An intervention that reduces stress in people who combine work with informal care: randomized controlled trial results

European Journal of Public Health, May 2018

The aim of the research was to examine whether a role-focused self-help course intervention would decrease caregiver stress and distress, and functioning problems, among people who suffer stress because they combine paid work with informal care.

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An intervention that reduces stress in people who combine work with informal care: randomized controlled trial results

The European Journal of Public Health An intervention that reduces stress in people who combine work with informal care: randomized controlled trial results Edwin J. Boezeman 0 1 Karen Nieuwenhuijsen 0 1 Judith K. Sluiter 0 1 0 Coronel Institute of Occupational Health, Amsterdam Public Health Research Institute, Academic Medical Center, University of Amsterdam , Amsterdam , The Netherlands 1 Institute, Academic Medical Center, University of Amsterdam , Meibergdreef 15, 1105 AZ Amsterdam , The Netherlands, Tel: Background: The aim of the research was to examine whether a role-focused self-help course intervention would decrease caregiver stress and distress, and functioning problems, among people who suffer stress because they combine paid work with informal care. Methods: A pre-registered (NTR 5528) randomized controlled design was applied (intervention vs. wait list control). Participants (n = 128) were people who had paid work and were suffering stress due to their involvement in informal care activities. Participants allocated to the intervention group (n = 65) received the role-focused self-help course. Control group members (n = 63) received this intervention after all measurements. Prior to the random allocation (pre-test), and 1 month (post-test 1) and 2 months (post-test 2) after allocation, all participants completed a questionnaire that measured their caregiver stress (primary outcome), distress, work functioning, negative care-to-work interference and negative care-to-social and personal life interference. Mixed model ANOVAs were used to test the effectiveness of the intervention. Results: Two months after allocation, the intervention group participants had lower levels of caregiver stress and distress compared with the control group participants. The intervention did not directly resolve impaired work functioning or interference of care with work and social/personal life. Conclusion: The intervention decreases caregiver stress and distress in people who suffer stress because they combine paid work with informal caring. The intervention (Dutch version) can be downloaded at no cost from www.amc.nl/mantelzorgstress. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . - . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Introduction nformal care takes place in the private sphere, it involves the Iunpaid provision of care and assistance to a significant other person (e.g. parent, spouse and child) who suffers from a chronic health problem.1 Informal caregivers are ordinary individuals who at one time adopted the role of caregiver out of compassion and/or a sense of duty. Due to a lack of formal training or relevant work experience, most informal caregivers initially were, and many still are, largely unfamiliar or uncomfortable with providing care. The provision of informal care represents a role and a responsibility that are in addition to other roles and responsibilities (e.g. work role, family commitments). Of the people who combine paid work with informal care, there are those who need care and support because they suffer stress and functioning problems due to their involvement in informal care. It is expected that more employed people will become involved in informal care in the near future, due to for instance the aging population,1?4 and that the number of employed people experiencing stress and functioning problems due to involvement in informal care will increase. Interventions5?8 have been developed to help individuals fulfil the caregiver role and to counteract associated negative consequences for personal wellbeing and functioning. However, the current interventions are not easily accessible nor fully relevant to those who combine paid work with informal care. Notably, they do not focus on effectively combining the work role with the role of informal caregiver, do not take into account paid work as a resource or a burden and do not address strategies relevant to uphold functioning at work. According to role theory,9?11 a lack of understanding of how to perform a task (i.e. role ambiguity) and conflicting task demands (i.e. role conflict) represent a source of stress for employees, and hence hinder task performance. Research corroborates that role ambiguity and role conflict represent stressors to people who perform paid work.12 Qualitative studies13?17 conducted among those who combine paid work with informal caregiving have identified a range of problems related to (i) a lack of understanding of how to fulfil the role of informal caregiver (i.e. role ambiguity) and (ii) interference of the role of informal caregiver with the role of worker and/or family member (i.e. role conflict). Strategies offering role clarity and ways to minimize role conflicts may thus help to reduce stress in, and support the functioning of, these people. Selfmanagement psycho-education materials and/or computer-based learning modules may prove an effective method for the delivery of such interventions.18,19 Objective A role-focused self-help intervention may help those who combine paid work with informal care (i) understand and shape the informal caregiver role and (ii) combine the work role with the role of informal caregiver. The aim of this research was to examine whether such an intervention would decrease the caregiver stress, and the distress and functioning