Perinatal DepressionNCT06001021

Cognitive Behavioral Couple Therapy for Perinatal Distress

A study testing Psychopharmacological Intervention, Cognitive Behavioral Couple Therapy and Combination of Psychopharmacological Intervention and CBCT in people with Perinatal Depression and Perinatal Anxiety, run by Sameera Shafiq at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 19 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Perinatal Depression, Perinatal Anxiety
What is being tested?: Psychopharmacological Intervention, Cognitive Behavioral Couple Therapy and Combination of Psychopharmacological Intervention and CBCT
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 96 participants
Where: 1 sitePakistan
Study dates: 15 Aug 2023to 28 Oct 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 19 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Show all 10Show fewer

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.

Who cannot join

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.

Show all 13Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

University of Gujrat
Gujrat

Other trials in Pakistan

About this study

Official title: The Effectiveness of Psychopharmacological Intervention Versus Cognitive Behavioral Couple Therapy and Their Combination in Perinatal Distressed Couples: A Randomized Clinical Trial

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.

Read the 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 reducing symptoms of distress among couples during the perinatal period through a randomized clinical trial?
Will dyadic coping strategies, social support, domains of quality of life, and well-being be improved in couples at the post-test level compared to the pre-test level by therapeutic intervention through a randomized clinical trial?
What will be the effect size of post-test intervention?

Procedures and Protocol

The investigator will ask willing participants (screened for high risk) to select one of their preferred treatment modes out of the following

Medications (antidepressants and/or anxiolytics).
Cognitive Behavioural Therapy without Zikr.
Cognitive Behavioural Therapy with Zikr.
Combination of medications and cognitive behavioral therapy.
Combination of medications, cognitive behavioral therapy, and Zikr. A list of willing participants will be prepared. Each participant will have one in five chances of getting the preferred treatment mode after study is over. There will be two groups (experimental and control). To put people into one of the two groups, the investigator will select by randomization via online calculator random number generation. Participants will not know to which group they actually belong. This information will be recorded in the investigator's files, but the research assistant will not look at these files until after the research is finished. This is the best way the investigators have to testing without being influenced by what they think or hope might happen. Thus, the participants and the research assistant will be double blinded in the trial. The investigator and research assistant will then compare which of the two has the best results. The healthcare professionals (consultant gynecologists and investigator's research assistant) will be looking after the participants very carefully during the study. If there are anything participants are concerned about or that is bothering them about the research they will talk to the researcher, research assistant, gynaecologist or staff. A placebo or inactive medicine looks like real medicine but it is not. It is a dummy or pretend medicine. It has no effect on a person because it has no real medicine in it. The investigator wants to know whether medicine is good, therefore some people will be given the medicine and others will be given the pretend or a dummy medicine. For the research to be good, it is important that participants do not know whether they have been given real medicine or pretend or dummy medicine. This is one of the best ways the investigator have for knowing what the medicine that are being tested really does. But the participants given a placebo or no intervention will be informed at the end of the study and will be given treatment with medication as they are wait-list control. Moreover, the participants in the intervention group will receive their preferred treatment after the completion of the study. Participants will receive psychopharmacological treatment according to the National Institute for Health and Care Excellence (NICE) guidelines. Description of the Process During the research, a couple has to make ten visits to attend ten sessions in the hospital.

