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RESULTS | PMC9854322 | |||
Sample characteristics | PCP | The final sample size included 58 participants (Figure The baseline characteristics of 58 participants included in the analysis are summarized in Table Analysis sample characteristics at baseline (Abbreviations: Pap, Papanicolaou; PCP, primary care provider. | PMC9854322 | |
Feasibility and acceptability | We recruited and randomized the target sample size of 123 with a retention rate of 50.4% (or 60.2% after accounting for early dropouts in the intervention arm; e.g., those who completed the baseline assessment but left the study before receiving the study intervention, The CHECC‐uP intervention was highly acceptable. All intervention women who responded to the acceptability questionnaire ( | PMC9854322 | ||
Changes in Pap test screening and psychosocial outcomes | depression | CERVICAL CANCER | At 6 months, 50% of WLH in the intervention group received a Pap test, compared to 21.9% of women in the control group (28.1% difference; Outcome changes over 6 months
Abbreviation: Pap, Papanicolaou.
Group difference in mean change scores from baseline to 3 months divided by the standard deviation at baseline.Group difference in mean change scores from baseline to 6 months divided by the standard deviation at baseline.For other psychosocial variables, the absolute value of effect sizes ranged from 0.25 to 0.58 at 3 months and from <0.01 to 0.54 at 6 months. For cervical cancer knowledge, the intervention arm had a greater increase at 3 months, but the difference was not sustained at 6 months, with relatively no difference between the intervention and control arms. For self‐efficacy, the intervention arm had a greater increase, but with a reduced effect size at 6 months. Cultural beliefs addressing cultural barriers, such as modesty, declined for both groups at 3 months, with the intervention arm having a significantly greater reduction. At 6 months, the intervention arm maintained the declining trend while the control arm reversed back. Finally, depression scores declined for both groups at 3 months, but the intervention arm had a greater decrease with an effect size of 0.28; though the difference was not sustained at 6 months. For all psychosocial variables, the statistical test of change over time was significant only for cultural beliefs at 3 months ( | PMC9854322 |
DISCUSSION | CERVICAL CANCER | We found that a multifaceted, health literacy‐focused intervention (CHECC‐uP) can promote Pap testing among Black WLH. However, we experienced a high attrition rate in the study sample. The findings demonstrate the preliminary efficacy of CHECC‐uP for Black WLH as a potential strategy to reduce cervical cancer disparities in this population. To the best of our knowledge, CHECC‐uP is the first intervention to integrate health literacy education as an active component to promote Pap testing among WLH. The statistically significant difference in Pap test rates observed among WLH in the trial (28.1% difference) is higher than other reported rates for HIV‐negative women, ranging from 5% to 24%.Health literacy consists of multiple dimensions that go beyond one's reading ability.Our retention rate was not optimal. We had higher dropouts among younger women and women who scored higher on the cultural attitudes and beliefs scale. The role of age in cervical cancer screening participation is not at all consistent.Another important lesson learned from this pilot trial is that at least one‐third of the attrition observed in our study was early dropouts in the intervention arm, which led to a change in the education format from group sessions to individually based sessions. Benefits of group‐based education have included cost savingStudy limitations include an insufficient sample size to detect a statistically significant change in outcomes, which resulted from high attrition. Nevertheless, the effect sizes estimated for the study variables are encouraging and warrant further investigation to test the efficacy of the intervention, especially given the high acceptability and satisfaction of WLH with the study intervention. Additionally, given the multifaceted nature of the study intervention, we are unable to tease out active intervention components. The intervention acceptability indicators (e.g., satisfaction with the intervention and receipt, helpfulness and application of the intervention materials) seem to suggest overall synergy between health literacy education and follow‐up components, which should be maintained in future implementations of CHECC‐uP. Finally, the generalizability of study findings is limited by the inclusion of only Black, African American women in the study sample from a low‐income, urban community. Nationally, 41% of WLH are Black, with 49% having less than a high school education and 44% having household incomes at or below federal poverty guidelines. | PMC9854322 | |
CONCLUSION | CERVICAL CANCER | Pilot testing of the CHECC‐uP intervention resulted in promising effect sizes and high acceptability among low‐income Black WLH. We incorporated health literacy education as a new approach to promote Pap test screening among WLH. The findings support integrating health literacy into a future intervention framework to transform the design of cervical cancer screening interventions for WLH. High attrition observed in our study sample highlights the need for considering systematic strategies, such as the federal Lifeline programme for free phones and services, in future trials to successfully retain a study sample from underserved, low‐income communities. It is possible that the positive effects of improved health literacy required for the uptake of cervical cancer screening may be more evident with a larger sample size than that of our pilot trial. | PMC9854322 | |
AUTHOR CONTRIBUTIONS | All authors approved the final version of the manuscript. Hae‐Ra Han originated the study and led the writing. Jeanne Murphy‐Stone and Phyllis Sharps contributed to the development of the study concept and design. Hae‐Ra Han, Kyra J. W. Mendez, Nancy Perrin, Joycelyn Cudjoe, Gregory Taylor and Dorcas Baker contributed to the acquisition, analysis or interpretation of data. Hae‐Ra Han drafted the manuscript, and all authors contributed to the critical revision of the manuscript. Hae‐Ra Han also supervised the study. | PMC9854322 | ||
CONFLICT OF INTEREST | The authors declare no conflict of interest. | PMC9854322 | ||
ETHICS STATEMENT | The study was approved by the Johns Hopkins Medicine IRB. Informed consent was obtained from all individual participants included in the study. | PMC9854322 | ||
ACKNOWLEDGEMENTS | AIDS, Dorothy | EVANS, AIDS | This study was funded by Johns Hopkins University Center for AIDS Research (P30AI094189) and Dorothy Evans Lyne Fund. | PMC9854322 |
DATA AVAILABILITY STATEMENT | Study data will be made available upon reasonable request to the corresponding author. De‐identified data will be made available upon reasonable request. | PMC9854322 | ||
REFERENCES | PMC9854322 | |||
Background | DISORDERS | Stress-related disorders have become a major challenge for society and are associated with rising levels of sick leave. The provision of support to facilitate the return to work (RTW) for this patient group is of great importance. The aim of the present study was to evaluate whether a new systematic procedure with collaboration between general practitioners (GPs), rehabilitation coordinators (RCs) and employers could reduce sick leave days for this patient group. | PMC10512560 | |
Method | Employed patients with stress-related diagnoses seeking care at primary health care centres (PHCCs) were included in either the intervention group ( | PMC10512560 | ||
Results | The median number of registered gross sick leave days was lower for the control group at six, 12 and 24 months after inclusion, but the difference was not statistically significant. The control group had significantly fewer net sick leave days at three months ( | PMC10512560 | ||
Conclusions | stress-related disorders | The PRIMA intervention, which applied a standardized procedure for employer involvement in the rehabilitation process for patients with stress-related disorders, actually increased time to RTW compared to TAU. However, at 24 months, the benefit of TAU could no longer be confirmed. The study was registered on 16/01/2017 (ClinicalTrials.gov, NCT03022760). | PMC10512560 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12875-023-02151-0. | PMC10512560 | ||
