NCT Number: NCT03043573
The present collaborative R01 study, between Cornell and Johns Hopkins, aims to compare Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) vs. Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) in improving cognitive, affective, and functioning outcomes.
Looking for future studies?
Notify Me60 year–85 year
All sexes
Interventional
Not applicable
Johns Hopkins University School of Medicine, Baltimore, Maryland, United States
The present collaborative R01 study, between Cornell and Johns Hopkins, aims to compare Problem Adaptation Therapy for Mild Cognitively Impaired Older Adults (PATH-MCI) vs. Supportive Therapy for Cognitively Impaired Older Adults (ST-CI) in improving cognitive, affective and functioning outcomes. Psychotherapy, also known as talking therapy, is the use of psychological methods to help a person change and overcome problems in desired ways. PATH-MCI differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver. Supportive Therapy incorporates standard of care approaches by using non-specific techniques to provide a supportive environment and help patients to express their feelings & focus on their strengths and abilities.
The investigators plan to randomize 80 treatment subjects, older adults (40 at Cornell and 40 at Johns Hopkins) with MCI-depression. 80 study partners may also be potentially recruited. Both sites have shown feasibility of recruitment, randomization, retention, and assessment procedures for patients with MCI. Cornell has shown evidence of administration of PATH in this population. Certified mental health clinicians in PATH-MCI and ST-CI will administer 15 in-office sessions in six months.
The investigators propose to compare the effects of 15 sessions (12 weekly in first 12 weeks and 3 monthly booster sessions afterwards) of PATH-MCI vs. ST-CI in 80 older adults (treatment subjects) with MCI-depression. Research assistants, unaware of study hypotheses and participant randomization status, will perform research assessments at baseline and at 6 (no cognitive measures), 12, 24, 36 (no cognitive measures) and 52 weeks after randomization.
There will also be optional blood draws at study entry, 12, and 52 weeks. The purpose of the blood draws is to better understand whether response to psychotherapy treatment is affected by genes, by inflammation, or by the possible memory factor called BDNF (brain-derived neurotrophic factor). Also, all therapy sessions will be audiotaped (if the patient consents) and Dr. Shermer (a clinician outside of the Weill Cornell Institute of Geriatric Psychiatry) will evaluate randomly selected sessions and rate the therapists' adherence and competence based on the PATH-MCI and ST Adherence Scales
The study partner will provide information about the treatment subject and participate in treatment if agreed by the treatment subject. To explore the effects of PATH-MCI on the study partner, the investigators will collect the following data from the study partner: demographic, burden (Short Zarit Burden interview), and treatment satisfaction (Client Satisfaction Questionnaire).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Problem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver.
ST focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors.
Other names: ST
Time frame: Baseline, 12, 24, and 52 Weeks
Global cognition will be assessed by the Repeatable Battery for the Assessment of Neuropsychological Status Total Score (RBANS). The total score represents the simple sum of the five cognitive domain index scores (Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory). Total raw scores are converted based on the subjects age and a RBANS scoring manual. Higher scores indicate better functionality. The total scores range from 200 to 800.
Time frame: Baseline, 6, 12, 24, 36, and 52 Weeks
The 12-item WHODAS-II (World Health Organization Disability Assessment Schedule) assesses functional impairment across six domains of daily living. Each item is scored on a 5-point Likert scale ranging from 0 (No difficulty), 1 (Mild Difficulty), 2 (Moderate Difficulty), 3 (Severe Difficulty) and 4 (Extreme difficulty or cannot do). Each individual item has a minimum score of 0 and a maximum of 4. The total raw score is computed by summing all 12 items, resulting in a possible score range of 0 to 48. Higher score reflect greater functional impairment. Lower scores indicate better functional status and less reported difficulty with daily activities.
Time frame: Baseline, 6, 12, 24, 36, and 52 Weeks
Depression assessed by Montgomery Asberg Depression Rating Scale (MADRS) Total Score. The MADRS is a 10 item questionnaire assessing severity of depression by scoring participants on mood, anxiety, sleep, concentration, appetite, and suicidal thoughts. The lowest score is 0, no depression symptoms, and the highest possible score is 60, severe depression symptoms.
Time frame: Baseline, 12, 24, and 52 Weeks
The Delayed Recall subscale of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) assesses memory function across multiple tasks. It includes the following components: List Recall Total Score (range: 0-10), List Recognition Total Score (range: 0-20), Story Recall Total Score (range: 0-12), and Figure Recall Total Score (range: 0-20). The raw scores from these four components are summed to yield a Delayed Memory Index raw total score ranging from 0 to 62, with higher scores indicating better memory performance.
To facilitate standardized interpretation, raw total scores are converted to age-adjusted Index Scores using normative data provided in the RBANS manual. These Index Scores have a mean of 100 and a standard deviation of 15, and are normed by decade (e.g., 60-69, 70-79, 80-89). Higher Index Scores reflect better memory functioning relative to age-matched peers.
Time frame: Baseline, 12, 24, and 52 Weeks
Trail Making Test is a neuropsychological assessment where raw scores are converted into a scaled score range from 1 to 25. Participants with scores between 1 - 8 have impaired performance; Mid range scores typically fall between 10 - 16, and subjects who fair the best on this measure have scores ranging from 20 - 25.
Time frame: Baseline, 6, 12, 24, 36, and 52 Weeks
Perceived Stress Scale s the most widely used psychological instrument for measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. The 10-item measure has 4 choice options; (0=Never, 1=Almost Never, 2=Sometimes, 3=Fairly Often, 4=Often). 4 items are reversed scored and the total score is summed across all items ranging from 0 to 40. Lower scores are better and indicate less stress.
Weill Medical College of Cornell University
Other
Acronym: PATH-MCI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04418856
Behavior, Behavioral Symptoms
Reykjavik, Iceland
View Trial DetailsNCT06487611
Behavior, Behavioral Symptoms
Hong Kong
View Trial DetailsNCT05917379
Anxiety, Anxiety Disorders
Hefei, Anhui, China
View Trial DetailsNCT07273604
Anxiety, Anxiety Disorders
San Cristóbal de La Laguna, Santa Cruz de Tenerife, Spain
View Trial Details