Salivary cortisol and alpha-amylase as stress markers to evaluate an individualized music intervention for people with dementia: feasibility and pilot analyses.

OBJECTIVES: We investigated salivary biomarkers of stress, more specifically, cortisol and alpha-amylase, to evaluate effects of individualized music listening (IML) in people with dementia. METHOD: Participants were N = 64 nursing home residents with dementia (meanage = 83.53 ± 7.71 years, 68.8% female). Participants were randomly assigned to either listening to their favorite music every other day for a period of six weeks (intervention), or standard care (control). Using the Saliva Children`s Swab (SCS), saliva was collected before, after, and 20 min after IML sessions at the beginning and end of the intervention period for the analysis of salivary alpha-amylase and cortisol. RESULTS: Using the SCS was feasible in people with dementia. Nevertheless, there was no effect of IML on salivary stress markers. DISCUSSION: Although using SCS was feasible, active patient engagement is required. Future studies need to corroborate findings in larger samples. TRIAL REGISTRATION: German Clinical Trials Register: DRKS00015641, ISRCTN registry: ISRCTN59052178.

Unraveling the optimal balance of problem-related affective experiences and need satisfaction in cognitive-behavioral therapy: A response surface analysis.

Objective: Although therapists are encouraged to balance emotionally involving work on the patient's problems with need satisfaction in therapy sessions, effects of this balance have rarely been studied empirically. Hence, we examined congruence effects between problem-related affective and need-satisfying experiences in cognitive-behavioral therapy (CBT). Method: 165 distressed family caregivers rated problem-related affective experiences, need-satisfying experiences comprising self-esteem, positive interpersonal, and control experiences, as well as coping experiences after 12 CBT sessions. We examined within-person congruence effects of problem-related affective and need-satisfying experiences on subsequent coping in multilevel response surface analysis. Further, we included between-person problem-related affective and need-satisfying experiences and pretreatment depression and anxiety as moderators of within-person effects. Results: A slight predominance of self-esteem over problem-related affective experiences as well as exact correspondence between problem-related affective and both interpersonal and control experiences was most predictive of coping. Between-person moderators supported a cross-level balance heuristic of problem-related affective and self-esteem experiences. Finally, a stronger emphasis on self-esteem and interpersonal over problem-related affective experiences proved more beneficial for patients with high anxiety and low depression. Conclusions: The findings highlight the importance of balancing problem-related affective and need-satisfying experiences in CBT and provide insights into how balancing may be tailored to specific patients.

How do care-related beliefs contribute to depression and anxiety in family caregivers of people with dementia? Testing a cognitive vulnerability-stress model.

OBJECTIVES: Care-related beliefs are considered risk factors for decreased mental health in family caregivers of people with dementia. However, their exact role in the caregiver stress process remains unclear. Hence, we tested a cognitive vulnerability-stress model of depression and anxiety in family caregivers of people with dementia. METHOD: A cross-sectional study was conducted using baseline data from a caregiver intervention trial (N = 322). Within Bayesian moderated mediation analysis, we examined mediation of effects of objective demands (severity of dementia, challenging behavior, caregiving intensity, caregiving duration) on depression and anxiety via subjective caregiver burden and moderation by care-related beliefs in four domains (dysfunctional caregiving standards, dysfunctional attitudes towards dementia, functional self-care-related beliefs, functional acceptance-related beliefs). RESULTS: The relation between objective demands and subjective burden was amplified by dysfunctional caregiving standards and dysfunctional attitudes towards dementia and mitigated by functional self-care-related beliefs. Further, functional acceptance-related beliefs attenuated the effect of subjective caregiver burden on depression. CONCLUSION: The study provides preliminary evidence for a cognitive vulnerability-stress model of depression and anxiety in family caregivers of people with dementia. The results indicate that the four-domain model of care-related beliefs is a valuable framework for future research and may serve as a heuristic model for cognitive-behavioral therapy in this population.

Telephone-Based Acceptance and Commitment Therapy for Caregivers of Persons with Dementia: Results of a Randomized Controlled Trial.