In the first visit, rapport will be built and pre-test assessment will be done in the following two approaches Quantitative Approach
Indigenously developed Parental Perinatal Distress Scale (PPDS).
Multidimensional Scale for Perceived Social Support (MSPSS).
Dyadic Coping Inventory (DCI).
Flourishing Scale (FS).
World Health Organization's Quality of Life Brief (WOLQOL-BREF) Qualitative Approach • In a qualitative approach, the semi-structured interviews will be conducted to explore the present stressors and expectations, and perceptions about the effectivity of treatments for perinatal distress among couples. Group 1 will be given medications or placebo for two weeks and/or for four to five weeks maximum (as per requirement) by the consultant gynaecologist. They have to visit after two weeks for post-test assessment. After treatment, the medicine will be tapered off to stop the intake. As explained before, neither participant will know whether they have received the medicine or the placebo. But in the end placebo participants will be debriefed and will be continued with real medication. Group 2, Group 3, Group 4 and Group 5 will continue the following 10 sessions (two sessions, each one hour per week) of CBCT with the investigator.
In the second session, participants will be psycho-educated for perinatal period distress, couples' physical and mental health and impact on the fetus-infant, the prevalence of depression and anxiety, and the significance of identification. Progressive muscle relaxation exercises will be carried out along with deep breathing. Feedback on the session will be taken.
In the third session, participants will be psycho-educated on the theoretical model of cognitive-behavioral couple therapy with some historical highlights and empirical standing. A thought log will be given for homework. Feedback for deep breathing and progressive muscle relaxation will be carried out.
In the fourth, fifth, sixth, seventh, eighth, and ninth session, feedback will be taken on homework and session. Various techniques of Cognitive Behavioural Couple Therapy will be applied based on the nature and contents of identified precipitating, perpetuating, and present stressors. In addition, relevant techniques will be incorporated from other modalities with eclecticism. Tasbeeh in Zikr will be given to group 3 and group 5 who opted for it in the screening process.
On the tenth visit, feedback on the session and homework will be taken. post-test assessment will be done in the following two approaches Group 6 will be exposed to one of the two conditions. 50% of couples will get a placebo and 50% will receive routine treatment care with no intervention. However, after the completion of the research, intervention groups and waitlist group (control) will be briefed and will be delivered with an intervention mode of treatment of their choice as selected earlier. Posttest assessment will be carried out by the following instruments Quantitative Approach • Indigenously developed Parental Perinatal Distress Scale (PPDS). • Multidimensional Scale for Perceived Social Support (MSPSS). • Dyadic Coping Inventory (DCI).
Flourishing Scale (FS).
World Health Organization's Quality of Life Brief (WOLQOL-BREF) Qualitative Approach
In a qualitative approach, the semi-structured interview will be conducted to explore the conception about the perinatal distress and perceptions about effectivity of treatments for perinatal distress among couples. Duration The research takes place from 15th August, 2023 to 30th September, 2023. Screening (for Major Depressive Disorder, Generalized Anxiety Disorder) with PPDS will be carried out on the couples who visit the gynecological ward of the hospital in August. After screening and signed informed consent, it will be necessary for participants to come to the clinic/hospital for 10 days in total, for one hour session each day in end of August and whole month of September (two sessions per week, each for one hour). The investigator and the research assistant would like to meet with participants twice in the upcoming month after the participant's last session visit for a final check-up in follow-ups.

Conditions: Perinatal Depression, Perinatal Anxiety
Being tested: Psychopharmacological Intervention, Cognitive Behavioral Couple Therapy, Combination of Psychopharmacological Intervention and CBCT, Placebo and No Intervention
Keywords: Cognitive Behavioral Couple Therapy (with or without Zikr), Pharmacology Intervention, Their combination

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Psychopharmacological InterventionDrug
Escitalopram 5-10 mg in antenatal period; Sertraline 12.5-25 mg in postnatal period) and/or Benzodiazepine (Alprazolam, 0.25-0.50 mg).
Cognitive Behavioral Couple TherapyBehavioural
CBCT intervention from a trained psychologist in CBT.
Combination of Psychopharmacological Intervention and CBCTOther
Medication will be prescribed by a consultant gynecologist and CBCT (conditions: with or without Zikr) will be provided by a trained psychologist.
Placebo and No InterventionOther
Control waitlist group will be provided with either a placebo by a consultant gynaecologist or no intervention by a trained psychologist

Study groups in NCT06001021
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Placebo and No Intervention
Other	No intervention	This group will receive no intervention from a trained psychologist.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: 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
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.
Measured: 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).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Aug 202328 Oct 2023

