
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by insulin 
resistance and hyperglycemia, affecting millions of individuals worldwide(Galicia-Garcia et al., 
2020). According to the International Diabetes Federation (IDF), the global prevalence of diabetes 
continues to rise, with T2DM accounting for approximately 90% of all cases. The global prevalence 
of impaired glucose tolerance is estimated to be 7.5% (374 million) in 2019 and projected to reach 
8.0% (454 million) by 2030 and 8.6% (548 million) by 2045 (Saeedi et al., 2019). Despite 
advancements in medical treatment, achieving optimal glycemic control remains a challenge for 
many patients(Khursheed et al., 2019). Research indicates that psychosocial factors, such as stress, 
depression, anxiety, and lack of social support, significantly impact diabetes self-management and 
overall health outcomes (McCoy & Theeke, 2019). Addressing these factors is crucial, as they are 
often overlooked in traditional diabetes care, which primarily focuses on pharmacological and dietary 
interventions (Khunti et al., 2025). 
Diabetes Distress (DD) is common in Type II Diabetes Mellitus, and is linked with poor 
diabetes control (Tran et al 2021, Zhaung 2020 &  Geleta, et al., 2020). Diabetes distress is a 

Page 5 of 18 
worldwide problem in people with diabetes mellitus of all ages and has been demonstrated across 
various populations and cultures (Onyenekwe et al., 2020). Diabetes distress is defined as an 
emotional state that leads towards the feelings of stress, guilt, and denial that arise from living with 
diabetes and associated with the burden of self-management (Kreider 2017). This is often 
unrecognized responses that arise when individual are overwhelmed when facing the responsibility 
of managing a chronic life-long disease (Aljuiad 2018). Diabetes distress is an essential predictor of 
clinical outcomes in type II diabetes mellitus such as poor self care, self-management, and reduced 
treatment adherence among patients with diabetes (Bawa et al.,2020 & Kretchy et al., 2020).  
Diabetes distress and depression are the most common mental problem factors in diabetes , 
they are highly correlated and affect diabetes self-management, health behavior and related health 
outcomes ( Andreas  2021 & Trans et al,., 2021). Depression is a common co-morbidity in individuals 
with diabetes, compared to those without diabetes (Ellis & Edge 2010), affecting approximately 20% 
of all patients (Daneiol et al 2012). In Pakistan the prevalence was reported as 49.2% for depression 
in patients with Diabetes Mellitus (Malik et al.,2019).  
Diabetes also leads to other psychological problems such as health related anxiety which is 
an obsessive and irrational worry about having a serious medical condition. Health anxiety has been 
infrequently examined in individuals with diabetes (Claude et al., 2013).  Diabetes distress lead to 
health related anxiety because patients with chronic illness such as diabetes commonly experience 
fears of illness or symptoms recurring or worsening as it leads toward lower adherence to treatment, 
fewer positive health behaviors; and increased medical costs (Lebel 2020). There is a significant 
association between anxiety and depression among patient with diabetes (Sharma et al., 2021). 
Diabetes has a significant negative impact on mental health and quality of life (Knowles et 
al., 2020). Diabetes distress is associated with reduced quality of life, because patients with diabetes 
are often burdened by multiple co-morbidities and disease complications that contributes to develop 
these problems among diabetic patients (Burno et al 2019). Diabetes distress, depression and anxiety 
leads toward decreased health related quality of life among diabetic patients (Onyenekwe et al., 
2020). Clinical depression is highly prevalent in diabetes, being up to two times more common among 
patients with diabetes than those without and also reduces overall quality of life and life expectancy 
among diabetic patients (Alzahrani et al 2019). 
Diabetes distress and diabetes self-management share a complex relationship. When 
individuals experience high levels of diabetes distress and depression, they feel overwhelmed, 
frustrated, or emotionally burdened by the demands of managing their condition (Schmitt et al., 
2021). This emotional strain can lead to reduced motivation, avoidance of self-care behaviors, and 
lower adherence to essential diabetes management tasks such as monitoring blood glucose, following 
dietary plans, and taking medications as prescribed. Over time, poor self-management result in 
deteriorating health outcomes, further increasing distress and creating a negative cycle (Lin et al., 
2017).  
Social support serves as a crucial buffer against the challenges posed by diabetes distress. It 
encompasses emotional, informational, and practical assistance from family, friends, and healthcare 
providers. Robust social support has been linked to improved self-care behaviors, and enhanced QOL 
(Baek et al., 2014). A systematic review found that social support positively affects medication 
adherence and disease management, leading to reduced stress and improved acceptance of the 
condition. Adequate social support can mitigate diabetes distress by providing emotional reassurance 
and practical assistance. Conversely, lack of support may exacerbate feelings of isolation and stress. 
Research indicates that individuals with higher social support experience lower levels of diabetes-
related distress(Parviniannasab et al., 2024). 
Diabetes stigma and diabetes distress are significant psychosocial challenges faced by 
individuals living with diabetes. Diabetes stigma involves negative attitudes, blame, and stereotypes 
from society, often leading to feelings of shame or guilt, particularly for those with type 2 diabetes 
who may be unfairly judged for their lifestyle choices (Xing et al., 2023). This stigma can result in 