OBJECTIVES: Family caregivers of persons with dementia (PwD) experience high levels of distress. We used a randomized-controlled trial to investigate the effects of telephone-based acceptance and commitment therapy (tbACT) for family caregivers. METHODS: Caregivers were randomly allocated to an intervention group (tbACT, n = 41) or an untreated control group (CG, n = 40). The intervention consisted of eight weekly sessions of tbACT. Depression and anxiety (primary outcomes), physical symptoms, pre-death grief, care-related thoughts, acceptance (secondary outcomes), quality of life, coping and well-being (well-being/coping outcomes) were assessed pre- and post-assessment. A 6-month follow-up was conducted. RESULTS: Compared to CG participants, tbACT participants had at post-assessment significantly lower depressive symptoms; fewer physical symptoms (rheumatic pain); better physical health; more resource utilization (coping with daily hassles, social support); better coping with the care situation and better emotional well-being. During the six-month follow-up, tbACT participants showed less pre-death grief, fewer physical symptoms, and more utilization of resources related to coping with daily hassles. CONCLUSIONS: tbACT is a feasible and promising psychotherapeutic intervention for family caregivers of PwD. Because of small sample size our results are preliminary. CLINICAL IMPLICATIONS: Most of the effects of tbACT were not maintained 6 months after the intervention, suggesting that booster sessions may be helpful.

Love yourself as a therapist, doubt yourself as an institution? Therapist and institution effects on outcome, treatment length, and dropout.

OBJECTIVE: Research suggests that some therapists achieve better outcomes than others. However, an overlooked area of study is how institution differences impact patient outcomes independent of therapist variance. This study aimed to examine the role of institution and therapist differences in adult outpatient psychotherapy. METHOD: The study included 1428 patients who were treated by 196 therapists at 10 clinics. Two- and three-level hierarchical linear regression models were employed to investigate the effects of therapists and institutions on three dependent patient variables: (1) symptom change, (2) treatment duration, and (3) dropout. Level three explanatory variables were tested. RESULTS: The results showed that therapist effects (TE) were significant for all three types of treatment outcome (7.8%-18.2%). When a third level (institution) was added to the model, the differences between therapists decreased, and significant institution effects (IE) were found: 6.3% for symptom change, 10.6% for treatment duration, and 6.5% for dropout. The exploratory analyses found no predictors able to explain the systematic variation at the institution level. DISCUSSION: TE on psychotherapy outcomes remain a relevant factor but may have been overestimated in previous studies due to not properly distinguishing them from differences at the institution level.

Enhancing the acceptance of smart sensing in psychotherapy patients: findings from a randomized controlled trial.

Objective: Smart sensing has the potential to make psychotherapeutic treatments more effective. It involves the passive analysis and collection of data generated by digital devices. However, acceptance of smart sensing among psychotherapy patients remains unclear. Based on the unified theory of acceptance and use of technology (UTAUT), this study investigated (1) the acceptance toward smart sensing in a sample of psychotherapy patients (2) the effectiveness of an acceptance facilitating intervention (AFI) and (3) the determinants of acceptance. Methods: Patients (N = 116) were randomly assigned to a control group (CG) or intervention group (IG). The IG received a video AFI on smart sensing, and the CG a control video. An online questionnaire was used to assess acceptance of smart sensing, performance expectancy, effort expectancy, facilitating conditions and social influence. The intervention effects of the AFI on acceptance were investigated. The determinants of acceptance were analyzed with structural equation modeling (SEM). Results: The IG showed a moderate level of acceptance (M = 3.16, SD = 0.97), while the CG showed a low level (M = 2.76, SD = 1.0). The increase in acceptance showed a moderate effect in the intervention group (p < .05, d = 0.4). For the IG, performance expectancy (M = 3.92, SD = 0.7), effort expectancy (M = 3.90, SD = 0.98) as well as facilitating conditions (M = 3.91, SD = 0.93) achieved high levels. Performance expectancy (γ = 0.63, p < .001) and effort expectancy (γ = 0.36, p < .001) were identified as the core determinants of acceptance explaining 71.1% of its variance. The fit indices supported the model's validity (CFI = .95, TLI = .93, RMSEA = .08). Discussion: The low acceptance in the CG suggests that enhancing the acceptance should be considered, potentially increasing the use and adherence to the technology. The current AFI was effective in doing so and is thus a promising approach. The IG also showed significantly higher performance expectancy and social influence and, in general, a strong expression of the UTAUT factors. The results support the applicability of the UTAUT in the context of smart sensing in a clinical sample, as the included predictors were able to explain a great amount of the variance of acceptance.

