Submitted:
05 February 2025
Posted:
05 February 2025
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Abstract
Keywords:
1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Participants and Procedure
2.3. Measures
2.3.1. Phase-I (Baseline Assessment)
2.3.2. Phase-II (Intervention)
2.3.3. Phase-III (Follow-Up Assessment)
2.4. Data Analysis Procedure
2.5. Ethical Considerations
2.6. Trial Registration
3. Results
3.1. Post-intervention and Follow-up Results
3.2. Multivariate Test
3.3. Univariate Test
3.4. Post-Hoc Comparisons
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Abbreviations
| EPDS | Edinburg postnatal depression scale |
| PSS | Perceived stress scale |
References
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| ADAPT-ITT Phases | Methodology |
|---|---|
| 1. Assessment | The community advisory board, consisting of six members, was formulated and included two patients, one nurse, one gynaecologist, one psychiatrist, and one nutritionist. Need assessment was conducted through in-depth interviews with stakeholders such as pregnant with antenatal depression and perceived stress. |
| 2. Decision | Decisions related to adapting the intervention were based on the community advisory board’s recommendation and the results of in-depth interviews. |
| 3. Adaptation | Theatre testing (Pretesting) of the original intervention was carried out. Furthermore, pretesting the intervention with the target population to determine the thoughts related to the intervention, mobilize feedback on the content, and obtain recommendations for improving acceptability for target populations. Modifications were made according to the recommendations of the community advisory board; it focuses on culture, ethnicity, language, cultural groups, and religions, reinforcing what is necessary to fit the country’s sociocultural context. PI demonstrated the intervention to five patients. The provider panel obtained feedback from patients. The feedback was incorporated with the help of the community advisory team. |
| 4. Production | 1st draft of the intervention was formulated and presented before the community advisory board for further feedback and approval. |
| 5.Topical experts | Topical experts were identified to review and provide feedback on the 1st draft of the intervention. The content area expert, comprising six members, was identified as two psychiatric nurses, one gynecologist, two psychiatrists, and one nutritionist. Topical experts were identified with the endorsement of the community advisory board team. |
| 6. Integration | Feedback from topical experts was integrated to finalize the intervention. |
| 7. Training | Two graduate female nurses were trained to administer intervention to the new population. The training consisted of three days of four-hour sessions daily. |
| 8. Testing | A feasibility trial was conducted to assess the feasibility of the intervention. It is employed to determine the study’s primary outcome by quantitative data on baseline and post-intervention from the study participants. |
| Major themes | Sub-themes |
|---|---|
| Theme-I: Psychosomatic response | Symptoms of antenatal depression Symptoms of perceived stress |
| Theme 2: Psychosocial determinant of maternal mental health | Reproductive factors Family dynamics Financial constraints Cultural beliefs and related factors |
| Theme 3: Influence of family dynamics gender preference | Male gender preferences Roles of in-laws and their family members on gender preference |
| Theme 4: Coping mechanism for managing stress and antenatal depression | Faith-based coping Seeking emotional support Relaxation through hobbies and communication with family members |
| Theme 5: Contextualized health interventions in Pakistan context | Culturally tailored approaches Religious applicable methods |
| Variable | Control n (%) |
Intervention n (%) |
P-Value |
|---|---|---|---|
| Age Group (Years) | |||
| 18–24 | 13 (31) | 9 (11) | 0.468 |
| 25–31 | 14 (33) | 19 (45) | |
| ≥32 | 15 (36) | 14 (33) | |
| Education | |||
| Illiterate | 1 (2.4) | 3 (7.1) | 0.638 |