Page 6 of 18 
discrimination and internalized negative beliefs, further exacerbating emotional struggles. Both 
stigma and distress can lead to mental health issues like anxiety and depression, and reduced 
QOL(Wang et al., 2021). 
The biopsychosocial model provides a comprehensive framework for understanding and 
managing diabetes by considering the interconnected roles of biological, psychological, and social 
factors(Ozturk et al., 2023 ; Amsah et al., 2022). Traditionally, diabetes care focused primarily on 
biological aspects such as insulin resistance, hyperglycemia(Rahman et al., 2021), and medication 
management (Thottapillil et al., 2021). While these elements remain crucial, the biopsychosocial 
model emphasizes that diabetes is not merely a biological condition but a complex interplay of 
various dimensions. Biological factors include genetic predisposition, obesity, and metabolic 
disturbances, which form the foundation of diabetes pathology. Effective management requires 
addressing these aspects through medications, lifestyle modifications, and regular health monitoring 
(Hunt, 2024). 
Existing literature support that different psychological interventions has been used to manage 
psychological problems of patients with diabetes such as cognitive behavioral therapy (CBT) helps 
people change thinking and behavior to manage mental health conditions (Abbas et al., 2023), 
diabetes self-management education (DSME) provides significant effectiveness to lifestyle changes 
and the self-care of T2DM patients (Ernawati et al., 2021), motivational interviewing (MI) is a patient 
centered, following, and directing communication approach that places the responsibility for 
decision-making and effective in reducing HbA1C, depressive symptoms, emotional distress, and 
increasing self-efficacy. Mindfulness based intervention (MBI) increases levels of mindfulness and 
non-judgmental acceptance, and decreases negative reactivity and repetitive negative thinking, which 
in turn lead to improving adherence to medical care and the ability to manage negative emotion (Ni 
et al., 2021), and diabetes wellbeing program (DWELL) for diabetes led to significant improvements 
in metabolic health measures and produced significant positive changes across a range of 
psychological measures such as patient empowerment, illness perceptions, eating behaviors and self-
care behaviors (Hatzidimitriadou et al., 2025). 
While existing psychological therapies are effective for addressing general psychological 
issues such as depression or anxiety, they often fall short in addressing the unique, multifaceted 
challenges faced by individuals with diabetes (Diribe et al., 2024). Diabetes introduces specific 
stressors, including the constant burden of self-management (Yu et al., 2020) (e.g., blood glucose 
monitoring, dietary restrictions), health anxiety, and societal stigma, which generic therapies may not 
fully tackle (Akshatha & Nayak, 2024 & Harvey, 2015) . A tailored psychosocial program is 
necessary because it integrates biological, psychological, and social factors(Kusnanto et al., 
2018)  into a holistic approach, as outlined by the Biopsychosocial Model (Amsah et al., 2022). For 
instance, it can combine medical care with emotional, and social support lead to reduction of diabetes 
distress, health anxiety and stigma, thus improving QOL and treatment adherence providing a more 
comprehensive solution. In essence, a tailored psycho-social program will fill the gaps left by existing 
therapies, offering a comprehensive, diabetes-specific approach that addresses the unique needs of 
individuals living with diabetes (Bajwa, 2024) (Cimo & . Dewa, 2025). 
Objectives {7} 
The current study is designed to measure the role of PSP with T2DM patients. There are following 
objectives of this current study, such as 
 
