Cognitive behavior therapy for diabetes distress, depression, health anxiety, quality of life and treatment adherence among patients with type-II diabetes mellitus: a randomized control trial

The current research is a prospective randomized control trial (RCT) in which we assessed the effectiveness of CBT using EXP and WLC conditions with T2DM patients using pre-and post-test measures. Outcome measures were obtained at the baseline and post-interventions. The participants were taken from different public and private hospitals of the district Faisalabad, Punjab, Pakistan. The study protocol was approved by the Institutional Review Board (IRB), Government College University, and Faisalabad, Pakistan (i.e., Ref.No. GCUF/ERC/2270). Furthermore, the protocol was also registered and approved by the Thai Clinical Trial Registry (i.e., TCTR20210703002 on 03 July, 2021) with the following URL: https://​www.​thaiclinicaltria​ls.​org/​show/​TCTR20210703002).

Consultant medical doctors first diagnosed patients with T2DM after evaluating them using medical evaluations from reliable laboratories (i.e., Agha Khan University Laboratories & Shaukat Khanum Memorial Trust Laboratories) at outpatient settings of different hospitals. and. Then the diagnosed participants were referred to us for the inclusion in our study. These participants first went through our clinical psychologists for psychological assessment and evaluation. The number of needed participants was calculated through G-Power software using the effect size (f) = 0.20, α = 0.05, power (1-β error prob.) =0.95 with actual power = 0.96 which gave us the total required sample size of56 (experimental and waitlist control conditions combined) [27]. Therefore, in this RCT, 130 participants were initially enrolled for eligibility assessment, 90 patients qualified the inclusion criteria, and they were allocated to two different treatment conditions (i.e., EXP = 45 & WLC = 45) through random assignment (see Fig. 1). A total of 62 patients completed all the required procedures of the present study. Participants’ age range was 23 to 50 years.

In this RCT, people diagnosed with Type-II Diabetes Mellitus (T2DM) availing outpatient treatment facilities under consultant practitioners in different hospitals of Faisalabad were recruited. Participants who achieved mean item score of 3 or above (moderate distress) on DDS and were belonging to mild depressive symptoms category or higher on PHQ were included and allocated for two treatment conditions. Only those patients were included who had been diagnosed at-least 6-month ago (and at most 10 years ago) with T2DM and had been experiencing depressive symptoms for at-least two-weeks. Respondents who were suffering from major depressive disorder, persistent mood disorder and health anxiety disorder were excluded from the study as the protocol of their treatment was out of the scope of the present study. Patients were taken from all socioeconomic statuses. Participants with Type-I diabetes mellitus, duration of illness of less than 6 months and more than 10 years, not availing any medical treatment or receiving inpatient treatment were excluded from the study. Participants with any physical disability, severe physical/head injury, or undergoing any surgical treatment were also excluded from the study. Participants who did not sign the consent form or did not complete all the research procedures were also excluded from the study.

A clinical psychologists conducted in-depth clinical interviews with patients in one-on-one settings. In the interview, the central focus was given to exploring the current presenting complaints, duration of illness, nature of the problems, and symptoms severity in terms of psychiatric problems. In order to cross check, the symptoms severity baseline measures, i.e., DDS (for diabetes distress) and PHQ (for depressive symptoms severity) were administered. Moreover, patients under treatment and experiencing T2DM for the last 6 months and experiencing depressive symptoms more than 2 weeks were selected for this RCT. Structured Clinical Interview for Diagnosis (SCID) was used to screen out any patients suffering from major depressive disorder, persistent mood disorders and health anxiety disorder and such patients were excluded. They were excluded from this RCT because they were referred for further psychological evaluation and treatment (i.e., psychiatric medication if need and extensive psychotherapy along with T2DM treatment). Furthermore, participants who achieved mean item score of 3 or above (moderate distress) on DDS and were belonging to mild depressive symptoms category or higher on PHQ were considered eligible for this RCT because they had diabetes distress and depressive symptoms due to T2DM and they were coming for treatment on regular bases. They were then randomly assigned to the two different treatment conditions.

