Trial Outcomes & Findings for Thinking Healthy Program Peer Delivered Plus (NCT NCT02658994)
NCT ID: NCT02658994
Last Updated: 2021-04-28
Results Overview
The PHQ-9 is a 9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression. The results may be used to make a depression diagnosis according to the DSM-IV criteria. The PHQ-9 asks about patients experience in the last two weeks. Questions are about the level of interest in doing things, feeling down or depressed, difficulty with sleeping, energy levels, eating habits, self-perception, ability to concentrate, speed of functioning and thoughts of suicide. Responses range from "0" (not at all) to "3" (nearly every day). Scores range from 0-27, a total of 10 or above is suggestive of the presence of depression. PHQ-9 score Depression severity 0-4 minimal depression 5-9 mild depression 10-14 moderate depression 15-19 moderately severe depression 20+ severe depression
COMPLETED
NA
1154 participants
36 months post-partum
2021-04-28
Participant Flow
1154 pregnant women were enrolled in the study. Enhanced usual care (EUC) group had 287, THPP had 283, no prenatal depression had 584. The study team attempted to interview all women at all follow up visits (baseline, 3 mo, 6 mo, 12 mo, 24 mo, 36 mo). If a woman missed a previous visit, (LTFU, temporarily absent, refused) she was not excluded from participating in further visits. Therefore, the number of participants at each follow up visit may increase and decrease but will not exceed 1154.
Participant milestones
| Measure |
Enhanced Usual Care
Women in the control clusters who were depressed prenatally have been receiving Enhanced Usual Care (EUC). At the time of the screening, women, their Lady Health Workers, and their local primary health care facility were informed of the diagnosis, and women were given an information sheet about depression and how to access care. There are no new EUC protocols put in place post-partum as part of the THPP+.
|
THPP+
As part of THPP+, the intervention will continue from the 6th month postnatal through 36 months postnatal and so will consist of an additional 30 months of lower intensity services that are unique to THPP+. The THPP+ will also include additional group sessions to be held every other month for a total of 18 over the intervention duration. The content will be a continuation of the previous THPP sessions with continuing emphasis on self-care as well as the baby's health and development.
Thinking Healthy Program Peer Delivered Plus
|
No Prenatal Depression
No prenatal depression recorded at baseline.
|
|---|---|---|---|
|
Enrollment
STARTED
|
287
|
283
|
584
|
|
Enrollment
COMPLETED
|
287
|
283
|
584
|
|
Enrollment
NOT COMPLETED
|
0
|
0
|
0
|
|
3 Month Follow up
STARTED
|
287
|
283
|
584
|
|
3 Month Follow up
COMPLETED
|
221
|
223
|
451
|
|
3 Month Follow up
NOT COMPLETED
|
66
|
60
|
133
|
|
6 Month Follow up
STARTED
|
287
|
283
|
584
|
|
6 Month Follow up
COMPLETED
|
228
|
230
|
471
|
|
6 Month Follow up
NOT COMPLETED
|
59
|
53
|
113
|
|
12 Month Follow up
STARTED
|
287
|
283
|
584
|
|
12 Month Follow up
COMPLETED
|
228
|
223
|
489
|
|
12 Month Follow up
NOT COMPLETED
|
59
|
60
|
95
|
|
24 Month Follow up
STARTED
|
287
|
283
|
584
|
|
24 Month Follow up
COMPLETED
|
220
|
210
|
473
|
|
24 Month Follow up
NOT COMPLETED
|
67
|
73
|
111
|
|
36 Month Follow up
STARTED
|
287
|
283
|
584
|
|
36 Month Follow up
COMPLETED
|
216
|
206
|
467
|
|
36 Month Follow up
NOT COMPLETED
|
71
|
77
|
117
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Enhanced Usual Care
n=287 Participants
Informing participants and LHWs about depression status and ways to seek help.
|
THPP and THPP+
n=283 Participants
Group based booster sessions which included peer support behavioral activation and problem solving.
|
No Prenatal Depression
n=584 Participants
No prenatal depression at baseline.
