TriangleNCT02420223 · OUTCOME
Patient-reported Depression and Anxiety Scores
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- units on a scale
- Interval / dispersion
- Standard Deviation
- Time frame
- Baseline and 4 weeks
What was measured
This measure will be assessed using the Hospital Anxiety and Depression Scale (HADS). The HADS scale includes fourteen 4-response Likert-scale questions graded 0 to 3. Seven questions are specific to depression; 7 questions are specific to anxiety. The score is the total of the responses in their respective categories. Lower scores indicated less depression and/or anxiety. Scores 0-7 indicate normal status; scores 8-10 suggest borderline abnormal status; and scores 11-21 indicate abnormal status. Only anxiety scores are presented.
Analysis population: One propranolol subject was discontinued due to symptomatic hypotension. Two control subjects were discontinued doe to initiation of beta-blocker therapy for cardiac arrhythmia.
Groups in this outcome
Propranolol
Patient's randomized to the Propranolol arm will be starting 7 days prior to transplant and continuing through 28 days post-transplant. Propranolol will start at 20mg twice daily and will be titrated to 40mg twice daily as tolerated. Both groups will come back to the hospital weekly in order to assess items such as patient's level of anxiety, depression, your adherence, and also to monitor for side effects. The patient's will complete questionnaires during your visit. These will take approximately 15 minutes to complete. This will continue for up to 7 total weeks for patient's on the Propranolol arm. Propranolol
Control Arm
Both groups will come back to the hospital weekly in order to assess items such as patient's level of anxiety, depression, your adherence, and also to monitor for side effects. The patient's will complete questionnaires during your visit. These will take approximately 15 minutes to complete. This will continue for 6 total weeks for patient's on the control arm.
| Group | Source count |
|---|---|
| Propranolol | 12 |
| Control Arm | 13 |
Reported measurements
Baseline Anxiety Score
| Group | Source count |
|---|---|
| Propranolol | 12 |
| Control Arm | 13 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Propranolol | 7.3 | 3.5 | Not reported | Not reported | Not reported |
| Control Arm | 7.4 | 3.7 | Not reported | Not reported | Not reported |
4-Week Anxiety Score
| Group | Source count |
|---|---|
| Propranolol | 11 |
| Control Arm | 11 |
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Propranolol | 4.4 | 2.3 | Not reported | Not reported | Not reported |
| Control Arm | 5.2 | 3.7 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 3.5
- value
- 7.3
- group Id
- OG001
- spread
- 3.7
- value
- 7.4
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 13
- units
- Participants
- title
- Baseline Anxiety Score
- categories
- measurements
- group Id
- OG000
- spread
- 2.3
- value
- 4.4
- group Id
- OG001
- spread
- 3.7
- value
- 5.2
- denoms
- counts
- group Id
- OG000
- value
- 11
- group Id
- OG001
- value
- 11
- units
- Participants
- title
- 4-Week Anxiety Score
- denoms
- counts
- group Id
- OG000
- value
- 12
- group Id
- OG001
- value
- 13
- units
- Participants
- description
- This measure will be assessed using the Hospital Anxiety and Depression Scale (HADS). The HADS scale includes fourteen 4-response Likert-scale questions graded 0 to 3. Seven questions are specific to depression; 7 questions are specific to anxiety. The score is the total of the responses in their respective categories. Lower scores indicated less depression and/or anxiety. Scores 0-7 indicate normal status; scores 8-10 suggest borderline abnormal status; and scores 11-21 indicate abnormal status. Only anxiety scores are presented.
- dispersion Type
- Standard Deviation
- groups
- description
- Patient's randomized to the Propranolol arm will be starting 7 days prior to transplant and continuing through 28 days post-transplant. Propranolol will start at 20mg twice daily and will be titrated to 40mg twice daily as tolerated. Both groups will come back to the hospital weekly in order to assess items such as patient's level of anxiety, depression, your adherence, and also to monitor for side effects. The patient's will complete questionnaires during your visit. These will take approximately 15 minutes to complete. This will continue for up to 7 total weeks for patient's on the Propranolol arm. Propranolol
- id
- OG000
- title
- Propranolol
- description
- Both groups will come back to the hospital weekly in order to assess items such as patient's level of anxiety, depression, your adherence, and also to monitor for side effects. The patient's will complete questionnaires during your visit. These will take approximately 15 minutes to complete. This will continue for 6 total weeks for patient's on the control arm.
- id
- OG001
- title
- Control Arm
- param Type
- MEAN
- population Description
- One propranolol subject was discontinued due to symptomatic hypotension. Two control subjects were discontinued doe to initiation of beta-blocker therapy for cardiac arrhythmia.
- reporting Status
- POSTED
- time Frame
- Baseline and 4 weeks
- title
- Patient-reported Depression and Anxiety Scores
- type
- SECONDARY
- unit Of Measure
- units on a scale
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice