To report the primary outcomes of a cluster randomized clinical trial of Behavioral Activities Intervention (BE-ACTIV), a behavioral intervention for depression in nursing homes.
Twenty-three nursing homes randomized to BE-ACTIV or treatment as usual (TAU); 82 depressed long-term care residents recruited from these nursing homes. BE-ACTIV participants received 10 weeks of individual therapy after a 2-week baseline. TAU participants received weekly research visits. Follow-up assessments occurred at 3- and 6-month posttreatment.
BE-ACTIV group participants showed better diagnostic recovery at posttreatment in intent-to-treat analyses adjusted for clustering. They were more likely to be remitted than TAU participants at posttreatment and at 3-month posttreatment but not at 6 months. Self-reported depressive symptoms and functioning improved in both groups, but there were no significant treatment by time interactions in these variables.
BE-ACTIV was superior to TAU in moving residents to full remission from depression. The treatment was well received by nursing home staff and accepted by residents. A large proportion of participants remained symptomatic at posttreatment, despite taking one or more antidepressants. The results illustrate the potential power of an attentional intervention to improve self-reported mood and functioning, but also the difficulties related to both studying and implementing effective treatments in nursing homes.
Depression, Nursing homes, Intervention, Clinical trial.
In this paper, we report the primary outcomes of a clinical trial of a behavioral intervention for depression tailored for nursing home residents. Depression is prevalent in nursing homes and raises risk for medical morbidity, mortality, and poor quality of life. Although there are evidence-based treatments (EBTs) for depression in older adults, nursing home settings present a number of delivery and implementation challenges, as well as special characteristics of the population, that limit the utility of these EBTs for residents. We used a combined effectiveness/efficacy approach for developing and testing an intervention that could address some of these challenges. The Behavioral Activities Intervention (BE-ACTIV) involves 10 weekly sessions delivered by a mental health therapist (MHT). The MHT works collaboratively with activities staff members.
Rates of major and minor depression, and subsyndromal depressive symptoms, are higher in nursing homes than among community dwellers (Fullerton, McGuire, Feng, Mor, & Grabowski, 2009; Teresi, Abrams, Homes, Ramirez, & Eimicke, 2001). Depression among those in residential care is related to decreased cognitive status, functional capacity, clinician-rated health, pain (Katz & Parmelee, 1997), greater use of nursing time (Fries et al., 1993), suicidality (Reynolds et al., 1998), and increased mortality (Rovner et al., 1991). The common comorbidity of depression and dementia further increases risks (Kales et al., 2005), including increased agitation and aggression (Lyketsos et al., 1999), increasing the amount of care, and the stress on the caregiver. Treatments for depression in nursing homes must be applicable to the range of depressive syndromes seen in these settings and to those residents with cognitive impairment.
Antidepressant medications are sometimes effective in treating frail elders (Snowden, Sato, & Roy-Byrne, 2003) but may fail to improve functional disability or self-care (Katz, Simpson, Curlik, & Parmelee, 1990) or mitigate bereavement (Reynolds et al., 1999) or hopelessness (Szanto, Reynolds, Conwell, Begley, & Houck 1998). Antidepressants produce an increased risk of side effects (Thapa, Gideon, Cost, Milam, & Ray, 1998). They are increasingly used in nursing homes, but there are concerns about the typical quality of medication management (Gaboda, Lucas, Siegel, Kalay, & Crystal, 2011; Shah, Schoenbachler, Streim, & Meeks, 2012; Weintraub, Datto, Streim, & Katz, 2002). These shortcomings suggest the need for psychosocial interventions, but psychotherapy is rarely used in nursing homes (Shah et al., 2012; Snowden, Piacitelli, & Koepsell, 1998).
Hyer, Carpenter, Bishmann, and Wu (2005) reviewed 19 clinical trials for psychosocial interventions in nursing homes that included depressive symptoms as outcomes. Despite noting numerous methodological limitations, including failure to select participants based on well-defined depression criteria, lack of treatment manuals, small sample sizes, and lack of follow-up assessments, they concluded that there is preliminary support for the efficacy of psychosocial interventions to alleviate depressive symptoms. Since that review, eight randomized, controlled studies have been published (Brodaty et al., 2003; Cernin and Lichtenberg, 2009; Hyer, Yeager, Hilton, & Sacks, 2009; Jones, 2003; Hsu & Wang, 2009; Sood, Cisek, Zimmerman, Zaleski, & Fillmore, 2003; Tappen & Williams, 2009; Tsai, Wong, Tsai, & Ku, 2008). Although promising, most of these trials were very small; the two larger trials (Brodaty et al., 2003; Tsai et al., 2008) were carried out in Australia and Taiwan, respectively, and showed no group × time differences at posttreatment. There remains the need for carefully designed controlled studies of interventions for depression among nursing home residents.