Study protocol: randomized controlled trial of an individualized music intervention for people with dementia in the home care setting.

BACKGROUND: Studies suggest that individualized music listening is an effective, non-pharmacological intervention for improving the quality of life of people with dementia in the institutional care setting. Noting that most people with dementia live at home, we conduct a randomized controlled trial to assess the feasibility and effectiveness of an app-based individualized music listening intervention for people with dementia in the home care setting. The intervention is delivered by family caregivers. METHODS: We will recruit N = 130 dyads consisting of one person with dementia living at home and their family caregiver. After a baseline assessment, dyads are randomly assigned by gender to either the intervention or control group. People with dementia in the intervention group listen to individualized music playlists for 20 min every other day for six weeks via the self-developed Individualized Music and Dementia app. The control group receives standard care. All dyads complete paper-and-pencil questionnaires six weeks before the start of the intervention (T0), directly before the intervention (T1), directly after the intervention (T2), and six weeks later (T3). During the intervention period, all caregivers also complete daily ecological momentary assessments via the app. During three home visits, a trained project member will observe the dyads and collect hair samples. After the intervention, semi-structured interviews will be conducted to collect information about participants' experiences with the app and intervention. The primary outcome is the attainment of individual goals established during the baseline assessment. Secondary outcomes are the well-being, physiological stress and quality of life of people with dementia and their caregivers; people with dementia's behavioural and psychological symptoms of dementia, resistance during care, and reactions to the music; caregivers' burden of care, positive aspects of care, and caregiving self-efficacy; and the quality of the caregiver-care recipient interaction. DISCUSSION: Our study will assess the extent to which an app-based individualized music listening intervention is feasible and effective for enhancing the well-being and quality of life of people with dementia living at home and their family caregivers. TRIAL REGISTRATION: German Clinical Trials Register DRKS00025502 and ISRCTN registry ISRCTN68084105, https://doi.org/10.1186/ISRCTN68084105.

Sounds of Difference: A Typology of Reactions of People With Dementia to Individualized Music in the Presence of a Monitoring Person.

BACKGROUND AND OBJECTIVES: Despite promising effects of individualized music listening (IML) for people with dementia, the individualized nature and heterogeneity of reactions to IML remain underexplored. We aimed to develop an empirically derived typology of directly observed reactions of people with dementia to IML and propose recommendations for tailoring the intervention to the respective types. RESEARCH DESIGN AND METHODS: An ideal-type analysis was conducted on 108 video recordings of 45 people with mainly severe dementia (78% female, mean age of 83.02 years, all White participants) listening to recorded individualized music. Dimensions were identified for capturing similarities and differences between types. RESULTS: The analysis yielded 10 types of reactions ("expressing and sharing joy," "self-disclosure stimulated by music," "concentrated, absorbed listening," "blissful enjoyment," "experience of the music as bittersweet," "sharing memories," "releasing tension," "tensing up and rejecting," "predominant search for social exchange," "no interpretable reaction") and 3 dimensions ("valence" from negative to positive, "arousal" from calm to activated, "communicative activity" from defensive/resistant to proactive), resulting in a three-dimensional coordinate system, providing a holistic representation and facilitating a systematic contrast of identified reaction types to IML. DISCUSSION AND IMPLICATIONS: Reactions to IML were influenced by the interaction with the project staff, who monitored the sessions. Based on these observations, we propose recommendations for tailoring both the behavior of the monitoring person (e.g., engaging in synchronous activities like clapping along) and the setup of the intervention (e.g., communal vs individual listening) to each type, which may improve the effects of IML.

Between- and within-person effects of affective experiences on coping in CBT: Direct effects and interplay with therapeutic alliance and resource activation.