First posted21 Aug 2023
Study start15 Aug 2023
Primary completion30 Sep 2023
Study completion28 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (24)Papers the sponsor has linked to this study.
Other trials for Perinatal DepressionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Model description: 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
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 96 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06001021
Sponsor's protocol ID: UOG/ORIC/2022/393
Status last verified: Jul 2025
First submitted: 26 Jun 2023
Last updated: 13 Aug 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Langan R, Goodbred AJ. Identification and Management of Peripartum Depression. Am Fam Physician. 2016 May 15;93(10):852-8.
PubMed 27175720
Schoretsanitis G, Westin AA, Stingl JC, Deligiannidis KM, Paulzen M, Spigset O. Antidepressant transfer into amniotic fluid, umbilical cord blood & breast milk: A systematic review & combined analysis. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Apr 20;107:110228. doi: 10.1016/j.pnpbp.2020.110228. Epub 2021 Jan 2.
PubMed 33358964
Nishimura A, Furugen A, Umazume T, Kitamura S, Soma M, Noshiro K, Takekuma Y, Sugawara M, Iseki K, Kobayashi M. Benzodiazepine Concentrations in the Breast Milk and Plasma of Nursing Mothers: Estimation of Relative Infant Dose. Breastfeed Med. 2021 May;16(5):424-431. doi: 10.1089/bfm.2020.0259. Epub 2021 Jan 15.
PubMed 33449825
Saito J, Tachibana Y, Wada YS, Yakuwa N, Kawasaki H, Suzuki T, Sago H, Yamatani A, Murashima A. Transfer of brotizolam, periciazine, and sulpiride in cord blood and breast milk, and alprazolam in breast milk: a case report. J Pharm Health Care Sci. 2022 Apr 1;8(1):10. doi: 10.1186/s40780-022-00241-2.
PubMed 35361275
Solmi M, Fornaro M, Ostinelli EG, Zangani C, Croatto G, Monaco F, Krinitski D, Fusar-Poli P, Correll CU. Safety of 80 antidepressants, antipsychotics, anti-attention-deficit/hyperactivity medications and mood stabilizers in children and adolescents with psychiatric disorders: a large scale systematic meta-review of 78 adverse effects. World Psychiatry. 2020 Jun;19(2):214-232. doi: 10.1002/wps.20765.
PubMed 32394557
Yazdy MM, Mitchell AA, Louik C, Werler MM. Use of selective serotonin-reuptake inhibitors during pregnancy and the risk of clubfoot. Epidemiology. 2014 Nov;25(6):859-65. doi: 10.1097/EDE.0000000000000157.
PubMed 25171134
Wilbraham D, Berg PH, Tsai M, Liffick E, Loo LS, Doty EG, Sellers E. Abuse Potential of Lasmiditan: A Phase 1 Randomized, Placebo- and Alprazolam-Controlled Crossover Study. J Clin Pharmacol. 2020 Apr;60(4):495-504. doi: 10.1002/jcph.1543. Epub 2019 Nov 20.
PubMed 31745991
Pinheiro E, Bogen DL, Hoxha D, Ciolino JD, Wisner KL. Sertraline and breastfeeding: review and meta-analysis. Arch Womens Ment Health. 2015 Apr;18(2):139-146. doi: 10.1007/s00737-015-0499-y. Epub 2015 Jan 15.
PubMed 25589155
Lee H, Koh JW, Kim YA, Chun KC, Han JY, Hwang JH, Choi JS, Joo SH, Kwon HY. Pregnancy and Neonatal Outcomes After Exposure to Alprazolam in Pregnancy. Front Pharmacol. 2022 Apr 25;13:854562. doi: 10.3389/fphar.2022.854562. eCollection 2022.
PubMed 35548333
Petric D, Peitl MV, Peitl V. High doses alprazolam induced amenorrhoea and galactorrhoea. Psychiatr Danub. 2011 Mar;23(1):123-4.
PubMed 21448116
Akhtar A, Rahman A, Husain M, Chaudhry IB, Duddu V, Husain N. Multidimensional scale of perceived social support: psychometric properties in a South Asian population. J Obstet Gynaecol Res. 2010 Aug;36(4):845-51. doi: 10.1111/j.1447-0756.2010.01204.x.
PubMed 20666955
Bodenmann G. Dyadic coping inventory: Test manual. Bern, Switzerland: Huber. 2008.
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.
PubMed 30283370
Diener E, Wirtz D, Biswas-Diener R, Tov W, Kim-Prieto C, Choi DW, Oishi S. New measures of well-being. Assessing well-being: The collected works of Ed Diener. 2009:247-66.
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.
PubMed 29951429

