Cognitive Behavioral Couple Therapy for Perinatal Distress
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.
Timeline
- Start
- 2023-08-15
- Primary completion
- 2023-09-30
- Completion
- 2023-10-28
Outcome
Met primary endpoint
registry p = 0.000; Mean Difference (Final Values) -35.55 (90% CI -38.90 to -32.19) NCT06001021 ↗
registry p = 0.000; Mean Difference (Final Values) 23.96 (90% CI 19.59 to 28.32) NCT06001021 ↗
registry p = 0.00; Mean Difference (Final Values) 86.89 (90% CI 78.33 to 95.46) NCT06001021 ↗
registry p = 0.000; Mean Difference (Final Values) 22.26 (90% CI 19.41 to 25.12) NCT06001021 ↗
registry p = 0.000; Mean Difference (Final Values) 16.44 (90% CI 15.02 to 17.87) NCT06001021 ↗
registry p = 0.000; Mean Difference (Final Values) 16.60 (90% CI 15.16 to 18.04) NCT06001021 ↗
registry p = 0.000; Mean Difference (Final Values) 8.26 (90% CI 7.52 to 9.01) NCT06001021 ↗
registry p = 0.000; Mean Difference (Final Values) 23.73 (90% CI 21.64 to 25.81) NCT06001021 ↗
Publications
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- Background Bodenmann G. Dyadic coping inventory: Test manual. Bern, Switzerland: Huber. 2008.
- Background Choudhry FR, Al-Worafi YM, Akram B, Ahmed MA, Anwar Ul Haq M, Khan TM, Rehman IU, Barki N, Munawar K, Kamal A, Kassab YW, Bakrin FS, Golden KJ. Factor Structure of Urdu Version of the Flourishing Scale. Front Psychol. 2018 Sep 19;9:1513. doi: 10.3389/fpsyg.2018.01513. eCollection 2018.
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- Background Saqib Lodhi F, Raza O, Montazeri A, Nedjat S, Yaseri M, Holakouie-Naieni K. Psychometric properties of the Urdu version of the World Health Organization's quality of life questionnaire (WHOQOL-BREF). Med J Islam Repub Iran. 2017 Dec 25;31:129. doi: 10.14196/mjiri.31.129. eCollection 2017.
- Background Shafiq S, Bano Z, Randhawa SS, Khan KH, Muhammad QU, Muhammad A. Effectiveness of adapted cognitive behaviour therapy for dysthymia: An evidence based case study. J Pak Med Assoc. 2022 Mar;72(3):554-556. doi: 10.47391/JPMA.1412.
- Background Shujja S, Adil A, Randall AK, Bodenmann G, Malik F. Psychometric properties and validity of Dyadic Coping Inventory-Urdu Version for use in Pakistan. Interpersona: An International Journal on Personal Relationships. 2020 Dec 22;14(2):183-99.
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- Background Almurjan A, Macfarlane H, Badhan RKS. The application of precision dosing in the use of sertraline throughout pregnancy for poor and ultrarapid metabolizer CYP 2C19 subjects: A virtual clinical trial pharmacokinetics study. Biopharm Drug Dispos. 2021 Jun;42(6):252-262. doi: 10.1002/bdd.2278. Epub 2021 May 5.
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- Background Eichentopf L, Hiemke C, Conca A, Engelmann J, Gerlach M, Havemann-Reinecke U, Hefner G, Florio V, Kuzin M, Lieb K, Reis M, Riemer TG, Serretti A, Schoretsanitis G, Zernig G, Grunder G, Hart XM. Systematic review and meta-analysis on the therapeutic reference range for escitalopram: Blood concentrations, clinical effects and serotonin transporter occupancy. Front Psychiatry. 2022 Oct 17;13:972141. doi: 10.3389/fpsyt.2022.972141. eCollection 2022.
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Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Alprazolam | Small molecule | 0.25 mg | Oral |
| Subject | Alprazolam | Small molecule | 0.5 mg | Oral |
| Subject | Escitalopram | Small molecule | 5 mg | Oral |
| Subject | Escitalopram | Small molecule | 10 mg | Oral |
| Subject | Sertraline | Small molecule | 12.5 mg | Oral |
| Subject | Sertraline | Small molecule | 25 mg | Oral |