Trial Outcomes & Findings for Trial to Test Effectiveness of Depression Intervention for Mistreated Older Adults (NCT NCT04258579)

Last Updated: 2023-08-28

Results Overview

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. The scores presented for each time point are absolute values.

Recruitment status

COMPLETED

Study phase

Target enrollment

40 participants

Primary outcome timeframe

6 weeks, 9 weeks, 12 weeks

Results posted on

2023-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	Video PROTECT Participants will receive PROTECT therapy once a week for 9 weeks. 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.
Overall Study STARTED	40
Overall Study COMPLETED	27
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Video PROTECT Participants will receive PROTECT therapy once a week for 9 weeks. 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.
Overall Study Withdrawal by Subject	7
Overall Study Lost to Follow-up	3
Overall Study Protocol Violation	2
Overall Study Adverse Event	1

Baseline Characteristics

Trial to Test Effectiveness of Depression Intervention for Mistreated Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Video PROTECT n=40 Participants Participants will receive PROTECT therapy once a week for 9 weeks. 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.
Age, Continuous	70.50 years STANDARD_DEVIATION 6.97 • n=93 Participants
Sex: Female, Male Female	34 Participants n=93 Participants
Sex: Female, Male Male	6 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	22 Participants n=93 Participants
Race (NIH/OMB) White	14 Participants n=93 Participants
Race (NIH/OMB) More than one race	2 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Clinically Significant Depressive Symptoms, as Measured by the MADRS	23.00 units on a scale STANDARD_DEVIATION 8.22 • n=93 Participants
Assessment of Quality of Life, as Measured by the WHO-QOL Domain 1	21.38 units on a scale STANDARD_DEVIATION 6.34 • n=93 Participants
Assessment of Quality of Life, as Measured by the WHO-QOL Domain 2	18.08 units on a scale STANDARD_DEVIATION 5.04 • n=93 Participants
Assessment of Quality of Life, as Measured by the WHO-QOL Domain 3	8.45 units on a scale STANDARD_DEVIATION 3.03 • n=93 Participants
Assessment of Quality of Life, as Measured by the WHO-QOL Domain 4	25.30 units on a scale STANDARD_DEVIATION 6.26 • n=93 Participants
Assessment of Stress, as Measured by the PSS	22.45 units on a scale STANDARD_DEVIATION 7.74 • n=93 Participants
Assessment of Meaningful Activities, as Measured by the BADS Domain 1	19.89 units on a scale STANDARD_DEVIATION 8.29 • n=93 Participants
Assessment of Meaningful Activities, as Measured by the BADS Domain 2	22.46 units on a scale STANDARD_DEVIATION 8.57 • n=93 Participants
Assessment of Meaningful Activities, as Measured by the BADS Domain 3	16.00 units on a scale STANDARD_DEVIATION 7.14 • n=93 Participants
Assessment of Meaningful Activities, as Measured by the BADS Domain 4	17.79 units on a scale STANDARD_DEVIATION 7.66 • n=93 Participants

PRIMARY outcome

Timeframe: 6 weeks, 9 weeks, 12 weeks

Population: The overall number of participants analyzed was 40 at baseline, 30 at week 6, 30 at week 9, and 26 at week 12. The decline in participants analyzed at each time point is due to participant withdrawal by the study team or by their request.

Outcome measures

Outcome measures
Measure	Video PROTECT n=30 Participants Participants will receive PROTECT therapy once a week for 9 weeks. 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 Week 6 Outcomes	19.13 units on a scale Standard Deviation 9.47
Change in Clinically Significant Depressive Symptoms as Measured by the MADRS Week 9 Outcomes	16.87 units on a scale Standard Deviation 11.69
Change in Clinically Significant Depressive Symptoms as Measured by the MADRS Week 12 Outcomes	15.00 units on a scale Standard Deviation 9.32

PRIMARY outcome

Timeframe: 6 weeks, 9 weeks, 12 weeks

Population: The overall number of participants analyzed was 30 at week 6, 30 at week 9, and 26 at week 12. The decline in participants analyzed at each time point is due to participant withdrawal by the study team or by their request.

In all conditions, changes in assessment of quality of life measured by the World Health Organization Quality of Life (WHO-QOL) scale. World Health Organization-Quality Of Life scale. The overall scores range between 26-130. In all domains, higher scores indicate better health. Domain 1 measures physical health (scores range from 7-35). Domain 2 measures psychological health (scores range from 6-30). Domain 3 measures social health (scores range from 3-15). Domain 4 measures environmental health (scores range from 8-40). The scores presented for each time point are absolute values.

