[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07239609":3,"trial-entities:NCT07239609":124,"trial-summary:NCT07239609":133},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":22,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":39,"secondary_outcomes":57,"sex":82,"minimum_age":83,"maximum_age":84,"healthy_volunteers":15,"eligibility_criteria":85,"std_ages":99,"locations":102,"central_contacts":118,"overall_officials":121,"references":122,"see_also_links":123},"NCT07239609","TexasTechU7","ACT for Individuals With MNCD and Their Care Partners","Acceptance and Commitment Therapy for Individuals With MNCD and Their Care Partners: An In-Person and Telehealth Individual Therapy Approach","RECRUITING","2027-12-31","2025-11","2026-05-15","2026-04-01","Texas Tech University","OTHER",true,"This project aims to implement and evaluate a dyadic intervention (i.e., acceptance commitment therapy) for persons with AD\u002FADRD and their care partners. We hypothesize the intervention will be feasible, acceptable, and show preliminary efficacy of the dyadic interveniotns.","Alzheimer's Disease (AD) and Alzheimer's Disease Related Dementias (AD\u002FADRD) are life-limiting, long-term, neurodegenerative conditions estimated to affect more than 6.5 million adults over the age of 65 in the U.S. (Alzheimer's Association, 2023a). A majority of persons with AD\u002FADRD are over the age of 75 (73%; Alzheimer's Association, 2023a). With an aging population (estimated 1 in 6 people in the world will be over the age of 60 by 2030; World Health Organization, 2022), no known cure, and modern medical advances increasing life expectancy, the prevalence of AD\u002FADRD continues to rise, an estimated 13.8 million by 2060 (Alzheimer's Association, 2023a). Due to this mostly affecting older adults, 69.1% are living with a comorbid diagnosis (e.g., hypertension; diabetes) (Bennett et al., 2018; Poblador-Plou et al., 2014). AD\u002FADRD presents a global health crisis, posing profound challenges to not only the individuals with the disease, but has downstream effects on the family unit and the healthcare systems. As number of individuals with AD\u002FADRD are expected to increase over the next 10 years, it is vital to investigate non-pharmacological interventions for this population in order to improve the negative consequences of this diagnosis. This study aims to bridge this gap by investigating a modified evidence-based intervention, Acceptance Commitment Therapy (ACT), for persons with AD\u002FADRD and their care partners.\n\nAn integral part of an AD\u002FADRD journey is the care partner, who is usually a spouse or adult child. These care partners provide more than 10 billion hours of care in the United States to individuals with AD\u002FADRD. This has been found to result in negative outcomes, including high rates of pre-death grief, caregiver burden, and stress. There have been numerous non-pharmacological interventions for these care partners, but few studies have investigated the effects of dyadic interventions for persons with AD\u002FADRD and their care partners. Dyadic interventions have been found to be effective in improving psychosocial outcomes with persons with other chronic conditions (e.g., cancer) and their care partners (Hu etl a., 2019). The overarching goal of this project is to evaluate if acceptance commitment therapy will have a positive effect on persons recently diagnosed with early stage AD\u002FADRD.\n\nMore specifically, we will:\n\n1. Evaluate the feasibility and acceptability of this shortened ACT program for persons with MCI or MNCD.\n2. Assess the preliminary efficacy of this ACT program for persons with MCI or MNCD.\n3. Evaluate if this intervention program has positive downstream effects on the care partners.",[19,20,21],"Depression in Adults","Anxiety Disorder Generalized","Grief",[23,24,25],"Mild Cognitive Impariment","Mild Neurocognitive Disorder","Dyadic intervention","INTERVENTIONAL","TREATMENT",[29],"PHASE1",{"count":31,"type":32},100,"ESTIMATED",[34],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BEHAVIORAL","Acceptance Commitment Therapy","Acceptance and Commitment Therapy (ACT) is a form of cognitive-behavioral therapy that aims to enhance psychological flexibility through six core processes: acceptance, cognitive defusion, being present, self-as-context, values clarification, and committed action. Rather than attempting to eliminate difficult thoughts and feelings, ACT encourages individuals to accept them while committing to behavior changes consistent with their personal values.",[36],[40,44,48,51,54],{"measure":41,"description":42,"timeFrame":43},"Patient Health Questionnaire-9","PHQ-9 is used to assess the presence and severity of depressive symptoms.","6 weeks",{"measure":45,"description":46,"timeFrame":47},"Geriatric Depression Short From","GDS short