Alzheimer disease and Alzheimer disease-related dementias (ADRDs) are conditions characterized by progressive declines in memory, language, behavior, and personality and produce early symptoms that include increased forgetfulness, communication challenges, and loss of recognition of places, time, and routines [1-3]. These early symptoms tend to worsen over time and undermine the independence, health, and well-being of persons living with ADRDs and their family care partners, many of whom are romantic or spousal partners [4-6]. Because both individuals and their partners (often referred to as “the second patient”) experience life disruptions stemming from ADRD symptoms that amplify stress, role changes, and relationship strain [6,7], both individuals and their romantic partners require early support [8]. This need is ever more pressing; by 2030, it is expected that 75 million individuals will be living with ADRD worldwide [5].

In the time following the onset of ADRD symptoms and particularly after receiving a formal diagnosis, many individuals (23%-53%) and their care partners (35%-50%) experience clinically elevated emotional distress (ie, depression and anxiety symptoms) [9-13]. These elevated rates are not surprising given the poor prognosis and lack of disease-modifying interventions for ADRDs, limited resources to assist with early challenges, difficulties engaging in social support, and changes to established roles and responsibilities (eg, caretaking) [14-16]. Early emotional distress is an important intervention target in dyads facing ADRDs for several reasons. First, distress is interdependent (ie, correlated and bidirectionally influenced) within dyads. Second, untreated distress is likely to become chronic, and chronic emotional distress is difficult to treat and linked to the deterioration of dyads’ physical and mental health, relationship quality, and quality of life [9,14,17,18]. Third, distress interferes with dyads’ ability to effectively communicate and cope with early challenges linked to ADRDs, which can impact long-term adjustment [9,14].

Early psychosocial interventions may help individuals with ADRDs and their care partners adjust to challenges and plan collaboratively for the future, which can alleviate distress and maintain overall relationship quality and well-being [8]. Existing interventions for early or moderate-stage ADRDs primarily target family care partners, and several interventions demonstrate lasting improvements in depression symptoms and quality of life [5]. Dyads commonly express strong preferences to participate in interventions together, and dyadic interventions in the first few years of ADRD diagnosis demonstrate promise in reducing dyads’ emotional distress as well as neuropsychiatric symptoms expressed by the person living with ADRD [19]. Interventions have historically ignored the “window of opportunity” to meaningfully include persons with ADRDs in interventions shortly after diagnosis, limiting their potential to assist in collaborative treatment and planning before symptoms progress [20-22]. Currently, there are no dyadic psychosocial interventions that prioritize delivery in the first weeks and months after diagnosis to promote dyadic adjustment to ADRDs [20,23-25].

Dyadic interventions may be a more effective, efficient, and economical avenue for promoting positive adjustment to ADRDs for individuals and their care partners earlier in the course of the illness [24,26]. Our team has developed successful dyadic interventions to prevent distress following medical adversity, including Recovering Together, a 6-session dyadic resiliency intervention that addresses emotional distress in patients and informal care partners shortly after neurointensive care unit admission for acute neurological conditions [27,28]. Recovering Together program uses interpersonal theories of adjustment aimed toward preventing chronic stress and transdiagnostic resiliency skills that we expect could also serve as mechanistic treatment targets for other neurological conditions such as ADRDs [29-37]. We then leveraged the NIH (National Institutes of Health) Stage Model for intervention development and in-depth interviews with ADRD clinician experts and dyads (Figure 1) to inform the development of a similar intervention to address early challenges linked to ADRDs [38,39].

This study protocol is part of a larger 5-year study that aims to use the prior research, methodology, program content, and procedures of the Recovering Together program as a basis for developing the novel Resilient Together for Dementia (RT-ADRD). Our primary objective is to describe the protocol for the open pilot study of RT-ADRD that will inform a subsequent pilot feasibility trial of the program relative to a control condition (NIH Stage Model Stage 1a). In this study, we aim to gather comprehensive information from dyads regarding the feasibility of assessment, feedback on the intervention components, applicability of study measures, and to identify potential issues prior to the feasibility trial.

This open pilot study was approved by the Icahn School of Medicine at Mount Sinai Independent Review Board (23-01360) and is registered on ClinicalTrials.gov (NCT06421545). Participants will provide electronic consent to participate via the REDCap (Research Electronic Data Capture; Vanderbilt University) HIPAA (Health Insurance Portability and Accountability Act)-compliant web-based application using a hospital-approved e-consent feature. Prospective participants will be given ample time to review the contents of the consent form as well as speak with the study coordinator who will provide detailed information about the study and answer any questions. The participants will also be reminded that they may decline to participate and can discontinue participation at any time. Participants will be given a copy of the consent form and will be invited to ask questions about their participation at any point over the course of the study. The identity of the participants will not be revealed in the presentation or publication of any results from this project. To protect confidentiality, all data will be deidentified and only identifiable by subject codes. Participants will be individually compensated US $80 for completion of the pre- and posttest assessments, for a total of US $160 per dyad at the end of the program.