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effectiveness of Psychopharmacological Intervention Versus Cognitive Behavioral Couple Therapy and Their Combination in Perinatal Distressed Couples: A Randomized Clinical Trial
ClinicalTrials.gov ID: NCT06001021
Acronym / sponsor ID: UOG/ORIC/2022/393
Conditions: Perinatal Depression, Perinatal Anxiety
Keywords: Cognitive Behavioral Couple Therapy (with or without Zikr), Pharmacology Intervention, Their combination
Study type: Interventional
Recruitment status: Completed
Enrolment: 96 participants (actual)
Lead sponsor: Sameera ShafiqUniversity, hospital or other
Study start: 15 Aug 2023 (actual)
Primary completion: 30 Sep 2023 (actual)
Study completion: 28 Oct 2023 (actual)
First posted: 21 Aug 2023 (actual)
Results: Posted 13 Aug 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

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 reducing symptoms of distress among couples during the perinatal period through a randomized clinical trial?
Will dyadic coping strategies, social support, domains of quality of life, and well-being be improved in couples at the post-test level compared to the pre-test level by therapeutic intervention through a randomized clinical trial?
What will be the effect size of post-test intervention?

Procedures and Protocol

The investigator will ask willing participants (screened for high risk) to select one of their preferred treatment modes out of the following

Medications (antidepressants and/or anxiolytics).
Cognitive Behavioural Therapy without Zikr.
Cognitive Behavioural Therapy with Zikr.
Combination of medications and cognitive behavioral therapy.
Combination of medications, cognitive behavioral therapy, and Zikr. A list of willing participants will be prepared. Each participant will have one in five chances of getting the preferred treatment mode after study is over. There will be two groups (experimental and control). To put people into one of the two groups, the investigator will select by randomization via online calculator random number generation. Participants will not know to which group they actually belong. This information will be recorded in the investigator's files, but the research assistant will not look at these files until after the research is finished. This is the best way the investigators have to testing without being influenced by what they think or hope might happen. Thus, the participants and the research assistant will be double blinded in the trial. The investigator and research assistant will then compare which of the two has the best results. The healthcare professionals (consultant gynecologists and investigator's research assistant) will be looking after the participants very carefully during the study. If there are anything participants are concerned about or that is bothering them about the research they will talk to the researcher, research assistant, gynaecologist or staff. A placebo or inactive medicine looks like real medicine but it is not. It is a dummy or pretend medicine. It has no effect on a person because it has no real medicine in it. The investigator wants to know whether medicine is good, therefore some people will be given the medicine and others will be given the pretend or a dummy medicine. For the research to be good, it is important that participants do not know whether they have been given real medicine or pretend or dummy medicine. This is one of the best ways the investigator have for knowing what the medicine that are being tested really does. But the participants given a placebo or no intervention will be informed at the end of the study and will be given treatment with medication as they are wait-list control. Moreover, the participants in the intervention group will receive their preferred treatment after the completion of the study. Participants will receive psychopharmacological treatment according to the National Institute for Health and Care Excellence (NICE) guidelines. Description of the Process During the research, a couple has to make ten visits to attend ten sessions in the hospital.

