CRITICALLY APPRAISED PAPER (CAP) Li, R., Cooper, C., Barber, J., Rapaport, P., Griffin, M., & Livingston, G. (2014). Coping strategies as mediators of the effect of the START (strategies for RelaTives) intervention on psychological morbidity for family carers of people with dementia in a randomised controlled trial. Journal of Affective Disorders, 168, 298 305. http://dx.doi.org/10.1016/j.jad.2014.07.008 CLINICAL BOTTOM LINE: There is increasing evidence of caregiver burden, including subsequent emotional and psychological consequences, for caregivers of individuals with disabilities. This study showed that increased emotion-focused coping as facilitated by STrAtegies for RelaTives (START) benefited carers with the greatest distress (as measured by Hospital Anxiety and Depression Scale [HADS]), although their use of dysfunctional coping strategies remained high. START can prevent and treat caregiver psychological morbidity, though its effect on caregivers varies with distress level. It is increasingly important for practitioners, especially occupational therapists working in home health or outpatient facilities, to remember the need to assist those caring for people with dementia and that although dysfunctional coping strategies remain highly used, there is general benefit to using functional, emotion-focused coping strategies. Because each caregiver s circumstances and dispositions are different, practitioners working with people with dementia and their families should note that psychological interventions work differently for each person, but that programs such as the START emotion-focused coping strategies have established evidence that they can be used to prevent and treat caregiver psychological morbidity. RESEARCH OBJECTIVE(S): List study objectives. Determine whether increased emotion-focused coping strategies mediate the effects of the START intervention in reducing psychological morbidity symptoms and whether those effects were moderated by the severity of baseline symptoms. DESIGN TYPE AND LEVEL OF EVIDENCE: Level I: Randomized controlled trial 1
SAMPLE SELECTION: How were subjects recruited and selected to participate? Please describe. Subjects were self-identified family caregivers of people with dementia. Caregivers were recruited between November 2009 and June 2011. They were approached by their clinician and given an information sheet. Researchers recruited self-identified family caregivers who provided at least weekly support for a person diagnosed with dementia who, within the last year, had been referred to one of four study sites (three mental health dementia service sites, one neurology center). INCLUSION CRITERIA Caregivers who provided at least weekly support for a person diagnosed with dementia and were referred in the past year to one of four study sites (three mental health dementia services, one specialist neurology center). EXCLUSION CRITERIA Caregivers who could not give informed consent, were participating in another study as family caregivers, or lived more than 1.5 hours away from the research base. SAMPLE CHARACTERISTICS N= (Number of participants taking part in the study) 187 #/ (%) Male #/ (%) Female Ethnicity Disease/disability diagnosis Caregivers who provided at least weekly support for a person diagnosed with dementia. 40% of carers met criteria for overall psychological morbidity (HADS-T 16+). Patients had mild to moderate dementia. INTERVENTION(S) AND CONTROL GROUPS Group 1: Intervention Brief description of the intervention START was adapted from the Coping with Caring manual (Gallagher-Thompson, et al., 2002). The standardized manual was designed to allow flexibility and be individually tailored to address each carer s particular issues and difficulties. Intervention was implemented in addition to treatment as usual. There were 8 sessions and they covered: 1. Overview of dementia and its symptoms; carer stress; and introducing relaxing exercises. 2 5. Behavioral management; changing unhelpful thoughts; assertive communication; promoting emotion-focused coping strategies such as seeking emotional support and 2
positive reframing. 6. Future care needs, with UK-specific information about care and legal planning, and information leaflets about making common decisions. 7. Planning pleasant activities (behavioral activation) 8. Maintaining the skills learned over time., p. 299 Each session included a relaxation exercise. Carers had homework to complete in between sessions. How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? 166 received at least one session; 130 received at least 5 sessions. 122 were analyzed for mediation, and 133 were analyzed for HADS. A location convenient to the carer, usually his or her home, without the patient in the room 10 therapists with undergraduate degrees in psychology and no professional clinical qualifications were trained in the intervention in a formal, standardized program with ongoing clinical supervision from a clinical psychologist. Each therapist had between 11 and 31 carers, with the median number of carers being 17 per therapist. 