We will conduct an open pilot of RT-ADRD dyadic intervention involving dyads comprising (1) individuals with a recent ADRD diagnosis and (2) their spousal or romantic care partners, with a target recruitment of up to N=10 dyads, or 20 total participants. This study is designed to gather data that can be used to revise the intervention before a larger pilot feasibility trial.

Eligible participants will be adult dyads who are partners that currently live together and are willing to participate in the RT-ADRD intervention that are (1) English speaking, (2) patient with newly diagnosed (within 3 months) with an ADRD diagnosis after age 65 years (determined by medical chart review and provider referral), (3) patient with cognitive assessment scores and symptoms consistent with early-stage ADRD, as determined by Clinical Dementia Rating scale scores of 0.5 (very mild) or 1.0 (mild dementia) and Montreal Cognitive Assessment (MoCA) scores of 17-25, obtained via a review of medical records (if patients do not have cognitive assessment scores available, we will administer the MoCA to confirm eligibility), (4) either partner demonstrates clinically elevated emotional distress, as determined by Hospital Anxiety and Depression Scale [40], subscale scores >8 or Geriatric Depression Scale [41], scores > 5, and (5) both partners demonstrate the ability to understand study and research protocol, as determined by the University of California Brief Assessment of Capacity to Consent [42], >12. Individuals will not be eligible for the study if (1) either partner has a co-occurring terminal illness, and (2) patient was diagnosed with forms of dementia with clinical profiles that would preclude participation (eg, highly symptomatic Frontotemporal Dementia–behavioral variant), as determined by the treatment team.

Dyads will be recruited from the Mount Sinai Departments of Neurology, Geriatrics and Palliative Medicine, and the hospital system’s broader dementia clinical care infrastructure. We will circulate information via flyers, presentations, and word-of-mouth referrals, and dyads can be self-referred or be referred by their treating dementia care providers. The study team will present the aims to all staff at the clinics to explain the purpose of the study, potential benefits to participants, and discuss best ways to facilitate referrals. The study team obtained a waiver of informed consent for the purpose of eligibility screening and will also review electronic medical records of patients treated in relevant clinics to inform providers of potential eligibility prior to diagnostic disclosure visits. All recruitment, screening, and consent procedures will be performed remotely via telephone, electronic survey through REDCap, email, and over a live video using health care system–supported videoconferencing.

Treating providers will obtain permission from the dyad to be contacted by the study team. If self-referred, interested dyads will also have the option to respond to a brief survey via QR code or URL to a secure REDCap platform listed on the distributed study flyers. The study team will contact interested participants via telephone to schedule a telephone or live video call with the study research assistant, who will describe the study to potential participants and conduct screening for eligibility (including capacity to consent). If either dyad member is deemed ineligible based on screening criteria, the study team will provide dyad with a comprehensive list of resources containing local and national resources and document ineligibility in REDCap. If eligible and interested in participating, individuals will complete consent procedures by indicating verbal consent and documenting electronic consent a secure password-protected REDCap platform.

After enrollment, participants will be sent a baseline survey via a secure REDCap link to assess demographics, emotional distress, resiliency factors, and relationship functioning. Participants can also complete assessments via health care system–supported videoconferencing with the help of a trained research assistant. Once the dyad has completed the baseline survey, a member of the research team will schedule the first of 6 RT-ADRD treatment sessions together led by a PhD-level clinical psychologist with expertise in conducting dyadic interventions (SB). In advance of the treatment session, the dyad will be sent copy of the treatment manual to review the skills that will be taught during the 6-week treatment program. Each session will be audio recorded for the purpose of manual refinement. After completing treatment, dyad members will complete a similar set of surveys at posttest. Finally, they will participate in a single 60-minute exit interview together to gather comprehensive feedback on the material to further refine the intervention. Each dyad member will be compensated US $80 for completion of the pre- and posttest assessments, for a total of US $160 per dyad at the end of the program.

The RT-ADRD intervention will have 6 weekly live video treatment sessions lasting 30-60 minutes each delivered over health care system–supported videoconferencing; in-person and hybrid session options will be available as well, according to dyad preference. The content and procedures were developed by adapting the Recovering Together dyadic resiliency intervention for neurointensive care unit admitted dyads [27], and then revised using feedback from interviews with dementia care specialists [38], and from dyads interviewed after ADRD diagnosis [39]. Sessions for RT-ADRD contain content and training in resiliency skills that are particularly relevant after ADRD diagnosis for patients and their care partners. RT-ADRD was designed to include individual and interpersonal coping skills that are transdiagnostic (ie, relevant across mental and physical health conditions) and drawn from prominent evidence-based therapy approaches (eg, mindfulness, Dialectical Behavior Therapy, and Cognitive Behavioral Therapy). The sessions emphasize ways of using skills to cope with the common challenges experienced early after dementia diagnosis and focus on navigating challenges as a dyadic unit Dyads will also receive links with downloadable recordings of exercises for home practice of skills. The sessions are modular in nature, and dyads will choose 6 modules from a selection of 8 possible modules. The 8 modules are presented in Table 1.