OBJECTIVE: The role of affective experiences (AE) in cognitive-behavioral therapy (CBT) has rarely been investigated. We examined between- and within-person effects of AE on coping in CBT for family caregivers and interactions with therapeutic alliance and resource activation. METHODS: 67 family caregivers rated AE, therapeutic alliance, resource activation, and coping after each of 12 sessions of telephone-based CBT. We examined direct session-to-session effects of AE on coping in structural equation modeling and interactions of AE with therapeutic alliance and resource activation in multilevel models. RESULTS: AE did not directly predict coping. Instead, within-person effects of AE interacted with simultaneous within-person emotional bond. Given strong emotional bond, AE positively predicted coping, whereas given weak emotional bond, AE negatively predicted coping. Further, cross-level interactions of between-person AE and within-person agreement on collaboration and resource activation indicated that these positively predicted coping only in dyads with high between-person AE. CONCLUSION: AE may enhance coping when complemented with strong emotional bond. Further, within-person effects of agreement on collaboration and resource activation seem to rely on a certain degree of between-person AE. Results are discussed in relation to current findings on emotional processing in CBT.

Effects of general change mechanisms on outcome in telephone-based cognitive-behavioral therapy for distressed family caregivers.

BACKGROUND: The study investigated the influence of general change mechanisms (GCMs) on outcome in telephone-based cognitive-behavioral therapy (CBT) for family caregivers. METHODS: In a stepped-care intervention approach, highly distressed family caregivers received telephone-based CBT after completing a care counseling intervention. Sixty-six therapist-caregiver dyads rated emotional bond, agreement on collaboration, problem actuation, resource activation, clarification of meaning, and mastery after each of 12 therapy sessions. Outcomes were caregiver burden (SCQ-AV) and depression (CES-D) after therapy. Associations of GCMs with outcome were examined in multilevel regression models. RESULTS: Caregiver burden was significantly predicted by caregiver-rated emotional bond (ß = -0.18) as well as therapist-rated resource activation (ß = -0.26), problem actuation (ß = -0.22), clarification of meaning (ß = -0.18), and mastery (ß = -0.18). None of the GCMs predicted depression from any perspective. CONCLUSION: The findings suggest that GCMs are relevant for reducing caregiver burden in CBT for family caregivers and should be fostered in treatment manuals, in particular therapist-rated GCMs. Since therapist and caregiver perspectives differed in predicting caregiver burden, future research should investigate perspective congruence and its effect on therapy outcome.

Face-to-face versus telephone-based cognitive-behavioral therapy for family caregivers of people with dementia.

OBJECTIVE: The objective was to directly compare the effects and acceptability of telephone-based (TEL-CBT) with face-to-face cognitive-behavioral therapy (F2F-CBT) for family caregivers of people with dementia (PwD). METHOD: Caregivers for whom F2F participation was possible were allocated to F2F-CBT (n = 49). The other participants were randomized to TEL-CBT (n = 139) or CG (n = 134). CBT consisted of 12 sessions over 6 months. RESULTS: TEL-CBT yielded significantly better physical health (d = 0.27) and coping with daily hassles (d = 0.38) at posttest compared to F2F-CBT. Therapist competence, acceptability, and outcomes at follow-up did not differ between TEL-CBT and F2F-CBT. CONCLUSIONS: TEL-CBT is a valuable alternative to F2F-CBT for family caregivers of PwD as TEL-CBT has the advantage of higher accessibility while it does not significantly differ from F2F-CBT in effectiveness and caregivers' evaluation of the setting, their experience with the therapist, and their satisfaction.

Immediate effects of individualized music listening on behavioral and psychological symptoms of dementia: A randomized controlled trial.

