Trial Outcomes & Findings for Cognitive Behavioral Couple Therapy for Perinatal Distress (NCT NCT06001021)

Last Updated: 2025-08-13

Results Overview

The Generalized Anxiety Disorder Subscale and Major Depressive Disorder Subscale comprised 8 and 14 items respectively in Parental Perinatal Distress Scale. The response categories range from 0 to 3 scale. The total number of items in both subscales is 22. The summed scores obtained on 22 items range from 0 (minimum) to 66 (maximum). The high total score indicates worse symptoms of perinatal distress in the couples. In the present study, data mean and standard deviation specify absolute value at a pre-test and post-test assessment.

Recruitment status

COMPLETED

Study phase

Target enrollment

96 participants

Primary outcome timeframe

After recruitment, screening, randomization, and allocation, Pre-test Assessment on week 1 (Baseline Measures) and post-test assessment on week 10 (Outcome Measures) through the study period completion.

Results posted on

2025-08-13

Participant Flow

Participant milestones

Participant milestones
Measure	Psychopharmacological Intervention Escitalopram (5 mg) was prescribed by a gynecologist to high risk wives in antenatal period and to husbands in perinatal period. Sertraline (12.5 mg) was prescribed by a gynecologist to wives in the postnatal period.	CBCT Intervention 10 sessions each of 0ne hour, twice a week were carried out in group with the couples	CBCT Intervention With Zikr 10 sessions each of 0ne hour, twice a week were carried out in group with couples. Zikr (Ya Salam-The Peace Giver, Ya Rehman-The Merciful) was given for recitation.	Combined Intervention Without Zikr Escitalopram (5 mg) is prescribed by a gynecologist to high-risk wives in the antenatal period and to husbands in the perinatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period. 10 sessions each of 0ne hour, twice a week were carried out in group with couples.	Combined Intervention With Zikr Escitalopram (5 mg) is prescribed by a gynecologist to high-risk wives in the antenatal period and to husbands in the perinatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period. 10 sessions each of 0ne hour, twice a week were carried out in group with couples. Zikr (Ya Salam-The Peace Giver, Ya Rehman-The Merciful) were given for recitation.	Control Arm (Placebo) In Placebo, sugar Pill was prescribed by a gynecologist.	Control Arm (No Intervention) In no intervention, routine medical/gynecological checkups were carried out.
15 August 2023 to 30 September 2023 STARTED	16	16	16	16	16	8	8
15 August 2023 to 30 September 2023 COMPLETED	14	16	16	8	10	6	8
15 August 2023 to 30 September 2023 NOT COMPLETED	2	0	0	8	6	2	0
1 October 2023 to 28 October 2023 STARTED	14	0	0	8	10	0	0
1 October 2023 to 28 October 2023 COMPLETED	14	0	0	8	10	0	0
1 October 2023 to 28 October 2023 NOT COMPLETED	0	0	0	0	0	0	0
1 October 2023 to 28 October 2023) STARTED	14	0	0	8	10	0	0
1 October 2023 to 28 October 2023) COMPLETED	0	0	0	0	0	0	0
1 October 2023 to 28 October 2023) NOT COMPLETED	14	0	0	8	10	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Psychopharmacological Intervention Escitalopram (5 mg) was prescribed by a gynecologist to high risk wives in antenatal period and to husbands in perinatal period. Sertraline (12.5 mg) was prescribed by a gynecologist to wives in the postnatal period.	CBCT Intervention 10 sessions each of 0ne hour, twice a week were carried out in group with the couples	CBCT Intervention With Zikr 10 sessions each of 0ne hour, twice a week were carried out in group with couples. Zikr (Ya Salam-The Peace Giver, Ya Rehman-The Merciful) was given for recitation.	Combined Intervention Without Zikr Escitalopram (5 mg) is prescribed by a gynecologist to high-risk wives in the antenatal period and to husbands in the perinatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period. 10 sessions each of 0ne hour, twice a week were carried out in group with couples.	Combined Intervention With Zikr Escitalopram (5 mg) is prescribed by a gynecologist to high-risk wives in the antenatal period and to husbands in the perinatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period. 10 sessions each of 0ne hour, twice a week were carried out in group with couples. Zikr (Ya Salam-The Peace Giver, Ya Rehman-The Merciful) were given for recitation.	Control Arm (Placebo) In Placebo, sugar Pill was prescribed by a gynecologist.	Control Arm (No Intervention) In no intervention, routine medical/gynecological checkups were carried out.
15 August 2023 to 30 September 2023 Withdrawal by Subject	2	0	0	8	6	2	0
1 October 2023 to 28 October 2023) Withdrawal by Subject	14	0	0	8	10	0	0