Keywords | Open access funding provided by University of Gothenburg. | PMC10512560 | ||
Background | stress-related exhaustion disorder, exhaustion disorder, stress-related mental disorders, CMD, stress disorders | DISORDERS | During the last decade, common mental disorders are the most prevalent diagnoses leading to sick leave among Swedish workers. Within this group, stress-related mental disorders were the most common diagnoses, including acute stress reaction, reaction to severe stress and stress-related exhaustion disorder (ED) [The consequences of stress-related disorders can be found at all levels: for individuals, who often have long-lasting symptoms and sick leave; for employers, due to loss of productivity and high levels of absenteeism and turnover; and for society, due to increased costs for social security and health care [Work-related conditions often play an important role, and factors such as high demands and low control, high workload, low reward, and job insecurity increase the risk of developing stress-related symptoms [Several systematic reviews on the effect of RTW interventions in people with common mental disorders (CMD), including work-related stress, have been conducted and have shown ambiguous [There are, however, recent examples of promising interventions in clinical settings. In a non-controlled clinical trial consisting of a 24-week multimodal intervention at two specialised rehabilitation centres in Sweden, including sessions with rehabilitation coordinators and rehabilitation meetings for patients with stress-induced exhaustion disorder, researchers found improved self-reported RTW rates [Thus, the current evidence suggests that the question of how to best help people who are on sick leave due to stress disorders to reintegrate into the workforce needs to be explored further. The present study aims to fill that knowledge gap. In recent years, rehabilitation coordinators (RCs) have been introduced in the Swedish health care system. Their role is to provide individual support to sick-listed patients and to coordinate with other public services and employers in the RTW process [ | PMC10512560 |
Aim | stress-related disorders | The aim of this study is to evaluate whether a systematic procedure involving collaboration between GPs, RCs and employers can reduce sick-leave days for patients with stress-related disorders during a 24-month follow-up period. An intervention group will be compared to treatment as usual (TAU). | PMC10512560 | |
Methods | PMC10512560 | |||
Study design | CMD | The study took place in Region Västra Götaland, a county council of considerable size, encompassing nearly 20% of the Swedish population, with 200 public and private primary health care centres (PHCCs). The study was conducted at the Institute of Stress Medicine (ISM), Region Västra Götaland, and the Department of Work Science and Sociology, University of Gothenburg. PRIMA is part of the New Ways research programme, which is aimed at the identification and treatment of CMD and to provide support for persons with CMD so that they can continue to work, at the Section for Social Medicine and Public Health, Sahlgrenska Academy, University of Gothenburg. The study was registered on 16/01/2017 (ClinicalTrials.gov, NCT03022760). | PMC10512560 | |
Recruitment, randomization and sample | post-traumatic stress disorder, PTSD, post-traumatic stress syndrome | RECRUITMENT | The recruitment of PHCCs took place between January and October 2016. A total of 30 PHCCs were invited to participate from both public and private health care centres, and 22 accepted to participate (15 from public health care centres and seven from private health care centres). The centres were matched in pairs based on similarities in terms of size, ownership, socioeconomic conditions in the catchment area and the average proportion of enrolled patients that had a mental health diagnosis. The extent of RC resources was also taken into consideration. From each pair, one centre was randomly selected to the intervention group (The recruitment of patients took place at the 22 PHCCs between November 2016 and January 2018. The patients were invited to participate in the study at the intervention centres by their assigned RC. At the control centres, eligible patients were invited to participate by their GP.Employed patients with a F43 diagnosis as the main diagnosis were eligible for participation, for summary of diagnostic criteria (see Table Summary of F 43 diagnoses included in the present studyPatients with post-traumatic stress disorder (PTSD), patients who did not read or speak Swedish and patients who have had a sick-leave period of more than 60 consecutive days during the past three years were excluded. Patients seeking care for stress-related symptoms who met the inclusion criteria were included in the study after giving their informed consent. Treatment as usual (TAU), such as medical treatment or therapy, was offered to both cases and controls during the process. In total, 135 patients were recruited to the study, 66 to the intervention group and 69 to the control group. The allocation of participant patients is described in Fig. Flowchart of allocation of participant patients. PHCC = primary health care centres. TAU = treatment as usual. PTSD = post-traumatic stress syndrome. * Exclusion criteria: a former completed period of sick leave exceeding 60 days during the past three years. ** Sick leave was not registered in the sick leave insurance systemThe final study sample included 112 participants, 54 participants in the intervention group and 58 participants in the control group (see Table Study sample
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The intervention | stress-related disorders | The design of the intervention was based on the Person-Environment-Occupation model (PEO) that originates from occupational therapy, where occupational performance depends on the interaction between the person (P), the environment (E) and the occupation (O) [The intervention comprised a) a one-day training where all participant GPs and RCs were invited, b) a standardized procedure for GPs and RCs to follow after training and c) the opportunity for GPs to seek clinical advice from specialist physicians in the research group (see Fig.
The training day was intended to increase the knowledge of both GPs and RCs about stress-related disorders and RTW. The lectures and workshops were conducted by experienced physicians, a psychologist and an occupational therapist who were also researchers at the Institute of Stress Medicine (ISM) or at the University of Gothenburg. The participants learned more about stress-related symptoms with a focus on long-term stress and ED and the most common stressors associated with ED. Another topic covered was the working conditions, psychosocial work environment, and factors that facilitate or hinder return to work. The lectures also covered work ability, based on the PEO model, as well as how to evaluate a patient's work ability. Additionally, information about the social insurance system and regulations surrounding sick leave was provided. They were also informed why the employer should be involved at an early stage of the rehabilitation process and how the employer would be involved. A total of 76 GPs and 13 RCs underwent the one-day training; the number of participating GPs per centre varied from 2 to 13, however, all GPs working at the intervention PHCCs could contribute by referring patients for inclusion in the study. The standardised procedure (Part B in Fig. | PMC10512560 | |