is a brief, self-report screening tool designed to identify depressive symptoms in older adults.","6 Weeks",{"measure":49,"description":50,"timeFrame":43},"The Generalized Anxiety Disorder-7","GAD-7 is used to assess the severity of generalized anxiety symptoms",{"measure":52,"description":53,"timeFrame":47},"General Anxiety Scale-10","The GAS-10 is designed to assess the severity of general anxiety symptoms",{"measure":55,"description":56,"timeFrame":43},"Pre-death grief-12","The PG-12 examines pre-death grief for persons with life limiting illnesses and their care partners.",[58,61,64,67,70,73,76,79],{"measure":59,"description":60,"timeFrame":47},"Dyadic Coping Inventory","The DCI assess how couples support each other and cope together with stress.",{"measure":62,"description":63,"timeFrame":47},"Short Form Health Survey (SF-12)","The SF-12 measures functional health and well-being",{"measure":65,"description":66,"timeFrame":47},"Purpose in Life Scale","The PIL is designed to assess an individual's sense of meaning and purpose in life.",{"measure":68,"description":69,"timeFrame":47},"Herth Hope Index","The HHI is designed to measure an individual's level of hope",{"measure":71,"description":72,"timeFrame":47},"Inclusion of Other in the Self Scale","The IOS is designed to assess perceived closeness in interpersonal relationships",{"measure":74,"description":75,"timeFrame":47},"Perceived Stress Scale","The PSS is a measure the degree to which individuals perceive their lives as stressful",{"measure":77,"description":78,"timeFrame":47},"Pittsburgh Sleep Quality Index","The PSQI assess sleep quality and disturbances.",{"measure":80,"description":81,"timeFrame":47},"Repeatable Battery for the Assessment of Neuropsychological Status","The RBANS is a neuropsychological assessment designed to evaluate cognitive functioning","ALL","18 Years",null,{"inclusion":86,"exclusion":93,"raw_text":98},[87,88,89,87,90,89,91,92],"18+","MMSE= 21-27","Able to communicate in English","Identifies as a care partner of a person with MNCD","MMSE= 28-30","Is a family member or friend of the person with MNCD",[94,95,96,97],"Currently in an intervention for reducing anxiety or depression related to their dementia","MMSE= 28+ or less than 21","MMSE= \\\u003C28","Is a formal (paid) caregiver","Inclusion Criteria\n\nInclusion (person with MCI or MNCD):\n\n* 18+\n* MMSE= 21-27\n* Able to communicate in English\n\nInclusion (care partner):\n\n* 18+\n* Identifies as a care partner of a person with MNCD\n* Able to communicate in English\n* MMSE= 28-30\n* Is a family member or friend of the person with MNCD\n\nExclusion Criteria\n\nExclusion (person with MCI or MNCD):\n\n* Currently in an intervention for reducing anxiety or depression related to their dementia\n* MMSE= 28+ or less than 21\n\nExclusion (care partner):\n\n* MMSE= \\\u003C28\n* Is a formal (paid) caregiver",[100,101],"ADULT","OLDER_ADULT",[103],{"facility":104,"status":8,"city":105,"state":106,"zip":107,"country":108,"contacts":109,"geoPoint":115},"Texas Tech University Plaza Building","Lubbock","Texas","79409-2051","United States",[110],{"name":111,"role":112,"phone":113,"email":114},"Jonathan Singer, Ph.D.","CONTACT","7757228066","jonsinge@ttu.edu",{"lat":116,"lon":117},33.57786,-101.85517,[119],{"name":111,"role":112,"phone":120,"email":114},"17757228066",[],[],[],{"nct_id":4,"conditions":125,"biomarkers":132},[126,127,128,129,21,130,131],"Alzheimer's Disease","Alzheimer's Disease Related Dementias","Depression","Generalized Anxiety Disorder","Mild cognitive disorder","Mild neurocognitive disorder",[],{"nct_id":4,"found":15,"summary":134,"prompt_version":144},{"design":135,"status":136,"heading":137,"summary":138,"follow_up":139,"word_count":140,"commitments":141,"compensation":142,"drugs_mentioned":143},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 100 participants, including both individuals with MNCD and their care partners.","completed","Acceptance and Commitment Therapy for Individuals with Mild Neurocognitive Disorder and Their Care Partners","This study is testing a type of talk therapy called Acceptance and Commitment Therapy (ACT) for people with mild neurocognitive disorder (MNCD) and their care partners. ACT helps people become more flexible in their thoughts and actions. We want to see if this therapy can help reduce symptoms of depression, anxiety, and grief. To join, you must be 18 or older and able to communicate in English. For individuals with MNCD, your Mini-Mental State Exam (MMSE) score should be between 21-27. Care partners must also be 18 or older, identify as a care partner, speak English, and have an MMSE score between 28-30. The study aims to enroll 100 participants.","The study will measure changes in depression and anxiety at 6 weeks after the intervention begins.",110,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]