Study design and description of the participants
This study was designed as a single-blind, randomized controlled. The sample size was designed to use 5% (p = 0.05) Type 1 error, 80% strength through statistical power analysis, and a two-way hypothesis test 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 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 inclusion criteria. The remaining 76 individuals were randomly assigned (using the simple random number table) to one of an intervention group or control group (n= 38 each). For control and intervention groups, randomizations were applied separately, using stratification variables produced by a web site of Research Randomizer/ https://www.randomizer.org/#randomize. The simple random number table was created for each group. Numerical distribution was ensured as formed according to 2 sets and unique numbers per set. Participants were included in the groups according to the number of randomizations. The baseline evaluation was carried out at the first meeting that was individually planned for the participants in each group after randomization. Nine subjects discontinued participation for various reasons in 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 (ethic number: GO15/731). This study was conducted between June 2015 and September 2017.
The scales described in detail below were applied to all participants. Both groups' participants completed the scales face to face with the same therapist guidance. The individuals were assessed at baseline, after the six modules (six weeks), and after the 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, alcohol consumption), body mass index (BMI) and medical history (e.g., monitoring, family history, 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 in performing (30). COPM can both used as an intervention and 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 socialization). First, the importance of each occupation is rated on a 10-point scale where 1 is “not important” and 10 is “extremely important”. Then, up to five most important activities are rated for performance from 1 (“do not perform well”) to 10 (“perform very well”) and for satisfaction, also from 1 (“not satisfied”) to 10 (“very satisfied”). The performance and satisfaction scores obtained are collected separately and divided by the number of activities to obtain performance and satisfaction scores (31). The test-retest reliability of the COPM is within the acceptable range; intra-class correlation and obtained coefficients for individuals with chronic diseases range from the scores were 0.86 to 0.89 for performance and 0.76 to 0.88 for satisfaction (32-34). The COPM has shown Turkish validity and reliability (35). COPM is recommended to use in diabetic subjects to identify what is important and their priorities (9).
Secondary Outcomes
The Diabetes Empowerment Scale (DES): The Diabetes Empowerment Scale (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 (36). 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 (37).
The Brief COPE: The Brief COPE measures strategies for coping with stress and includes 14 subscales that two-items are grouped in 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) (38). Humor and religion subscales are uncertain items to being inside the effective or ineffective coping style; therefore, they were excluded from both analyses (39). 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 highest subscale score means those coping strategies are used more. These tools are also valid and reliable in Turkish populations (40).
The World Health Organisation’s Five Well-Being Index (WHO-5): The World Health Organisation’s Five Well-Being Index (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 last two weeks (41). 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. WHO-5 has Turkish validity and reliability (42, 43) and a cut-off of less than <50% has been identified to screen for depression and reduced well-being (44).
Intervention
Participation in the everyday occupations of life is a vital part of humans and participation in meaningful occupations has a positive influence on health and well-being (45). Diabetes mellitus restrict individuals' participation in meaningful activities for the person (6). Diabetes mellitus is a complex disease and individuals need to choose from many topics to stay healthy in their ordinary daily life.
The intervention program focused on meaningful occupations defined by individuals. The PST method developed by D'Zurilla and Goldfried has been used to overcome the problems of participation of meaningful occupations. PST helps support the individual with a chronic disease to overcome the barriers of participation that develop as a result of problems experienced at home and in the community. This intervention program included the four steps of PST: the (1) problem definition, (2) generation of alternatives, (3) decision-making, (4) solution implementation, and verification (46). Especially, in the intervention program 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 program that includes the assessment tools, education, and problem-solving therapy, was implemented by the same therapist who has a cognitive behavioural therapy certificate and three years of problem-solving therapy experience. The intervention program was designed in six modules and performed once a week for six weeks, and each session containing approximately 60 minutes. The intervention was made face-to-face and individually in a clinical setting at a suitable time for the person. Both groups join modules 1 and 6, while modules 3, 4 and 5 are designed only for the intervention group. The content of the modules explained in detail below.
Module 1: The first module applied to the same procedure for both groups. The purpose of the first session was to complete all measurements together therapist for each group’s participant. For which participants were asked to keep a diary for a once, how to complete the diary for a typical day was also explained. The therapist and participants identified together with their problematic activities with COPM in both groups. The COPM allowed them to identify the goal by individuals of performance problems in their meaningful activities. The COPM has used as an evaluation tool for the control group; it was also used as the intervention tool for the intervention group in the next modules.
In addition, this module is equivalent to the “problem definition” step of problem-solving therapy for the intervention group. Briefly, It included setting as a measurable, realistic and attainable goal for the solution (47).
Module 2: The purpose of this session was to provide education with information about diabetes mellitus. The education was given 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 to 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 determining them.
Module 3: In this session, the “generation of alternatives” and decision making” step of problem-solving therapy was applied. It included the generation of alternatives to possible solution strategies and assessments of the advantages or disadvantages of each strategy to the action (47). The best solution strategy for the occupational performance problem that defined in Module 1 with the help of COPM was revealed. To determine the best strategy for overcoming the 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 recognize and use their environmental and personal resources. In addition, the completed diary was used to determine steps of action plans' time, frequency and duration when deciding daily schedules adaptation.
Module 4-5: In these sessions were contained in the "solution implementation and verification" step of problem-solving therapy. Moreover, shortly, it included the implementation of the strategies and verification of the solution (47). The action plan was reviewed through sharing the individual’s experiences and possible alternatives and new strategies are defined when necessary. They discussed together when carried out the solution plan, the individual, environmental, supportive and preventive factors, and consequences of the plan and whether problem-solving efforts had been successful or need to revision.
Sample questions of sharing of the action plan experience are as follows: What were opportunities or obstacles in the action plan experience? How the individual approached unpredictable developments? Which events were coped with 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 individuals' requirements when needs.
Module 6: The last session was designed for both groups, and all questionnaires were reapplied. Differently, the last session included the sharing of experiences and the discussion of future goals for the intervention group participants.
Statistical method
Data were analysed using IBM the 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 change score of the COPM, Brief COPE, DES and WHO-5 under controlling of 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 test was used for the differences in demographic variables between the groups (p < .05). Differences between the groups were analysed with the Independent t-tests (parametric) or Mann-Whitney U test (non-parametric). Group-time interaction differences (i.e., baseline, after six modules (six weeks) and after three months) were calculated using the Friedman test. The level of significance was set at 0.05. Quantitative variables were expressed as mean ± standard deviation (X ± SD), and qualitative data were described with percent (%) values.
Thematic analysis was used to evaluate the qualitative data of activities (COPM) and presented as percentages (%). The COPM data were categorized according to performance areas with 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.