Cognitive Behavioral Couple Therapy for Perinatal Distress

NCT06001021 | Completed Results DMC

• 1 other identifier: UOG/ORIC/2022/393
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The hypotheses of the study are

• There will be differences in perceived perinatal distress, dyadic coping strategies, social support, domains of quality of life, and well-being in couples at Pre- and Post-Test levels during the perinatal period in couples.
• There will be differences with psychopharmacological intervention on total scores of perceived perinatal distress, dyadic coping strategies, social support, domains of quality of life, and well-being between the experimental and wait list-placebo control groups.
• There will be differences in CBCT (condition: without Zikr) on total scores of perceived perinatal distress, dyadic coping strategies, social support, domains of quality of life, and well-being between the experimental and wait list control group.
• There will be differences in CBCT (condition: with Zikr) on total scores of perceived perinatal distress, dyadic coping strategies, social support, domains of quality of life, and well-being between the experimental and wait list-placebo control groups.
• There will be differences for combined psychopharmacology, and CBT (conditions: with Zikr, without Zikr ) dimensions on total scores of perceived perinatal distress, dyadic coping strategies, social support, domains of quality of life, and well-being between experimental and wait list-placebo control group.

Conditions

Perinatal Depression; Perinatal Anxiety

Keywords

Cognitive Behavioral Couple Therapy (with or without Zikr); Pharmacology Intervention; Their combination

Outcome Measures

Primary Outcomes (5)

• The Sum of Scores of Major Depressive Disorder Subscale and Generalized Anxiety Disorder Subscale

  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.

  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.

• The Sum of Scores on Multidimensional Scale for Perceived Social Support (MSPSS)

  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.

  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.

• The Sum of Scores on Dyadic Coping Inventory (DCI)

  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.

  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.

• The Sum of Scores on Flourishing Scale (FS)

  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.

  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.

• The Sum of Scores on Each Subscale of World Health Organization Quality of Life (WHOQOL-BREF)

  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.

  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.

Secondary Outcomes (2)

• Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0

  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).

• Changes in Blood Concentration (Either ng/ml or mg/L) Levels for Escitalopram and Sertraline

  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).

Study Arms (5)

Psychopharmacological Intervention

EXPERIMENTAL

This group will receive psychopharmacological intervention with perinatal safe light doses of antidepressants (see Langan et al., 2016; Schoretsanitis et al., 2021) and/or anxiolytic medications (see Nishimura et al, 2021; Saito et al, 2022) by a gynecologist. Selective Serotonin Reuptake Inhibitor (Escitalopram, 5-10 mg in pregnancy and Sertraline, 12.5-25 mg in postpartum) and/or Benzodiazepine (Alprazolam, 0.25-0.5 mg) will be prescribed in tablet form per day.

Drug: Psychopharmacological Intervention

Cognitive Behavioral Couple Therapy (CBCT) Intervention

EXPERIMENTAL

This group will receive CBCT intervention from a trained psychologist in CBT. There are two conditions of CBCT, i) with Zikr, and ii) without Zikr.

Behavioral: Cognitive Behavioral Couple Therapy

Combined Intervention

EXPERIMENTAL

This group will receive Medicine (prescribed by a consultant gynecologist) and CBCT intervention (with or without Zikr) from a trained psychologist in CBT.

Drug: Psychopharmacological Intervention; Behavioral: Cognitive Behavioral Couple Therapy; Other: Combination of Psychopharmacological Intervention and CBCT

Control (Placebo and No Intervention)

PLACEBO COMPARATOR

This group will receive a placebo from a gynecologist or no intervention from a trained psychologist.

Other: Placebo and No Intervention

Other

NO INTERVENTION

This group will receive no intervention from a trained psychologist.

Interventions

Psychopharmacological Intervention DRUG

Escitalopram 5-10 mg in antenatal period; Sertraline 12.5-25 mg in postnatal period) and/or Benzodiazepine (Alprazolam, 0.25-0.50 mg).

Combined Intervention; Psychopharmacological Intervention

Cognitive Behavioral Couple Therapy BEHAVIORAL

CBCT intervention from a trained psychologist in CBT.

Cognitive Behavioral Couple Therapy (CBCT) Intervention; Combined Intervention

Combination of Psychopharmacological Intervention and CBCT OTHER

Medication will be prescribed by a consultant gynecologist and CBCT (conditions: with or without Zikr) will be provided by a trained psychologist.

Combined Intervention

Placebo and No Intervention OTHER

Control waitlist group will be provided with either a placebo by a consultant gynaecologist or no intervention by a trained psychologist

Control (Placebo and No Intervention)

Eligibility Criteria

• Age: 19 Years - 45 Years
• Gender Eligibility Details: Couples (wives and husbands)
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The fourth month of pregnancy till the seventh month of the antenatal period.
• One week after delivery/birth till one year of a child in the postnatal period.
• Screened by PPDS as high-risk couples (for the level of severe symptomology) for Major Depressive Disorder (cut-off score 29 to 42) and/or Generalized Anxiety Disorder (cut-off score 17 to 24), and their Comorbidity.
• Dose requirements in any one of the antidepressant and/or anxiolytic, such as escitalopram (5-10 mg), sertraline (12.5-25 mg), and/or alprazolam (0.25-0.50 mg) per day.
• Wives accompanied by their husbands.
• Willingness to participate as a couple in the study.
• No physical disorder is present and/or no medication use.
• No psychiatric disorder history or presence
• No psychotropic medication use (presence or history)
• No disability is present.

You may not qualify if:

• Unwilling couples to participate in the study.
• Wife and/or couple is in an emergency.
• Wife and/or couple has unstable mental health.
• Wife accompanied by close relatives other than a spouse.
• Wife in the first week of delivery.
• Dose requirements in any one of the antidepressant and/or anxiolytic, such as escitalopram (above10 mg), sertraline (above 25 mg), and/or alprazolam (above 0.50 mg) per day.
• Couples screened with depressive disorder and/or anxiety disorder having psychotic features.
• Couples screened with depressive disorder and/or anxiety disorder having suicidal ideation.
• Couples screened with depressive disorder and/or anxiety disorder having mania/hypomanic features.
• Couples having diabetes.
• Couples having cardiovascular disorders.
• Presence or history of any physical or psychiatric disorder and/or use of medications
• Any intellectual, visual, or hearing disability present in either spouse of a couple.

Sponsors & Collaborators

• Sameera Shafiq: lead

Study Sites (1)

University of Gujrat

Gujrat, Pakistan

Location

Related Publications (24)

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Results Point of Contact

• Title: Dr. Sameera Shafiq (Lecturer, M. Phil, QAU; Ph.D., UOG)
• Organization: University of Gujrat

sameera.shafiq@uog.edu.pk

923345116648

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants will be randomly assigned to any of the above six arms by random number generation via online calculator.net. The outcome assessor (research assistant) will not be provided with information regarding the allocation of the participants to each group. Hence, the research assistant and participants will be blind to getting the questionnaires filled.
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: The first arm receives psychopharmacological medication. The second arm received CBCT (without Zikr). The third arm received CBCT (with Zikr). The fourth receives a combination of psychopharmacological medication and CBCT without Zikr The fifth arm receives a combination of psychopharmacological medication, CBCT, and with Zikr. The sixth control group receives either a placebo or no CBCT intervention

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: August 21, 2023
• Study Start: August 15, 2023
• Primary Completion: September 30, 2023
• Study Completion: October 28, 2023
• Last Updated: August 13, 2025
• Results First Posted: August 13, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)