Trial Outcomes & Findings for Responsive e-Health Intervention for Perinatal Depression in Healthcare Settings (NCT NCT03995316)
NCT ID: NCT03995316
Last Updated: 2023-10-12
Results Overview
The PHQ-9 measures self-reports of depressive symptoms within the prior 2 weeks and has been well-validated, shown high test-retest reliability, shown high internal consistency, and shown to be responsive to changes in treatment. Response options are on a 4-point scale (0 = not at all, 3 = nearly every day). The minimum overall score is 0 and the maximum overall score for the PHQ-9 is 27. Higher values represent more severe depression status.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
191 participants
Primary outcome timeframe
Pretest (at enrollment) and posttest (3 months post enrollment)
Results posted on
2023-10-12
Participant Flow
Participant milestones
| Measure |
Treatment As Usual + MMB 2.0
Women assigned to use MMB 2.0, along with NorthShore HealthSystem's well established usual care, will be guided by the program to move sequentially through 6 sessions, one of which becomes available for use each week, while interacting with engaging activities within each session along with recommended practice activities to encourage transfer of learning and skills to everyday routines. Content is presented using text, interactions, animations, and videos. MMB includes daily tracking and charting of mood and pleasant activities as well as online access to a library, covering a range of issues of concern to pregnant women and new mothers. Integrated text messages offer both motivational messages and links to access specific portions of session content in the MMB 2.0 program. The study coordinator will also provide up to 3 supportive coaching calls to each woman in the MMB 2.0 condition. These calls complement and thus are adjunctive to the MMB 2.0 program.
|
Treatment As Usual Only
NorthShore HealthSystem's treatment as usual, or usual care, has been in place since 2003. Screen positive women randomized to this condition will receive social work assessment by phone, followed by community mental health referral as indicated. Referrals will vary by need and may include psychotherapy, support groups, or psychiatry. Referrals will include consideration of geographic proximity, insurance, and acuity. Consistent with routine practice, NorthShore staff will document time spent during evaluation and in making specific referrals.
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
95
|
|
Overall Study
COMPLETED
|
86
|
92
|
|
Overall Study
NOT COMPLETED
|
10
|
3
|
Reasons for withdrawal
| Measure |
Treatment As Usual + MMB 2.0
Women assigned to use MMB 2.0, along with NorthShore HealthSystem's well established usual care, will be guided by the program to move sequentially through 6 sessions, one of which becomes available for use each week, while interacting with engaging activities within each session along with recommended practice activities to encourage transfer of learning and skills to everyday routines. Content is presented using text, interactions, animations, and videos. MMB includes daily tracking and charting of mood and pleasant activities as well as online access to a library, covering a range of issues of concern to pregnant women and new mothers. Integrated text messages offer both motivational messages and links to access specific portions of session content in the MMB 2.0 program. The study coordinator will also provide up to 3 supportive coaching calls to each woman in the MMB 2.0 condition. These calls complement and thus are adjunctive to the MMB 2.0 program.
|
Treatment As Usual Only
NorthShore HealthSystem's treatment as usual, or usual care, has been in place since 2003. Screen positive women randomized to this condition will receive social work assessment by phone, followed by community mental health referral as indicated. Referrals will vary by need and may include psychotherapy, support groups, or psychiatry. Referrals will include consideration of geographic proximity, insurance, and acuity. Consistent with routine practice, NorthShore staff will document time spent during evaluation and in making specific referrals.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
10
|
3
|
Baseline Characteristics
Responsive e-Health Intervention for Perinatal Depression in Healthcare Settings
Baseline characteristics by cohort
| Measure |
Treatment As Usual + MMB 2.0
n=96 Participants
Women assigned to use MMB 2.0, along with NorthShore HealthSystem's well established usual care, will be guided by the program to move sequentially through 6 sessions, one of which becomes available for use each week, while interacting with engaging activities within each session along with recommended practice activities to encourage transfer of learning and skills to everyday routines. Content is presented using text, interactions, animations, and videos. MMB includes daily tracking and charting of mood and pleasant activities as well as online access to a library, covering a range of issues of concern to pregnant women and new mothers. Integrated text messages offer both motivational messages and links to access specific portions of session content in the MMB 2.0 program. The study coordinator will also provide up to 3 supportive coaching calls to each woman in the MMB 2.0 condition. These calls complement and thus are adjunctive to the MMB 2.0 program.