Baseline Characteristics

Cognitive Behavioral Couple Therapy for Perinatal Distress

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Psychopharmacological Intervention n=14 Participants Escitalopram (5 mg) is prescribed by a gynecologist to high-risk couples in the antenatal period and to husbands in the postnatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period. Alprazolam (0.25 mg) is prescribed by a gynecologist to couples in antenatal and postnatal period.	CBCT Without Zikr Intervention n=16 Participants 10 sessions each of 0ne hour, twice a week were carried out.	CBCT With Zikr Intervention n=16 Participants 10 sessions each of 0ne hour, twice a week were carried out. Zikr (Ya Salam-The Peace Giver, Ya Rehman-The Merciful) was given for recitation.	Combined Intervention Without Zikr n=8 Participants Escitalopram (5 mg) is prescribed by a gynecologist to high-risk couples in the antenatal period and to husbands in the postnatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period. Alprazolam (0.25 mg) is prescribed by a gynecologist to couples in antenatal and postnatal period. 10 sessions each of 0ne hour, twice a week were carried out.	Combined Intervention With Zikr n=10 Participants Escitalopram (5 mg) is prescribed by a gynecologist to high-risk couples in the antenatal period and to husbands in the postnatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period. Alprazolam (0.25 mg) is prescribed by a gynecologist to couples in antenatal and postnatal period. 10 sessions each of 0ne hour, twice a week were carried out. Zikr (Ya Salam-The Peace Giver, Ya Rehman-The Merciful) were given for recitation.	Placebo Comparator n=6 Participants Sugar Pill was prescribed by a gynecologist.	No Intervention n=8 Participants Routine medical/gynecological checkups were carried out.	Total n=78 Participants Total of all reporting groups
Age, Continuous	30.35 years STANDARD_DEVIATION 3.83 • n=5 Participants	30.37 years STANDARD_DEVIATION 4.06 • n=7 Participants	30.68 years STANDARD_DEVIATION 4.98 • n=5 Participants	30.50 years STANDARD_DEVIATION 4.37 • n=4 Participants	28.25 years STANDARD_DEVIATION 3.01 • n=21 Participants	34.33 years STANDARD_DEVIATION 6.15 • n=10 Participants	30.62 years STANDARD_DEVIATION 2.97 • n=115 Participants	30.56 years STANDARD_DEVIATION 4.30 • n=24 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=10 Participants	4 Participants n=115 Participants	39 Participants n=24 Participants
Sex: Female, Male Male	7 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	3 Participants n=10 Participants	4 Participants n=115 Participants	39 Participants n=24 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Asian	14 Participants n=5 Participants	16 Participants n=7 Participants	16 Participants n=5 Participants	8 Participants n=4 Participants	10 Participants n=21 Participants	6 Participants n=10 Participants	8 Participants n=115 Participants	78 Participants n=24 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	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=24 Participants
Region of Enrollment Pakistan	14 participants n=5 Participants	16 participants n=7 Participants	16 participants n=5 Participants	8 participants n=4 Participants	10 participants n=21 Participants	6 participants n=10 Participants	8 participants n=115 Participants	78 participants n=24 Participants
Absolute Value of Scores for High Risk Perinatal Distress (Anxiety and Depression)	60.21 units on a scale STANDARD_DEVIATION 2.96 • n=5 Participants	59.06 units on a scale STANDARD_DEVIATION 3.15 • n=7 Participants	59.18 units on a scale STANDARD_DEVIATION 2.85 • n=5 Participants	58.75 units on a scale STANDARD_DEVIATION 3.28 • n=4 Participants	52.70 units on a scale STANDARD_DEVIATION 5.27 • n=21 Participants	51.66 units on a scale STANDARD_DEVIATION 2.33 • n=10 Participants	59.62 units on a scale STANDARD_DEVIATION 3.88 • n=115 Participants	57.93 units on a scale STANDARD_DEVIATION 4.41 • n=24 Participants