Outcome measures

Outcome measures
Measure	Video PROTECT n=30 Participants Participants will receive PROTECT therapy once a week for 9 weeks. 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 Assessment of Quality of Life, as Measured by the WHO-QOL Week 6 Outcomes- Domain 1	22.10 units on a scale Standard Deviation 6.39
Change in Assessment of Quality of Life, as Measured by the WHO-QOL Week 6 Outcomes- Domain 2	19.90 units on a scale Standard Deviation 4.99
Change in Assessment of Quality of Life, as Measured by the WHO-QOL Week 6 Outcomes- Domain 3	8.93 units on a scale Standard Deviation 3.36
Change in Assessment of Quality of Life, as Measured by the WHO-QOL Week 6 Outcomes- Domain 4	26.63 units on a scale Standard Deviation 6.18
Change in Assessment of Quality of Life, as Measured by the WHO-QOL Week 9 Outcomes- Domain 1	22.53 units on a scale Standard Deviation 7.24
Change in Assessment of Quality of Life, as Measured by the WHO-QOL Week 9 Outcomes- Domain 2	21.00 units on a scale Standard Deviation 5.71
Change in Assessment of Quality of Life, as Measured by the WHO-QOL Week 9 Outcomes- Domain 3	8.69 units on a scale Standard Deviation 3.49
Change in Assessment of Quality of Life, as Measured by the WHO-QOL Week 9 Outcomes- Domain 4	27.38 units on a scale Standard Deviation 6.18
Change in Assessment of Quality of Life, as Measured by the WHO-QOL Week 12 Outcomes- Domain 1	22.62 units on a scale Standard Deviation 6.04
Change in Assessment of Quality of Life, as Measured by the WHO-QOL Week 12 Outcomes- Domain 2	21.58 units on a scale Standard Deviation 4.31
Change in Assessment of Quality of Life, as Measured by the WHO-QOL Week 12 Outcomes- Domain 3	9.19 units on a scale Standard Deviation 3.14
Change in Assessment of Quality of Life, as Measured by the WHO-QOL Week 12 Outcomes- Domain 4	27.81 units on a scale Standard Deviation 5.64

PRIMARY outcome

Timeframe: Baseline, 6 weeks

Population: Due to participant withdrawal and loss to follow-up, the total number of participants at Week 6 was 30.

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.

Outcome measures

Outcome measures
Measure	Video PROTECT n=30 Participants Participants will receive PROTECT therapy once a week for 9 weeks. 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 Assessment of Stress, as Measured by the PSS Baseline	22.45 units on a scale Standard Deviation 7.74
Change in Assessment of Stress, as Measured by the PSS Week 6	20.53 units on a scale Standard Deviation 7.71

SECONDARY outcome

Timeframe: Baseline, 6 weeks

Population: 40 subjects were analyzed at baseline. Due to participant withdrawal and loss to follow-up, the total number of participants at Week 6 was 30.

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).

Outcome measures

Outcome measures
Measure	Video PROTECT n=40 Participants Participants will receive PROTECT therapy once a week for 9 weeks. 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 Assessment of Exposure to Meaningful Activities, as Measured by the BADS Week 6- Domain 1	22.79 units on a scale Standard Deviation 10.02
Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS Week 6- Domain 2	26.70 units on a scale Standard Deviation 10.02
Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS Baseline- Domain 1	19.89 units on a scale Standard Deviation 8.29
Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS Baseline- Domain 2	22.46 units on a scale Standard Deviation 8.57
Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS Baseline- Domain 3	16.00 units on a scale Standard Deviation 7.14
Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS Baseline- Domain 4	17.79 units on a scale Standard Deviation 7.66
Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS Week 6- Domain 3	17.45 units on a scale Standard Deviation 7.70
Change in Assessment of Exposure to Meaningful Activities, as Measured by the BADS Week 6- Domain 4	20.69 units on a scale Standard Deviation 6.59

Adverse Events

Video PROTECT

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Video PROTECT n=40 participants at risk Participants will receive PROTECT therapy once a week for 9 weeks. 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.
Psychiatric disorders Psychiatric Hospitalization	2.5% 1/40 • Number of events 1 • 12 weeks
Nervous system disorders Hospitalization due to Seizures	2.5% 1/40 • Number of events 1 • 12 weeks

Other adverse events

Other adverse events
Measure	Video PROTECT n=40 participants at risk Participants will receive PROTECT therapy once a week for 9 weeks. 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.
Injury, poisoning and procedural complications Emergency Room Visit	2.5% 1/40 • Number of events 1 • 12 weeks
Skin and subcutaneous tissue disorders Skin Irritation	7.5% 3/40 • Number of events 3 • 12 weeks

Additional Information

Dr. Jo Anne Sirey

Weill Cornell Medical College

Phone: 914-997-4333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place