Intervention adherence | RECRUITMENT | Among the two private and nine public intervention centres, the average proportion of enrolled patients that had a common mental health diagnosis in 2015 (the year the centres were recruited to the study) was 15% (range 13–18%). This was expected to provide a sound basis for patient recruitment. However, only five of the eleven intervention centres succeeded with protocol adherence. Together, RCs at these centres recruited 56 patients and successfully contacted 53 employers. In the six remaining centres, only 9 patients were recruited, and one employer contact was made. Post-intervention interviews with participant managers, RCs and GPs provide preliminary explanations for why centres failed or succeeded in their implementation. At the centres that succeeded, the RC had a clear role vis-à-vis the GPs, and routines for working with sickness certification and insurance medicine were well established before these centres engaged in the study. In other words, the compatibility between the intervention and pre-existing workflows was high. Second, centres that struggled with high workloads and staff turnover failed in their implementation. Here, both GPs and RCs were tasked with managing the daily operations, and their ‘readiness for change’ was low. However, these explanations should be explored further in future research. | PMC10512560 | |
Outcome measures and statistical analyses | The primary outcome measures were the number of registered sick leave days for cases and controls at three, six, 12 and 24 months after inclusion. Data was retrieved from the Swedish Social Insurance Agency’s Micro Database for Analysing Social Insurance (MiDAS). In Sweden, sick leave benefits are granted for 25%, 50%, 75% or 100% of a working day, depending on how much the ability to work is reduced because of the diagnosis. Both gross days (number of sick days, regardless of extent of sick leave) and net days (number of sick days converted into whole sick days) were used as outcomes in this study.The Mann–Whitney test was used to investigate the difference in gross and net days between the groups, with the level of significance set to | PMC10512560 | ||
Results | Descriptive statistics for the intervention group and the control group (TAU) in gross and net days are presented in Table
Comparisons of registered sick leave days between the intervention group and TAUMann–Whitney Test, sd = standard deviation, Q1;Q3 = first and third quartileWhen looking at net days (i.e. the number of sick leave days converted into whole days), the advantage of the control group was further strengthened. At three months after inclusion, the control group had a median of 20 sick-leave days less than the intervention group ( | PMC10512560 | ||
Discussion | The aim of the present study was to investigate whether the application of a standardised approach in a primary health care setting in patients with stress-related diagnoses could facilitate RTW. The findings point to the contrary: the PRIMA intervention appears to have protracted RTW times during the first year of follow-up. There was a significant difference in net sick leave days between cases and controls at three, six and 12 months after inclusion, where participants in the intervention group had more sick-leave days than those in the TAU group. At 24 months, the benefit of TAU for RTW could no longer be confirmed.Previous attempts have highlighted the challenges of designing interventions with significant return to work (RTW) benefits. A recent review study focusing on RTW interventions for burned-out employees found inconclusive evidence regarding their effectiveness in facilitating RTW [Another possible explanation for the results could be, as mentioned in Holmgren et al. [The second component of the intervention was the standardised process, where contact with the employer was established and a plan for RTW was elaborated between the patient, the employer, the RC and the GP. It is plausible that this component also prolonged, rather than reduced the time to RTW. The employer´s readiness for RTW may not be in line with the patient´s readiness, and this could potentially prolong the process. Seing et al. [Since we only use sick leave days as an outcome, we have no insight into the patients’ wellbeing after the intervention. It is possible that even though the intervention failed to reduce time to RTW, the elaborated plan for RTW, which was agreed upon with the employer, provided a safe environment that helped reduce symptoms in the intervention group. Glise et al. found [Van Hess et al. [The intervention in this study was based on the PEO model, which emphasizes the importance of considering not only individual factors that affect RTW, but also the work environment and occupation. Previous research has shown that work-related stress is associated to the psychosocial work environment, such as low co-worker support, low supervisor support, low procedural justice, low relational justice and a high effort–reward imbalance [An interesting finding was that the difference between the groups was no longer significant after 24 months. This raises the question whether the results would be different if there was a longer follow-up period, i.e., if the intervention would have promoted more sustainable RTW. A follow-up period of two years can be considered to be quite extensive in comparison to similar studies but still too short to detect differences in relapse into sickness absence between cases and controls. A strength of the present study is that the data on sick leave was retrieved from official registers and not self-reported, reducing the risks for recall bias and drop-out. | PMC10512560 | ||
Limitations | CMD | We would like to explore the possibility that TAU is adequate on its own. This has been confirmed in other studies on CMD in primary health care. Kivi et al. [In addition to the problems that have already been discussed – i.e. issues with the intervention content, lack of data on symptom development and limited knowledge about what happened in the control group – there is one more important limitation to be raised. It would have been desirable to make sub-group comparisons within the intervention group in order to deepen our knowledge about the mechanisms involved [ | PMC10512560 | |
Conclusion | stress-related disorders | The aim of this randomised controlled trial was to evaluate whether a systematic procedure of collaboration between general practitioners and rehabilitation coordinators, which involved the employer in the rehabilitation of sick-listed patients with stress-related disorders, could reduce the number of sick-leave days during a 24-month follow-up period. Contrary to what was expected, the intervention prolonged the RTW time, measured as net sick leave days at three, six, and 12 months after inclusion, as compared to treatment as usual. At 24 months, no significant difference between cases and controls was found. | PMC10512560 | |
Acknowledgements | We would like to thank Sandra Pettersson and Marie Hagsjö for participation and help with data collection and Sandra Pettersson for assisting with data analysis. | PMC10512560 | ||
Authors’ contributions | LB had the major responsibility for the planning of the study, AB for analysis of the data and writing the first draft of manuscript. KH, MB, KG, AP and KS contributed to the planning of the study, interpretation of the data and writing of the manuscript. All authors read and approved the final version of the manuscript. | PMC10512560 | ||
Funding | Open access funding provided by University of Gothenburg. The study received financial support from the Swedish Research Council for Health, Working Life and Welfare, grant number 2015–00703. | PMC10512560 | ||
Availability of data and materials | The datasets generated and analysed during the current study is available from the corresponding author on reasonable request. | PMC10512560 | ||
Declarations | PMC10512560 | |||
Ethics approval and consent to participate | The study was approved 11/04/2016 by the regional ethical review board in Gothenburg, Sweden, with the reference number 234–16, and conducted according to the 1964 Declaration of Helsinki. Informed consent to participate in the study was obtained from all participants. | PMC10512560 | ||
Consent for publication | Not applicable. | PMC10512560 | ||
Competing interests | The authors declare no competing interests. | PMC10512560 | ||
References | PMC10512560 | |||
Highlights | high-functioning | SECONDARY | These authors contributed equally to this work.What are the main findings?Highly functioning adults with a sedentary lifestyle benefit physically and mentally from forest therapy and mountain hiking.Women predominantly benefited highly from mountain hiking regarding hemopoietic system and aerobic capacity. Both genders profited mentally from contact with nature.What is the implication of the main finding?Forest therapy and mountain hiking could be safe and health-promoting interventions for high-functioning adults with a sedentary lifestyle and could be applied in primary prevention as well as in secondary prevention. | PMC9859399 |