Absolute Value of Scores for Dyadic Coping Strategies	40.07 units on a scale STANDARD_DEVIATION 2.26 • n=5 Participants	38.87 units on a scale STANDARD_DEVIATION 2.65 • n=7 Participants	40.25 units on a scale STANDARD_DEVIATION 2.56 • n=5 Participants	42.50 units on a scale STANDARD_DEVIATION 1.60 • n=4 Participants	39.70 units on a scale STANDARD_DEVIATION 2.90 • n=21 Participants	40.66 units on a scale STANDARD_DEVIATION 1.63 • n=10 Participants	40.12 units on a scale STANDARD_DEVIATION 1.64 • n=115 Participants	40.11 units on a scale STANDARD_DEVIATION 2.47 • n=24 Participants
Absolute Value of Scores for Perceived Social Support	20.07 units on a scale STANDARD_DEVIATION 3.02 • n=5 Participants	20.06 units on a scale STANDARD_DEVIATION 2.76 • n=7 Participants	18.31 units on a scale STANDARD_DEVIATION 1.99 • n=5 Participants	21.00 units on a scale STANDARD_DEVIATION 2.00 • n=4 Participants	17.50 units on a scale STANDARD_DEVIATION 1.58 • n=21 Participants	19.16 units on a scale STANDARD_DEVIATION 3.31 • n=10 Participants	18.87 units on a scale STANDARD_DEVIATION 2.03 • n=115 Participants	19.28 units on a scale STANDARD_DEVIATION 2.59 • n=24 Participants
Absolute Value of Scores for Wellbeing	11.14 units on a scale STANDARD_DEVIATION 2.07 • n=5 Participants	11.12 units on a scale STANDARD_DEVIATION 2.12 • n=7 Participants	10.50 units on a scale STANDARD_DEVIATION 2.28 • n=5 Participants	11.37 units on a scale STANDARD_DEVIATION 1.68 • n=4 Participants	9.80 units on a scale STANDARD_DEVIATION 1.75 • n=21 Participants	10.33 units on a scale STANDARD_DEVIATION 1.63 • n=10 Participants	9.87 units on a scale STANDARD_DEVIATION 1.64 • n=115 Participants	10.66 units on a scale STANDARD_DEVIATION 1.99 • n=24 Participants
Absolute Value of Scores for Physical Subscale of World Health Organization Quality of Life Bref	9.21 units on a scale STANDARD_DEVIATION 1.36 • n=5 Participants	9.75 units on a scale STANDARD_DEVIATION 1.23 • n=7 Participants	9.56 units on a scale STANDARD_DEVIATION 1.31 • n=5 Participants	10.62 units on a scale STANDARD_DEVIATION 0.91 • n=4 Participants	9.70 units on a scale STANDARD_DEVIATION 1.33 • n=21 Participants	9.66 units on a scale STANDARD_DEVIATION 0.81 • n=10 Participants	9.37 units on a scale STANDARD_DEVIATION 1.59 • n=115 Participants	9.65 units on a scale STANDARD_DEVIATION 1.28 • n=24 Participants
Absolute Value of Score for Psychological Subscale of World Health Organization Quality of Life Bref	8.500 units on a scale STANDARD_DEVIATION 1.09 • n=5 Participants	7.93 units on a scale STANDARD_DEVIATION 1.28 • n=7 Participants	8.93 units on a scale STANDARD_DEVIATION 0.92 • n=5 Participants	9.25 units on a scale STANDARD_DEVIATION 0.70 • n=4 Participants	8.90 units on a scale STANDARD_DEVIATION 0.99 • n=21 Participants	9.16 units on a scale STANDARD_DEVIATION 0.75 • n=10 Participants	8.50 units on a scale STANDARD_DEVIATION 0.92 • n=115 Participants	8.65 units on a scale STANDARD_DEVIATION 1.07 • n=24 Participants
Absolute Value of Scores for Social Subscale of World Health Organization Quality of Life Bref	3.50 units on a scale STANDARD_DEVIATION 0.61 • n=5 Participants	3.87 units on a scale STANDARD_DEVIATION 0.61 • n=7 Participants	3.43 units on a scale STANDARD_DEVIATION 0.62 • n=5 Participants	3.75 units on a scale STANDARD_DEVIATION 0.70 • n=4 Participants	3.70 units on a scale STANDARD_DEVIATION 0.48 • n=21 Participants	3.50 units on a scale STANDARD_DEVIATION 0.54 • n=10 Participants	4.00 units on a scale STANDARD_DEVIATION 0.75 • n=115 Participants	3.66 units on a scale STANDARD_DEVIATION 0.61 • n=24 Participants
Absolute Value of Scores for Environment Subscale of World Health Organization Quality of Life Bref	9.28 units on a scale STANDARD_DEVIATION 1.06 • n=5 Participants	8.68 units on a scale STANDARD_DEVIATION 0.79 • n=7 Participants	9.68 units on a scale STANDARD_DEVIATION 0.79 • n=5 Participants	10.25 units on a scale STANDARD_DEVIATION 0.88 • n=4 Participants	9.40 units on a scale STANDARD_DEVIATION 0.96 • n=21 Participants	10.00 units on a scale STANDARD_DEVIATION 0.89 • n=10 Participants	9.00 units on a scale STANDARD_DEVIATION 1.19 • n=115 Participants	9.38 units on a scale STANDARD_DEVIATION 1.02 • n=24 Participants