Participant enrollment started on the 10th of July 2021, and trial completed on the 31st of December 2021, at different hospitals in the Faisalabad. Initially, participants’ baseline assessment was completed in the hospital’s outpatient setting. After qualifying the eligibility criteria, participants were interviewed and were invited for intake at the psychoogical clinic. Participants who met the study criteria and gave written informed consent to participate in the study were registered for this randomized clinical trial. Participants assigned to treatment conditions were assessed (pre-assessment), and at treatment completion, they were again assessed (post-assessment) with the duration of 4 months between the two assessments. We provided 8 to 10 CBT-based therapeutic sessions based on a particular agenda and goal (see interventions). Participants allocated to waitlist control were also assessed at pre-and post-assessment stages with the same time interval allocated for the experimental group.

We randomly assigned participants to treatment conditions so that both conditions were with similar and matchable group characteristics. Furthermore, all the patients were blinded with respect to the identification of the group they were assigned to. We told the participants that they were being randomized to receive psychological treatment, and its goal was to reduce their level of distress and depressive symptoms.

During the initial briefing, the participants were guided about the advantages of adherence and disadvantages of non-adherence, the importance of quality of life [23], reduced depression and anxiety [28], and also about improving their problem-solving abilities [29] to improve physiological functioning and to reduce stress and mood disturbance [30]. Then CBT was administered. CBT is an evidence-based intervention designed to address cognitive and behavioral problems efficiently. The CBT-based treatment plan was structured and delivered individually to each patient. Treatment was completed in 16 weeks, and therapeutic session frequency was one session in 10–12 days intervals with 45–60 minutes. In the initial sessions of the treatment, the therapist discussed about the process of treatment sessions, frequency, duration, the role of the therapist and client, the significance of patients’ active participation, and homework assignments. CBT protocol was structured according to Beck [31], Hilliard et al. [32] and Hood et al. [33]. The main components of the CBT were psychoeducation, cognitive conceptualization, adherence training, activity scheduling, problem-solving, improving coping strategies, muscle relaxation and imagery, and, lapse and relapse prevention (see supplementary material). The therapist asked the patients to come with a diary to write down important notes, daily homework assignments, and activity schedules and to write the current issues for discussion in the upcoming session. We received written feedback after each session. Almost all the patients easily understood the therapeutic process, therapy concept, content, and the mechanism for change.

Descriptive statistics (Mean & SD) was used to calculate sample demographic characteristics, whereas, group characteristics were compared at pre-test using χ² and t-test to compare variables. A repeated measures ANOVA statistic was used for the assessment time (pre- versus post-test) to evaluate the effects and benefits of the interventions (within-group effects). Frequency distribution statistics were used to find out the severity of the symptoms. An alpha of .05 was used for all analyses, and p-value <.01was submitted to Bonferroni correction using IBM SPSS Statistics (Version 25).

A total of 130 participants were recruited, and n = 90 met the inclusion criteria. Participants were equally divided into experimental (EXP) = 45(50%) and waitlist control (WLC) = 45(50%), and they were statistically analyzed (see Fig. 1). There were no significant differences found between EXP vs. WLC among the demographic characteristics; such as age, gender, education, glucose level, family system, occupation, socioeconomic status, duration of illness, types of treatment, duration of treatment, checkup, hypertension, BMI, family history and obesity respectively (see Table 1).

We found a significant mean difference between EXP and WLC conditions in post-testing scores on PHQ which indicates CBT substantially decreased depressive symptoms among patients with T2DM. Findings indicate that significant mean differences were found between EXP and WLC groups on SHAI which indicates that the CBT played a 77% role in reducing the level of health anxiety in the experimental group. Furthermore, significant mean differences were found between baseline and post-testing scores on the scale of EBS, PDS, RDS, IDS and overall DDS between EXP and WLC which indicates CBT reduced 63% emotional burden, 68% physician burden, 66% of regimen distress, 53% of interpersonal distress and 76% of overall diabetes distress of EXP group. Similarly, EXP group was found to be significantly different as compared to WLC on PBNA, ADPB, CRNA and overall GMAS which shows that CBT also improved adherence to treatment; such as: 48% patient behavior related non-adherence, 42% additional disease and pill burden describe non-adherence, 51% cost related non adherence and 57% over all general medication adherence to treatment. Analysis reveals a significant difference between EXP and WLC after CBT on SATS, IMPS, WORS, and overall DQLS which shows CBT sessions improved satisfaction to the degree of 41%, impact to the degree of 43%, non-worried behavior to the degree of 41%, and, overall diabetes patients’ quality of life to the degree of 58%. Furthermore, findings show that CBT produced a significant difference in changing lifestyle as compared to WLC on WALS, MPAS, VPAS and IPAQ which shows that patients with T2DM improved their quality of life after getting CBT sessions; such as: walking activities to the degree of 69%, moderate physical activities to the degree of 23%, vigorous physical activities to the degree of 33%, and overall daily physical activities to the degree of 73% (see Table 2).