|
Treatment As Usual Only
n=95 Participants
NorthShore HealthSystem's treatment as usual, or usual care, has been in place since 2003. Screen positive women randomized to this condition will receive social work assessment by phone, followed by community mental health referral as indicated. Referrals will vary by need and may include psychotherapy, support groups, or psychiatry. Referrals will include consideration of geographic proximity, insurance, and acuity. Consistent with routine practice, NorthShore staff will document time spent during evaluation and in making specific referrals.
|
Total
n=191 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
Age · <=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Age · Between 18 and 65 years
|
96 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Age, Categorical
Age · >=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
31.7 years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
32.1 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
31.9 years
STANDARD_DEVIATION 5.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
78 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
157 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
27 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
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
96 participants
n=5 Participants
|
95 participants
n=7 Participants
|
191 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pretest (at enrollment) and posttest (3 months post enrollment)The PHQ-9 measures self-reports of depressive symptoms within the prior 2 weeks and has been well-validated, shown high test-retest reliability, shown high internal consistency, and shown to be responsive to changes in treatment. Response options are on a 4-point scale (0 = not at all, 3 = nearly every day). The minimum overall score is 0 and the maximum overall score for the PHQ-9 is 27. Higher values represent more severe depression status.
Outcome measures
| Measure |
Treatment As Usual + MMB 2.0
n=96 Participants
Women assigned to use MMB 2.0, along with NorthShore HealthSystem's well established usual care, will be guided by the program to move sequentially through 6 sessions, one of which becomes available for use each week, while interacting with engaging activities within each session along with recommended practice activities to encourage transfer of learning and skills to everyday routines. Content is presented using text, interactions, animations, and videos. MMB includes daily tracking and charting of mood and pleasant activities as well as online access to a library, covering a range of issues of concern to pregnant women and new mothers. Integrated text messages offer both motivational messages and links to access specific portions of session content in the MMB 2.0 program. The study coordinator will also provide up to 3 supportive coaching calls to each woman in the MMB 2.0 condition. These calls complement and thus are adjunctive to the MMB 2.0 program.
|
Treatment As Usual Only
n=95 Participants
NorthShore HealthSystem's treatment as usual, or usual care, has been in place since 2003. Screen positive women randomized to this condition will receive social work assessment by phone, followed by community mental health referral as indicated. Referrals will vary by need and may include psychotherapy, support groups, or psychiatry. Referrals will include consideration of geographic proximity, insurance, and acuity. Consistent with routine practice, NorthShore staff will document time spent during evaluation and in making specific referrals.
|
|---|---|---|
|
Change in Primary Health Questionnaire (PHQ-9)
Pretest
|
10.68 score on a scale
Standard Deviation 4.96
|
10.24 score on a scale
Standard Deviation 5.57
|
|
Change in Primary Health Questionnaire (PHQ-9)
Posttest
|
5.78 score on a scale
Standard Deviation 4.42
|
7.48 score on a scale
Standard Deviation 5.67
|
SECONDARY outcome
Timeframe: Pretest (at enrollment) and posttest (3 months post enrollment)The 7-item GAD measures generalized anxiety. Response options are on a 4-point scale (0 = did not apply to me, 3 = applied to me most of the time). A total sum score was computed. The minimum overall score is 0 and the maximum overall score is 21. Higher values represent more severe symptoms of generalized anxiety.
Outcome measures
| Measure |
Treatment As Usual + MMB 2.0
n=96 Participants
Women assigned to use MMB 2.0, along with NorthShore HealthSystem's well established usual care, will be guided by the program to move sequentially through 6 sessions, one of which becomes available for use each week, while interacting with engaging activities within each session along with recommended practice activities to encourage transfer of learning and skills to everyday routines. Content is presented using text, interactions, animations, and videos. MMB includes daily tracking and charting of mood and pleasant activities as well as online access to a library, covering a range of issues of concern to pregnant women and new mothers. Integrated text messages offer both motivational messages and links to access specific portions of session content in the MMB 2.0 program. The study coordinator will also provide up to 3 supportive coaching calls to each woman in the MMB 2.0 condition. These calls complement and thus are adjunctive to the MMB 2.0 program.
|
Treatment As Usual Only
n=95 Participants
NorthShore HealthSystem's treatment as usual, or usual care, has been in place since 2003. Screen positive women randomized to this condition will receive social work assessment by phone, followed by community mental health referral as indicated. Referrals will vary by need and may include psychotherapy, support groups, or psychiatry. Referrals will include consideration of geographic proximity, insurance, and acuity. Consistent with routine practice, NorthShore staff will document time spent during evaluation and in making specific referrals.