PRIMARY outcome

Timeframe: After recruitment, screening, randomization, and allocation, Pre-test Assessment on week 1 (Baseline Measures) and post-test assessment on week 10 (Outcome Measures) through the study period completion.

Population: The target enrollment was met and planned statistical analyses were performed. The impact of treatment (psychopharmacological medicine; CBCT; CBCT along with Zikr; combined (Psychopharmacological medicine and CBCT); combined (Psychopharmacological and CBCT along with Zikr), placebo comparator, and no intervention is measured for perinatal distress via ANCOVA after controlling for baseline pre-test scores for perinatal distress (depression and anxiety) and monthly income in SPSS-24.

Outcome measures

Outcome measures
Measure	Psychopharmacological Intervention n=14 Participants Escitalopram (5 mg) is prescribed by a gynecologist to high-risk couples in the antenatal period and to husbands in the postnatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period.	CBCT Without Zikr Intervention n=16 Participants 10 sessions each of 0ne hour, twice a week were carried out.	CBCT With Zikr Intervention n=16 Participants 10 sessions each of 0ne hour, twice a week were carried out. Zikr (Ya Salam-The Peace Giver, Ya Momin-The Faith Giver, Ya Rehman-The Merciful) was given for recitation.	Combined Intervention Without Zikr n=8 Participants Escitalopram (5 mg) is prescribed by a gynecologist to high-risk couples in the antenatal period and to husbands in the postnatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period. 10 sessions each of 0ne hour, twice a week were carried out.	Combined Intervention With Zikr n=10 Participants Escitalopram (5 mg) is prescribed by a gynecologist to high-risk couples in the antenatal period and to husbands in the postnatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period. 10 sessions each of 0ne hour, twice a week were carried out. Zikr (Ya Salam-The Peace Giver, Ya Rehman-The Merciful) were given for recitation.	Placebo Comparator n=6 Participants Sugar Pill was prescribed by a gynecologist.	No Intervention n=8 Participants Routine medical/gynecological checkups were carried out.
The Sum of Scores of Major Depressive Disorder Subscale and Generalized Anxiety Disorder Subscale	18.14 score on a scale Standard Deviation 2.03	17.31 score on a scale Standard Deviation 2.33	15.62 score on a scale Standard Deviation 2.47	8.62 score on a scale Standard Deviation 1.50	9.50 score on a scale Standard Deviation 1.35	53.33 score on a scale Standard Deviation 2.87	60.12 score on a scale Standard Deviation 4.12

PRIMARY outcome

Population: The target enrollment was met and planned statistical analyses were performed. The impact of treatment (psychopharmacological medicine; CBCT; CBCT along with Zikr; combined (Psychopharmacological medicine and CBCT); combined (Psychopharmacological and CBCT along with Zikr), placebo comparator, and no intervention is measured for perceived social support via ANCOVA after controlling for baseline pre-test scores for perinatal distress (depression and anxiety) and monthly income in SPSS-24.

