Trial to Test Effectiveness of Depression Intervention for Mistreated Older Adults
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|ClinicalTrials.gov Identifier: NCT04258579|
Recruitment Status : Recruiting
First Posted : February 6, 2020
Last Update Posted : July 29, 2020
|Condition or disease||Intervention/treatment||Phase|
|Depression Depression in Old Age Elder Abuse Anxiety||Behavioral: PROTECT with Technology Augmentation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The investigators will be comparing data collected from this project to previously collected data from the first phase of this project, in which PROTECT was delivered only in-person.|
|Masking:||None (Open Label)|
|Official Title:||EM/PROTECT-Hybrid: Improving Depression in Elder Mistreatment Victims|
|Actual Study Start Date :||July 15, 2020|
|Estimated Primary Completion Date :||January 2022|
|Estimated Study Completion Date :||May 2022|
Experimental: Video PROTECT
Participants will receive PROTECT therapy once a week for 9 weeks.
Behavioral: PROTECT with Technology Augmentation
PROTECT is a therapeutic intervention focused on treating victims of elder abuse who are experiencing depression. PROTECT therapy will be delivered through video. Participants will be provided with a mobile device (iPhone), and a wearable device (smart watch) that will track sleep, mood, steps, and heart rate.
- Change in clinically significant depressive symptoms as measured by the MADRS [ Time Frame: Baseline, 6 weeks, 9 weeks, 12 weeks ]In all conditions, the change in clinically significant depressive symptoms as measured on the Montgomery Asberg Depression Rating Scale (MADRS). Scores are categorized as following: 0 to 6 - Normal /symptom absent. 7 to 19 - Mild depression. 20 to 34 - Moderate depression. >34 - Severe depression.
- Change in assessment of Quality of Life, as measured by the WHO-QOL [ Time Frame: Baseline, 6 weeks, 9 weeks, 12 weeks ]In all conditions, changes in assessment of quality of life measured by the World Health Organization Quality of Life (WHO-QOL) scale. Scores across 4 domains (Physical Health, Psychological, Social Relationships, and Environment) range from 0-100, with higher scores indicating a higher quality of life.
- Change in assessment of stress, as measured by the PSS [ Time Frame: Baseline, 6 weeks ]In all conditions, changes in assessment of stress measured by the Perceived Stress Scale (PSS) scale. Scores range from 0-40. Scores ranging from 0-13 are considered low stress, scores ranging from 14-26 are considered moderate stress, and scores ranging from 27-40 are considered high perceived stress.
- Change in assessment of exposure to meaningful activities, as measured by the BADS [ Time Frame: Baseline, 6 weeks ]In all conditions, changes in assessment of meaningful activities measured by the Behavioral Activation for Depression Scale (BADS). Scores are divided across 4 domains: Activation subscale scores range from 0-42, Avoidance/Rumination subscale scores range from 0-48, Work/School Impairment subscale scores range from 0-30, Social Impairment subscale scores range from 0-30. For all subscales, high scores are consistent with the subscale title (e.g., high scores on Activation subscale = more activation).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04258579
|Contact: Jo Anne Sirey, Ph.D.||email@example.com|
|United States, New York|
|Weill Cornell Medicine||Recruiting|
|New York, New York, United States, 10065|
|Contact: Jo Anne Sirey, Ph.D. 914-997-4333 firstname.lastname@example.org|
|Principal Investigator: Jo Anne Sirey, Ph.D.|
|Principal Investigator:||Jo Anne Sirey, Ph.D.||Weill Medical College of Cornell University|