problems, of individuals who combine paid work with informal care. Methods Ethics The research was conducted in accordance with the Declaration of Helsinki.20 The Medical Ethics Committee of the Academic Medical Center judged (reference number: W15_220#15.0260) that a comprehensive evaluation was not required since this study was not subject to the Medical Research Involving Human Subjects Act. allocations were done by researcher K.N. Control group members received the self-help course after all measurements. Trial design Participants A randomized controlled parallel group design was developed, documented (Dutch Trial Register: NTR 5528) and used (intervention vs. wait list control). The participants were people who suffered stress because they combine paid work with informal caregiving. The research was conducted in the Netherlands in the private sphere of the participants. Paid workers involved in informal care were informed about the self-help course plus the research and invited to participate. The participants were recruited via community organizations across the Netherlands that offer support to informal caregivers. These organizations spread the recruitment message digitally (e.g. via email, digital newsletters, social media, etc.) among the informal caregivers in their respective regions. The recruitment message was also spread via message boards in hospitals, and via patient organizations and labour unions. The recruitment message contained the contact details of researcher E.J.B., individuals interested in participation applied for participation by contacting this researcher directly. In response, between December 2015 and August 2016, people who suffered stress due to combining paid work with informal caregiving self-applied for participation. General questions were used by researcher E.J.B. to verify whether the individuals who had applied for participation met the inclusion criteria. The inclusion criteria were (i) at least 23 years of age, (ii) informal caregiver for at least 2 h a week, (iii) involved in paid work for at least 12 h a week and (iv) self-reported stress complaints due to the involvement in informal care. Individuals who met the inclusion criteria were included in the research by researcher E.J.B. The intervention The intervention was a role-focused self-help course (i.e. E-book plus a non-obligatory internet support module) developed for people who combine paid work with informal care. It contained exercises, texts and practical suggestions. Its introduction text encouraged users to complete the self-help course at their own convenience, and made it clear that users (i) could choose the order in which they would complete its elements and (ii) could opt to complete only those elements that they found most relevant to their specific care plus work situation. From a role theory perspective, the selected materials are suitable for helping people who have paid work (i) to understand and shape the informal caregiver role and (ii) to combine the role of informal caregiver with other roles (i.e. the work role, social roles). The materials were adapted because in their original format they were of less practical relevance to those who have paid work and are involved in informal care (e.g. texts were made relevant to the context of the participants, texts were shortened but key elements were retained, exercises were made applicable for use without the help of a therapist or social worker, etc.). The materials were adapted from (i) The ?learning to be a family caregiver? intervention programme,21 (ii) a stressmanagement programme,22 (iii) The ADAPT method,7,23 (iv) the role clarity intervention24 and (v) an inventory of general strategies (e.g. stress management, problem solving, etc.) helpful for caregivers.25 Randomization Researcher E.J.B. who included the participants was not involved in their allocation. The allocation list, generated using Arifin?s26 randomization procedure, was kept concealed from E.J.B. All random Blinding Researcher E.J.B. responsible for data-analysis was told by researcher K.N. that the dataset contained either correct or incorrect codes for the conditions that the participants were allocated to and was instructed to analyse the data using the potentially fake codes for the conditions. Thus, E.J.B. was kept blind during data-analysis. The research participants were not blinded. Outcomes After informed consent, the participants completed a baseline questionnaire (pre-test). After allocation the participants completed a follow-up questionnaire after 1 and 2 months. The demographic variables were recorded with factual questions. All scales used had good internal consistency ( 0.70). Caregiver stress (primary outcome) was measured with the 13item Modified Caregiver Strain Index that has three answer options (i.e. ?Yes, on a regular basis?, ?Yes, sometimes? and ?No?).27 An example item is ?I feel completely overwhelmed (e.g. I worry about the person I care for; I have concerns about how I will manage)?. The scale score ranges from 0 to 26; a high score indicates a high level of caregiver stress. Distress was measured with the 5-point (i.e. ?No?, ?Sometimes?, ?Regularly?, ?Often?, ?Very often or Constantly?) 