Abstract | skeletal muscle mass | Background: Lifelong physical activity is related to longer health span, which is reflected at an individual level, and is of substantial socioeconomic relevance. Sedentary lifestyles, on the other hand, pose an increasingly major public health problem. In addition, the COVID-19 pandemic had a negative impact on activity levels and well-being. Previous research indicates that contact with nature might improve exercise levels as well as well-being. Methods: This randomized, controlled clinical trial (ANKER-study) investigated the effects of two types of nature-based therapies (forest therapy and mountain hiking) in couples (FTG: n = 23; HG: n = 22;) with a sedentary or inactive lifestyle on health-related quality of life, relationship quality and other psychological and physiological parameters. Results: The results of this study displayed that healthy and highly functioning women and men with sedentary lifestyles mentally benefit from contact with nature (quality of life, satisfaction with life, mood, internal and external health-related control beliefs). The gender-specific effect on women is most visible in the physiological outcomes (hemopoietic system, aerobic capacity, skeletal muscle mass and hydration) of mountain hiking. Men and women showed small improvements in blood pressure as a result of the interventions. Conclusions: The ANKER-study provides a method for valid comparison of forest therapy interventions for the first time. Regarding the COVID-19 pandemic, the nature-based intervention presented could offer a multimodal contribution to maintaining a more active lifestyle, further contact with nature that affects peoples physical as well as mental health, and an improvement in social interaction. | PMC9859399 | |
1. Introduction | inflammation | INFLAMMATION | There is a considerable body of evidence on sustaining health benefits of being active and a scientific consensus that physical activity—in adequate dosage—should be used in the promotion, maintenance and recovering of physical as well as mental health [In order to promote the enjoyment of physical activity and, thus, encourage adherence and support a healthy lifespan for all individuals, it is important to consider different lifestyles [Clinically relevant health benefits for a wide range of conditions could be achieved at levels of physical activity clearly below current international recommendations (e.g., least 150 min of weekly moderate to vigorous physical activity) [Therefore, effective lifestyle interventions should take an integrated approach to health and promote the importance of healthy lifestyles such as reducing sedentary time and increasing physical activity, additionally promoting healthy eating as well as managing stress [Further, evidence shows that exposure to immunoregulatory microorganisms (“Old Friends”) is essential for humans to decrease immune (re)activity and inflammation [Additionally, predominantly in high-income countries, a significant decline in physical activity has been observed (insufficient activity in 2001: 31.6%, in 2016: 36.8%). Globally, more than a quarter of the population has insufficient levels of physical activity. Furthermore, beyond reduced contact with nature, urbanization thus leads to lifestyle changes as work and leisure activities shift indoors, encouraging inactive or sedentary behavior [A possible approach to reconnect with nature and “Old Friends” as well as to increase physical activity, could be Green Exercise. This means exercise in nature, as it is the case in particular with mountain hiking or, in a less intensive form, with forest therapy. Mountain hiking can be described as a long-lasting activity of moderate intensity at different altitudes [Likewise, the positive effect of nature and its specific elements on human health is the essential component of forest therapy: This approach of nature connection therapy, also known as “forest bathing”/”Shinrin-Yoku”, is a collective term for activities designed to improve human health or well-being in a forest environment. The crucial element of forest therapy is recognition for the forest environment using the five human senses, which can be combined with meditation, breathing exercises, forest walks, various recreational activities, and cognitive behavioral therapy [Forest therapy has been shown to be effective in improving immune function; a hypothesis for this is that the forest biodiversity and microbiome has a significant impact; more precisely, phytoncides from trees can reverse stress-induced immunosuppression and thus, normalize immune function and neuroendocrine hormone levels [Although, there are further studies on positive health effects of forests [The purpose of the ANKER-study (“Algund Nature and Climate Therapy: Green Exercise vs. Nature Connection”) is to investigate long-term effects of two types of nature-based therapies—mountain hiking vs. forest therapy—in couples with a sedentary lifestyle on health-related quality of life (HRQOL), relationship quality and other psychological and physiological parameters. | PMC9859399 |
2. Materials and Methods | PMC9859399 | |||
2.1. Study Design and Settings | The present data were collected as part of the ANKER-Study (ISRCTN43292449); this randomized, controlled clinical trial investigated the effects of two types of nature-based therapies in couples with a sedentary lifestyle on health-related quality of life, quality of relationship, psychological and physiological parameters. Therefore, two intervention groups—a hiking group (HG) and a forest therapy group (FTG)—were included. The allocation ratio was set at equal sample size. The study protocol was approved by the Ethics Committee of Bolzano, Italy (reference number 18-2019) and can be accessed with further details on materials and methods at | PMC9859399 | ||
2.2. Participants | acute infection, arteriosclerotic, fever, alcoholism, respiratory diseases, cardiac insufficiency, psychiatric, malignant neoplastic disorders, renal insufficiency | RESPIRATORY DISEASE, ACUTE INFECTION, UNCONTROLLED HYPERTENSION, EVENT, DISORDERS, METABOLIC DISEASE, IMMUNODEFICIENCY | Couples with a sedentary lifestyle were the defined group of interest in the ANKER-Study, therefore, participants had to meet the following inclusion criteria: age 50–60 years, relationship-duration > 1 year, BMI ≥ 25 and ≤30, sedentary lifestyle (International Physical Activity Questionnaire Short Form (IPAQ-SF) < 3.00 METmin/week) and the ability to participate in moderate hiking tours (Physical Activity Readiness Questionnaire/PAR-Q). The following exclusion criteria were applied: active lifestyle, immunologically mediated chronic conditions or immunodeficiency, severe respiratory diseases, acute or untreated psychiatric disorders, uncontrolled hypertension, uncontrolled metabolic disease, acute infection or fever, diagnosis of or treatment for malignant neoplastic disorders within the last 5 years, arteriosclerotic event < 6 months before enrollment, cardiac insufficiency, renal insufficiency, diagnosis or history of alcoholism, current recreational drug use, currently smoking > 10 cigarettes/day, orthopedic contraindications for hiking, medication intake > 5mg/d prednisone, colchicine, Imuran, methotrexate, azathioprine, cyclophosphamide or cyclosporine, intake of weight-loss drugs or preparations as well as pregnancy. By selecting people between 50 and 60 years of age, the interventions studied could contribute to maintaining the ability to work in this age group, as this would be a primary preventive measure to maintain health. The participating couples were recruited online via webpage ( | PMC9859399 |