OBJECTIVES: Evidence suggests that individualized music listening (IML) can effectively reduce the behavioral and psychological symptoms of dementia (BPSD). So far, however, studies have been primarily based on questionnaire measures of BPSD completed by proxy. We therefore investigate effects of IML on BPSD based on systematic observation. We address the methodological limitations of previous observational studies by using a validated instrument, time-based sampling, and longitudinal analytical methods. METHODS: We compared BPSD of nursing home residents with dementia in an IML intervention group (IG; n = 44) and a control group (CG; n = 46) in a randomized controlled trial (DRKS00013793; ISRCTN59052178). Trained raters observed 18 BPSD in 15 four-minute intervals before, during and after an IML session. We used t-tests to compare BPSD in the IG and CG before, during and after the session and piecewise latent curve modelling to compare BPSD trajectories across 1 hour. RESULTS: BPSD were observed less frequently in the IG than in the CG during, but not before or after the session. Likewise, whereas the CG experienced a stable trajectory of BPSD, the IG experienced a u-shaped trajectory characterized by stability before the session, a decrease during the session, and increase after the session. There was significant interindividual variability in baseline BPSD and in the pre- and post-session slopes. DISCUSSION: Our results provide additional evidence that IML effectively reduces BPSD, although the effect is short-lived. As IML rarely has negative side effects, is highly accepted and easily implemented, IML should be integrated into the everyday care routines for people with dementia. CLINICAL TRIAL REGISTRATION: German Clinical Trials Register DRKS00013793; ISRCTN registry, ISRCTN59052178.

Effects of nursing home placement on the mental health trajectories of family caregivers of people with dementia: findings from the Tele.TAnDem intervention study.

OBJECTIVES: The objective was to compare mental health trajectories between family caregivers of people with dementia (PwD) who institutionalize the care recipient (nursing home caregivers [NHC]) and caregivers who continue to provide care at home (at-home caregivers [AHC]) as well as investigate effects of a telephone-based cognitive-behavioral therapy (TEL-CBT) intervention on these trajectories. METHODS: Using linear growth models, we compared the trajectories of depressive symptoms, caregiver grief, anxiety, and quality of life (QoL) over one year (baseline - T0, 6 months - T1, and 12 months - T2) between 28 NHC and 163 AHC who had been randomized to receive 12 sessions of TEL-CBT (n = 99) or to usual care (n = 92). RESULTS: NHC reported significantly higher depression, anxiety, and caregiver grief at T0 and showed significant reductions in depression and anxiety over time compared to AHC. TEL-CBT significantly enhanced overall QoL of NHC. CONCLUSIONS: The study extends previous findings of improved mental health of family caregivers of PwD after institutionalization and emphasizes the need for interventions before nursing home placement. TEL-CBT which has previously been shown to be effective for family caregivers of PwD also seems promising for supporting NHC.Supplemental data for this article is available online at https://doi.org/10.1080/13607863.2021.2022598 .

The Caregiver Thoughts Scale: An Instrument to Assess Functional and Dysfunctional Thoughts about Caregiving.

OBJECTIVES: Caregivers' care-related thoughts critically effect their well-being. Currently, there is a lack of validated measures to systematically assess caregivers' functional and dysfunctional thoughts. We therefore aimed to develop a measure of caregivers' thoughts that assesses not only their dysfunctional but also their functional thoughts in multiple domains. METHODS: A pool of potential questionnaire items was generated from therapy sessions with caregivers and was rated by experts. A sample of 322 main family caregivers (Mage = 63.9 years) of a person with dementia then completed a set of 28 items about their care-related thoughts and a number of related measures at three measurement points. Items were then aggregated via a formative measurement approach based on theoretical considerations. Correlational analyses were used to examine the construct validity of the subscale scores. RESULTS: The final 28-item scale assesses caregiving thoughts in four distinct domains: dysfunctional caregiving standards, self-care, dysfunctional assumptions about dementia, and acceptance. The correlational analyses demonstrated the subscales' construct validity, by showing that scale scores are meaningfully related to theoretically relevant constructs. CONCLUSIONS: The Caregiving Thoughts Scale is a promising measure of caregivers' thoughts in four important domains. CLINICAL IMPLICATIONS: The scale can be applied in clinical research settings.

Pragmatic Effectiveness of Face-to-Face Cognitive-Behavioral Therapy for Family Caregivers of People with Dementia.