 To investigate the impact of Psycho-Social Program (PSP) for reducing diabetes-related 
distress, ad depression among T2DM patients 
 To investigate the impact of Psycho-Social Program (PSP) for reducing health anxiety and 
stigma among T2DM patients 
 To investigate the impact of Psycho-Social Program (PSP) for improving quality of life, and 
treatment adherence among individuals with T2DM. 

Page 7 of 18 
 
 
Hypothesis of the Study 
After review of the literature, the following hypotheses such as;  
 Psycho-social program (PSP) will play a significant role to reduce mental health problems 
among patients with T2DM. 
 Psycho-social program (PSP) will play a significant role to reduce diabetes distress, among 
patients with T2DM. 
 Psycho-social program (PSP) will play a significant role to reduce depression among patients 
with T2DM. 
 Psycho-social program (PSP) will play a significant role to reduce health anxiety among 
patients with T2DM. 
 Psycho-social program (PSP) will play a significant role to reduce stigma among patients with 
T2DM. 
 Psycho-social program (PSP) will play a significant role for enhancing quality of life, and 
treatment among individuals with T2DM 
Trial design {8} 
 Randomized control trial design would be used in this study. It would be two arm study and 
there would be two groups an experimental and wait-list control group. Experimental group will 
receive intervention and another group would be placed in waitlist. In this research, parallel group 
design would be used. We will give treatment to all participants in a parallel way.  Allocation ratio 
and framework would be equivalence i.e., treatment group and control group would be equal number 
of participants.   
Methods: Participants, interventions and outcomes 
Study setting {9} 
Randomized control trial design would be used in this study to find out the impact of PSP for 
psychiatric comorbidity and adherence to treatment among patients with T2DM. 
Participants 
 
In this study, the participants would be patients diagnosed with type II diabetes mellitus. For 
this purpose, N=80 diabetic patients would be approached from different hospitals of Faisalabad. 
Sample would be comprised of male and female with type II diabetes mellitus. In order to collect the 
data for our study, purposive sampling technique would be used. Patient age range would be 30-40 
years. Participants would be divided into two group each group will be comprised of n=40. One group 
will be experimental group and second group will be wait-list control group. 
Eligibility criteria {10} 
 
The patients diagnosed with Type II Diabetes Mellitus (T2DM) male and female participants aged 
30-40 years will be included in our study. The participants from different hospitals or clinic of 
Faisalabad will be included in our study. The patient with Type 1 Diabetes Mellitus (T1DM) would 
be excluded from our study. The patient with other serious co-morbid medical illness such as cancer, 
heart problems, and stroke will be excluded from our study. The patient with physical disability would 
be excluded from our study.  
Who will take informed consent? {26a} 
 Researcher will be taken consent from all of the participants through consent form.  
Additional consent provisions for collection and use of participant data and biological 
specimens {26b} 
Informed consent will be given and confidentially would be ensures. Researcher will guide 
the participant that their participation would be volunteer.  
Interventions 
Psycho-Social Program (PSP) would be used as a intervention strategy for the diabetes 

Page 8 of 18 
patients to deal with their diabetes distress, health anxiety, depression, quality of life and adherence 
to treatment. 
Explanation for the choice of comparators {6b} 
Psycho-Social Program (PSP) would be used as a intervention strategy for T2DM patients to deal 
with their depression, stigma, social support,  quality of life and adherence to treatment. 
Intervention description {11a} 
Structured intervention program for the patients with mental health problems, who availed 
cognitive behavior therapy and who availed both medication and cognitive behavior therapy is given.   
 