| Primary | 5 (11.9) | 7 (16.7) | |
| Middle/Matric | 13 (31) | 15 (35.7) | |
| Intermediate | 20 (47.6) | 14 (33.3) | |
| Master& above | 3 (7.1) | 3 (7.1) | |
| Employment Status | |||
| Housewife | 32 (76.19) | 29 (69.05) | 0.08 |
| working women | 10 (23.81) | 13 (30.95) | |
| Husband Education | |||
| Illiterate | 1 (3.7) | 3 (11.1) | 0.065 |
| Primary | 5 (18.5) | 3 (11.1) | |
| Middle/Matric | 2 (7.4) | 6 (22.2) | |
| Intermediate | 3 (11.1) | 9 (33.3) | |
| Master& above | 16 (59.3) | 15 (55.6) | |
| Household Income | |||
| Good | 30 (71.4) | 22 (52.4) | 0.058 |
| Poor | 12 (28.6) | 20 (47.6) | |
| Un-Planned Pregnancy | |||
| Yes | 25 (59.5) | 32 (76.2) | 0.08 |
| No | 17 (40.05) | 10 (23.8) | |
| Gravity | |||
| 1–2 | 12 (28.6) | 12 (28.6) | 0.497 |
| 3–4 | 10 (23.8) | 14 (33.3) | |
| 5–6 | 20 (47.6%) | 16 (38.1) | |
| History of Abortions | |||
| Yes | 11 (26.2) | 6 (14.3) | 0.175 |
| No | 31 (73.8) | 36 (85.7) |
| Question | Controln (%) | Interventionn (%) | P-Value |
|---|---|---|---|
| I have been able to laugh and see the funny side of things | |||
| As much as I always could | 9 (21.43) | 7 (16.67) | 0.081 |
| Not quite so much now | 3 (7.14) | 4 (9.52) | |
| Definitely not so much now | 18 (42.86) | 16 (38.10) | |
| Not at all | 12 (28.57) | 15 (35.71) | |
| I have looked forward with enjoyment to things | |||
| As much as I ever did | 5 (11.9) | 8 (19.05) | 0.071 |
| Rather less than I used to | 11 (26.19) | 8 (19.05) | |
| Definitely less than I used to | 15 (35.71) | 11 (26.19) | |
| Hardly at all | 11 (26.19) | 15 (35.71) | |
| I have blamed myself unnecessarily when things went wrong | |||
| Yes, most of the time | 8 (19.05) | 8 (19.05) | 0.636 |
| Yes, some of the time | 16 (38.10) | 21 (50) | |
| Not, very often | 14 (33.3) | 11 (26.19) | |
| No, Never | 4 (9.52) | 2 (4.76) | |
| I have been anxious or worried for no good reason | |||
| No, not at all | 2 (4.76) | 1 (2.38) | 0.36 |
| Hardly ever | 10 (23.81) | 7 (16.67) | |
| Yes, sometimes | 22 (52.38) | 19 (45.24) | |
| Yes, very often | 8 (19.05) | 15 (35.71) | |
| I have felt scared or panicky for no very good reason | |||
| Yes, most of the time | 3 (7.14) | 5 (11.9) | 0.145 |
| Yes, some of the time | 17 (40.48) | 10 (23.81) | |
| Not, very often | 15 (35.71) | 19 (45.24) | |
| No, Never | 7 (16.67) | 8 (19.05) | |
| Things have been getting on top of me | |||
| Yes, most of the time, I haven’t been able to cope at all | 6 (14.29) | 8 (19.05) | 0.221 |
| Yes, sometimes I haven’t been coping as well as usual | 9 (21.43) | 4 (9.52) | |
| No, most of the time, I have coped quite well | 12 (28.57) | 9 (21.43) | |
| No, I have been coping as well as ever | 15 (35.71) | 11 (26.19) | |
| I have been so unhappy that I have had difficulty sleeping | |||
| Yes, most of the time | 5 (11.9) | 13 (21.43) | 0.144 |
| Yes, some of the time | 13 (30.95) | 5 (11.9) | |
| Not, very often | 17 (40.48) | 22 (52.38) | |
| No, Never | 7 (16.67) | 6 (14.29) | |
| I have felt sad or miserable | |||
| Yes, most of the time | 9 (21.43) | 8 (19.05) | 0.69 |
| Yes, some of the time | 8 (19.05) | 7 (16.67) | |
| Not, very often | 17 (40.48) | 22 (52.38) | |
| No, Never | 8 (19.05) | 5 (11.9) | |
| I have been so unhappy that I have been crying | |||
| Yes, most of the time | 10 (23.81) | 6 (14.29) | 0.09 |
| Yes, some of the time | 8 (19.05) | 8 (19.05) | |
| Not, very often | 15 (35.71) | 25 (59.52) | |
| No, Never | 9 (21.43) | 3 (7.14) | |
| The thought of harming myself has occurred to me | |||
| Yes, most of the time | 8 (19.05) | 5 (11.9) | 0.055 |
| Yes, some of the time | 11 (26.19) | 8 (19.05) | |
| Not, very often | 9 (21.43) | 21 (50) | |
| No, Never | 14 (33.3) | 8 (19.05) |
| Question | Control n (%) | Interventionn (%) | P-Value |
|---|---|---|---|
| In the last month, how often have you been upset because of something that happened unexpectedly? | |||
| Almost Never | 0 (0) | 1 (2.38) | 0.07 |
| Sometimes | 13 (30.95) | 9.52) | |
| Fairly Often | 16 (38.1) | 23 (54.76) | |
| Very Often | 13 (30.95) | 14 (33.3) | |