BE-ACTIV was developed collaboratively with nursing home staff to be feasible within current staffing structures and mental health reimbursement systems. The development process and theoretical rationale for the intervention have been presented elsewhere (Meeks & Depp, 2002; Meeks, Looney, Van Haitsma & Teri, 2008; Meeks, Teri, Van Haitsma, & Looney, 2006; Meeks, Young, & Looney, 2007). The conceptual model is based on a revised version of Lewinsohn’s (1974) original behavioral model of depression (Lewinsohn, Hoberman, Teri, & Hautzinger, 1985), which posits that stressful circumstances disrupt behavioral regularity, disrupting the balance between positive and negative affect. Heightened negative self-awareness diminishes the ability to regulate positive affect, perpetuating dysphoria and inhibiting the person’s ability to maintain emotional equilibrium. Nursing homes and other institutional settings further limit access to positive activities (Hopko, Lejuez, LePage, Hopko, & McNeil, 2003). BE-ACTIV is designed to restore the balance of positive to negative affect by affording consistent opportunity to experience positive reinforcement from the environment. We adapted a treatment manual developed for family caregivers of dementia patients (Teri, Logsdon, Uomoto, & McCurry, 1997) to create a hybrid, collaborative, individualized therapy that utilizes a mental health professional but also involves nursing home activity staff (Meeks et al., 2008). The current paper reports on the results of a cluster randomized clinical trial of BE-ACTIV in 23 nursing homes. We report the outcomes for the following primary hypotheses.
H1: As compared with nursing home residents receiving treatment as usual (TAU), residents randomized to BE-ACTIV will, after 10 weeks, be more likely to show diagnostic recovery. In addition, treated residents will show symptomatic improvement in depression and functioning (social and daily activities).
H2: As compared with nursing home residents receiving TAU, residents randomized to BE-ACTIV will continue to show superior outcomes related to diagnosis, symptoms, and functioning at 3- and 6-month posttreatment.
A two-group, cluster randomized, control group design compared BE-ACTIV and a TAU control group. The unit of randomization was the nursing home, with residents nested within nursing homes; nursing homes were blocked by size (greater or fewer than 100 beds). The treatment phase was 10 weeks following a 2-week baseline assessment period. Participants were reassessed on diagnosis and symptom measures immediately posttreatment. There were two follow-up assessments, at 3- and 6-month posttreatment.
Treatment as usual.
Residents in TAU nursing homes continued to receive the treatments already available to them, which for most meant receiving antidepressants. Research staff visited them weekly for 12 weeks to collect self-rated mood data, spending 5–30min per visit. Research staff supervised by the third author reviewed treatment records to code medication management and other treatments. To control for the effects of staff participation in training, the first author provided a 2-hr training session for activities staff in TAU facilities that was equal in length to the training provided in the treatment homes, but of different content, focused on understanding dementia and roles of activity staff in managing behavior problems, but not on depression or pleasant events.
Behavioral Activities Intervention.
BE-ACTIV invol ved two baseline assessment visits (same as TAU group) and 10 weekly sessions between the resident and a MHT, during which the MHT assessed the availability and individual reinforcement value of pleasant activities (Meeks et al., 2008). Staff facilitators, who assisted the resident to carry out the planned activities, were invited to Sessions 1, 5, and 10. MHTs also met weekly with staff facilitators at each treatment facility without the resident present. MHTs were clinical psychology doctoral students who completed a training seminar and practicum on the intervention. MHTs exceeded a criterion of 80% adherence with manual expectations across 10 sessions of treatment with at least one clinical case before taking on a study client. Staff facilitators participated in a 2-hr training program on depression, pleasant events, and behavior management by the first author and received a manual outlining staff responsibilities. To insure treatment integrity, we provided staff members with resources such as craft supplies or audio players when needed to carry out some of the requested pleasant events. Supplementary Table 1 summarizes the BE-ACTIV treatment sessions.