2.3. Intervention | Participants of both intervention groups spent a seven-day vacation in Algund (Italy, 46°40′57.5″ N 11°07′19.0″ E, 350 m AMSL), a region that is characterized by its mild, nearly Mediterranean climate. All participants were housed in local hotels, got the same meals, and did not receive lifestyle recommendations during the non-intervention phase.The HG took part in guided, moderate hiking tours every day (3–4 h), except for one rest day in the middle of the intervention week. The nature group received daily 3–4 h of standardized nature connection therapy sessions with a psychologist trained for this purpose. Forest therapy was characterized by low physical activity and oriented on a holistic framework that promoted meaningful connections at the three levels of “connection with nature”, “connection with others”, and “connection with oneself”. In forest therapy, each day had a specific theme that was worked on (mindfulness and relaxation, connection to nature, social connections, connection to self, goal setting and next steps). After a practice phase, the participants finished the intervention each day with a written self-reflection. These interventions were conducted in two separate, but identical sequences: The first part of the study population completed the ANKER-Study in October 2019, the second part in June 2021. | PMC9859399 | ||
2.4. Data Collection and Outcomes | Forearm venous blood, NRS | INS | Medical examinations at T1 (day 0; before the intervention), and T2 (day 7; after the intervention) were performed at the Department of Sports Medicine, Tappeiner Hospital, Merano (Italy). Follow-up examinations at T3 (day 60) took place at the Paracelsus Medical University, Salzburg (Austria); the follow-up examination at T4 (day 180) was carried out as an online survey. More details are shown in The ANKER study investigated the following long-term effects on T1, T2, T3 and T4: Health-related quality of life (Short form health survey (SF12), EuroQol (EQ-5D-5L), Quality of relationship (Partnership Questionnaire (PFB) and Problem List (PL)) as primary outcomes. A further primary outcome—the Intercultural Quality of Life Comic will become part of a separate paper due to its extensive results and an additional validation (throughout the following questionnaires: Subjective impairments of the participants (Complaints list (B-L’), BFI-10 questionnaire (10 Item Big Five Inventory) and Health-related control beliefs (HLOC) in this context. Secondary parameters were nature connectedness (Connectedness to Nature Scale (CNS), Nature Relatedness Scale (NRS) and Inclusion to Nature Scale (INS)), sociopsychological well-being in the sense of flourishing of personality (Flourishing Scale (FS-D), life satisfaction (Satisfaction with Life Scale (SWLS), health-related control beliefs (FEGK), subjective impairments of the participants Mindfulness (Mindful Attention and Awareness Scale (MAAS). Measurements of the International Physical Activity Questionnaire Short Form (IPAQ-SF) were collected at T1, T3 and T4 to assess a possible long-term impact of the intervention on the subjects’ physical activity behavior. Additionally, the following physiological parameters were collected on T1, T2 and T3: static balance (MFT-S3 Check), body composition via Bio Impedance Analysis (Four-terminal impedance analyzer), differential blood count (Forearm venous blood), fractional exhaled nitric oxide (FeNO; NioxMinoThe short-term effects collected as part of the ANKER-study will be presented in a follow-up paper due to the quantity and consequent complexity of these data. | PMC9859399 |
2.5. Statistical Analysis | All statistical analyses were performed in the sense of an intention-to-treat analysis using the R-GNU software environment (General Public License, R Foundation for Statistical Computing, Vienna, Austria). Statistical significance was set at the level of α < 0.05. Baseline data were analyzed using unpaired Students-Fully nonparametric variance type tests (ANOVA type statistics) from the nparLD (Nonparametric Longitudinal Data Analysis) package [ | PMC9859399 | ||
2.6. Randomization and Sample Size | Pairwise randomization of the couples to groups was completed according to the following stratification factors: Age, general health (PHQ-9), closeness to nature (NRS-6), BMI, activity level (IPAQ-SF) and relationship duration [ | PMC9859399 | ||
3. Results | PMC9859399 | |||
3.1. Study Participants and Baseline Characteristics | ADVERSE EFFECTS | Two hundred and fifty-seven individuals were screened for eligibility to participate in this study, 165 were excluded: 49 individuals did not meet the inclusion criteria, 116 individuals declined to participate due to personal reasons or the COVID-19 pandemic. In October 2019, 24 people were enrolled in the HG and 28 in the FTG; in June 2021, 20 people were enrolled in the HG and 18 in the FTG. This time gap occurred due to limited scientific staff resources. The four groups were pooled into one HG (n = 42) and one FTG (n = 46) for examination. Two participants from the HG did not receive allocated intervention (personal reasons) and two further participants were excluded from the analysis because they did not meet inclusion criteria anymore (relationship status). Consequently, 42 participants of the HG and 46 participants of the forest therapy group (Except for relationship duration, baseline characteristics showed no relevant differences in inclusion criteria between the study groups (The hiking intervention as well as the forest therapy were well tolerated by all participants. No adverse effects or harms were observed in any group. | PMC9859399 | |
3.2. Tour Data | On average, the mountain hikes lasted 03:29 h, the participants covered a distance of 7.36 km and 521 m of altitude. The FTG participated each day in standardized forest therapy sessions for 3–4 h, assisted by a psychologist. The sessions were characterized by low physical activity ( | PMC9859399 | ||
3.3. Primary Outcomes | Results from the F1-LD-F1 analysis of primary outcomes are accessible in The F1-LD-F1 model for the SF-12 total score revealed a significant main effect for time (The F1-LD-F1 model for the EQ5D-5L visual analogue scale revealed a significant main effect for time (Regarding the quality of relationship (PFB total score), both groups start with high baseline levels (HG: 61.10 ± 12.24, FTG: 59.64 ± 13.13). Scores ≥ 54 are considered as a mostly happy relationship. The F1-LD-F1 model for the PFB Total Score revealed a significant main effect for time ( | PMC9859399 | ||
3.6. Body Composition | Results from the F1-LD-F1 analysis of Body Parameters are presented in F1-LD-F1 model for body mass index revealed a significant main effect for time (F1-LD-F1 model for reactance revealed a significant main effect for time (Within the female subgroup, the Fat Free Mass Index presented with a significant main effect for time (Within the male subgroup, significant main effects for time were found for Fat Free Mass Index ( | PMC9859399 | ||
3.7. Questionnaires | INS | F2-LD-F1 models revealed gender-specific effects for the connectedness to nature scale (CNS, Nature connectedness increased in both intervention groups as significant main effects for time were found for the CNS, INS and NRS-6. F1-LD-F1 model for MAAS Total revealed only a significant main effect for time ( | PMC9859399 | |
3.8. Sample Size Simulation | Consistent with the bootstrap sample size simulation for the primary outcome SF12 Total Score, a sample size of at least n = 50 per group is needed to achieve a power of 1−β = 0.87 in the case nparLD analysis for the comparison of the two interventions, mountain hiking and forest therapy. A larger sample size is required for analysis using ANOVA−at least n = 80 per group is required to achieve a power of 1−β = 0.87 (see | PMC9859399 | ||
