N/A
N=96
Cognitive Behavioral Couple Therapy for Perinatal Distress
Perinatal Depression · Perinatal Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT06001021 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: The Sum of Scores of Major Depressive Disorder Subscale and Generalized Anxiety Disorder Subscale — 18.14; 17.31; 15.62; 8.62 score on a scale — p=0.000
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Psychopharmacological Intervention (Drug); Cognitive Behavioral Couple Therapy (Behavioral); Combination of Psychopharmacological Intervention and CBCT (Other); Placebo and No Intervention (Other)
- Age
- Adult · 19+ yrs
- Sex
- All
- Sponsor
- Sameera Shafiq
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Sum of Scores of Major Depressive Disorder Subscale and Generalized Anxiety Disorder Subscale |
18.14; 17.31; 15.62; 8.62; 9.50; 53.33 | 0.000 sig |
| PRIMARY The Sum of Scores on Multidimensional Scale for Perceived Social Support (MSPSS) |
22.14; 38.31; 47.00; 79.00; 80.50; 18.66 | 0.000 sig |
| PRIMARY The Sum of Scores on Dyadic Coping Inventory (DCI) |
105.42; 153.25; 155.93; 161.37; 162.40; 41.16 | 0.00 sig |
| PRIMARY The Sum of Scores on Flourishing Scale (FS) |
19.78; 38.56; 38.31; 52.37; 50.80; 9.83 | 0.000 sig |
| PRIMARY The Sum of Scores on Each Subscale of World Health Organization Quality of Life (WHOQOL-BREF) |
29.07; 29.12; 30.06; 29.50; 30.20; 10.00 | 0.000 sig |
| SECONDARY Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0 |
2; 0; 0; 1; 1; 0 | — |
| SECONDARY Changes in Blood Concentration (Either ng/ml or mg/L) Levels for Escitalopram and Sertraline |
— | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT06001021). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.