|
Total
n=1154 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=287 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=584 Participants
|
0 Participants
n=1154 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
287 Participants
n=287 Participants
|
283 Participants
n=283 Participants
|
584 Participants
n=584 Participants
|
1154 Participants
n=1154 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=287 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=584 Participants
|
0 Participants
n=1154 Participants
|
|
Sex: Female, Male
Female
|
287 Participants
n=287 Participants
|
283 Participants
n=283 Participants
|
584 Participants
n=584 Participants
|
1154 Participants
n=1154 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=287 Participants
|
0 Participants
n=283 Participants
|
0 Participants
n=584 Participants
|
0 Participants
n=1154 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Pakistan
|
287 participants
n=287 Participants
|
283 participants
n=283 Participants
|
584 participants
n=584 Participants
|
1154 participants
n=1154 Participants
|
|
Mother's education
None
|
55 Participants
n=287 Participants
|
52 Participants
n=283 Participants
|
63 Participants
n=584 Participants
|
170 Participants
n=1154 Participants
|
|
Mother's education
Primary (1-5)
|
71 Participants
n=287 Participants
|
68 Participants
n=283 Participants
|
87 Participants
n=584 Participants
|
226 Participants
n=1154 Participants
|
|
Mother's education
Middle or secondary (6-12)
|
134 Participants
n=287 Participants
|
145 Participants
n=283 Participants
|
338 Participants
n=584 Participants
|
617 Participants
n=1154 Participants
|
|
Mother's education
Tertiary >13
|
27 Participants
n=287 Participants
|
18 Participants
n=283 Participants
|
96 Participants
n=584 Participants
|
141 Participants
n=1154 Participants
|
|
Nuclear family
|
49 Participants
n=287 Participants
|
50 Participants
n=283 Participants
|
59 Participants
n=584 Participants
|
158 Participants
n=1154 Participants
|
|
Total number of children in the household
First pregnancy
|
72 Participants
n=287 Participants
|
65 Participants
n=283 Participants
|
212 Participants
n=584 Participants
|
349 Participants
n=1154 Participants
|
|
Total number of children in the household
1-3
|
183 Participants
n=287 Participants
|
180 Participants
n=283 Participants
|
336 Participants
n=584 Participants
|
699 Participants
n=1154 Participants
|
|
Total number of children in the household
4 or more
|
32 Participants
n=287 Participants
|
38 Participants
n=283 Participants
|
36 Participants
n=584 Participants
|
106 Participants
n=1154 Participants
|
|
Duration of depression (chronicity)
<12 weeks
|
38 Participants
n=287 Participants • This group did not have prenatal depression at baseline.
|
35 Participants
n=283 Participants • This group did not have prenatal depression at baseline.
|
—
|
73 Participants
n=570 Participants • This group did not have prenatal depression at baseline.
|
|
Duration of depression (chronicity)
>12 weeks
|
155 Participants
n=287 Participants • This group did not have prenatal depression at baseline.
|
171 Participants
n=283 Participants • This group did not have prenatal depression at baseline.
|
—
|
326 Participants
n=570 Participants • This group did not have prenatal depression at baseline.
|
|
Duration of depression (chronicity)
Data missing
|
94 Participants
n=287 Participants • This group did not have prenatal depression at baseline.
|
77 Participants
n=283 Participants • This group did not have prenatal depression at baseline.
|
—
|
171 Participants
n=570 Participants • This group did not have prenatal depression at baseline.
|
|
SES (assets)
Lowest quintile
|
74 Participants
n=287 Participants
|
85 Participants
n=283 Participants
|
71 Participants
n=584 Participants
|
230 Participants
n=1154 Participants
|
|
SES (assets)
Lower-middle quintile
|
67 Participants
n=287 Participants
|
71 Participants
n=283 Participants
|
93 Participants
n=584 Participants
|
231 Participants
n=1154 Participants
|
|
SES (assets)
Middle quintile
|
55 Participants
n=287 Participants
|
50 Participants
n=283 Participants
|
126 Participants
n=584 Participants
|
231 Participants
n=1154 Participants
|
|
SES (assets)
Upper-middle quintile
|
47 Participants
n=287 Participants
|
39 Participants
n=283 Participants
|
145 Participants
n=584 Participants
|
231 Participants
n=1154 Participants
|
|
SES (assets)
Upper quintile
|
44 Participants
n=287 Participants
|
38 Participants
n=283 Participants
|
149 Participants
n=584 Participants
|
231 Participants
n=1154 Participants
|
PRIMARY outcome
Timeframe: 36 months post-partumThe PHQ-9 is a 9-question instrument given to patients in a primary care setting to screen for the presence and severity of depression. The results may be used to make a depression diagnosis according to the DSM-IV criteria. The PHQ-9 asks about patients experience in the last two weeks. Questions are about the level of interest in doing things, feeling down or depressed, difficulty with sleeping, energy levels, eating habits, self-perception, ability to concentrate, speed of functioning and thoughts of suicide. Responses range from "0" (not at all) to "3" (nearly every day). Scores range from 0-27, a total of 10 or above is suggestive of the presence of depression. PHQ-9 score Depression severity 0-4 minimal depression 5-9 mild depression 10-14 moderate depression 15-19 moderately severe depression 20+ severe depression
Outcome measures
| Measure |
Enhanced Usual Care
n=216 Participants
Informing participants and LHWs about depression status and ways to seek help.
