The Couple in Control: A Communication-Focused Program
- Conditions
- Mild Cognitive Impairment
- Interventions
- Behavioral: Couple in Control (CiC) Program
- Registration Number
- NCT05423912
- Lead Sponsor
- Emory University
- Brief Summary
The purpose of this study is to develop and pilot test a communication-based psychoeducation program for persons with mild cognitive impairment (MCI) and their care partners to improve their interpersonal management of MCI.
- Detailed Description
Up to 21% of older adults exhibit symptoms of mild cognitive impairment (MCI), a term used to describe a compilation of cognitive and behavioral symptoms that approach but don't meet the threshold for a dementia diagnosis. Noticeably characterized by losses in executive function and memory that can affect critical life domains like employment, housing, health care, and finances, it is also a life condition of considerable indeterminacy both for the person living with the condition and for care partners. While many individuals experience worsened symptoms leading to an Alzheimer's disease (AD) diagnosis within five years, MCI can be caused by a variety of disease processes making disease trajectory and prognosis vague and uncertain.
For most diagnosed with MCI, the experience is shared with another, typically a spouse or partner. For the dyad and both parties in an MCI couple, the period following an MCI diagnosis is often one of extended emotional turbulence and ambiguity. Care partner dyads coping with MCI face changes in role identity resulting in significant consequences for relationships. Emotional adjustment to MCI, unique for each dyad, has implications for subsequent family coping, psychological stress, physical fatigue, social isolation, decision-making, financial well-being, and more. While MCI psychoeducation programs exist, they almost always target the person with MCI and not the patient-care partner dyad. Communication patterns between patients and care partners in oncology and HIV/AIDS settings are shown to influence the coping and care outcomes of dyads. With similar communication issues noted in MCI dyads, the goal of this pilot project is to develop and test the feasibility and preliminary efficacy and evaluate acceptability of a group program, The Couple in Control (CiC), to provide couples facing MCI with communication skills and interpersonal strategies that will establish or restore a sense of agency and emotional well-being as they navigate this period of transition and uncertainty.
This study uses a one-arm, pre/post design to assess the acceptability, feasibility, and preliminary efficacy in 4 cohorts of 6 MCI dyads each (for a total of 48 individuals) to take part in a trial of the CiC program. Participants meet in virtual intervention group meetings over the course of 8 to 9 consecutive weeks and take part in structured quantitative interviews prior to the intervention and then 4 and 8 weeks post-intervention.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 48
- Dyads composed of individuals with a clinician-confirmed diagnosis of MCI and a primary care partner
- Can read, speak, and understand English
- Have internet connectivity and a separate zoom-enabled device for each dyad member
- Dyads must live together, as this will provide sufficient opportunity for intervention homework and communication practice activities
- Individuals who are not yet adults (infants, children, teenagers)
- Pregnant women
- Prisoners
- Individuals who are not able to clearly understand and speak English
- Those living with MCI will need to successfully complete a capacity to consent survey to be included in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Couple in Control Program for Persons with Mild Cognitive Impairment (MCI) Couple in Control (CiC) Program Persons with MCI participating in the Couple in Control (CiC) Program. Couple in Control Program for Care Partners of MCI Participants Couple in Control (CiC) Program Care partners participating in the Couple in Control (CiC) Program with the MCI participant they care for.
- Primary Outcome Measures
Name Time Method Change in Caregiver Competence Scale Score Among Care Partners Baseline, 4 weeks post-program, 8 weeks post-program Caregiver mastery is assessed using the 4-item Caregiver Competency scale. This instrument asks respondents to rate how well their confidence and how well they handle difficult situations with caregiving with 4 items that are scored on a 4-point scale. Responses of "not at all" are scored as 1 and responses of "completely" are scored as 4. Total scores range from 4 to 16 where higher scores indicate greater feelings of competence with providing care.
Change in Feasibility of the Program as Determined Through Qualitative Interviews Baseline, 4 weeks post-program, 8 weeks post-program A sub-sample of 20 participants will take part in qualitative interviews to evaluate the feasibility of the prototype Couple in Control program. Feasibility of the program is evaluated by the extent to which the intervention can be implemented as planned. Participant attendance, completion of homework assignments, and group participation will be collected to assess intervention feasibility.
- Secondary Outcome Measures
Name Time Method Change in Center for Epidemiological Studies - Depression Scale (CESD) Score Baseline, 4 weeks post-program, 8 weeks post-program The Center for Epidemiological Studies-Depression (CES-D), is a 20-item measure that asks caregivers to rate how often over the past week they experienced symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = rarely or none of the time, 1 = some or little of the time, 2 = moderately or much of the time, 3 = most or almost all the time). Total scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Change in Perceived Stress Scale (PSS-14) Score Baseline, 4 weeks post-program, 8 weeks post-program The 14-item Perceived Stress Scale (PSS-14) is a measure of the degree to which situations in one's life are appraised as stressful. Participants are asked questions about their thoughts and feelings during the last month. Responses are given on a 5-point scale where "never" is scored as 0 and "very often" is scored as 4. Total scores range from 0 to 56 with higher scores indicating greater perceived stress.
Change in Dyadic Relationship Scale Caregiver Version Score Baseline, 4 weeks post-program, 8 weeks post-program The caregiver version of the Dyadic Relationship Scale includes 11 items which are responded to on a 4-point scale where "strongly disagree" is scored as 1 and "strongly agree" is scored as 4. There are two subscales which assess dyadic strain (5 items) and positive dyadic interaction (6 items). Total scores for the dyadic strain subscale range from 5 to 20 and higher scores indicate greater levels of strain. Total scores for the positive dyadic interaction subscale range from 6 to 24 and higher scores indicate greater positive interactions.
Trial Locations
- Locations (1)
Emory Clinic at Executive Park
🇺🇸Atlanta, Georgia, United States