The analysis reveals that scores significantly decreased throughout the treatment among the experimental group on PHQ, HAI, and DDS, and the group’s scores enhanced on MAS. CBT played an influential role in addressing depressive symptoms, health-related anxiety, and diabetes distress. On the other hand, CBT played a supportive role in increasing treatment adherence (see Fig. 2).

Findings showed a significant improvement in symptoms of depression in the EXP group. The score in the pre-vs. post of the EXP group is as follows: minimal depressive symptoms 0% vs. 3.7%, mild depressive symptoms 7.4% vs.37.1%, moderate depressive symptoms 40.8% vs. 59.3%; this indicates that CBT significantly reduced depressive symptoms. Similarly, at pre-assessment, the moderate-severe depressive symptoms were in 33.4% of the participants, and severe depressive symptoms were in 18.5% of the participants which got reduced due to CBT at post-assessment, while no significant change was observed in the waitlist control group (see Table 3).

Findings show that CBT significantly improved adherence to treatment among individuals with T2DM. Post-testing analysis reveals that the individuals from the EXP group got an improvement in their treatment adherence considerably. For example, high adherence, which was at 2(7.41%) at baseline, increased 10(37.04%), good adherence, which was at 3(11.12%) at baseline, improved to 12(44.45%), partial adherence, which was at 13(46.15%) at the baseline, shrank to 3(11.12%) as people moved to higher categories, and, low adherence, which was at 6(22.23%) at baseline, again shrank to 2(7.41%) as people moved to higher categories. In the case of WLC, no significant difference was observed, such as, high adherence at baseline had 3(8.57%) participants and at post-analysis stage there were 2(5.71%); good adherence at baseline had 6(17.14%) participants and at post-analysis stage there were 5(14.29%); partial adherence at baseline had 15(42.86%) participants and at post-analysis stage there were 18(51.43%); low adherence at baseline had 9(25.71%) participants and at post-analysis stage there were 6(17.14%); whereas, poor adherence at baseline had 2(5.71%) participants and at post-analysis stage there were 4(11.43%) (see Table 4).

The current study has some limitations. First, only patients with Type II diabetes mellitus were taken in the study. Second, patients were taken only from outpatient departments. Third, major focus was given only to diabetes distress, depressive symptoms, health anxiety, medication adherence and physical activities; many other factors; such as, patients’ coping mechanisms, social and emotional support systems, and others comorbid medical conditions, diagnosed psychiatric disorders and aging factors, were not investigated in this study. Fourth, the cognitive behavior therapy session was mainly designed for patients with T2DM having psychiatric problems, not psychiatric disorders. Fifth point I that we could not enroll a large-enough number of participants (due to Covid-19) in this RCT that come from different age groups, especially above age 50, who might have more diabetes problems. Lastly, this RCT does not say anything about the patients who have a history of chronic diabetes greater than 10 years. Nonetheless, if future researches target the aforesaid areas, it will be a helpful contribution to the literature as well as to the generalizability of the results.

This paper provides contributions to fill the knowledge gap in this ignored area of research. This paper also recommends that future researchers should check the effectiveness of CBT for patients with T1DM and T2DM having severe depressive and anxiety-related disorders. This study provides valuable background for mental health practitioners to treat and develop the guidelines and protocol for patients with diabetes mellitus and other chronic illnesses such as diabetes, cancer, HIV/AIDS. Cognitive behavior therapy played a substantial role in developing patient insight and motivation, so, it is also recommended that other practitioners should carry out qualitative studies on the variables of this research in order to know the qualities and limitations of this strategy and give even more suitable strategies to deal with the problems faced with T2DM within the field of cognitive behavior therapy.