|
THPP and THPP+
n=206 Participants
Group based booster sessions which included peer support behavioral activation and problem solving.
|
No Prenatal Depression
n=467 Participants
No prenatal depression at baseline.
|
|---|---|---|---|
|
Depression (PHQ-9 Instrument)
|
6.48 score on a scale
Standard Deviation 6.25
|
5.84 score on a scale
Standard Deviation 5.80
|
3.44 score on a scale
Standard Deviation 4.53
|
PRIMARY outcome
Timeframe: 36 monthsThe SDQ is a parent-reported measure of 25 child attributes with five subscales of 5 items each; emotional symptoms, conduct problems, hyperactivity, peer problems, and prosocial behavior. The TD score is calculated on the basis of four subscales (omitting prosocial behavior) with a score range of 0-40 points. The SDQ is widely used in low and middle-income countries and has been translated into Urdu. High SDQ scores are associated with a substantial increase in psychiatric risk. The TD score of our child participants is listed as a mean in the values below. TD score of 0-13 is considered "close to average, clinically significant problems in this area are unlikely," 14-16 is "slightly raised, which may reflect clinically significant problems," and 17-40 is "high, there is substantial risk of clinically significant problems in this area."
Outcome measures
| Measure |
Enhanced Usual Care
n=216 Participants
Informing participants and LHWs about depression status and ways to seek help.
|
THPP and THPP+
n=206 Participants
Group based booster sessions which included peer support behavioral activation and problem solving.
|
No Prenatal Depression
n=467 Participants
No prenatal depression at baseline.
|
|---|---|---|---|
|
Child Strength and Difficulties Questionnaire (SDQ) Total Difficulties (TD) Score
|
14.72 score on a scale
Standard Deviation 6.13
|
14.73 score on a scale
Standard Deviation 6.04
|
13.69 score on a scale
Standard Deviation 6.34
|
SECONDARY outcome
Timeframe: 36 months post-partumWHODAS 2.0 was used to assess disability in the women in the cohort, the 12-item questionnaire was used to assess level of functionality over the last 30 days. The cohort was asked questions 2-13, and simple scoring was used. Responses to questions were none (0 points), mild difficulty (1 point), severe difficulty (2 points), and extreme difficulty/cannot do (4 points). Responses to the items were summed and scaled to a 0-100 scale to compute a total score, where 0 indicated no disability and 100 indicated full disability.
Outcome measures
| Measure |
Enhanced Usual Care
n=216 Participants
Informing participants and LHWs about depression status and ways to seek help.
|
THPP and THPP+
n=206 Participants
Group based booster sessions which included peer support behavioral activation and problem solving.
|
No Prenatal Depression
n=467 Participants
No prenatal depression at baseline.
|
|---|---|---|---|
|
Disability (WHO Disability Assessment Schedule 2.0)
|
16.11 score on a scale
Standard Deviation 9.12
|
16.71 score on a scale
Standard Deviation 8.52
|
5.61 score on a scale
Standard Deviation 6.46
|
SECONDARY outcome
Timeframe: 36 monthsBayley Scales of Infant Development-III (BSITD) is an individually administered assessment of the child's achievement of developmental milestones across five areas. For this study, we focus on receptive language and fine motor domains at 36 months. A higher score means higher functioning. The two subscales are not combined, but treated as separate variables. The subscales are scaled according to the procedure outlined in the Bayley reference manual, the scaled score minimum and maximums at 36 months are: Receptive- min: 5; max: 19, Fine Motor- min: 2; max: 19.
