CRITICALLY APPRAISED PAPER (CAP) Amen, A., Fonareva, I., Haas, M., Lane, J. B., Oken, B. S., Wahbeh, H., & Zajdel, D. (2010). Pilot controlled trial of mindfulness meditation and education for dementia caregivers. Journal of Alternative and Complementary Medicine, 16(10), 1031 1038. http://dx.doi.org/10.1089/acm.2009.0733 CLINICAL BOTTOM LINE: Researchers explored whether mindfulness-based interventions improve the overall quality of life in caregivers of individuals with dementia. This randomized controlled trial compared the effects of a mindfulness-based cognitive therapy (MBCT) program to both an active education program based on Powerful Tools for Caregivers and an inactive respite-only intervention. A sample size of 31 participants, all providing care for a close family member with progressive dementia, was used in this study. Participants in the mindfulness meditation and education groups received a 90-minute session once a week for 7 weeks and incorporated at-home implementation of learned knowledge. Participants in the respite-only group received a 3-hour session once a week for 7 weeks. The results indicated that participation in a mindfulnessbased meditation program has the potential to improve perceived stress and depressed mood of caregivers for people with dementia. Although this was a pilot study and further research is needed, the results support the potential use of mindfulness meditation to improve the overall well-being of caregivers for people with dementia. Additionally, although this study did not specifically include occupational therapists as care providers, the results indicate that mindfulness meditation can improve the overall quality of life in caregivers and therefore clinicians can utilize this information to educate caregivers in the different ways to manage and reduce commonly experienced psychological symptoms. RESEARCH OBJECTIVE(S) List study objectives. Determine if mindfulness meditation is an effective intervention to use with caregivers of people with dementia (p. 1031). This particular study was designed as a pilot for future larger studies by establishing a cause for further research and by refining the clinical trial design. DESIGN TYPE AND LEVEL OF EVIDENCE: Level I: Randomized controlled trial 1
SAMPLE SELECTION How were subjects selected to participate? Please describe. Researchers did not specify the methods used to recruit participants. Once recruited, participants agreed to be randomized to one of the three groups and committed to participate in the outlined interventions. Inclusion Criteria The adults included in the study were relatively healthy adults ranging from 45 85 years old who were caring for a family member with progressive dementia for at least 12 hours a week. Participants had to have a high enough baseline stress level with a score greater than 9 on the Perceived Stress Scale. Exclusion Criteria Participants were excluded from the study if they had unstable medical conditions, cognitive dysfunction with a score of less than 25 on the Modified Telephone Interview for Cognitive Status, were on medications that have not been stable for at least 2 months, had significant visual impairments with corrected binocular visual acuity worse than 20/50, or had previous experiences with stress-reduction classes. SAMPLE CHARACTERISTICS N= (Number of participants taking part in the study) 31 #/ (%) Male 6/(19%) #/ (%) Female 25/(81%) Ethnicity White: 28 African American: 1 Asian: 2 Disease/disability diagnosis Relatively healthy adults who were at risk for high levels of stress due to the different stressors associated with caregiving. INTERVENTION(S) AND CONTROL GROUPS Add groups if necessary Group 1 Brief description of the intervention The meditation intervention group used mindfulness-based stress reduction (MBSR) and MBCT. Researchers aimed to help the participants understand their reactions to stress and to teach skills to help with negative reactions while encouraging self-care and feelings of competence. Each session included a discussion about stress, relaxation, meditation, and the mind body interaction. Instruction and practice of meditation were provided and encouraged at each session and for practice at home. There also were discussions 2
on successes and problems encountered related to the exercises and applying the learned principles to their daily lives. How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? The practiced meditation consisted of seated meditation. Participants began by bringing awareness to their breaths, body sensations, and then to cognitive and emotional experiences. They practiced various exercises such as mindfulness participation in daily activities like washing the dishes and coping strategies adapted from the 3-Minute Breathing Space in which individuals bring awareness to difficult situations and their responses, then shift focus to breathing, and then return to the situation in a non-reactive way. Researchers did not discuss where each of the sessions occurred. However, there was at-home implementation of the learned knowledge and participants were encouraged to practice at home and were provided with written materials and recorded audio instructions. A clinical psychologist trained in MBSR and MBCT. The sessions took place weekly and each session was 90 minutes. Participants met weekly for a total of 7 weeks. Group 2 Brief description of the intervention How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? Participants in this group were educated on ways to reduce personal stress, change negative self-talk, communicate their needs to family members and health care providers, communicate more efficiently during troubling situations, and make tough caregiving decisions. Also, participants received a caregiver help book that was developed for the class. Participants completed weekly assignments from this book and were asked to carry out actions plans that they developed independently, such as meeting with a friend for coffee. While subjects were in session, the person that they were caring for was provided with respite care. Teachers trained in Powerful Tools for Caregivers The sessions occurred weekly and each session was 90 minutes. Participants met weekly for a total of 7 weeks. 3