The Multidimensional Scale for Perceived Social Support comprised 12 items. There are 1 to 7 scoring categories. The sum of score for 12 items range from 12 (minimum) to 84 (maximum). The high score indicates better social support for perinatal couples. In the present study, data mean and standard deviation specifies absolute values in post-test assessment.

Outcome measures

Outcome measures
Measure	Psychopharmacological Intervention n=14 Participants Escitalopram (5 mg) is prescribed by a gynecologist to high-risk couples in the antenatal period and to husbands in the postnatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period.	CBCT Without Zikr Intervention n=16 Participants 10 sessions each of 0ne hour, twice a week were carried out.	CBCT With Zikr Intervention n=16 Participants 10 sessions each of 0ne hour, twice a week were carried out. Zikr (Ya Salam-The Peace Giver, Ya Momin-The Faith Giver, Ya Rehman-The Merciful) was given for recitation.	Combined Intervention Without Zikr n=8 Participants Escitalopram (5 mg) is prescribed by a gynecologist to high-risk couples in the antenatal period and to husbands in the postnatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period. 10 sessions each of 0ne hour, twice a week were carried out.	Combined Intervention With Zikr n=10 Participants Escitalopram (5 mg) is prescribed by a gynecologist to high-risk couples in the antenatal period and to husbands in the postnatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period. 10 sessions each of 0ne hour, twice a week were carried out. Zikr (Ya Salam-The Peace Giver, Ya Rehman-The Merciful) were given for recitation.	Placebo Comparator n=6 Participants Sugar Pill was prescribed by a gynecologist.	No Intervention n=8 Participants Routine medical/gynecological checkups were carried out.
The Sum of Scores on Multidimensional Scale for Perceived Social Support (MSPSS)	22.14 score on a scale Standard Deviation 1.40	38.31 score on a scale Standard Deviation 4.40	47.00 score on a scale Standard Deviation 2.00	79.00 score on a scale Standard Deviation 3.20	80.50 score on a scale Standard Deviation 2.63	18.66 score on a scale Standard Deviation 3.32	18.62 score on a scale Standard Deviation 1.59

PRIMARY outcome

Population: The target enrollment was met and planned statistical analyses were performed. The impact of treatment (psychopharmacological medicine; CBCT; CBCT along with Zikr; combined (Psychopharmacological medicine and CBCT); combined (Psychopharmacological and CBCT along with Zikr), placebo comparator, and no intervention is measured for dyadic coping via ANCOVA after controlling for baseline pre-test scores for perinatal distress (depression and anxiety) and monthly income in SPSS-24.

Dyadic Coping Inventory comprised 37 items with 1 to 5 scoring categories. However, items 36 and 37 were not included in the scoring as these were evaluative items. The sum of scores for the remaining 35 items range from 35 (minimum) to 175 (maximum). The high score indicates better-than-average levels of coping skills in perinatal couples. In the present study, data mean and standard deviation specifies absolute values in post-test assessment.

