Study design and description of the participants
This study was designed as a single-blind, randomised controlled trial. The sample size was determined using 5% (p = 0.05) Type 1 error, 80% strength through statistical power analysis, and a two-way hypothesis testing and consisted of 33 subjects per group. Participants for this study were selected from individuals who presented at the internal medicine outpatient department of a state hospital in Turkey. Individuals who were diagnosed with type 2 diabetes mellitus, were aged between 18 and 65 and were literate in Turkish were included in this study, and individuals with a diagnosis of a mental illness or cancer were excluded from this study. A total of 86 individuals were referred to this study.
Eligibility assessments of individuals were taken before allocation to the study groups. Among the 86 referred individuals, 10 were excluded from this study because they did not meet the inclusion criteria. The remaining 76 individuals were randomly assigned (using the simple random number table) to either the intervention group or control group (n= 38 each). For the control and intervention groups, randomisation was applied separately using stratification variables produced by the website Research Randomizer (https://www.randomizer.org/#randomize). A simple random number table was created for each group. Numerical distribution was ensured as 2 sets of unique numbers were formed. The participants were assigned to the groups according to the randomisation number. The baseline evaluation was carried out at the first meeting that was individually planned for the participants in each group after randomisation. Nine subjects discontinued participation for various reasons during the process, and this study was therefore completed with 67 individuals with type 2 diabetes. Figure 1 shows the CONSORT flow diagram of this study.
All subjects gave consent after they were provided with verbal and printed information about this research project. Our study was conducted in accordance with the Helsinki Declaration (revised in 2013) after ethical approval was obtained (approval number: GO15/731). This study was conducted between June 2015 and September 2017.
The scales described in detail below were completed by all participants. Participants in both groups completed the scales face-to-face with the same therapist who provided guidance. The individuals were assessed at baseline, after six weeks, and after three months.
Measurements
Socio-demographic and clinical features form: Each participant was asked to complete a form to obtain demographic information, such as age, gender, marital status, health-related habits (e.g., smoking and alcohol consumption), body mass index (BMI) and medical history (e.g., monitoring, family history, and comorbidity).
Primary outcomes
The Canadian Occupational Performance Measure (COPM): The COPM is based on a semi-structured interview method and helps individuals identify and prioritise activities of importance that they have difficulty performing (31). The COPM can be used as both an intervention and an assessment tool. Specifically, the COPM is a measure of self-perceived occupational performance areas in self-care (personal care, functional mobility and community management), productivity (paid/unpaid work, household management and play/school) and leisure (quiet recreation, active recreation and socialisation). First, the importance of each occupation was rated on a 10-point scale where 1 is “not important” and 10 is “extremely important”. Then, up to five of the most important activities were rated for performance from 1 (“do not perform well”) to 10 (“perform very well”) and for satisfaction from 1 (“not satisfied”) to 10 (“very satisfied”). The obtained performance and satisfaction scores were separately collected and divided by the number of activities to obtain a performance score and a satisfaction score (32). The test-retest reliability of the COPM is within the acceptable range; intraclass correlation and obtained coefficients for individuals with chronic diseases ranged from scores of 0.86 to 0.89 for performance and 0.76 to 0.88 for satisfaction (33-35). The COPM has shown validity and reliability in Turkish samples (36). The COPM is recommended for use in diabetic subjects to identify what is important and their priorities (10).
Secondary outcomes
The Diabetes Empowerment Scale (DES): The DES is used in the measurement of diabetes-related psychosocial self-efficacy and consists of 28 items with three subscales as follows: managing the psychosocial aspects of diabetes; assessing dissatisfaction and readiness to change; and setting and achieving diabetes goals (37). Each question is rated between 1 for “strongly disagree” and 5 for “strongly agree”. Thus, higher scores indicate better psychosocial self-efficacy levels. The DES is a valid and reliable scale in Turkish populations (38).
The Brief COPE: The Brief COPE measures strategies for coping with stress and includes 14 subscales in which two items are grouped into two coping strategies: effective approach coping (active coping, acceptance, positive reframing, planning, use of emotional or instrumental support) and ineffective avoidant coping (denial, self-distraction, substance use, behavioural disengagement, venting and self-blame) (39). It is uncertain whether the humour and religion subscales are effective or ineffective coping styles; therefore, they were excluded from both analyses (40). Each question has a selection range from 1 (“I have not been doing this at all”) to 4 (“I have been doing this a lot”), and the higher subscale scores indicate using those coping strategies more. These tools are also valid and reliable in Turkish populations (41).
The World Health Organisation-Five Well-Being Index (WHO-5): The WHO-5 is used for the psychometric evaluation of emotional well-being, depression, and quality of life. This measure consists of five statements, which respondents rate on a scale of 0 (“never”) to 5 (“all the time”) considering the previous two weeks (42). The raw value, ranging from 0 to 25, is multiplied by four to determine the final score, with 0 representing the worst possible well-being and 100 the best. The WHO-5 has Turkish validity and reliability (43, 44), and a cut-off of less than 50% has been identified to screen for depression and reduced well-being (45).