Group 3 Brief description of the intervention How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? The participants in this inactive control group were provided with respite care once a week for a total of 3 hours over the course of 7 weeks. The caregivers in this group were able to choose what time during the week that they wanted the respite care. Also, this group did not attend the first session to ensure that it was a true control. The respite care was provided weekly for 3 hours at a time. Respite care was provided for a total of 7 weeks. Intervention Biases: Check yes, no, or and explain, if needed. Contamination: YES NO Comment: It is unclear if contamination was avoided, as minimal information was provided regarding study participants. Participants may have had opportunities to discuss their experiences with individuals in control groups, which may have influenced their thoughts and feelings. For example, the education group may have discussed concepts they learned with participants in the respite-only group. Co-intervention: YES NO Timing: YES NO Site: YES Comment: It is possible that there was co-intervention within this study. As previously stated, minimal information about the participants is provided. Therefore, it is not known if participants were receiving other services to manage caregiver stress. If the participants were receiving additional services, it may have influenced study results. Comment: Comment: The locations of where the groups met were not discussed in the article, which could have potentially influenced the results. The sites should be consistent for all groups to avoid any biases. 4
Use of different therapists to provide intervention: YES Comment: Different instructors who were trained in specific areas were used for the two different groups. As a result, the findings could have been influenced with more favorable outcomes in one group. MEASURES AND OUTCOMES Complete for each measure relevant to occupational therapy: Measure 1: Revised Memory and Behavior Problems Checklist (RMBPC) Caregiver-perceived stress was the primary outcome measure. This tool was designed specifically for studies relating to dementia and measures both the frequency of the problem behaviors and the effect that the behavior has on the caregiver. For the purpose of this study, measures of the reaction of the caregiver to the problem behaviors were the main focus of the RMBPC rather than the frequency (p. 1033). Measure 2: Measure 3: Caregiver Appraisal Tool Caregiver stress Perceived Stress Scale (PSS) Stress 5
Measure 4: Measure 5: Measure 6: Measure 7: The Center for Epidemiologic Studies Depression Scale (CESD) Depressed mood SF-36 Question 9 Subscore Energy and fatigue General Perceived Self-Efficacy Scale Self-efficacy Pittsburg Sleep Quality Index Sleep 6
Measure 8: Measure 9: Measure 10: Measure 11: This measure was administered only at the follow-up visit after the last class. Epworth Sleep Questionnaire Sleep This measure was administered only at the follow-up visit after the last class. Global Impression of Change Scale This measure was administered only at the follow=-up visit after the last class. Neuropsychiatric Inventory (NPI) Person with dementia s behavior was self-reported by the caregivers. Coping Response Inventory Coping strategies 7
Measure 12: Measure 13: Measure 14: Standardized 6-question, expectancy/credibility scale and a visual analog scale Expectancy/credibility of improvement Mindful Attention Awareness Scale (MAAS) and a measure for feelings of being non-judgmental (FFNJ), which was adapted from factor 5 from a factor analytic study of numerous mindfulness scales Mindfulness Self-rated scale of 1 6 on perceived stress, ability to cope with the situation, focus on the situation, and the demand level of the current situation at their home as well as in the laboratory Experience-based sampling This measure was administered at baseline and again at week 8. Participants were asked these questions at 5 random time points during wakeful hours on day 1 and again while in the lab at week 8. 8
Measure 15: Measure 16: Measure 17: Measure 18: 10-word list-learning task from the Alzheimer s Disease Assessment Scale-cognitive subscale Cognition Stroop Color and Word Test Cognition Attentional Network Test (ANT) Cognition Enzyme-linked immunoassays (ELISA) Cytokine measures 9
Measure 19: Salivary cortisol was attained 3 times during the assessment day: within 5 minutes of waking up, 30 minutes later before eating, and again at night between 10 and 11. All measurements were performed in duplicate. Class attendance and a biweekly diary logbook Adherence Class attendance was taken before the start of all classes and the diary logbook was used daily for participants in the meditation and education groups. Measurement Biases Were the evaluators blind to treatment status? Check yes, no, or, and if no, explain. YES Comment: Two researchers in the lab were not blinded to the assigned group. However, blinded research assistants performed all of the outcome assessments. The researchers who were not blinded were the primary contact persons with the research subjects and reminded subjects during appointment scheduling for the outcome assessments to not mention their assignment group to the research assistants who were performing the outcome assessments (p. 1034). Recall or memory bias. Check yes, no, or, and if yes, explain. YES NO Others (list and explain): Comment: Most measures were self-reported, which presents a potential for recall biases. However, there were no memory biases. RESULTS List key findings based on study objectives Include statistical significance where appropriate (p < 0.05) Include effect size if reported Primary outcome measures: Significant differences were found among the meditation, education, and respite-only groups on various measures. Revised and Memory Behavior Problem Checklist (RMBPC) reaction score 10