Outcome measures

Outcome measures
Measure	Psychopharmacological Intervention n=14 Participants Escitalopram (5 mg) is prescribed by a gynecologist to high-risk couples in the antenatal period and to husbands in the postnatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period.	CBCT Without Zikr Intervention n=16 Participants 10 sessions each of 0ne hour, twice a week were carried out.	CBCT With Zikr Intervention n=16 Participants 10 sessions each of 0ne hour, twice a week were carried out. Zikr (Ya Salam-The Peace Giver, Ya Momin-The Faith Giver, Ya Rehman-The Merciful) was given for recitation.	Combined Intervention Without Zikr n=8 Participants Escitalopram (5 mg) is prescribed by a gynecologist to high-risk couples in the antenatal period and to husbands in the postnatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period. 10 sessions each of 0ne hour, twice a week were carried out.	Combined Intervention With Zikr n=10 Participants Escitalopram (5 mg) is prescribed by a gynecologist to high-risk couples in the antenatal period and to husbands in the postnatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period. 10 sessions each of 0ne hour, twice a week were carried out. Zikr (Ya Salam-The Peace Giver, Ya Rehman-The Merciful) were given for recitation.	Placebo Comparator n=6 Participants Sugar Pill was prescribed by a gynecologist.	No Intervention n=8 Participants Routine medical/gynecological checkups were carried out.
The Sum of Scores on Dyadic Coping Inventory (DCI)	105.42 score on a scale Standard Deviation 2.97	153.25 score on a scale Standard Deviation 1.77	155.93 score on a scale Standard Deviation 3.83	161.37 score on a scale Standard Deviation 3.24	162.40 score on a scale Standard Deviation 4.90	41.16 score on a scale Standard Deviation 1.16	40.25 score on a scale Standard Deviation 1.48

PRIMARY outcome

Population: The target enrollment was met and planned statistical analyses were performed. The impact of treatment (psychopharmacological medicine; CBCT; CBCT along with Zikr; combined (Psychopharmacological medicine and CBCT); combined (Psychopharmacological and CBCT along with Zikr), placebo comparator, and no intervention is measured for perceived wellbeing via ANCOVA after controlling for baseline pre-test scores for perinatal distress (depression and anxiety) and monthly income in SPSS-24.

The Flourishing Scale comprised 8 items with 1 to 7 scoring categories. Sum of scores range from 8 (minimum) to 56 (maximum) for eight items. The high score indicates better well-being in perinatal couples. In the present study, data mean and standard deviation specifies absolute values in pre-test and post-test assessment.

Outcome measures

Outcome measures
Measure	Psychopharmacological Intervention n=14 Participants Escitalopram (5 mg) is prescribed by a gynecologist to high-risk couples in the antenatal period and to husbands in the postnatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period.	CBCT Without Zikr Intervention n=16 Participants 10 sessions each of 0ne hour, twice a week were carried out.	CBCT With Zikr Intervention n=16 Participants 10 sessions each of 0ne hour, twice a week were carried out. Zikr (Ya Salam-The Peace Giver, Ya Momin-The Faith Giver, Ya Rehman-The Merciful) was given for recitation.	Combined Intervention Without Zikr n=8 Participants Escitalopram (5 mg) is prescribed by a gynecologist to high-risk couples in the antenatal period and to husbands in the postnatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period. 10 sessions each of 0ne hour, twice a week were carried out.	Combined Intervention With Zikr n=10 Participants Escitalopram (5 mg) is prescribed by a gynecologist to high-risk couples in the antenatal period and to husbands in the postnatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period. 10 sessions each of 0ne hour, twice a week were carried out. Zikr (Ya Salam-The Peace Giver, Ya Rehman-The Merciful) were given for recitation.	Placebo Comparator n=6 Participants Sugar Pill was prescribed by a gynecologist.	No Intervention n=8 Participants Routine medical/gynecological checkups were carried out.
The Sum of Scores on Flourishing Scale (FS)	19.78 score on a scale Standard Deviation 3.40	38.56 score on a scale Standard Deviation 1.89	38.31 score on a scale Standard Deviation 2.33	52.37 score on a scale Standard Deviation 2.97	50.80 score on a scale Standard Deviation 2.57	9.83 score on a scale Standard Deviation 1.60	9.50 score on a scale Standard Deviation 1.51

PRIMARY outcome

Population: Target enrollment was met, planned statistical analyses were performed. The impact of treatment (psychopharmacological; CBCT; CBCT along with Zikr; combined (Psychopharmacological and CBCT); combined (Psychopharmacological and CBCT along with Zikr), placebo comparator, and no intervention is measured for physical, psychological, social, and environmental quality of life via ANCOVA after controlling for pre-test scores for perinatal distress (depression and anxiety) and monthly income in SPSS-24.