|
|---|---|---|
|
Change in General Anxiety Disorder (GAD)
Pretest
|
5.23 score on a scale
Standard Deviation 3.90
|
5.96 score on a scale
Standard Deviation 4.43
|
|
Change in General Anxiety Disorder (GAD)
Posttest
|
2.81 score on a scale
Standard Deviation 2.82
|
4.12 score on a scale
Standard Deviation 3.83
|
SECONDARY outcome
Timeframe: Pretest (at enrollment) and posttest (3 months post enrollment)The 7-item stress will measure generalized stress. Response options are on a 4-point response option (0 = did not apply to me, 3 = applied to me most of the time). A total sum score was computed. The minimum overall score is 0 and the maximum overall score is 21. Higher values represent more severe symptoms of generalized stress.
Outcome measures
| Measure |
Treatment As Usual + MMB 2.0
n=96 Participants
Women assigned to use MMB 2.0, along with NorthShore HealthSystem's well established usual care, will be guided by the program to move sequentially through 6 sessions, one of which becomes available for use each week, while interacting with engaging activities within each session along with recommended practice activities to encourage transfer of learning and skills to everyday routines. Content is presented using text, interactions, animations, and videos. MMB includes daily tracking and charting of mood and pleasant activities as well as online access to a library, covering a range of issues of concern to pregnant women and new mothers. Integrated text messages offer both motivational messages and links to access specific portions of session content in the MMB 2.0 program. The study coordinator will also provide up to 3 supportive coaching calls to each woman in the MMB 2.0 condition. These calls complement and thus are adjunctive to the MMB 2.0 program.
|
Treatment As Usual Only
n=95 Participants
NorthShore HealthSystem's treatment as usual, or usual care, has been in place since 2003. Screen positive women randomized to this condition will receive social work assessment by phone, followed by community mental health referral as indicated. Referrals will vary by need and may include psychotherapy, support groups, or psychiatry. Referrals will include consideration of geographic proximity, insurance, and acuity. Consistent with routine practice, NorthShore staff will document time spent during evaluation and in making specific referrals.
|
|---|---|---|
|
Change in Stress
Pretest
|
9.61 score on a scale
Standard Deviation 4.05
|
10.36 score on a scale
Standard Deviation 4.53
|
|
Change in Stress
Posttest
|
5.79 score on a scale
Standard Deviation 3.47
|
8.10 score on a scale
Standard Deviation 4.65
|
SECONDARY outcome
Timeframe: Pretest (at enrollment) and posttest (3 months post enrollment)The 9-item BADS measures self-reports of activation, avoidance/rumination, work/school impairment, and social impairments. Response options are on a 7-point scale (0 = nota at all, 6 = completely) and a total sum score was computed. The minimum overall score is 0 and the maximum overall score is 54. Higher values represent more severe depression status related to behavioral activation.
Outcome measures
| Measure |
Treatment As Usual + MMB 2.0
n=96 Participants
Women assigned to use MMB 2.0, along with NorthShore HealthSystem's well established usual care, will be guided by the program to move sequentially through 6 sessions, one of which becomes available for use each week, while interacting with engaging activities within each session along with recommended practice activities to encourage transfer of learning and skills to everyday routines. Content is presented using text, interactions, animations, and videos. MMB includes daily tracking and charting of mood and pleasant activities as well as online access to a library, covering a range of issues of concern to pregnant women and new mothers. Integrated text messages offer both motivational messages and links to access specific portions of session content in the MMB 2.0 program. The study coordinator will also provide up to 3 supportive coaching calls to each woman in the MMB 2.0 condition. These calls complement and thus are adjunctive to the MMB 2.0 program.
|
Treatment As Usual Only
n=95 Participants
NorthShore HealthSystem's treatment as usual, or usual care, has been in place since 2003. Screen positive women randomized to this condition will receive social work assessment by phone, followed by community mental health referral as indicated. Referrals will vary by need and may include psychotherapy, support groups, or psychiatry. Referrals will include consideration of geographic proximity, insurance, and acuity. Consistent with routine practice, NorthShore staff will document time spent during evaluation and in making specific referrals.
|
|---|---|---|
|
Change in Behavioral Activation for Depression Scale (BADS)
Pretest
|
25.15 score on a scale
Standard Deviation 7.99
|
24.46 score on a scale
Standard Deviation 8.66
|
|
Change in Behavioral Activation for Depression Scale (BADS)
Posttest
|
31.15 score on a scale
Standard Deviation 8.41
|
29.37 score on a scale
Standard Deviation 9.41
|
SECONDARY outcome
Timeframe: Pretest (at enrollment) and posttest (3 months post enrollment)The 8-item ATQ measures negative thoughts associated with depression. Response options are on a 4-point scale (0 = not at all, 3 = all the time) and a total mean score was computed and can range from 0 to 3. Higher values represent more severe depression status related to experiencing automatic thoughts.