was the primary outcome measure and significant differences were noted between the groups from pretest to posttest, p = 0.030. Furthermore, the average RMBPC reaction scores after intervention for participants in the respite-only group were found to be higher when compared to the participants in the meditation group, p = 0.041, and education group, p = 0.027. No differences were found between the meditation and education groups in relation to RMBPC reaction scores post intervention, p = 0.839. Also, there were no relationships found between expectancy or credibility and improvement in the RMBPC. Secondary outcome measures: Overall, the RMBPC confidence scores after intervention demonstrated a significant difference among the three groups, p = 0.026. Also, the average RMBPC post intervention confidence score for participants in the respite-only group was lower than the score for those in the meditation group, p = 0.010. At the same time, there was a significant difference between the meditation group and the education group in relation to RMBPC confidence scores post intervention, p = 0.036. Furthermore, significant group differences were reported in relation to the Stroop Interference, p = 0.038. Similarly, there were group differences found for the Attentional Network Test (ANT) median reaction times for cue congruent trials, p = 0.032. Additionally, participants in the respite-only group had higher scores than participants in the education group for median reaction times for cue congruent trials post intervention, p = 0.010. Comparably, the ANT alerting score among the three groups also differed, p = 0.045. The ANT alerting scores for participants in the respite-only group were lower when compared to participants in the education group, p = 0.019, and meditation group, p = 0.053. No other differences were reported between the intervention outcomes on self-report, cognitive performance, or cytokine measures. Mindfulness: The intervention on mindfulness measures showed to have no effect. Perceived Stress Scale (PSS) scores before and after intervention were contrary related to the Mindfulness Attention Awareness Scale (MAAS) and mindfulness measure of being non-judgmental adapted from factor five (FFNJ). Furthermore, MAAS and FFNJ scores were correlated with the Center for Epidemiologic Studies Depression Scale (CESD) scores, ps < 0.05. Additionally, PSS scores before and after intervention were correlated with CESD scores, ps < 0.01. Was this study adequately powered (large enough to show a difference)? Check yes, no, or, and if no, explain. YES Comment: Were appropriate analytic methods used? Check yes, no, or, and if no, explain. 11
YES Comment: Were statistics appropriately reported (in written or table format)? Check yes or no, and if no, explain. YES Comment: Was the percent/number of subjects/participants who dropped out of the study reported? YES Four participants (13%) did not complete the study in its entirety. Limitations: What are the overall study limitations? The researchers noted a few limitations within this pilot study. First, for further studies it would be important to understand that there are differences amongst caregiver self-rated stress assessments when given in clinical settings compared to those given in-home. Furthermore, future studies may want to consider using a 2:2:1 ratio when randomizing participants into the different groups to minimize costs because all three groups received some sort of respite care in addition to the interventions used. The use of additional underrepresented minorities is encouraged in future research to effectively generalize research to represent the typical population. Also, it would be beneficial to look into the adherence of the given mindfulness meditation to practice at home to see if this contributes to the results. With these given suggestions, researchers believe that conclusions will be able to be more strongly supported. CONCLUSIONS State the authors conclusions related to the research objectives. A standardized assessment (RMBPC), which measured behaviors and ratings of the behaviors, was used to test the hypothesis that mindfulness is an effective form of intervention for dementia caregivers (p. 1035). Statistically significant results from the RMBPC supported the hypothesis (p. 1035). There was a significant effect on RMPC by group for baseline RMBPC, with both active interventions showing improvement compared to the respite-only group. The analyses computed revealed that there is evidence to support this topic; however, further research needs to be conducted to fully generalize the results because this was only a small pilot study. Overall, this study supports the hypothesis that a mindfulness intervention is effective in improving the overall well-being of dementia caregivers (p. 1036). This is a pilot study and will need further research to support strong generalizations. However, results from this small study favor the direction that mindfulness-based meditation is something to consider when addressing the well-being of dementia caregivers. Occupational therapists have knowledge in the field of 12
alternative medicines such as the meditation and can offer many aspects of the intervention. Occupational therapists can run different groups for dementia caregivers using this intervention, provide adaptive techniques if needed, encourage the use of meditation, provide evidence to support the benefits of meditation, and performing activity analyses if needed to modify the intervention. This study goes with the field of occupational therapy because it is concerned with improving participants overall functioning and helping them return to their chosen everyday life. This work is based on the evidence-based literature review completed by: Michelle Ghaul, Alyssa Denneny, Christopher Eisenmann, OT students, Richard Stockton College of New Jersey, and Megan Foti, DOT, MS, OT/R, Faculty Advisor, Richard Stockton College of New Jersey 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 13