Session   
Target Goals 
Objectives   
Techniques  
Session 1 Introduction & Goal Setting  
Build rapport and set individual 
goals for self-management. 
Group introductions, g
Motivational Interview
Session 2 Managing Diabetes Distress  
Address emotional responses and 
coping strategies. 
CBT techniques: thoug
cognitive restructuring
Session 3  Enhancing Self-Management 
Skills  
Building Motivation and 
Resilience 
Build skills for medication, diet, 
and glucose management. 
Foster motivation and long-term 
adherence. 
Self-monitoring logs, p
exercises. 
Group reflections, suc
reinforcement. 
Session 4 Social Support and 
Relationship Building  
Stress Management and 
Emotional Well-being  
Strengthen social networks for 
emotional support. 
Develop stress management 
techniques to reduce burnout. 
Peer support groups, r
exercises. 
Guided mindfulness se
exercises. 
Session 5 Muscle relaxation and 
breathing exercise  
Engage family in supporting 
diabetes management. 
Family counseling ses
communication skill-b
 

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Criteria for discontinuing or modifying allocated interventions {11b} 
Those participants who will not interested in intervention due to their time if they will not come at 
their session time as well as they quit the intervention then we will remove in our research and if we 
will need to modify the treatment plan then we will modify the intervention according to the 
participants benefit. 
Strategies to improve adherence to interventions {11c} 
Strategies to learn how to manage depression, stigma, and enhance social support, quality of 
life, and adherence to treatment through deep breathing exercise, problem solving worksheet, 
exposure therapy and role playing. 
Relevant concomitant care permitted or prohibited during the trial {11d} 
Participants will be permitted to follow the guideline given by the therapist as to take care of 
their mental health by following the assignment for each session and prohibited to perform any 
activity that can hinder to improve their adherence such as avoid becoming worried, anxious etc.  
Provisions for post-trial care {30} 
We have study follow up plan and in-contact with hospital doctors then we will assess the 
participants after 6 months 
Outcomes {12} 
This study would provide valuable information to the mental health practitioners to treat and 
develop the guidelines and protocol for patients with T2DM. PSP played substantial role as 
supportive intervention to develop insight, motivation and positive attitude toward treatment as well 
as to enhance adherence to treatment among patients with T2DM. And there would be substantial 
decrease in the stigma and depression, and increase social support, quality of life and adherence to 
treatment among patients with T2DM after the completion of the intervention program. 
Participant timeline {13} 
In this research, the patient would be diagnosed with T2DM. For this purpose, N=80 
diagnosed patients with T2DM would be taken from hospital. Sample would be comprised of both 
males and females. In order to collect the sample for the desired study, purposive sampling technique 
would be used. Patient’s age range would be between 20 to 40 years. Participant would be divided 
into two groups. In group one, the diagnosed patients of T2DM who are availing antiretroviral therapy  
group diagnosed T2DM patients would be taken and cognitive behaviour therapy would not 
be provided to them. Each of the group will be comprised of n= 40 
 
 
 
 
 
 
 
 
 
 
 
 

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CONSORT Flowchart Diagram of T2DM 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Note: This diagram completed after the completion of this research.  
 
Sample size {14} 
In this study, patients would be recruited from different hospital of Faisalabad. Participants’ 
enrollment started after trial registration and a three to four months period would be allocated to each 
patient to achieve treatment goals. Initially patients would be assessed for eligibility, inclusion and 
Assessed for eligibility (n=200) 
Excluded (n= 0) 
   Not meeting inclusion criteria (n=0) 
   Declined to participate (n= 0) 
  Other reasons (n=) 
Analysed (n=0) 
 Excluded from analysis (give reasons) (n= 0) 
Lost to follow-up (give reasons) (n=0) 
Discontinued intervention (Due to incomplete 
treatment intervention) (n=0)  
Allocated to treatment condition (n= 0) 
 Received allocated intervention (n= 0) 
 Did not receive allocated intervention 
(Experimental group) (n= 0) 
Lost to follow-up (give reasons) (n=0) 
Discontinued intervention (They did not 
complete post-assessment) (n=0) 
Allocated to Control Condition (n= 0) 
 Received allocated intervention (n=0) 
 Did not receive allocated intervention 
(control group) (n=0) 
Analysed (n=0) 
 Excluded from analysis (Due to severe 
psychiatric problems) (n= 0) 
Allocation 
Analysis 
Follow-Up 
Randomized (n= 0) 
Enrollment 

Page 11 of 18 
exclusion criteria would be checked. In the next step, participants would be allocated to interventions 
after the baseline assessment. Then participants would receive the interventions.  
Recruitment {15} 
The participants would be recruited from the settings of hospitals of Faisalabad. 
Assignment of interventions: allocation 
Initially researcher would take permission from hospital of Faisalabad and data would be 
collected from hospital. Informed consent would be given and confidentially would be ensures. 
Structured interview would be performed, the first meeting with experimental and waitlist control 
group would be to explain the nature and purpose of this intervention. The first group will receive 
PSP and second group will not receive PSP. Total 6-8 structured sessions of PSP would be conducted 
by following the training modules of cognitive behavior therapy. After conducting interviews with 
the T2DM patient’s one on one assessment thoroughly conducted on each patient who will receive 
cognitive behavior therapy to record their baseline score. Then sessions of PSP will be conducted 
with T2DM patients, each session will agenda session. The review of each session will be performed 
with the help of session record sheet. After the completion of intervention program the comparison 
of both groups will be recorded separately and then compare for findings the difference and to check 
the effects of the intervention. 
Sequence generation {16a} 
Initially researcher would take permission from hospital and data would be collected from 
hospital. Informed consent would be given and confidentially would be ensures. Structured interview 
would be performed, the first meeting with experimental and waitlist control group would be to 
explain the nature and purpose of this intervention. The experimental group will receive PSP and 
control group will not receive PSP. Total 8 structured sessions of cognitive behavior therapy would 
be conducted by following the training modules of PSP. After conducting interviews with the patients 
on one assessment thoroughly conducted on each patient who will receive cognitive behavior therapy 
to record their baseline score. Then sessions of cognitive behavior therapy will be conducted with 
patient, each session will be agenda session. The review of each session will be performed with the 
help of session record sheet. After the completion of intervention program, the comparison of 
experimental and control groups will be recorded separately and then compare for findings the 
difference and to check the effects of the intervention. 
Concealment mechanism {16b} 
Intervention would be provided physically i.e., face to face interaction between researcher 
and participants.  
Implementation {16c} 
Therapist will generate the allocation sequence and would enroll the T2DM diagnosed 
patients. And then participants would be randomly assign to the experimental and waitlist control 
group. 
Assignment of interventions: Blinding 
Who will be blinded {17a} 
No one will be blinded after assignment to interventions. At initial of the study, researcher 
describe the purpose and procedure of the study to the participants and take consent from all 
participants then researcher would start the study. 
Procedure for unblinding if needed {17b} 
In this research, researcher and participants would be unblind because the purpose of this to 
promote and manage their depression, stigma and enhance social support, quality of life and 

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adherence to treatment. Before, starting the study researcher would take informed consent from all of 
the patient and give briefing about the study. Then those patients show willingness to take part in the 
study then research recruit those patients. 
Data collection and management 
Plans for assessment and collection of outcomes {18a} 
Following assessment tools would be used to collect the data from T2DM patients. 
Demographic form. 
A demographic form will be formed to obtain necessary information about each patient i.e. 
age of the patient, education, socioeconomic status, and family system, and total family members, 
marital status, duration of illness, hospital name. This form will be used for further analysis of the 
result section. 
Diabetes Distress Scale (DDS-17 Polonsky, Fisher, Esarles, Hesseler & Mullan 2005).   
Diabetes Distress Scale (DDS-17) is used to assess the distress related to diabetes. It is consist 
of 17 items. Each item of the DDS-17 has a six-point Likert scale from 1 (indicating no problem) to 
6 (indicating a very serious problem). The total DDS-17 score was calculated by summing a patient’s 
responses to the 17 items and dividing by the number of items on the scale. DM distress was 
considered clinically significant (moderate distress) if the total score was > 2, and severe if the score 
was ≥ 3. DDS-17 also assesses other components including emotional-related distress, physician-
related distress, regimen-related distress, and interpersonal-related distress.  Its reliability was 
reported 0.87 Cronbach’s alpha.  
 