OBJECTIVES: The objective was to investigate the pragmatic effectiveness of face-to-face cognitive-behavioral therapy (F2F-CBT) for family caregivers of people with dementia (PwD) implemented in a routine care setting relative to usual care in a quasi-experimental study. METHODS: Participants indicating that attendance of F2F-CBT was possible were assigned to F2F-CBT (n = 49). F2F-CBT consisted of 12 sessions over 6 months. Effects were evaluated at posttest and 6-month follow-up on a variety of outcomes relative to usual care (CG; n = 134). RESULTS: At posttest, F2F-CBT yielded significantly fewer symptoms of depression (d = 0.37), better emotional well-being (d = 0.64), and better coping with the care situation (d = 0.52) than CG. At 6-month follow-up, the effect on emotional well-being was retained (d = 0.44) and social relationships were rated significantly better in F2F-CBT than CG (d = 0.34). CONCLUSIONS: F2F-CBT proved to be effective in supporting family caregivers of PwD. However, only relatively few caregivers were able to regularly attend face-to-face sessions. CLINICAL IMPLICATIONS: CBT seems particularly suitable for supporting family caregivers of PwD in coping with the complex psychological burden. Delivery via telephone or internet could be a necessary alternative to F2F-CBT for reducing barriers to participation.

[Burden experienced by caregiving relatives during the corona pandemic]. / Belastungserleben pflegender Angehöriger während der Coronapandemie.

BACKGROUND: Family caregivers are faced with a variety of challenges and burdens. Recent online studies showed that these burdens have increased even more during the corona pandemic. Here we conducted a low-threshold written survey to assess psychological distress in highly burdened family caregivers during the corona pandemic in Germany. METHOD: Both quantitative and qualitative analyses were conducted within the context of a tiered counselling intervention study for highly burdened family caregivers (N = 165) to assess their experience of burden, anxieties, worries and desires regarding care. RESULTS: A quarter of all caregivers (26%) reported high fear of becoming infected with SARS-CoV­2 and 50% feared their care recipient could get infected. Almost half of all caregivers reported (47%) that corona had a high impact on the care situation and increased the burden of caregiving (51%). A loss of professional support and less time for themselves were reported most often. The desire for additional support was frequently expressed. The level of care, the age of the caregiver and the previous use of care services were found to be predictors of the psychological distress experienced by care recipients. CONCLUSION: The results illustrate an increased burden related to caregiving during the corona pandemic. In order to cope with this complex additional burden, there is an even higher need for support to improve care and social participation for both care recipients and caregivers during the pandemic.

Does age matter? Initial treatment goals of older adults with major depression in outpatient cognitive behavioural therapy.

BACKGROUND: Personal treatment goals (PTG) are important means to tailor psychotherapy to the needs of the patient, leading to increased engagement and greater improvement in relevant outcomes. According to lifespan developmental research, motivational goals in old age differ from goals of younger people, with management of losses rather than growth becoming more prevalent. However, this study is the first to systematically investigate age-specific differences in PTGs. METHOD: We used routine data from patients with major depression assessed at the beginning of outpatient cognitive behavioural therapy. Initial high-priority PTGs were assessed using the Bern Inventory of Treatment Goals (BIT-C). Older patients (≥60 years, n = 52) were matched to younger patients (<60 years, n = 52) with regard to severity of depression, number of comorbidities, gender and level of education. RESULTS: Using a mixed method approach, high-priority PTGs of both age groups were focused most strongly on reducing depressive symptoms and, subsequently, anxiety. At the same time, older patients focused more strongly on PTGs related to well-being and functioning, while younger patients' emphasis was on personal growth. Furthermore, better coping with the ageing process and physical losses emerged as important PTGs for some older patients. CONCLUSION: Initial PTG themes are specific to diagnosis, but also seem to differ in regard to age. Thus, it is important to develop age-sensitive measures that allow appropriate and efficient tailoring of psychotherapy to meet older patients' needs and preferences.

Clients' and therapists' experiences of five general change mechanisms during an Internet-based cognitive behavioral intervention for family caregivers.

OBJECTIVES: Despite its efficacy, little is known about what makes Internet-based cognitive behavioral therapy (iCBT) effective. We, therefore, analyze participants' and therapists' experiences of Grawe's five general change mechanisms (alliance, resource activation, clarification, problem actuation, mastery) during an iCBT intervention for family dementia caregivers, and how their experiences were related to treatment outcomes. METHOD: Participants (N = 30) exchanged eight weekly messages with a therapist via an Internet platform. We used the Bern Post Session Report to assess participants' and therapists' experiences of the general change mechanisms after each session. RESULTS: Treatment outcomes were associated with therapists' overall experiences of alliance, clarification, and mastery. Participants experienced more problem actuation than therapists. Only participants' and therapists' experiences of clarification over time differed. CONCLUSIONS: Grawe's general change mechanisms are also relevant for iCBT. We recommend considering Grawe's framework when designing Internet-based therapeutic interventions and when training therapists to deliver such interventions.