| In the last month, how often have you felt that you were unable to control the important things in your life? | |||
| Almost Never | 0 (0) | 1 (2.38) | 0.061 |
| Sometimes | 13 (30.95) | 4 (9.52) | |
| Fairly Often | 16 (38.1) | 23 (54.76) | |
| Very Often | 13 (30.95) | 14 (33.33) | |
| In the last month, how often have you felt nervous and “stressed”? | |||
| Almost Never | 1 (2.38) | 1 (2.38) | 0.144 |
| Sometimes | 8 (19.05) | 6 (14.29) | |
| Fairly Often | 23 (54.76) | 21 (50) | |
| Very Often | 10 (23.81) | 14 (33.3) | |
|
In the last month, how often have you felt confident about your ability to handle your problems? |
|||
| Never | 14 (33.33) | 9 (21.43) | |
| Almost Never | 12 (28.57) | 24 (57.14) | 0.064 |
| Sometimes | 13 (30.95) | 8 (19.05) | |
| Fairly Often | 3 (7.14) | 1 (2.38) | |
| Very Often | 0 (0) | 0(0) | |
| In the last month, how often have you felt that things were going your way | |||
| Never | 4 (9.52) | 9 (21.43) | 0.088 |
| Almost Never | 16 (38.10) | 23 (54.76) | |
| Sometimes | 15 (35.71) | 7 (16.67) | |
| Fairly Often | 6 (14.29) | 3 (7.14) | |
| Very Often | 1 (2.38) | 0 (0) | |
|
In the last month, how often have you found that you could not cope with all the things that you had to do? |
|||
| Almost Never | 1 (2.38) | 0 (0) | 0.144 |
| Sometimes | 15 (35.71) | 10 (23.81) | |
| Fairly Often | 17 (40.48) | 27 (64.29) | |
| Very Often | 9 (21.43) | 5 (11.9) | |
|
In the last month, how often have you been able to control irritations in your life? |
|||
| Never | 5 (11.9) | 13 (30.95) | |
| Almost Never | 17 (40.48) | 16 (38.1) | 0.154 |
| Sometimes | 14 (14.29) | 10 (7.14) | |
| Fairly Often | 6 (14.29) | 3 (0) | |
| Very Often | 0 (0) | 0 (0) | |
|
How often have you felt that you were on top of things in the last month? |
|||
| Never | 15 (35.71) | 13 (30.95) | |
| Almost Never | 16 (38.1) | 22 (52.38) | |
| Sometimes | 11 (26.19) | 5 (11.9) | |
| Fairly Often | 0 (0) | 1 (2.38) | |
| Very Often | 0 (0) | 1 (2.38) | |
|
In the last month, how often have you been angered Because of things that were outside of your control? |
|||
| Almost Never | 1 (2.38) | 2 (4.76) | 0.254 |
| Sometimes | 20 (7.62) | 8 (19.05) | |
| Fairly Often | 16 (38.1) | 22 (52.38) | |
| Very Often | 5 (11.9) | 10 (23.81) | |
|
In the last month, how often have you felt difficulties We’re piling up so high that you could not overcome them? |
|||
| Almost Never | 1 (2.38) | 1 (2.38) | 0.479 |
| Sometimes | 0 (0) | 1 (2.38) | |
| Fairly Often | 12 (28.57) | 6 (14.29) | |
| Very Often | 19 (45.24) | 21 (50) |
| Scale | Group | Mean± SD | P-Value |
|---|---|---|---|
| EPDS | Control | 26.73 ± 6.42 | 0.161 |
| Intervention | 28.54 ± 5.24 | ||
| PSS | Control | 22.33 ± 2.39 | 0.268 |
| Intervention | 22.85 ± 1.88 |
| Scale | Gender Preference | Mean ± SD | P-Value |
|---|---|---|---|
| EPDS Score | Female | 27.17 ± 6.85 | 0.171 |
| Male | 24.71 ± 3.89 | ||
| PSS Score | Female | 22.64 ± 2.66 | 0.92 |
| Male | 22.58 ± 2.03 |
| Measure | Source | Sum of Squares | df | Mean Square | F | p-value |
|---|---|---|---|---|---|---|
| Antenatal Depression | Time | 434.738 | 2 | 217.369 | 21.244 | <0.001 |
| Perceived Stress | Time | 1771.665 | 2 | 885.837 | 310.748 | < 0.001 |
| Group | Variable | Time (I) | Mean (I) | Mean (J) | Mean Difference (I-J) | p-value |
|---|---|---|---|---|---|---|
| Intervention | Depression | T(1 vs 2) | 28.548 | 24.548 | 4 | <0.001 |
| T(1 vs 3) | 28.548 | 23.381 | 5.167 | <0.001 | ||
| T(2 vs 3) | 24.548 | 23.381 | 1.167 | 0.001 | ||
| Stress | T(1 vs 2) | 22.857 | 12.643 | 10.214 | <0.001 | |
| T(1 vs 3) | 22.857 | 12.31 | 10.548 | <0.001 | ||
| T(2 vs 3) | 12.643 | 12.31 | 0.333 | 0.043 | ||
| Control | Depression | T(1 vs 2) | 26.734 | 26.332 | 0.402 | 0.514 |
| T(1 vs 3) | 26.734 | 26.231 | 0.503 | 0.472 | ||
| T(2 vs 3) | 26.332 | 26.231 | 0.101 | 0.765 | ||
| Stress | T(1 vs 2) | 22.333 | 21.992 | 0.341 | 0.626 | |
| T(1 vs 3) | 22.333 | 21.872 | 0.461 | 0.489 | ||
| T(2 vs 3) | 21.992 | 21.872 | 0.12 | 0.758 |
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