16-item distress scale of the 4DSQ.28 An example item is ?During the past week, did you feel tense??. After measurement, the procedure for aggregating the distress-scores was used (i.e. 3-point scale; ?No? = 0, ?Sometimes? = 1, all other responses = 2).28 The scale ranges from 0 to 32; a high score indicates a high level of distress. The composite weighted work functioning method29 was used to combine the participants? capacity for work scores, quality and quantity of work scores and recovery from work scores, into a single work functioning score. It has good construct and discriminative validity.29 The scale ranges from 0 to 100; a high work functioning score indicates impaired work functioning. Capacity for work was measured with the mental?interpersonal work demands subscale plus the physical work demands subscale (15 items) of the Caregiver Work Limitations Questionnaire.30 Quantity of work was measured with the 5-item output demands subscale of the Caregiver Work Limitations Questionnaire.30 Recovery from work was measured with the Need for Recovery Subscale.31 Quality of work was measured with subscales that record fulfilment of in-role and extra-role work responsibilities.32 Care-to-work interference, and care-to-social and personal life interference, were measured with adapted versions of the negative interference scales of the SWING instrument.33 The SWING hometo-work interference scale was transformed into a care-to-work interference scale by replacing the word ?home? with ?care situation? in the scale items. The SWING work-to-home interference scale was transformed into a care-to-social and personal life interference scale by replacing the word ?work? with ?care situation? in the items and by broadening the scale item content to social life. The adapted scales used the original SWING response categories (i.e. ?Never?, ?Sometimes?, ?Often? and ?Always?).33 The scales range from 0 to 24; a high score indicates a high level of interference. Sample size and statistics G-power34 analyses showed minimum sample size requirements (n = 78) for adequate power for the statistical test (i.e. power 0.80). A larger sample size was aimed for to compensate for potential non-response or ?loss? of participants during the research. Mixed model analysis of variance was used to examine whether the intervention group reported less caregiver stress, distress and functioning problems, over time than the control group. A partial eta-square Z2p of between 0.06 and 0.14 indicates a medium effect size.35 Results Sample In total, 156 individuals were included and 128 participants (n = 128) were randomized. Figure 1 shows the flow diagram and table 1 presents the respondents? characteristics. Effects of the role-focused self-help intervention The mixed model ANOVA results showed an effect of time on caregiver stress, F(2, 192) = 9.0, P < 0.001, Z2P ? 0:09. It also showed a significant Time Group interaction effect, F(2, 192) = 4.8, P < 0.01, Z2P ? 0:05. Over time, a clear decline in caregiver stress was observed in the intervention group (Mbaseline = 14.1, SD = 5.3; Mpost-test 1 month = 12.4, SD = 5.5; Mpost-test 2 months = 10.9, SD = 5.8). This was not the case in the control group (Mbaseline = 14.7, SD = 4.7; Mpost-test 1 month = 14.8, SD = 5.7; Mpost-test 2 months = 14.2, SD = 5.4). Bonferroni corrected post hoc tests made clear that the level of caregiver stress 2 months after baseline was significantly lower than the level of caregiver stress at baseline measurement (P = 0.001). Table 2 presents an overview of the means over time. Further, the mixed model ANOVA results showed an effect of time on distress, F(2, 186) = 10.2, P < 0.001, Z2P ? 0:10. It also showed a significant Time Group interaction effect, F(2, 186) = 7, P < 0.01, Z2P ? 0:07. Over time, a clear decline in distress was observed in the intervention group (Mbaseline = 16.6, SD = 7.4; Mpost-test 1 month = 14.6, SD = 6.8; Mpost-test 2 months = 11.3, SD = 7.2). This was not the case in the control group (Mbaseline = 19.2, SD = 7.4; Mpost-test 1 month = 19, SD = 7.9; Mpost-test 2 months = 18.7, SD = 8.7). Bonferroni corrected post hoc tests made clear that the level of distress 2 months after baseline was significantly lower than the level of distress at baseline measurement (P = 0.001). Table 2 presents an overview of the means over time. No significant effects were observed on work functioning, care-towork interference or care-to-social and personal life interference. All Time Group interactions were found to be non-significant (P > 0.05). Discussion This study examined whether the role-focused self-help intervention would decrease the caregiver stress, and the distress and functioning problems, of individuals who combine paid work with informal care. Significant effects of the intervention on caregiver stress and distress were observed. Limitations The participants had self-applied for participation and some participants discontinued their participation on their own initiative. Thus, self-(de)selection bias may undermine the generalizability of the research findings. Furthermore, the study did not address clinical significance. Two months after allocation the number of individuals who had a worrisome distress score (i.e. score > 11)36 had nearly halved in the intervention group, while in the control group the number of individuals who reported such a distress score had decreased by only a tenth, X2( 1 ) = 14, P < 0.001. Yet, the clinical significance of the intervention remains an issue for research. For now, it is concluded that the research findings, and the intervention, are relevant to people who have paid work and report stress complaints due to their involvement in informal care and who are motivated and skilled to complete this intervention. Further, this research has its limitations, because (i) interventionadherence was not monitored and (ii) a waiting-list control condition was used. The care plus work situations of individuals who combine work with informal care are not static nor fully interchangeable. Hence, the intervention purpose wise was not a fixed-protocol fixed-dose intervention. In addition, the primary focus of the research was only on the overall effectiveness of the intervention. Detailed monitoring of intervention-adherence thus was less feasible and less relevant in the current research. Yet, information about active adherence to the intervention would have contributed to the credibility of the intervention. In case the participants did not actively use the intervention, then its effects may be attributed to factors other than the content of the