Trial Outcomes & Findings for Low Vision Depression Prevention Trial for Age Related Macular Degeneration (NCT NCT00769015)
NCT ID: NCT00769015
Last Updated: 2014-11-20
Results Overview
The primary outcome was a DSM-IV diagnosis of major or minor depression based on the Patient Health Questionnaire-9 (PHQ-9).13 The PHQ-9 includes the 9 criteria that define DSM-IV diagnoses of depression and is valid in low-vision patients. A scoring algorithm determines whether the profile of symptoms meets categorical diagnoses of depression. The model is adjusted for treatment group, vision stratum (20/70 to 20/100 vs. \< 20/100), baseline better eye scotoma size, baseline depression scores \[Patient Health Questionnaire (PHQ-9)\], Medical Outcome Study score (MOS-6), which is a global index of self-rated physical and mental health, and baseline neuroticism scores.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
188 participants
Primary outcome timeframe
4 months
Results posted on
2014-11-20
Participant Flow
Subjects were recruited from July 2009 through Feb 2013 from a large, private retina practice.
Participant milestones
| Measure |
BA-LVR
In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits
|
ST-LVR
Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
92
|
|
Overall Study
COMPLETED
|
87
|
76
|
|
Overall Study
NOT COMPLETED
|
9
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low Vision Depression Prevention Trial for Age Related Macular Degeneration
Baseline characteristics by cohort
| Measure |
BA-LVR
n=96 Participants
In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits
|
ST-LVR
n=92 Participants
Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy
|
Total
n=188 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
85.2 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
82.7 years
STANDARD_DEVIATION 6.9 • n=7 Participants
|
84.0 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
70 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
94 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
184 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsThe primary outcome was a DSM-IV diagnosis of major or minor depression based on the Patient Health Questionnaire-9 (PHQ-9).13 The PHQ-9 includes the 9 criteria that define DSM-IV diagnoses of depression and is valid in low-vision patients. A scoring algorithm determines whether the profile of symptoms meets categorical diagnoses of depression. The model is adjusted for treatment group, vision stratum (20/70 to 20/100 vs. \< 20/100), baseline better eye scotoma size, baseline depression scores \[Patient Health Questionnaire (PHQ-9)\], Medical Outcome Study score (MOS-6), which is a global index of self-rated physical and mental health, and baseline neuroticism scores.
Outcome measures
| Measure |
BA-LVR
n=87 Participants
In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits
|
ST-LVR
n=76 Participants
Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy
|
|---|---|---|
|
Depression
Total Sample
|
11 participants
|
18 participants
|
|
Depression
Worse Vision Group (< 20/100)
|
5 participants
|
11 participants
|
|
Depression
Better Vision Group (20/70 to 20/100)
|
6 participants
|
7 participants
|
SECONDARY outcome
Timeframe: 4 monthsDistance vision function was assessed using the near activities subscale of the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). This subscale measures self-reported difficulty in completing activities that require distance function. The subscale is scored from 0 to 100 with higher scores indicating better function. Changes in least squares mean (95% CI) from month 0 to month 4 are reported.
Outcome measures
| Measure |
BA-LVR
n=87 Participants
In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits
|
ST-LVR
n=76 Participants
Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy
|
|---|---|---|
|
Vision Function: Distance Activities
|
0.31 units on a scale
Interval -3.25 to 3.87
|
1.12 units on a scale
Interval -2.54 to 4.78
|
SECONDARY outcome
Timeframe: 4 monthsSelf-reported depencency was assessed using the Dependency subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating less dependency. Changes in least square means from baseline to 4 months are presented.
Outcome measures
| Measure |
BA-LVR
n=87 Participants
In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits
|
ST-LVR
n=76 Participants
Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy
|
|---|---|---|
|
Quality of Life: Dependency
|
2.07 units on a scale
Interval -4.03 to 8.18
|
5.54 units on a scale
Interval -0.73 to 11.81
|
SECONDARY outcome
Timeframe: 4 monthsNear vision function was assessed using the near activities subscale of the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). This subscale measures self-reported difficulty in completing activities that require near function. The subscale is scored from 0 to 100 with higher scores indicating better function. Changes in least squares mean (95% CI) from month 0 to month 4 are reported.
Outcome measures
| Measure |
BA-LVR
n=87 Participants
In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits
|
ST-LVR
n=76 Participants
Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy
|
|---|---|---|
|
Vision Function: Near Activities
|
4.78 units on a scale
Interval 1.34 to 8.21
|
2.36 units on a scale
Interval 1.27 to 5.99
|
SECONDARY outcome
Timeframe: 4 monthsSelf-reported menthal health was assessed using the Mental Health subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating better mental health. Changes in least square means from baseline to 4 months are presented.