World Health Organization Quality of Life Bref (WHOQOL-BREF) comprised 26 items with 1 to 5 scoring categories. Item 1 and item 2 were not included in the scoring domains because these were evaluative items. The remaining 24 items are classified in four subscales (physical, psychological, social, and environmental) of quality of life. Sum of scores for physical aspect (7 items) of life ranged from 7 (minimum) to 35 (maximum); 6(minimum) to 30 (maximum) for psychological subscale (6 items); 3 (minimum) to 20 (maximum) for social subscale(3 items); and 8 (minimum) to 40 (maximum) for environmental subscale (8 items) of life. The high score indicates a better quality of life in that particular subscale domain in perinatal couples. In the present study, data mean and standard deviation specifies absolute values in pre-test and post-test assessment.

Outcome measures

Outcome measures
Measure	Psychopharmacological Intervention n=14 Participants Escitalopram (5 mg) is prescribed by a gynecologist to high-risk couples in the antenatal period and to husbands in the postnatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period.	CBCT Without Zikr Intervention n=16 Participants 10 sessions each of 0ne hour, twice a week were carried out.	CBCT With Zikr Intervention n=16 Participants 10 sessions each of 0ne hour, twice a week were carried out. Zikr (Ya Salam-The Peace Giver, Ya Momin-The Faith Giver, Ya Rehman-The Merciful) was given for recitation.	Combined Intervention Without Zikr n=8 Participants Escitalopram (5 mg) is prescribed by a gynecologist to high-risk couples in the antenatal period and to husbands in the postnatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period. 10 sessions each of 0ne hour, twice a week were carried out.	Combined Intervention With Zikr n=10 Participants Escitalopram (5 mg) is prescribed by a gynecologist to high-risk couples in the antenatal period and to husbands in the postnatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period. 10 sessions each of 0ne hour, twice a week were carried out. Zikr (Ya Salam-The Peace Giver, Ya Rehman-The Merciful) were given for recitation.	Placebo Comparator n=6 Participants Sugar Pill was prescribed by a gynecologist.	No Intervention n=8 Participants Routine medical/gynecological checkups were carried out.
The Sum of Scores on Each Subscale of World Health Organization Quality of Life (WHOQOL-BREF) Post Test Assessment on Physical Subscale	29.07 score on a scale Standard Deviation 2.12	29.12 score on a scale Standard Deviation 2.02	30.06 score on a scale Standard Deviation 3.02	29.50 score on a scale Standard Deviation 2.07	30.20 score on a scale Standard Deviation 1.93	10.00 score on a scale Standard Deviation 0.89	10.50 score on a scale Standard Deviation 1.41
The Sum of Scores on Each Subscale of World Health Organization Quality of Life (WHOQOL-BREF) Post Test Assessment on Psychological Subscale	28.64 score on a scale Standard Deviation 1.08	28.37 score on a scale Standard Deviation 1.20	29.06 score on a scale Standard Deviation 0.92	28.75 score on a scale Standard Deviation 1.03	28.80 score on a scale Standard Deviation 1.22	9.66 score on a scale Standard Deviation 0.51	9.25 score on a scale Standard Deviation 0.70
The Sum of Scores on Each Subscale of World Health Organization Quality of Life (WHOQOL-BREF) Post Test Assessment on Social Subscale	13.50 score on a scale Standard Deviation 0.75	13.56 score on a scale Standard Deviation 0.96	13.93 score on a scale Standard Deviation 0.92	13.50 score on a scale Standard Deviation 0.92	13.90 score on a scale Standard Deviation 0.99	3.66 score on a scale Standard Deviation 0.99	4.12 score on a scale Standard Deviation 0.64
The Sum of Scores on Each Subscale of World Health Organization Quality of Life (WHOQOL-BREF) Post Test Assessment on Environmental Subscale	37.92 score on a scale Standard Deviation 1.14	38.31 score on a scale Standard Deviation 1.13	38.18 score on a scale Standard Deviation 1.10	37.87 score on a scale Standard Deviation 1.12	38.70 score on a scale Standard Deviation 0.94	10.16 score on a scale Standard Deviation 0.75	9.62 score on a scale Standard Deviation 0.74

SECONDARY outcome

Timeframe: After recruitment, screening, randomization, and allocation, number of participants with treatment-related adverse events as assessed by CTCAE v4.0 on week 11 and week 12 (follow-ups) through the study period (two and half months).