intervention materials (e.g. receiving attention, positive expectations, etc.). Further, while waiting-list control conditions have their benefits that contribute to the internal validity of the research,37 they also equal lack of treatment and nocebo.37,38 The use of only a waitinglist control condition raises the question of whether the observed effect of the intervention should be specifically attributed to the content of the intervention or to a non-specific effect (e.g. placebo). Thus, for now it can only be concluded that the intervention decreased the caregiver stress and distress of research participants, and further research is needed on why the intervention thus affected these outcomes. The research findings may motivate occupational health professionals to encourage individuals who combine paid work with informal care to complete the role-focused intervention. However, it should be acknowledged that people who combine paid work with informal care may also suffer stressors other than role problems, and interventions beyond psycho-education (e.g. legal aid) thus may be of help when needed. Furthermore, the intervention did not improve the participants? work functioning. In addition, while self-management internet-based interventions have their advantages (e.g. cost-effectiveness, accessibility, etc.), it is also the case that such interventions may have negative side effects (e.g. decreased inclinations to ask health professionals for help when in-person help would be needed).39 Thus, while the intervention represents a way to support people who combine paid work with informal caregiving, professionals should understand that these people may still have additional need for their support and care. Suggestions for research Further research should clarify why the intervention decreases the caregiver stress and distress of individuals who combine paid work with informal care. In case the intervention decreases stress in its users due to a non-specific effect (e.g. receiving attention and positive expectations), then the observed decrease in stress may only be short-lived for users. Should this be the case, then the intervention may need improvements to help its users make the critical role changes for sustained stress reduction. Researchers can use a three-armed randomized controlled trial design to examine whether participants allocated to the intervention group report decreased caregiver stress as compared with participants allocated to respectively a placebo group and a waiting-list or nocebo group. Further, researchers can conduct a user study and closely monitor intervention-adherence and time spend on elements of the intervention, to examine whether specific elements of the intervention are more effective than others and to gain a better understanding of the role theory processes of the intervention. Furthermore, researchers can examine whether the intervention affects outcomes that represent an increased ability to fulfil the role of informal caregiver and/or increased ability to combine the work role with the role of informal caregiver, for instance caregiver self-efficacy. Further, the relevance of the intervention to the work functioning of those who combine a paid job with informal caregiving should be further examined. It may be the case that, for instance, when stress reduces in these people due to the effect of the intervention, they may as a result be better able to undertake action to resolve their functioning problems. In addition, the study outcome on work functioning may have been different if only the functioning of the research participants 2 months after allocation had been included in the analysis. This issue should be further explored, because post hoc one-way ANOVAs revealed that only 2 months after allocation the intervention group had significantly less severe work functioning problems (M = 33, SD = 2.01) than the control group (M = 40, SD = 1.88), F( 1, 101 ) = 6.2, P < 0.05. Thus, researchers should further examine effects of the intervention on the functioning of people who combine paid work with informal care. In this context, it is of interest to not only examine effects on work functioning but to also examine whether the intervention helps people who combine paid work with informal care to function more effectively in the role of informal caregiver in the private non-work situation. Conclusion The role-focused intervention reduced caregiver stress and distress in people who suffer stress because they combine paid work with informal caregiving. Funding This research was partially funded by a grant awarded by the Instituut Gak, grant number 2014-513. Conflicts of interest: None declared. Key points People who combine paid work with informal caregiving may suffer caregiver stress and distress. The newly developed role-focused self-help course reduces caregiver stress and distress in these people. Occupational health professionals, academic researchers and those who combine paid work with informal care can freely download and use the E-book containing the role-focused selfhelp course (Dutch version) via www.amc.nl\mantelzorgstress. 1 2 3 4 5 6 7 8 9 Boumans N , Dorant E . Double-duty caregivers: healthcare professionals juggling employment and informal caregiving. A survey on personal health and work experiences . J Adv Nurs 2014 ; 70 : 1604 - 14 . Pitsenberger J. Juggling work and elder caregiving: work-life balance for aging American workers . AAOHN J 2006 ; 54 : 181 - 5 . Mazanec SR , Daly BJ , Douglas SL , Lipson AR . Work productivity and health of informal caregivers of persons with advanced cancer . 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Boezeman, Edwin J, Nieuwenhuijsen, Karen, Sluiter, Judith K. An intervention that reduces stress in people who combine work with informal care: randomized controlled trial results, European Journal of Public Health, 2018, 485-489, DOI: 10.1093/eurpub/cky052