4. Discussion | ± | ELEVATED BLOOD PRESSURE, HYPERTENSION | The ANKER-Study was conducted before and during the COVID-19 pandemic and investigated the effects of two different types of nature-based therapies in couples with a sedentary lifestyle. Effects of mountain hiking and forest therapy on health-related quality of life, relationship quality, and other psychological and physiological parameters were investigated. The COVID-19 theme was taken up in this paper, as this pandemic influenced not only organizational aspects, but it also changed the perspective towards gender-specific implications, as the impact of this pandemic is esteemed meaningfully higher for women than for men. Women, especially working women, are disproportionately responsible for most domestic tasks, including care for children and elderly [Current research on COVID-19 and human-nature relationships, indicates that women are more likely to attribute higher values to nature and recreation than men [The results with regard to physiological parameters, on the other hand, were different regarding gender: Since both interventions took place in altitudes of ~1500 m, their hematopoietic system was stimulated; as this exposed the subjects to the interactions between low barometric pressure and partial-pressure of OVital signs were kept as physiological control parameters in this study, whereby a very positive trend was observed for blood pressure in both gender groups: In our study, persons with sedentary lifestyle initially showed a slightly elevated blood pressure (HG: 135.40 ± 19.07/83.38 ± 10.20 bpm, FTG:132.30 ± 16.80/82.83 ± 10.66 bpm), which already approached the recommended range immediately after the one-week intervention (HG: 130.74 ± 13.36/81.90 ± 8.01bpm, FTG:129.80 ± 16.27/81.50 ± 9.63bpm), so a clinically relevant change can be assumed. Gatterer et al. stated that in elderly persons with hypertension, moderate intensity hiking only at weekends may reduce systolic blood pressure; otherwise, it did not improve cardiovascular risk factors in healthy older people. They did not find gender-specific differences [Forest therapy in the ANKER-study was professionally guided by a specialized psychologist. Findings exhibited that guided forest therapy programs promote positive emotional changes and social bonding through interaction with others [Moreover, there are also differences in the gender-specific influence of COVID-19: Amplified risk for developing mental health problems for women during the pandemic is experienced with pregnancy or intimate partner violence [During the COVID-19 pandemic, concerned women, older persons, college-educated respondents, and white-collar workers noted the greatest use of the forest as a recreation site. Nonetheless, women and people with elementary education expressed the most fears related to visiting the forest. In contrast, men and people who lived in rural areas and small towns, as well as respondents who performed activities related to the forest, were most involved in exploring and working in the forest and [ | PMC9859399 |
Strengths and Limitations | To enhance the methodological quality and evidence, while decreasing the risk of bias, as required in reviews on the topic of forest therapy [Nature relatedness in the ANKER-Study was assessed via three questionnaires (Connectedness to Nature Scale, Inclusion to Nature Scale and Nature Relatedness Scale). The results indicated that connectedness to nature is a stable personality characteristic, as the scores changed only slightly, even though significance occurred over time, i.e., low clinical significance can be expected. Furthermore, it could be assumed that there was a selection bias in the present study population, because especially persons with a high affinity to nature would volunteer to participate in such a study design, which is also reflected in the high, stable values of these three questionnaires. As the bootstrap sample size simulation based on the results of the ANKER study shows, a sample size of n ≥ 80 persons is recommended in order to similarly match the psychological and physiological parameters of nature-based interventions. Although, in this study only about half of the recommended subjects participated, significant results could be obtained already, therefore higher case numbers are likely to generate even clearer and clinically more relevant results. Additionally, further research specific to women with regard to mountain hiking and also forest therapy should be conducted to further elucidate the effects of these interventions on female gender and to ascertain their backgrounds, e.g., fears related to visiting the forest [Buckley and Brough [ | PMC9859399 | ||
5. Conclusions | DISEASES | The ANKER-study, with its forest classification survey, provides for the first time a method for a more valid comparison of forest therapy interventions. The long-term results of this study showed that healthy, highly functioning women and men with sedentary lifestyles benefit mentally from contact with nature. The gender-specific effect of mountain hiking on women is most visible in physiological parameters. Further research should investigate forest therapy as a health-promoting intervention for individuals with immobility or internal diseases. Advanced gender-specific research, especially with regard to these interventions on women, is also recommended. Regarding the COVID-19 pandemic, the nature-based intervention presented could offer a multimodal contribution to maintaining or creating a more active lifestyle, further contact with nature that affects people’s physical as well as mental health, and an improvement in social interaction. Overall, focus should be on high quality research to make these types of nature-based therapies more applicable and prescribable for a working-adult population. | PMC9859399 | |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC9859399 | ||
Author Contributions | Conceptualization, A.H. and C.P.; Methodology, A.H., C.P. and J.F.; Investigation, A.H., C.P., J.F., M.B., R.W.-E., G.S., M.K., M.N., S.B. and R.Z.; Resources, G.S., S.R., V.D.N. and M.K.; Project administration, A.H., C.P. and R.W.-E.; Funding acquisition, A.H. and C.P.; Statistics, J.F. and D.H.; Writing: original draft preparation, D.H. and J.F., Writing: review and editing, D.H., J.F., C.P., R.W.-E. and M.B.; Visualization, D.H. and J.F.; Supervision, A.H. All authors have read and agreed to the published version of the manuscript. | PMC9859399 | ||
Institutional Review Board Statement | The study was conducted according to the guidelines of the Declaration of Helsinki and approved by the Ethics Committee of Bolzano, Italy (reference number 18-2019, 14 March 2019). This article corresponds to the Consort Statement 2010 [ | PMC9859399 | ||
Informed Consent Statement | Informed consent was obtained from all participants for this study. | PMC9859399 | ||
Data Availability Statement | The data presented in this study are available on request from the corresponding author. | PMC9859399 | ||
Conflicts of Interest | The authors declare no conflict of interest. The funders had no role in the design of the study, the collection, analyses, or interpretation of data. Additionally, whether in the writing of the manuscript, nor in the decision to publish the results. | PMC9859399 | ||
References | tenderness | Study schedule [Study flowchart of included and excluded patients.Mean ± standard deviation of aerobic capacity for the female and male subgroups on days 0, 7 and 60 (forest therapy vs. mountain hiking).Sample size simulation based on data of the ANKER-Study. Upper graphic shows the comparison of the two intervention groups (forest therapy vs. mountain hiking) for primary outcome SF12 Total Score. The graphs below present gender-specific analyses of aerobic capacity for woman and men. Sample size simulation was performed for nparLD and ANOVA.Baseline characteristics of the study population regarding inclusion criteria.BMI: Body Mass Index, IPAQ-Short: Score of International Physical Activity Questionnaire in metabolic equivalent (MET) minutes per week, NRS-6: Nature Relatedness Scale 6, PHQ-9: Patient Health Questionnaire.Characteristics of the intervention program.* The values in the FTG can only be given as an average—they vary depending on the participant and individual execution of the exercises. ** The difference in ascent and descent was caused by the use of a mountain cable car.Results from the F1-LD-F1-model for primary outcomes.F1-LD-F1 model with group (forest therapy or hiking), time and the interaction of group and time (group*time); T1 = day 0/baseline, T2 = day 7/after intervention week, T3 = day 60/follow-up 1, T4 = day 180/follow-up 2; ** <0.01, * <0.05, n. s./not significant ≥0.05; Results for the Partnership Questionnaire Subscales dispute behavior, tenderness and commonality/communication can be found in Results from the F1-LD-F1-model for differential blood count and aerobic capacity.F1-LD-F1 model with time and treatment (forest therapy or hiking) and the interaction of treatment and time (treat_ time); Measuring times: T1 = day 0 baseline measurement, T2 = day 7 after intervention, T3 = day 60 follow-up, T4 = day 180 follow-up; ** <0.01, * <0.05, n. s./not significant ≥0.05; Abbreviations: adj. | PMC9859399 | |