Outcome measures
| Measure |
BA-LVR
n=87 Participants
In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits
|
ST-LVR
n=76 Participants
Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy
|
|---|---|---|
|
Quality of Life: Mental Health
|
2.23 units on a scale
Interval -3.2 to 7.66
|
4.25 units on a scale
Interval -1.32 to 9.81
|
SECONDARY outcome
Timeframe: 4 monthsSelf-reported role functioning was assessed using the Role Difficulties subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating fewer role difficulties . Changes in least square means from baseline to 4 months are presented.
Outcome measures
| Measure |
BA-LVR
n=87 Participants
In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits
|
ST-LVR
n=76 Participants
Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy
|
|---|---|---|
|
Quality of Life: Role Functioning
|
2.33 units on a scale
Interval -1.46 to 6.12
|
.93 units on a scale
Interval -2.96 to 4.82
|
SECONDARY outcome
Timeframe: 4 monthsSelf-reported social function was assessed using the Social Functioning subscale from the National Eye Institute Vision Function Questionaire-25 (NEI-VFQ). Scores range from 0 to 100, with higher scores indicating better social function. Changes in least square means from baseline to 4 months are presented.
Outcome measures
| Measure |
BA-LVR
n=87 Participants
In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits
|
ST-LVR
n=76 Participants
Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy
|
|---|---|---|
|
Quality of Life: Social Function
|
-.38 units on a scale
Interval -5.59 to 3.84
|
-2.00 units on a scale
Interval -7.46 to 3.47
|
Adverse Events
BA-LVR
Serious events: 30 serious events
Other events: 11 other events
Deaths: 0 deaths
ST-LVR
Serious events: 28 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BA-LVR
n=96 participants at risk
In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits
|
ST-LVR
n=92 participants at risk
Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy
|
|---|---|---|
|
General disorders
death NOS
|
5.2%
5/96 • Number of events 5 • 12 months
|
4.3%
4/92 • Number of events 4 • 12 months
|
|
Vascular disorders
Stroke/TIA
|
8.3%
8/96 • Number of events 8 • 12 months
|
3.3%
3/92 • Number of events 3 • 12 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory
|
1.0%
1/96 • Number of events 1 • 12 months
|
4.3%
4/92 • Number of events 4 • 12 months
|
|
Cardiac disorders
Cardiac
|
2.1%
2/96 • Number of events 2 • 12 months
|
3.3%
3/92 • Number of events 3 • 12 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer
|
3.1%
3/96 • Number of events 3 • 12 months
|
2.2%
2/92 • Number of events 2 • 12 months
|
|
Renal and urinary disorders
UTI
|
0.00%
0/96 • 12 months
|
1.1%
1/92 • Number of events 1 • 12 months
|
|
Metabolism and nutrition disorders
dehydration
|
1.0%
1/96 • Number of events 1 • 12 months
|
0.00%
0/92 • 12 months
|
|
Musculoskeletal and connective tissue disorders
Break/fracture
|
8.3%
8/96 • Number of events 8 • 12 months
|
9.8%
9/92 • Number of events 9 • 12 months
|
|
Gastrointestinal disorders
GI
|
2.1%
2/96 • Number of events 2 • 12 months
|
2.2%
2/92 • Number of events 2 • 12 months
|
Other adverse events
| Measure |
BA-LVR
n=96 participants at risk
In BA-LVR, a low vision occupational therapist (OT) will deliver Behavior Activation (BA), a psychological treatment to prevent depression. This will be administered in the context of the standard of low vision care for OTs as defined by the American Occupational Therapy Association (AOTA). The OTs will collaborate with low vision optometrists, who will deliver the standard of low vision care as defined by the American Optometric Association. The optometrists will evaluate remaining vision and magnification needs, prescribe optical devices, and provide the OTs with initial care plans. The OTs will subsequently meet with subjects in their homes 6 times over 12 weeks to enhance device use, home modifications, and compensatory strategies.
BA-LVR: Low vision clinic-based optometry plus 6 in-home occupational therapy visits
|
ST-LVR
n=92 participants at risk
Subjects randomized to ST-LVR will receive clinic-based low vision optometry, in addition to 6 in-home Supportive Therapy (ST) sessions. ST is a placebo condition that controls for the attention that subjects in the active treatment arm will receive.
ST-LVR: Clinic-based low vision optometry plus 6 in-home sessions of Supportive Therapy
|
|---|---|---|
|
General disorders
falls with no break/uti
|
11.5%
11/96 • Number of events 11 • 12 months
|
5.4%
5/92 • Number of events 5 • 12 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place