Outcome measures
| Measure |
Enhanced Usual Care
n=216 Participants
Informing participants and LHWs about depression status and ways to seek help.
|
THPP and THPP+
n=206 Participants
Group based booster sessions which included peer support behavioral activation and problem solving.
|
No Prenatal Depression
n=467 Participants
No prenatal depression at baseline.
|
|---|---|---|---|
|
Infant Cognitive Development (Bayley Scales of Infant Development)
Child Bayley scaled receptive score
|
9.98 score on a scale
Standard Deviation 2.60
|
10.42 score on a scale
Standard Deviation 2.81
|
10.41 score on a scale
Standard Deviation 2.79
|
|
Infant Cognitive Development (Bayley Scales of Infant Development)
Child Bayley scaled fine motor score
|
11.38 score on a scale
Standard Deviation 4.12
|
11.42 score on a scale
Standard Deviation 4.05
|
11.31 score on a scale
Standard Deviation 3.99
|
SECONDARY outcome
Timeframe: 36 months post-partumSCID is a semi-structured interview for the diagnoses of psychiatric disorders. It has been cross-culturally adapted for assessing depression among women during pregnancy and in the postpartum period. The PHQ-9 inquires about frequency of depressive symptoms in the last 2 weeks. Given that the PHQ-9 is a screening tool, we use the SCID module for current major depressive episode as a diagnostic tool to assess the criterion-related validity of using the scores from the PHQ-9 to measure the number of symptoms endorsed by the woman over time. The diagnostic and statistical manual of mental disorders (DSM) IV diagnosis of current major depressive episode is generated through the SCID algorithm. If a woman was diagnosed with at least 1 MDE she was included in the outcome below.
Outcome measures
| Measure |
Enhanced Usual Care
n=216 Participants
Informing participants and LHWs about depression status and ways to seek help.
|
THPP and THPP+
n=206 Participants
Group based booster sessions which included peer support behavioral activation and problem solving.
|
No Prenatal Depression
n=467 Participants
No prenatal depression at baseline.
|
|---|---|---|---|
|
Number of Participants With Depression (SCID Major Depressive Episode)
|
48 Participants
|
34 Participants
|
42 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 monthsChild growth was analyzed with the weight-for-age and length-for-age z scores.
Outcome measures
| Measure |
Enhanced Usual Care
n=216 Participants
Informing participants and LHWs about depression status and ways to seek help.
|
THPP and THPP+
n=206 Participants
Group based booster sessions which included peer support behavioral activation and problem solving.
|
No Prenatal Depression
n=467 Participants
No prenatal depression at baseline.
|
|---|---|---|---|
|
Infant Physical Development [Z-scores (Based on WHO Criteria)]
length-for-age
|
-1.03 z score
Standard Deviation 1.01
|
-1.12 z score
Standard Deviation 1.13
|
-0.96 z score
Standard Deviation 1.11
|
|
Infant Physical Development [Z-scores (Based on WHO Criteria)]
weight-for-age
|
-0.95 z score
Standard Deviation 1.03
|
-1.06 z score
Standard Deviation 0.97
|
-0.94 z score
Standard Deviation 0.98
|
Adverse Events
Enhanced Usual Care
THPP and THPP+
No Prenatal Depression
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Enhanced Usual Care
n=287 participants at risk
Informing participants and LHWs about depression status and ways to seek help.
|
THPP and THPP+
n=283 participants at risk
Group based booster sessions which included peer support behavioral activation and problem solving.
|
No Prenatal Depression
n=584 participants at risk
No prenatal depression at baseline.
|
|---|---|---|---|
|
General disorders
Hernia
|
0.00%
0/287 • Through study completion, an average of 3 years
|
0.00%
0/283 • Through study completion, an average of 3 years
|
0.17%
1/584 • Number of events 1 • Through study completion, an average of 3 years
|
|
General disorders
Child illness
|
1.0%
3/287 • Number of events 3 • Through study completion, an average of 3 years
|
1.4%
4/283 • Number of events 4 • Through study completion, an average of 3 years
|
0.68%
4/584 • Number of events 4 • Through study completion, an average of 3 years
|
|
General disorders
Mother illness
|
0.00%
0/287 • Through study completion, an average of 3 years
|
0.35%
1/283 • Number of events 1 • Through study completion, an average of 3 years
|
0.17%
1/584 • Number of events 1 • Through study completion, an average of 3 years
|
|
General disorders
Child disability
|
0.00%
0/287 • Through study completion, an average of 3 years
|
0.00%
0/283 • Through study completion, an average of 3 years
|
0.17%
1/584 • Number of events 1 • Through study completion, an average of 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place