Outcome measures
| Measure |
Treatment As Usual + MMB 2.0
n=96 Participants
Women assigned to use MMB 2.0, along with NorthShore HealthSystem's well established usual care, will be guided by the program to move sequentially through 6 sessions, one of which becomes available for use each week, while interacting with engaging activities within each session along with recommended practice activities to encourage transfer of learning and skills to everyday routines. Content is presented using text, interactions, animations, and videos. MMB includes daily tracking and charting of mood and pleasant activities as well as online access to a library, covering a range of issues of concern to pregnant women and new mothers. Integrated text messages offer both motivational messages and links to access specific portions of session content in the MMB 2.0 program. The study coordinator will also provide up to 3 supportive coaching calls to each woman in the MMB 2.0 condition. These calls complement and thus are adjunctive to the MMB 2.0 program.
|
Treatment As Usual Only
n=95 Participants
NorthShore HealthSystem's treatment as usual, or usual care, has been in place since 2003. Screen positive women randomized to this condition will receive social work assessment by phone, followed by community mental health referral as indicated. Referrals will vary by need and may include psychotherapy, support groups, or psychiatry. Referrals will include consideration of geographic proximity, insurance, and acuity. Consistent with routine practice, NorthShore staff will document time spent during evaluation and in making specific referrals.
|
|---|---|---|
|
Change in Automatic Thoughts Questionnaire - Short Form (ATQ)
Pretest
|
1.23 score on a scale
Standard Deviation 0.65
|
1.24 score on a scale
Standard Deviation 0.66
|
|
Change in Automatic Thoughts Questionnaire - Short Form (ATQ)
Posttest
|
0.72 score on a scale
Standard Deviation 0.57
|
0.90 score on a scale
Standard Deviation 0.55
|
SECONDARY outcome
Timeframe: Pretest (at enrollment) and posttest (3 months post enrollment)The 8-item self-efficacy score measures confidence in one's ability to implement the skills taught in the program (e.g., how confident are you that you can increase your daily pleasant activities?). Response options are on 5-point scale (1 = not at all confident, , 5 = Very confident) and scores were averaged across the 8-items and can range from 1 to 5. A higher score indicates more self-efficacy to perform the tasks taught in the program.
Outcome measures
| Measure |
Treatment As Usual + MMB 2.0
n=96 Participants
Women assigned to use MMB 2.0, along with NorthShore HealthSystem's well established usual care, will be guided by the program to move sequentially through 6 sessions, one of which becomes available for use each week, while interacting with engaging activities within each session along with recommended practice activities to encourage transfer of learning and skills to everyday routines. Content is presented using text, interactions, animations, and videos. MMB includes daily tracking and charting of mood and pleasant activities as well as online access to a library, covering a range of issues of concern to pregnant women and new mothers. Integrated text messages offer both motivational messages and links to access specific portions of session content in the MMB 2.0 program. The study coordinator will also provide up to 3 supportive coaching calls to each woman in the MMB 2.0 condition. These calls complement and thus are adjunctive to the MMB 2.0 program.
|
Treatment As Usual Only
n=95 Participants
NorthShore HealthSystem's treatment as usual, or usual care, has been in place since 2003. Screen positive women randomized to this condition will receive social work assessment by phone, followed by community mental health referral as indicated. Referrals will vary by need and may include psychotherapy, support groups, or psychiatry. Referrals will include consideration of geographic proximity, insurance, and acuity. Consistent with routine practice, NorthShore staff will document time spent during evaluation and in making specific referrals.
|
|---|---|---|
|
Change in Self-Efficacy
Pretest
|
2.86 score on a scale
Standard Deviation 0.74
|
2.77 score on a scale
Standard Deviation 0.73
|
|
Change in Self-Efficacy
Posttest
|
3.40 score on a scale
Standard Deviation 0.79
|
3.05 score on a scale
Standard Deviation 0.78
|
Adverse Events
Treatment As Usual + MMB 2.0
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Treatment As Usual Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
David Smith
Oregon Research Behavior Intervention Strategies, Inc. dba Influents Innovations
Phone: 541-484-2123
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place