The Patient Health Questionnaire (PHQ-9;  Ahmad 2018).  
The PHQ-9 is the nine item depression scale of the Patient Health Questionnaire. It is based 
directly on the diagnostic criteria for major depressive disorders in Diagnostic and Statistical Manual 
Fourth Edition. The PHQ-9 scores "0" (not at all) to "3" (nearly every day). We will use Urdu version 
of this scale translated by Ahmed, Akhtar, & Shah (2018). 
Short Health Anxiety Inventory (SHAI; Salkovskis, 2002) 
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 (Salkovskis et al., 2002).  
Revised Version of Diabetes Quality of Life Questionnaire (RV-DQOL 13 Bujang et al. 2018 ). 
 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 (Bujang et al 2018). 
Multidimensional Scale of Perceived Social Support (MSPSS Zimet, 2016) 
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. 
Diabetes Stigma Assessment Scale (DSAS-2 Browne et al., 2016) 
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). 

Page 13 of 18 
Higher scores indicate greater perceived stigma. The DSAS-2 has been widely used and validated in 
various populations with diabetes. 
Plans to promote participant retention and complete follow-up {18b} 
Major focus was given to patients’ level of motivation and attitude toward treatment 
Participants would be given motivation by the therapist to be the part of study to achieve a better 
mental health and avoid the distress associated with their illness. The participants who will leave the 
study incomplete and would show less interest for being a part of study would be discontinuing the 
study. . 
Data management {19} 
Data manage on the SPSS. First, patient screen out and then select patient who meet inclusion 
criteria. Next step is baseline assessment to experimental and control group, and after that give PSP 
to the experimental group then comparison between experimental and control group. At last, compare 
the pre and post assessment of the patients  through paired sample T-test.    
Confidentiality {27} 
Demographic sheet would be used to collect personal information of the participants. 
Confidentiality would be ensured to the client that there information would be used only for research 
purpose and would be kept in privacy. 
Plans for collection, laboratory evaluation and storage of biological specimens for genetic or 
molecular analysis in this trial/future use {33} 
N/A 
Statistical methods 
Statistical methods for primary and secondary outcomes {20a} 
Statistical Analysis with descriptive statistics (M, SD, f), Chi-square statistics and t-test for matchable 
group characteristics, and repeated measures ANOVA for pre-and post-outcomes evaluation will be 
conducted. In this study sample sizes will be calculated using G-Power Software. All analyses will 
be conducted using SPSS-26. 
Interim analyses {21b} 
Dr. Qasir Abbas play as an interim analysis. He provides guidelines about the study. 
Methods for additional analyses (e.g. subgroup analyses) {20b} 
Descriptive statistics (i.e., Mean, Standard Deviation, Frequencies etc) will be used to 
calculate demographic characteristics of the sample. 
Methods in analysis to handle protocol non-adherence and any statistical methods to handle 
missing data {20c} 
We will follow the expert opinion to handle any issues related to non-adherence and missing data in 
our data. 
Plans to give access to the full protocol, participant level-data and statistical code {31c} 
All statistical computation would be calculated by using SPSS 24.0. 
Oversight and monitoring 
Composition of the coordinating center and trial steering committee {5d} 
The participants would be recruited from the hospital Faisalabad. 
Composition of the data monitoring committee, its role and reporting structure {21a} 
Supervisor; Dr. Qasir Abbas will monitor. 

Page 14 of 18 
Adverse event reporting and harms {22} 
In case if we face any inauspicious event in our study the entire research team will act upon to 
encounter and to prevent the harm to the study participant. 
Frequency and plans for auditing trial conduct {23} 
Once we conduct the trial then, we will provide the trial to participants.   
Plans for communicating important protocol amendments to relevant parties (e.g. trial 
participants, ethical committees) {25} 
All protocols will be designed after consultation with ethical committees, BOS etc and Institutional 
Review Board (IBR), then my topic are approved.  
 
Dissemination plans {31a} 
No sponsor for the study. 
Discussion 
Before initiating the study, research team will ensure to foreclose any practical or operational 
issues 
involved 
in 
performing 
the 
study 
to 
avoid 
future 
troublesome. 
Trial status 
Research proposal accepted from the Ethical Committee and Institutional Review Board 
(IRB) 
then 
trial 
would 
be 
register. 
Abbreviations 
The list of abbreviations is: 
Psycho-Social Program (PSP) 
Diabetes Distress (DD) 
Patient Health Questionnaire PHQ-9 
Multidimensional Scale of Perceived Social Support (MSPSS) 
Declarations 
 I, Ms Sana Latif, solemnly declare that the work submitted in thesis entitled “psycho-social 
program (psp) for mental health problems among patients with type 2 diabetes mellitus (t2dm): a 
randomized control trial” is my own and will not be presented to any other institution or university 
for the degree. Neither work will be plagiarized. It is an original work. 
 
This work will be completed at the Institute of Applied Psychology, Government college 
University Faisalabad under the supervision of Dr. Qasir Abbas.  
Acknowledgements 
First of all, I thank to Allah Almighty for his faithfulness and protection throughout my study 
that will be made it possible for me to encounter this success. I take this great opportunity to sincerely 
thank a number of people and institution who will be made it possible for my research paper  
 
My gratitude goes to my supervisor Dr. Qasir Abbas for dedicated to support and endless that 
he will offer me throughout my research process. He will put great effort in helping me in 
accomplishing this work successfully. Without his effort, this research would not have been what it 
looks like now. I will also very thankful to the chairperson of our institute. I would also express my 
great and sincere thanks to the administration of hospital and clinics and participants who will take 
part in our study to give permission and allow conducting this experiment.  My special thanks will 
go to my supportive family that I can’t find words to explain.  
Authors’ contributions {31b} 
 
Sana Latif Student of PhD Applied Psychology from GCUF 
 
Dr. Qasir Abbas as a supervisor 
 

Page 15 of 18 
 
 
Funding {4} 
There is no any kind of funding in research. 
Availability of data and materials {29} 
Data will be available if journal demand or for the beneficial informant for the researchers 
Ethics approval and consent to participate {24} 
After review of literature, the topic was decided. Then proposal is prepared and submitted in 
the Department Research Committee for technical review. Afterwards proposal will be defended in 
the meeting of the Board of advance Studies. Then, permission would be taken from department of 
Applied Psychology, Government College University Faisalabad. Reliable and valid psychological 
testing tools would be used in current study. Scale’s permission would be taken from the authors. 
 
In the process of study, we would adhere to four key elements for the person's right and 
dignity, competency, responsibility, integrity. Permission letters were taken from the head of 
department of Applied Psychology and then it will be submitted to the higher authorities of different 
colleges. A complete procedure of getting permission from the colleges will be ethically conducted. 
The complete idea of study implementation will be discussed with the Consultants to ensure a pure 
true experimental study. After their confirmation of order letter, the process of collecting desired 
information from targeted sample will be precede ahead. Inform the patients about possible risks and 
benefits of the study as by explaining it clearly to the subjects, also told the purpose of the study 
clearly. Obtain their written informed consent before involved the patients into the study, give the 
participants necessary details before collection of data. The subjects would be assured that their 
personal information will keep confidential and only used for research purpose. 
Consent for publication {32} 
 This research will be conducting by Sana Latif, student of Institute of Applied Psychology 
under the supervision of Dr. Qasir Abbas. The purpose of this research is to explore the impact of 
PSP to reduce the level of diabetes distress and depression, and to improve the level of social support, 
quality of life and treatment adherence among patient with T2DM. During this research you will be 
to fill demographic sheet and questionnaires. All of your information regarding research will be kept 
confidential and used only for research purpose. If you want to quit the research, you have to complete 
right to quit the research at any point.  
Competing interests {28} 
There is no Financial and other competing interests for principal investigators for the overall 
trial and each study site. 
Authors’ information (optional)  
Miss Sana Latif, student of the PhD Applied Psychology Government College University, 
GCUF Faisalabad.  
Supervisor: Dr. Qasir Abbass, Assistant Professor Government College University, GCUF 
Faisalabad.  
 
 
 
 
 
 

Page 16 of 18 
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