Long-term effects of telephone-based cognitive-behavioral intervention for family caregivers of people with dementia: Findings at 3-year follow-up.

INTRODUCTION: Long-term outcomes are of particular importance in evaluating interventions for family caregivers of people with dementia (PwD). So far, evidence for long-term effects (>6 months postintervention) is limited to four interventions. OBJECTIVE: We examined the long-term effects of Tele.TAnDem, a telephone-based cognitive-behavioral therapy (CBT) intervention, on a variety of outcomes at 3-year follow-up, the longest follow-up of any intervention study for caregivers of PwD (without continuous support). METHODS: Caregivers of PwD were randomly assigned to receive Tele.TAnDem consisting of 12 sessions over 6 months (intervention group [IG]) or usual care (control group [CG]). At 3-year follow-up (i.e., 2.5 years postintervention), 29 caregivers in the IG and 22 caregivers in the CG were still caring at home for a PwD. RESULTS: Caregivers in the IG reported significantly lower caregiver burden and higher quality of life regarding social relationships. CONCLUSIONS: Tele.TAnDem is successful in buffering detrimental effects of caregiving on caregiver burden and social relationships in the long term. The small- to medium-sized effects lie in the range of effect sizes reported in the few previous investigations. The findings add to the scant evidence that interventions yielding long-term outcomes have to date mostly been multicomponent interventions based on CBT principles with structured techniques and at least seven sessions over more than 2 months. (PsycInfo Database Record (c) 2021 APA, all rights reserved).

Relieving distressed caregivers (ReDiCare study): study protocol of a randomized pragmatic trial.

BACKGROUND: Providing care for someone with a disease or chronic condition can have a negative psychological, physical, social, and economic impact upon informal caregivers. Despite the socio-economic relevance and more than three decades of caregiver intervention research only very few translational efforts of successful interventions are reported. Still less of these interventions have been implemented into routine services. The aim of the ReDiCare study (German acronym BerTA) is to evaluate the effectiveness of a stepped counselling approach for burdened caregivers delivered by care counsellors of two long-term care insurances and registered psychotherapists. METHODS/ DESIGN: A pragmatic randomised controlled trial with 572 caregivers of older adults (≥ 60 years) receiving benefits of one of the two participating long-term care insurances. Participants are assigned (t0) to either the ReDiCare intervention or a control group receiving routine care and counselling. Data are collected at baseline (-t1), 3-month (t1), 9-month (t2) and 15-month (t3). The 9-month post-intervention assessment (t2) is the primary endpoint to evaluate the results on the primary and secondary outcomes, measured by self-reported questionnaires. Depressive symptoms measured with the CES-D are the primary outcome. The main secondary outcomes are physical complaints, utilization of psychosocial resources, caregiver self-efficacy and burden, positive aspects of caregiving and perceived care quality. A process evaluation, including audio tapes, self-report questionnaires and documentation will be conducted to examine internal and external validity of the intervention. Data on direct and indirect costs are collected for the (health) economic evaluation, using a health care perspective and a societal perspective. DISCUSSION: While comparable previous caregiver interventions have been developed and evaluated for specific caregiver groups (e.g. dementia caregivers, stroke caregivers), the ReDiCare study will indicate whether a stepped approach will be effective also in a broader group of caregivers. The intervention is one of the very few translational studies in caregiver intervention research and will provide valuable insights into relevant factors for training, intervention protocol adherence, effectiveness, and costs for future implementation steps. TRIAL REGISTRATION: Deutsches Register Klinischer Studien (German Clinical Trials Register), DRKS00014593 ( www.drks.de,  registered 14 May 2018) and International Clinical Trials Registry Platform, DRKS00014593  ( https://apps.who.int/trialsearch/ ).