Status:
COMPLETED
Cognitive Behavioral Couple Therapy for Perinatal Distress
Lead Sponsor:
Sameera Shafiq
Conditions:
Perinatal Depression
Perinatal Anxiety
Eligibility:
All Genders
19-45 years
Phase:
NA
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- an...
Detailed Description
The research questions of the study are • How effective will psychopharmacological treatment, CBCT (with or without Zikr) and combined medicine-CBCT (with or without Zikr) interventions be in reducin...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2023
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06001021
Start Date
August 15 2023
End Date
October 28 2023
Last Update
August 13 2025
Active Locations (1)
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1
University of Gujrat
Gujrat, Pakistan