Population: Adverse events (AE) were not assessed for CBCT (Without or With Zikr), Placebo \& No Intervention Arms; 0 specified absence. AE were assessed systematically with checklist in psychopharmacology \& combined arms (with, without Zikr); Zero specified absence of all-cause mortality and serious AE. Total Number of Participants at Risk showed Participant Flow module count. Other (non-serious) AE, mild transitional side effects (nausea, stomachache) were reported with frequency threshold above 5%.

Side effects of escitalopram and sertraline (5 mg/day, and 12.5 mg/day respectively) classified as Grade 1 level in CTCAE v4.0 as these settle down within two to three weeks of medication. A checklist assessed presence or absence of adverse events among participants in psychopharmacological intervention arm, combined intervention without zikr arm, and combined intervention with zikr arm qualitatively. The overall number of participants analyzed in Secondary Outcome Period Participants (1st Oct to 28 Oct) represent the total number of participants for whom an Outcome Measure was measured and analyzed from the Primary Outcome Period Participants, for each Arm/Group. The data were not collected and the outcome cannot be reported for arms without psychopharmacological intervention including "0" participants analyzed because medication was not administered.

Outcome measures

Outcome measures
Measure	Psychopharmacological Intervention n=14 Participants Escitalopram (5 mg) is prescribed by a gynecologist to high-risk couples in the antenatal period and to husbands in the postnatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period.	CBCT Without Zikr Intervention 10 sessions each of 0ne hour, twice a week were carried out.	CBCT With Zikr Intervention 10 sessions each of 0ne hour, twice a week were carried out. Zikr (Ya Salam-The Peace Giver, Ya Momin-The Faith Giver, Ya Rehman-The Merciful) was given for recitation.	Combined Intervention Without Zikr n=8 Participants Escitalopram (5 mg) is prescribed by a gynecologist to high-risk couples in the antenatal period and to husbands in the postnatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period. 10 sessions each of 0ne hour, twice a week were carried out.	Combined Intervention With Zikr n=10 Participants Escitalopram (5 mg) is prescribed by a gynecologist to high-risk couples in the antenatal period and to husbands in the postnatal period. Sertraline (12.5 mg) is prescribed by a gynecologist to women in postnatal period. 10 sessions each of 0ne hour, twice a week were carried out. Zikr (Ya Salam-The Peace Giver, Ya Rehman-The Merciful) were given for recitation.	Placebo Comparator Sugar Pill was prescribed by a gynecologist.	No Intervention Routine medical/gynecological checkups were carried out.
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 Other [Not Including Serious] Adverse Events: Nausea	2 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 Other [Not Including Serious] Adverse Events: Stomach Pain	1 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: After recruitment, screening, randomization, and allocation, changes in blood concentration levels for Escitalopram and Sertraline as assessed on week 12 (follow-up) through the study period (two and half months).

Population: No medicine was prescribed in CBCT (with, without Zikr), placebo, and no intervention arms and "N/A" indicate absence of assessment in these arms. The subjects withdraw from blood test consent in psychopharmacological arm, combined intervention with zikr arm, and combined intervention without zikr arm and "Zero" specified the absence of assessment of blood concentration levels (5 mg escitalopram or 12.5 mg sertraline) due to participants' withdrawal.

Gynaecologist prescribed 5 mg/day escitalopram antenatally or 12.5 mg/day sertraline postnatally. Assessment of blood concentration level via High Performance Liquid Chromatography was conditioned on consent of the participants. The overall number of participants analyzed in Secondary Outcome Period Participants (1st Oct to 28 Oct) represent the total number of participants from the Primary Outcome Period, for each Arm/Group. The data were not collected and the outcome cannot be reported for arms without psychopharmacological intervention including "0" participants. The participants withdrew from HPLC to avoid expansive biomedical tests, adhering to Pakistani cultural norm. The toxicity levels is not reported in the blood of the couples because 5 mg/day escitalopram (Eichentopf et al; Bellantuono et al) or 12.5 mg/day sertraline (Almurjan et al ; Heinonen et al) and is considered safe dose range with no sign of toxicity in blood concentration levels and no presence of adverse events.