8 sessions for 1 hour each N/A Group 2: Treatment-as-usual (TAU) Brief description of the intervention Assessment, diagnosis and information, drug treatment, cognitive stimulation therapy, practical support, treatment of neuropsychiatric and cognitive symptoms, and carer support, in line with NICE guidance (National Institute for Health and Clinical Excellence et al., 2011). How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? 87; 65 were analyzed for mediation and 75 were analyzed for HADS Intervention Biases: Check yes, no, or and explain if needed. 3
Contamination: YES NO Co-intervention: YES Timing: Site: YES YES Comment: Control group did not receive any START intervention. Comment: This should be No, because it wasn t inadvertent. This was planned as part of the TAU. Intervention was implemented in addition to the patients typical treatment in line with NICE guidelines which includes carer support and drug treatment. Comment: The study does not mention how the intervention sessions were spread out and how long the intervention lasted, which makes it difficult to judge if timing of intervention was appropriate or not for all carers. Comment: Site of intervention was wherever the carer felt most comfortable. Although it was usually at the home of the carer, it wasn t always. The other locations were not mentioned in the study. Use of different therapists to provide intervention: YES NO Comment: Although there were 10 different therapists involved in the intervention, they were trained by a standardized manual by the research team, and no therapist rated any carer with whom they worked. MEASURES AND OUTCOMES Complete for each measure relevant to occupational therapy: Measure 1: Name/type of measure used: What outcome was measured? reliable? Hospital Anxiety and Depression Scale (HADS) Psychological symptoms predictive of depressive disorders Mark checks for reliability and validity 4
valid? When is the measure used? Measure 2: Name/type of measure used: What outcome was measured? reliable? valid? When is the measure used? Measure 3: Name/type of measure used: What outcome was measured? reliable? valid? When is the measure used? Measure 4: Name/type of measure used: What outcome was measured? Baseline, 4 months, and 8 months post-randomization Brief Coping Orientation to Problems Experienced Inventory (Brief COPE) Frequency with which caregivers use various coping strategies: problemfocused, emotion-focused, dysfunctional coping in the past month. Baseline, 4 months, and 8 months post-randomization Zarit Burden Interview Subjective caring burden in the past month Baseline, 4 months, and 8 months post-randomization Neuropsychiatric Inventory (NPI) Frequency and severity of neuropsychiatric symptoms common in people with dementia 5
reliable? valid? When is the measure used? Baseline, 4 months, and 8 months post-randomization Measurement Biases You need to respond to every question Were the evaluators blind to treatment status? Check yes, no, or, and if no, explain. Comment: Recall or memory bias. Check yes, no, or, and if yes, explain. Others (list and explain): Comment: NPI requires self-report from the past one month. RESULTS List key findings based on study objectives Include statistical significance where appropriate (p < 0.05) Include effect size if reported Mediation: Regression analysis, as part of the MacKinnon and colleagues joint significance test, did not support the hypothesis that emotion-focused coping mediated treatment effects on psychological morbidity. - No association was found between randomization to the intervention and change in any coping strategy (including emotion-focused coping) over 4 months (mean difference in coping [intervention: TAU] = 0.68, 95% CI: 0.71, 2.06) after adjusting for baseline covariates. -Increased emotion-focused coping at 4 months decreased psychological morbidity at 8 months. -Each point increase in emotion-focused coping predicted a change in HADS-T score of.35 (95%CI: 0.51, 0.18). This study tested whether mediated treatment effects through coping varied with baseline HADS-T score. Regression analyses were conducted for emotion-focused, problem-focused, and dysfunctional coping to see if moderated mediation was established with baseline 6
