Trial Outcomes & Findings for Digital Data in Mental Health Therapy (NCT NCT04011540)
NCT ID: NCT04011540
Last Updated: 2024-05-28
Results Overview
The RAND 36-Item Health Survey is a set of generic, coherent, and easily administered health-related quality of life (HRQoL) measures. It explores eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Each item is scored on a 0 to 100 range. The lowest and highest possible scores are 0 and 100, respectively. A high score defines a more favorable health state (better outcome).
COMPLETED
NA
115 participants
2 months
2024-05-28
Participant Flow
Participant milestones
| Measure |
Intervention
Participants will receive a personalized digital data dashboards throughout the two-month study period.
Digital data: Receiving digital data prior to a scheduled mental health session
|
Usual Care
Usual care
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
58
|
|
Overall Study
COMPLETED
|
48
|
52
|
|
Overall Study
NOT COMPLETED
|
9
|
6
|
Reasons for withdrawal
| Measure |
Intervention
Participants will receive a personalized digital data dashboards throughout the two-month study period.
Digital data: Receiving digital data prior to a scheduled mental health session
|
Usual Care
Usual care
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
9
|
6
|
Baseline Characteristics
Digital Data in Mental Health Therapy
Baseline characteristics by cohort
| Measure |
Intervention
n=57 Participants
Participants will receive a personalized digital data dashboards throughout the two-month study period.
Digital data: Receiving digital data prior to a scheduled mental health session
|
Usual Care
n=58 Participants
Usual care
|
Total
n=115 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
30.9 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
32.2 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
31.5 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
103 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 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
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
PRIMARY outcome
Timeframe: 2 monthsPopulation: Changes value from baseline to 2 months. Note: the number of participants analyzed differs from total enrolled due to participants not completing the follow-up survey.
The RAND 36-Item Health Survey is a set of generic, coherent, and easily administered health-related quality of life (HRQoL) measures. It explores eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. It also includes a single item that provides an indication of perceived change in health. Each item is scored on a 0 to 100 range. The lowest and highest possible scores are 0 and 100, respectively. A high score defines a more favorable health state (better outcome).
Outcome measures
| Measure |
Intervention
n=48 Participants
Participants will receive a personalized digital data dashboards throughout the two-month study period.
Digital data: Receiving digital data prior to a scheduled mental health session
|
Usual Care
n=52 Participants
Usual care
|
|---|---|---|
|
Health-related Quality of Life (HRQoL), RAND 36-Item Health Survey Changed Value (Baseline to 2 Months)
|
-0.89 score on a scale
Interval -5.55 to 3.77
|
-1.85 score on a scale
Interval -5.73 to 2.04
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Changes value from baseline to 2 months. Note: the number of participants analyzed differs from total enrolled due to participants not completing the follow-up survey.
Patient health questionnaire-8 (PHQ-8) (Kroenke, Spitzer, \& Williams, 2001) is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-8 incorporates DSM-IV depression diagnostic criteria. Each question is rated on a scale of 0 to 3, minimum score is 0 and maximum score is 24. A total of 8 questions are administered. Lower scores indicate minimal depression (better outcome) and higher scores indicate severe depression (worse outcome).
Outcome measures
| Measure |
Intervention
n=47 Participants
Participants will receive a personalized digital data dashboards throughout the two-month study period.
Digital data: Receiving digital data prior to a scheduled mental health session
|
Usual Care
n=52 Participants
Usual care
|
|---|---|---|
|
Depressive Symptoms, Patient Health Questionnaire-8 (PHQ-8) Change Value
|
-1.20 score on a scale
Interval -2.31 to -0.08
|
-0.44 score on a scale
Interval -1.65 to 0.77
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Changes value from baseline to 2 months. Note: the number of participants analyzed differs from total enrolled due to participants not completing the follow-up survey.
GAD-7 is a 7-item anxiety scale. It has good reliability, as well as criterion, construct, factorial, and procedural validity. Each item is rated according to the frequency of the described problem. The responses are scored as follows: 0 = not at all, 1 = several days, 2 = more than half the days, 3 = nearly every day with a maximum score of 21 Scores are interpreted as 5 to 9, mild anxiety; 10 to 14, moderate anxiety; and 15 and above, severe anxiety. Lower scores represent mild anxiety (better outcome) while higher scores represent severe anxiety (worse outcome).
Outcome measures
| Measure |
Intervention
n=47 Participants
Participants will receive a personalized digital data dashboards throughout the two-month study period.
Digital data: Receiving digital data prior to a scheduled mental health session
|
Usual Care
n=52 Participants
Usual care
|
|---|---|---|
|
Anxiety Symptoms, Generalized Anxiety Disorder-7 (GAD-7) Change Value
|
-0.90 score on a scale
Interval -2.1 to 0.3
|
-1.14 score on a scale
Interval -2.38 to 0.1
|
SECONDARY outcome
Timeframe: 2 monthsPopulation: Mean change values from baseline to 2 months. Note: the number of participants analyzed differs from total enrolled due to participants not completing the follow-up survey.
Working Alliance Inventory (WAI) (Horvath and Greenberg 1986) is used to measure the service user-psychiatrist relationship from the service user perspective. The Working Alliance Inventory-Short Version (WAI-S) is based upon Bordins three-factor conceptualization of the provider and client relationship: collaboration on tasks, collaboration on goals and the bond between the client and therapist. Participants rate items on a 5-point Likert scale anchored at each end with 'rarely or never' (1) and 'always' (5). The total score is simply the sum of all the scores with the appropriate negative items reversed prior to summing. The total score ranges from 5 to 20. Higher scores indicate a better therapeutic alliance (better outcome). Higher positive mean change score represents 'worsened' alliance, whereas negative mean change score represents 'improved' alliance.
Outcome measures
| Measure |
Intervention
n=47 Participants
Participants will receive a personalized digital data dashboards throughout the two-month study period.
Digital data: Receiving digital data prior to a scheduled mental health session
|
Usual Care
n=52 Participants
Usual care
|
|---|---|---|
|
Therapeutic Relationship, Working Alliance Inventory (WAI) Change Value
|
0.36 score on a scale
Interval -1.52 to 2.25
|
-0.65 score on a scale
Interval -2.26 to 0.95
|
Adverse Events
Intervention
Usual Care
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place