Purpose | pneumonitis, toxicities, toxicity, testicular cancer | PNEUMONITIS, TESTICULAR CANCER, THROMBOEMBOLIC EVENT | Bleomycin, etoposide, and cisplatin combination chemotherapy (BEP) improves the survival of patients with testicular cancer, but is associated with potentially life-threatening toxicities like pneumonitis and thromboembolic events. This study explored the effects of physical exercise in patients with testicular cancer during or after BEP-chemotherapy on pulmonary and vascular endothelial toxicity. | PMC10657310 |
Methods | vascular endothelial dysfunction | TESTICULAR CANCER | In this post hoc analysis of a multicenter randomized clinical trial (NCT01642680), patients with metastatic testicular cancer scheduled to receive BEP-chemotherapy were randomized to a 24-week exercise intervention, initiated during (group A) or after BEP-chemotherapy (group B). Endpoints were pulmonary function (forced vital capacity (FVC), forced expiratory volume in one second (FEV1), lung transfer-coefficient and transfer factor for carbon monoxide (KCO, DLCO) and markers of vascular endothelial dysfunction (von Willebrand factor (vWF) and factor VIII). | PMC10657310 |
Results | Thirty patients were included. Post-chemotherapy, patients declined less in FVC, FEV1 and DLCO in group A compared to group B. Post-chemotherapy, vWF and factor VIII were significantly lower in group A compared to group B. After completion of exercise, started either during BEP-chemotherapy or thereafter, no between-group differences were found. At 1-year post-intervention, significant between-group differences were found in favour of group A in DLCO and KCO. | PMC10657310 | ||
Conclusions | pulmonary and vascular damage | TESTICULAR CANCER | Patients who exercised during BEP-chemotherapy better preserved FVC, FEV1 and DLCO, measured directly post-chemotherapy and 1-year post-intervention (DLCO, KCO). This coincided with less increase in vWF and factor VIII measured directly post-chemotherapy. These data support a beneficial role of a physical exercise intervention during BEP-chemotherapy on pulmonary and vascular damage in patients with testicular cancer. | PMC10657310 |
Trial registry | Cancer | CANCER | Optimal Timing of Physical Activity in Cancer Treatment (ACT) Registry URL: | PMC10657310 |
Supplementary Information | The online version contains supplementary material available at 10.1007/s00432-023-05469-5. | PMC10657310 | ||
Keywords | PMC10657310 | |||
Introduction | pulmonary toxicity, vascular endothelial dysfunction | TESTICULAR CANCER | The introduction of bleomycin, etoposide and cisplatin combination chemotherapy (BEP) has improved the long-term survival of patients with metastatic testicular cancer to more than 90% (Hanna and Einhorn Endothelial damage of the small vessels in the lung plays an important role in the development of bleomycin-induced pulmonary toxicity (Sleijfer Evidence mounts that engaging regularly in moderate-to-vigorous intensity aerobic physical exercise is beneficial for vascular endothelial function by increasing nitric oxide availability (Thompson et al. Based on these data, we hypothesized that structured physical exercise during BEP-chemotherapy attenuates pulmonary toxicity and vascular endothelial dysfunction in patients with metastatic testicular cancer. This exploratory analysis aimed to investigate the effect of a physical exercise intervention performed during or after BEP-chemotherapy on pulmonary function and markers of vascular endothelial dysfunction, measured before and post-chemotherapy, post-intervention, and 1-year post-intervention. | PMC10657310 |
Materials and methods | PMC10657310 | |||
Study design and participants | DER | This is an exploratory post hoc analysis of the multicenter, two-armed, randomized clinical ACT-trial. A detailed method description of the ACT-trial has been reported elsewhere (van der Schoot et al. Design of the tailored physical exercise intervention during or after BEP-chemotherapy | PMC10657310 | |
Procedures | The intervention consisted of two components: 12 weeks of supervised exercise followed by 12 weeks home-based unsupervised exercise. The supervised exercise consisted of aerobic exercise training thrice a week, resistance exercise training twice a week and optionally once per week leisure sports game activities. The intensity of aerobic exercise training was prescribed based on training heart rate (HR), calculated with the Karvonen formula (training HR = (HR | PMC10657310 | ||
Outcomes | Patients visited the outpatient clinic before the start of chemotherapy, directly post-chemotherapy, post-intervention and 1-year post-intervention (Fig. Data on bleomycin pulmonary toxicity were recorded using the following classification (Nuver et al. | PMC10657310 | ||
Sample size and statistical analysis | Descriptive statistics were used to analyse patient characteristics.Intention-to-treat linear mixed model analyses were performed for within-group and between-group differences at three timepoints—directly post-chemotherapy, post-intervention and 1-year post-intervention and were adjusted for baseline values. We calculated the standardized effect size (ES) by dividing the adjusted between-group mean difference of the measurement directly post-chemotherapy, post-intervention and 1-year post-intervention using the pooled T0 standard deviation. An ES < 0.2 was considered ‘no difference’, ES between 0.2 and 0.5 small difference, ES between 0.5 and 0.8 moderate difference and ES > 0.8 substantial difference (Cohen | PMC10657310 | ||
Discussion | testicular cancer, fatigue, pulmonary toxicity, vascular endothelial dysfunction | ENDOTHELIAL DYSFUNCTION, ADVERSE EVENTS, EVENT, EVENTS, ADVERSE EFFECTS, TESTICULAR CANCER, INFLAMMATORY RESPONSE | In this exploratory subgroup analysis of the ACT-trial, we found beneficial effects of a physical exercise intervention initiated during compared to after BEP-chemotherapy on pulmonary function parameters and markers of endothelial dysfunction in patients with metastatic testicular cancer. We found statistically significant differences between groups for FVC, FEV1, DLCO, KCO, vWF and factor VIII, measured directly post-chemotherapy in favour of the group that exercised during chemotherapy (group A). Also, 1-year post-intervention, significant differences were found in pulmonary function (KCO, DLCO) in favour of group A.Physical exercise may reduce the BEP-induced generation of reactive oxygen species and thereby prevent the development of vascular endothelial dysfunction and the consequent inflammatory response (Simioni et al. We also found that FEV1 and FVC were better preserved during chemotherapy in group A compared to group B. The physical exercise intervention during BEP-chemotherapy may maintain physical fitness and respiratory muscle strength and thereby possibly preserved values of FEV1 and FVC (Kenn et al. Results of the present study suggest that attending physical exercise during BEP-chemotherapy might protect against vascular endothelial dysfunction. Currently, limited data are available on effects of exercise on vascular endothelial dysfunction. A retrospective study in elderly male volunteers showed a significant inverse dose–response relationship between physical exercise and fibrinogen levels, factor VIII, vWF, t-Pa and PAI-1 (Wannamethee et al. In total, 3 out of 30 patients (10.0%, non-significant), all in group A, developed signs of bleomycin-induced pulmonary toxicity. Two out of 30 patients (13.3%, non-significant), all in group B, developed a vascular event. However, the small numbers make it difficult to draw conclusions about the clinical significance and importance of this finding. Future studies including larger patient cohorts attending physical exercise during and after BEP-chemotherapy, should monitor the occurrence of bleomycin-induced pulmonary toxicity and occurrence of vascular events.No adverse events related to the exercise intervention occurred in our study. In a study in which patients with testicular cancer were randomized to supervised high-intensity interval training (HIIT, 85–95% of HRComparison of the effects of exercise on treatment-related morbidity to a control group would have been very interesting. However, when the study protocol of the ACT-trial was written (2012), it was already known that physical exercise during and after treatment with chemotherapy has evident beneficial effects on various chemotherapy-related adverse effects, and that physical training was beneficial on several outcomes such as physical fitness, muscle strength, fatigue, and quality of life. In addition, exercise programs appeared to be safe. However, knowledge of the timing of the physical exercise training was lacking and therefore, the topic of this study was randomizing exercise during versus after chemotherapy.To our knowledge, this is the first study showing beneficial effects of physical exercise during BEP-chemotherapy on pulmonary function parameters and markers of vascular endothelial activation in patients with testicular cancer. The study had several strengths and limitations. Strengths are the randomized design and the high adherence rate to the physical exercise intervention. Limitations are the small patient groups and the lack of importance of DLCO in predicting bleomycin-induced pulmonary toxicity (Watson et al. | PMC10657310 |
Conclusion | toxicity, testicular cancer | TESTICULAR CANCER, EVENT, EVENTS | In this explorative analysis, patients who started the exercise intervention during BEP-chemotherapy better preserved their pulmonary function (DLCO, FVC), measured directly post-chemotherapy and 1-year post-intervention (DLCO, KCO). This coincided with less increase in factor VIII and vWF, measured directly post-chemotherapy. These data support a beneficial role of a physical exercise intervention during BEP-chemotherapy on pulmonary and vascular toxicity in patients with testicular cancer and warrant further investigation. Three patients in group A developed BIP, compared to none in group B. Two patients in group B developed a vascular event, compared to none in group A. The small numbers of patients with BIP and vascular events warrant caution when interpreting these data. | PMC10657310 |
Acknowledgements | Cancer | CANCER | The authors would like to thank all participating patients, oncologists, research staff, and physical therapists. Also, we would like to thank the Dutch Cancer Society, Alpe d’HuZes (Grant number: DCS 2011-5265) and the MD-PhD program provided by the Junior Scientific Master class at the UMCG, the Netherlands, for making this clinical trial possible. | PMC10657310 |
Author contributions | Conceptualization: AMEW, JAG. Data curation: GGFvdS, HLO, AMEW. Formal analysis: GGFvdS, HLO, AMEW, AMM. Funding acquisition: AMEW, JAG, GGFvdS. Investigation: AMEW, JAG, GGFvdS, HLO. Methodology: GGFvdS, HLO, AMEW, JAG. Project administration: GGFvdS, HLO, NLW. Resources: AMEW, NLW. Software: HLO. Supervision: AMEW, JAG. Validation: GGFvdS, HLO, AMEW. Visualization: HLO. Writing—original draft: GGFvdS, HLO, AMEW. Writing—review and editing: all authors. | PMC10657310 | ||
Funding | Cancer | CANCER | This work was supported by the Dutch Cancer Society, Alpe d’HuZes (Grant number: DCS 2011–5265) and the Graduate School of Medical Sciences, University of Groningen. The study's funders had no role in the design, data collection, management, analysis, interpretation, report writing and decision to submit the manuscript. | PMC10657310 |
Data availability | The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10657310 | ||
Declarations | PMC10657310 | |||
Conflict of interest | Cancer | CANCER | The authors declare the following financial interest/personal relationships which may be considered as potential competing interests: dr. A.M.E. Walenkamp: Grant: Dutch Cancer Society (inst). Research funding: Abbvie (inst), BMS (inst), Genzyme (inst), Karyopharm Therapeutics (inst), Roche (inst). Consulting of advisory role: Polyphor (inst), IPSEN (inst), Karyopharm (inst), Novartis (inst). Prof. Dr. J.A. Gietema: Research funding: Abbvie (inst), Roche (inst), Siemens (inst). No other potential conflicts of interest are reported by any of the authors. | PMC10657310 |
Consent to participate | Written informed consent was obtained from all patients. | PMC10657310 | ||
References | PMC10657310 | |||
Objective | comorbidity, cognitive behavior, chronic diseases, depressive symptoms, Diabetes distress, T2DM, diabetes | TYPE 2 DIABETES MELLITUS, CHRONIC DISEASES, DIABETES | Diabetes distress typically causes depressive symptoms; common comorbidity of diabetes unpleasantly affects patients’ medical and psychological functions. Psychotherapeutic interventions are effective treatments to treat depressive symptoms and to improve the quality of life in many chronic diseases including diabetes. The present study investigated the efficacy of cognitive behavior therapy (CBT) to treat depressive symptoms in patients with type 2 diabetes mellitus (T2DM) using experimental and waitlist control conditions. | PMC9896442 |
Materials and Methods | T2DM | A total of 130 diagnosed patients with T2DM were taken from outdoor patients services of different hospitals in Faisalabad. Ninety patients met the eligibility criteria and were randomly assigned to experimental ( | PMC9896442 | |
Results | diabetes distress | The findings indicated that patients who received CBT got a significant reduction in their diabetes distress F(1,60) = 222.710, | PMC9896442 | |
Conclusion | anxiety, cognitive behavior, diabetes distress, depressive symptoms | It is concluded that cognitive behavior therapy is an effective and promising intervention for depressive symptoms, diabetes distress, and health anxiety which also helps the person to promote quality of life, treatment adherence and physical activity. | PMC9896442 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s12888-023-04546-w. | PMC9896442 | ||
Keywords | PMC9896442 | |||
Introduction | death, guilt, anxiety, depression, diabetes mellitus, depressive symptoms, psychological disturbance, metabolic disease, Diabetes, accompanies emotional disturbances, T2DM, diabetes distress, diabetes | DIABETES MELLITUS, METABOLIC DISEASE, DIABETES, TYPE 2 DIABETES, DIABETES | Diabetes or diabetes mellitus is a metabolic disease that interferes with the human body’s ability to process and absorb glucose. It is the seventh leading cause of death, and about 422 million people live with diabetes worldwide (WHO 2020). The current scenario estimates that it will rise by 25% within 10 years to 454 million and 51% within 25 years to 548 million [Diabetes could be a reason of a variety of psychological disturbances in the people suffering from it. One such psychological disturbance is called diabetes distress (DD). DD is a big problem that accompanies emotional disturbances, stress, guilt feelings, and avoidance of treatment [Health anxiety (HA) is another factor which causes distress; it occurs when an individual misinterprets his bodily sensations or changes as the indicators of a life-threatening illness (Asmundson & Taylor, [Treatment adherence is usually described as the patient’s compliance with the prescribed medication [Cognitive Behavior therapy (CBT) is a form of psychological intervention which emphasizes the current state of affairs and, usually, it is a time-bound mode of therapy [Recent studies show that, in Asian countries, there is a need for improved mental health screening and treatment in diabetes care (Karla et al., 2020). CBT works effectively with depression and increases treatment adherence in diabetes patients as CBT is an evidence-based treatment therapy for depression as a comorbid condition with diabetes [CBT has the potential to addresses the emotional problems of patients with T2DMas it has been practiced with T2DM to reduce depressive symptoms [This current study aimed to examine the effectiveness of CBT through experimental and waitlist control conditions with type 2 diabetes patients. We hypothesized that CBT will effectively reduce diabetes distress and other depressive symptoms, will effectively deal with health-related anxiety concerns and distress due to diabetes, and will improve the patients’ treatment adherence and quality of life. | PMC9896442 |
Research design and methods | PMC9896442 | |||
Study design | T2DM | 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: | PMC9896442 | |
Participants | Type II Diabetes Mellitus, T2DM | TYPE II DIABETES MELLITUS | 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) [Flow Diagram of Patients with Type II Diabetes Mellitus | PMC9896442 |
Inclusion and exclusion criteria | anxiety disorder, physical/head injury, Diabetes Mellitus, depressive disorder, mood disorder, depressive symptoms, T2DM | DIABETES MELLITUS, DIABETES MELLITUS, PHYSICAL DISABILITY | 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. | PMC9896442 |
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