After consent, both dyad members will independently complete a pretest survey via a secure REDCap link (~30 minutes each) sent by a research coordinator. If needed, participants will also have the option of completing surveys with the assistance of a trained research coordinator via the videoconferencing “Share Screen” tool. The survey will include validated measures to gather information on hypothesized mechanisms of intervention, intervention targets, and treatment moderators, consistent with the overall conceptual model (Figure 2). The primary intervention targets (Table 2, secondary outcomes) are individuals’ emotional distress, relationship quality, and quality of life, which were selected based on their interdependence within dyads and the link of emotional distress to long-term mental and physical health outcomes and relationship functioning [9,14,17,18]. The hypothesized intervention mechanisms (Table 2; described further below) are transdiagnostic resiliency skills that demonstrated links to the same intervention targets in studies of prior dyadic interventions [27]. Following completion of the treatment sessions, dyads will complete a similar posttest survey in REDCap. Responses will be used to compare scores to population norms, examine interrelations among constructs, and inform procedures and the tailoring of RT-ADRD. The primary outcomes for this trial are feasibility and acceptability. In addition, we will use the 6-item Credibility and Expectancy Questionnaire [43] to assess treatment credibility at baseline. We will also use the 3-item Client Satisfaction Questionnaire [44] to assess satisfaction with RT-ADRD at posttest. We will gather comprehensive qualitative feedback on these benchmarks and report detailed information on study screening, enrollment, and intervention deliveries via health care system–supported videoconferencing or in person, to refine feasibility and acceptability benchmarks prior to further testing. A description of study measures is provided below (Table 2).

We will collect demographic information on participants’ gender, age, race, ethnicity, marital status, relationship length, education level (number of years in school), employment (status, occupation, and income), and mental health history. We will also collect ADRD clinical characteristics via electronic medical records, including the type of diagnosis, age at diagnosis, and date of diagnosis.

Feasibility-related measures will be assessed and compared to our prior dyadic intervention studies [27] using proportions at the individual-level on feasibility markers outlined in Table 2, as well as qualitative feedback from exit interviews. Acceptability will be evaluated with the percentage of individuals with scores above the midpoint on self-report questionnaires (Table 2), as well as feedback from exit interviews. Given our primary goal of establishing feasibility and acceptability, this open pilot was not powered to statistically evaluate signal of improvement in quantitative outcomes. However, we will examine preliminary effectiveness of the secondary outcomes using estimated treatment effects for each measure. We will also assess the relationship among treatment mechanisms and secondary outcomes using bivariate correlations, focusing on whether the direction of the association is consistent with our conceptual model. Qualitative data obtained from exit interview transcripts will be analyzed using a rapid data analysis approach to thematic analysis [55]. We will use overarching themes surrounding feasibility markers and participant suggestions to further refine the intervention.

ADRDs are conditions that are increasingly common among the aging population and have considerable negative impacts on individuals living with ADRD and their spousal care partners [5]. Currently, these dyads have few resources to assist them in navigating early challenges together and adjusting positively to the diagnosis and symptoms [24,25]. Dyads describe an interest in participating in interventions together early after ADRD diagnosis to assist in navigating support and adjusting to symptoms [8]; however, no such interventions exist. Adapting existing interventions has the potential to be effective and efficient in addressing dyads’ challenges to promote dyadic adjustment [27,28], and aid in preventing chronic individual and interpersonal stress. Thus, the RT-ADRD program is a timely potential solution to unmet needs reported by dyads at the time of ADRD diagnosis. The present study aims to refine RT-ADRD, a novel dyadic resiliency intervention for dyads at risk of chronic emotional distress early after ADRD diagnoses that includes individual and interpersonal resiliency training for both dyad members simultaneously to promote adjustment to ADRD.

The larger plan to develop and revise RT-ADRD is guided by the NIH Stage Model for behavioral intervention development [56]. This protocol provides the framework of our open pilot trial of RT-ADRD, stage 1B of the development of RT-ADRD. The intervention is novel and flexible, providing live video delivery of treatment sessions to maximize feasibility and adherence, while also providing the option of in-person sessions upon request. We will use the open pilot results to refine the program and inform the subsequent stage—a larger feasibility trial of RT-ADRD relative to an educational control condition (target N=60 dyads).

Currently, we are only conducting the intervention in English and with couple dyads. This results in important limitations for non–English speakers and for other caregiving dyads commonly facing ADRDs (eg, parent-child dyads). We plan to address these limitations with parallel studies and in subsequent trials by creating a version of the program in Spanish using established guidelines for linguistic adaptation. We also plan to conduct additional qualitative studies to identify adaptations needed to address a range of caregiving dyads.

The results from this open pilot trial will be used to inform the development of Resilient Together for Dementia, a dyadic resiliency program for those living with ADRDs and their romantic or spousal care partners. Our study will provide quantitative and qualitative data that we will use to refine the current iteration of the program. We will then test the refined intervention in a larger feasibility trial relative to an educational control condition.