Intervention programme
The complex nature of diabetes mellitus affects individuals' participation in life in different ways. This intervention programme is designed to use PST to overcome the problems of participation in meaningful occupations defined by individuals.
This intervention programme included the four steps of PST: (1) problem definition, (2) generation of alternatives, (3) decision-making, and (4) solution implementation and verification (46). In particular, the intervention programme considered the demands and priorities of the person at the stage of "problem definition" and the self-perceived occupational performance problems that were meaningful to the person.
This programme, which includes assessment tools, education, and PST, was implemented by the same therapist who has a cognitive behavioural therapy certificate and three years of PST experience. The intervention programme was six weeks in duration with one session a week, and each session lasted approximately 60 minutes. The intervention was face-to-face and individually held in a clinical setting at a suitable time for the person. The content of the six-week programme is explained in detail below.
Week 1: The purpose of the first session was for the intervention group participant to complete all measurements together with the therapist. The therapist also explained how to complete the diary on a typical day. The therapist and participants together identified the problematic activities with the COPM. The COPM allowed them to identify the individuals' goals regarding performance problems in their meaningful activities. The COPM was used as both an assessment and an intervention tool for the intervention group.
In addition, the first week is equivalent to the “problem definition” step of PST for the intervention group. Briefly, this step included setting a measurable, realistic, and attainable goal for the solution in the first week (47).
Week 2: The purpose of this session was to provide education with information about diabetes mellitus. The education was delivered one-to-one through a PowerPoint presentation. This educational information follows the National Standards for Diabetes Self-Management (48) and is based on a Person-Environment-Occupation Model (49). We, therefore, focused on therapeutic lifestyle changes that include basic knowledge and skills relating to diabetes as well as personal, environmental, and occupational factors that affect the condition. The emphasis was on the elements of daily life that could support or prevent effective diabetes management and the importance of identifying these elements.
Week 3: In this session, the “generation of alternatives” and “decision making” step of PST was applied. This step included the generation of alternatives to possible solution strategies and assessments of the advantages or disadvantages of each strategy related to the action (47). The best solution strategy for the occupational performance problem that was defined in the first week with the help of the COPM was determined. To determine the best strategy for overcoming obstacles, alternative solutions were explored through brainstorming, and an action plan was created once the most appropriate approach had been identified. The individual was encouraged to recognise and use their environmental and personal resources. In addition, the completed diary was used to determine the steps to adopt time, frequency and duration aspects of the action plan into a daily schedule.
Weeks 4 and 5: These sessions involved the "solution implementation and verification" step of PST. Moreover, it included the implementation of the strategies and verification of the solution (47). The action plan was reviewed by sharing the individual’s experiences, and possible alternatives and new strategies were defined when necessary. Together, they discussed when the solution plan was carried out, the individual, environmental, supportive, and preventive factors that were involved, the consequences of the plan and whether problem-solving efforts had been successful or needed revision.
Sample questions of sharing the action plan experience were as follows: What were opportunities or obstacles in the action plan experience? How did the individual approach unpredictable developments? Which events were coped with in a good or bad way? How could it be possible to reach the target in a different way?
The action plan was revised to consider an individual's requirements when needed.
Week 6: In the last session, all questionnaires were completed again. In addition, the last session included the sharing of experiences and the discussion of future goals.
Statistical method
Data were analysed using IBM Statistical Package for the Social Sciences (SPSS) version 21.0 software (50). Missing values were excluded from that analysis. A multiple regression analysis based on the change score on the COPM, Brief COPE, DES and WHO-5 after controlling for gender, occupational status, diabetes duration and treatment regime. To use controlling variables in the regression analysis, dummy variables were produced for ordinal variables. The Shapiro-Wilk test was used to evaluate the distribution of the collected data (normal = p > .05, not normal = p < .05). The chi-square and Mann-Whitney U tests were used to assess differences in demographic variables between the groups (p < .05). Differences between the groups were analysed with independent t-tests (parametric) or Mann-Whitney U tests (non-parametric). Group-time interaction differences (i.e., baseline, after six weeks and after three months) were calculated using the Friedman test. The level of significance was set at 0.05. Quantitative variables are expressed as the mean ± standard deviation (X ± SD), and qualitative data are described with percent (%) values.
Thematic analysis was used to evaluate the qualitative data of activities (COPM), which were presented as percentages (%). The COPM data were categorised according to performance areas with the MAXQDA code system, and percentage data were obtained. Coding was conducted with MAXQDA 11.0 (51) through which the qualitative data were coded as self-care, productivity or leisure to develop a picture of occupational performance across all areas of life.