psychological morbidity. Moderated mediation was established if regression analyses showed no relationship between baseline morbidity and overall treatment outcome. Additionally, the analyses must show a significant relationship between baseline morbidity and treatment effect on coping, and that coping predicted final HADS-T score. The following are the results. Moderated Mediation: Overall effect of treatment on decreasing HADS-T scores at 8 months (mean difference =.26, 95% CI: 2.12, 0.39) was not significantly moderated by baseline psychological morbidity, as measured by baseline HADS-T score. Emotion-Focused Coping: - The relationship between randomization status and emotion-focused coping at 4 months was significantly moderated by baseline HADS-T (p = <0.001). In other words, a higher baseline HADS-T score predicted higher emotion-focused coping in the intervention group. - Increased coping at 4 months predicted decreased HADS-T (improvement) at 8 months. Each point increase in emotion-focused coping predicted a change in HADS-T score of 0.35 (95% CI: 0.51, 0.20). - For cases with HADS-T scores of 16+ at baseline, there was a mediated treatment effect in which scores decreased 0.63 points (95% CI: 1.11, 0.158) at 8 months (via increased emotion-focused coping). - No evidence to suggest a mediated effect for possible cases (scores 8 15) or for non-cases (scores 0 7). - Post-hoc subgroup efficacy analysis for coping showed only cases reporting increased emotion-focused coping at the 4-month follow-up in the intervention group compared to the TAU group (mean difference = 2.05, 95% CI: 0.12, 3.98), with a small to medium effect size of Cohen s d = 0.37. Problem-Focused Coping: Problem-focused coping at 4 months did not significantly predict HADS-T at 8 months (p = 0.136). Dysfunctional Coping: - The relationship between randomization status and dysfunctional coping at 4 months was moderated by baseline HADS-T score (p = <0.001). In other words, a higher baseline HADS-T score predicted increased dysfunctional coping with intervention when compared to TAU. - Increased dysfunctional coping at 4 months predicted increased HADS-T at 8 months; each point increase in dysfunctional coping predicted an increase in HADS-T score of 0.26 (95% CI: 0.08, 0.43). Was this study adequately powered (large enough to show a difference)? Check yes, no, or, and if no, explain. Again mark the responses Note: This study was found to be adequately powered for the primary outcome (HADS-T) but not for coping. 7
Were appropriate analytic methods used? Check yes, no, or, and if no, explain. Were statistics appropriately reported (in written or table format)? Check yes or no, and if no, explain. Reported in written and table format Was the percent/number of subjects/participants who dropped out of the study reported? Limitations: What are the overall study limitations? There was no attentional control group The Brief COPE might not have been sensitive to all elements of coping, and no psychosocial treatment mechanisms (e.g., grief, recent life events, actual use of social support) other than coping were measured. CONCLUSIONS State the authors conclusions related to the research objectives. The findings suggest that family carers may benefit in different ways from START, which is a manualized intervention that could be tailored to the individual. Results of this trial did not support the authors hypothesis that emotion-focused coping strategies mediated the overall treatment effects on psychological morbidity. However, the authors did find that increased emotion-focused coping strategies accounted for one-third of the overall treatment effects of caregivers with psychological morbidity (HADS-T 16+). Participants who were the most psychologically distressed were able to change their coping style while the less distressed participants also benefited from the intervention through other mechanisms. It was concluded that START can effectively prevent and treat carer psychological morbidity. However, mechanisms of action appear to differ between the more and less distressed participants. References Gallagher-Thompson, D., Solano, N., McGee, J. S.,Krisztal, E.,Kaye, J.,Coon, D. W., & Thompson, L.W. (2002).Coping with Caregiving: Reducing Stress and Improving Your Quality of Life.Stanford University School of Medicine and VA Palo Alto Healthcare System. 8
Mackinnon, D. P., Lockwood, C. M., Hoffman, J. M., West, S. G., & Sheets, V. (2002). A comparison of methods to test mediation and other intervening variable effects. Psychological Methods, 7(1), 83 104. National Institute for Health and Clinical Excellence & Social Care Institute for Excellence. ( 2011). Dementia: Supporting people with dementia and their carers in health and social care. NICE clinical guideline 42 (amended March 2011). This work is based on the evidence-based literature review completed by Julianna Parks, OTS; Jeannie Tsui, OTS; Amanda Conklin, OTS; Nicholas Herring, OTS; and Rochelle Mendonca, PhD, OTR/L, Faculty Advisor, Temple University. CAP Worksheet adapted from Critical Review Form--Quantitative Studies. Copyright 1998, by M. Law, D. Stewart, N. Pollack, L. Letts, J. Bosch, & M. Westmorland, McMaster University. Used with permission. For personal or educational use only. All other uses require permission from AOTA. Contact: www.copyright.com 9