Inclusion and Exclusion Criteria
Nursing home staff identified residents who were: (a) aged 55 or older, residing in long-term care beds with an expected stay of 3 months or more, (b) diagnosis, positive facility screen, or treatment of depression, and (c) staff belief they were sufficiently cognitively intact to give consent. Exclusion criteria included: (a) under the care of or referral to Hospice for a terminal condition, (b) medical condition deemed unstable or terminal by nursing staff, (c) physical condition so deteriorated the resident was unable to participate in either self- or other-initiated activities, and (d) for the BE-ACTIV group only, resident receiving weekly psychotherapy. Research staff further screened consenting residents using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorder (DSM)-IV (SCID-IV), the Geriatric Depression Scale (GDS), and the Mini-Mental State Examination (MMSE). Residents scoring below 14 on the MMSE were excluded (see McGivney, Mulvihill, & Taylor, 1994). Residents were included if they had a GDS score of 11 or above and met criteria for DSM-IV depressive disorder.
Mini-Mental State Examination.
The MMSE (Folstein, Folstein, & McHugh, 1975) is one of the most widely used mental status examinations for dementia screening (Tombaugh & McIntyre, 1992). The MMSE consists of 11 items that cover orientation, registration, attention/calculation, recall, and language function. Scores range from 0 to 30.
Geriatric Depression Scale.
The GDS (Brink et al., 1982) is a 30-item, self-report depression screening scale developed for use with older adults. The psychometric properties of the scale are well established for a variety of settings (e.g., Koenig, Meador, Cohen, & Blazer, 1988; Snowdon, 1990). McGivney and colleagues (1994) found 84% sensitivity and 91% specificity rates in cognitively impaired patients with scores above 14, using a cutting score of 11. Internal consistency for this sample was .70. The GDS was given at baseline, posttreatment, and at 3- and 6-month follow-ups.
Participants’ age, sex, race, former occupation, and source of payment were collected from the residents’ medical charts at the nursing homes at baseline.
Medical data were extracted from nursing home charts at baseline, posttreatment, and 3- and 6-month posttreatment. Licensed nursing homes use the standardized Minimum Data Set (MDS) on all residents, completed annually and updated quarterly by facility staff. We used data from the most recent complete MDS and quarterly update. The version of the MDS used by the facilities changed from 2.0 to 3.0 during the study; medical and functional scales presented here are from the MDS 2.0, and the data from charts that included 3.0 were cross-walked to 2.0 items where possible. The scales reported here include number of current (nonmental health) disease diagnoses, number of medications prescribed, and activities of daily living (ADL) impairment. This latter scale consists of 10 ADL items rated from 0 to 4 (independent to total assist) or 8 (not performed at all during rating period) and summed for a total scale score. We also report weight in pounds and number of days on antidepressants, anxiolytics, hypnotics, and antipsychotics from the MDS data.
Psychotropic medication use.
At the time that the MDS was extracted from the charts, research assistants recorded all psychotropic drug use as indicated in the medical record.
Structured Clinical Interview for DSM-IV.
We used the mood disorders section of the SCID-IV, Non-Patient Research Version (First et al., 2002), to establish research diagnoses. When necessary, interviewers corroborated information from family members, staff, or from nursing home medical charts. The first author completed the pretreatment interviews, and the posttreatment and follow-up interviews were completed by the third author, who remained blind to condition throughout the study. Both interviewers had completed recommended training procedures for the SCID (Ventura, Liberman, Green, Shaner, & Mintz, 1998). The two interviewers achieved diagnostic reliability of .75 or better (kappas or intraclass correlations) on practice videotapes before conducting study interviews. Final diagnoses were arrived at by consensus between the two interviewers.
By the late 1400s, technology had improved enough that it was more possible for Europeans to explore far overseas. The technological advances were partly in ship design and partly in navigation.
One thing that helped allow exploration was bigger and better ships. The designs most often mentioned in textbooks are caravels and galleons. Both of these kinds of ships (caravels came first) were improvements on what had come before. They were larger and could carry more cargo and cannon (for protection). They had better sail designs and could sail more efficiently and with fewer crew members. These new kinds of ships made exploring more feasible.
In addition, there were changes in navigational technology. These included quadrants and astrolabes for determining latitude. It also included better tables of data that told navigators what their astrolabe readings meant. It included compasses and better types of charts and sailing directions (called rutters) for telling people where an explorer had been and how to retrace his steps.
These types of technological improvements made it more possible for Europeans to explore far away from their own shores by the late 1400s.