In the first visit, rapport will be built and pre-test assessment will be done in the following two approaches Quantitative Approach
Indigenously developed Parental Perinatal Distress Scale (PPDS).
Multidimensional Scale for Perceived Social Support (MSPSS).
Dyadic Coping Inventory (DCI).
Flourishing Scale (FS).
World Health Organization's Quality of Life Brief (WOLQOL-BREF) Qualitative Approach • In a qualitative approach, the semi-structured interviews will be conducted to explore the present stressors and expectations, and perceptions about the effectivity of treatments for perinatal distress among couples. Group 1 will be given medications or placebo for two weeks and/or for four to five weeks maximum (as per requirement) by the consultant gynaecologist. They have to visit after two weeks for post-test assessment. After treatment, the medicine will be tapered off to stop the intake. As explained before, neither participant will know whether they have received the medicine or the placebo. But in the end placebo participants will be debriefed and will be continued with real medication. Group 2, Group 3, Group 4 and Group 5 will continue the following 10 sessions (two sessions, each one hour per week) of CBCT with the investigator.
In the second session, participants will be psycho-educated for perinatal period distress, couples' physical and mental health and impact on the fetus-infant, the prevalence of depression and anxiety, and the significance of identification. Progressive muscle relaxation exercises will be carried out along with deep breathing. Feedback on the session will be taken.
In the third session, participants will be psycho-educated on the theoretical model of cognitive-behavioral couple therapy with some historical highlights and empirical standing. A thought log will be given for homework. Feedback for deep breathing and progressive muscle relaxation will be carried out.
In the fourth, fifth, sixth, seventh, eighth, and ninth session, feedback will be taken on homework and session. Various techniques of Cognitive Behavioural Couple Therapy will be applied based on the nature and contents of identified precipitating, perpetuating, and present stressors. In addition, relevant techniques will be incorporated from other modalities with eclecticism. Tasbeeh in Zikr will be given to group 3 and group 5 who opted for it in the screening process.
On the tenth visit, feedback on the session and homework will be taken. post-test assessment will be done in the following two approaches Group 6 will be exposed to one of the two conditions. 50% of couples will get a placebo and 50% will receive routine treatment care with no intervention. However, after the completion of the research, intervention groups and waitlist group (control) will be briefed and will be delivered with an intervention mode of treatment of their choice as selected earlier. Posttest assessment will be carried out by the following instruments Quantitative Approach • Indigenously developed Parental Perinatal Distress Scale (PPDS). • Multidimensional Scale for Perceived Social Support (MSPSS). • Dyadic Coping Inventory (DCI).
Flourishing Scale (FS).
World Health Organization's Quality of Life Brief (WOLQOL-BREF) Qualitative Approach
In a qualitative approach, the semi-structured interview will be conducted to explore the conception about the perinatal distress and perceptions about effectivity of treatments for perinatal distress among couples. Duration The research takes place from 15th August, 2023 to 30th September, 2023. Screening (for Major Depressive Disorder, Generalized Anxiety Disorder) with PPDS will be carried out on the couples who visit the gynecological ward of the hospital in August. After screening and signed informed consent, it will be necessary for participants to come to the clinic/hospital for 10 days in total, for one hour session each day in end of August and whole month of September (two sessions per week, each for one hour). The investigator and the research assistant would like to meet with participants twice in the upcoming month after the participant's last session visit for a final check-up in follow-ups.

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 5
Model description: 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

Arm	Type	Receives
Psychopharmacological Intervention	Experimental	Drug: Psychopharmacological InterventionThis 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.
Cognitive Behavioral Couple Therapy (CBCT) Intervention	Experimental	Behavioral: Cognitive Behavioral Couple TherapyThis group will receive CBCT intervention from a trained psychologist in CBT. There are two conditions of CBCT, i) with Zikr, and ii) without Zikr.
Combined Intervention	Experimental	Drug: Psychopharmacological Intervention, Behavioral: Cognitive Behavioral Couple Therapy, Other: Combination of Psychopharmacological Intervention and CBCTThis group will receive Medicine (prescribed by a consultant gynecologist) and CBCT intervention (with or without Zikr) from a trained psychologist in CBT.
Control (Placebo and No Intervention)	Placebo comparator	Other: Placebo and No InterventionThis group will receive a placebo from a gynecologist or no intervention from a trained psychologist.
Other	No intervention	–This group will receive no intervention from a trained psychologist.

Who may qualify

Ages: 19 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Psychopharmacological InterventionEscitalopram 5-10 mg in antenatal period; Sertraline 12.5-25 mg in postnatal period) and/or Benzodiazepine (Alprazolam, 0.25-0.50 mg).	Drug	Combined Intervention, Psychopharmacological Intervention
Cognitive Behavioral Couple TherapyCBCT intervention from a trained psychologist in CBT.	Behavioural	Cognitive Behavioral Couple Therapy (CBCT) Intervention, Combined Intervention
Combination of Psychopharmacological Intervention and CBCTMedication will be prescribed by a consultant gynecologist and CBCT (conditions: with or without Zikr) will be provided by a trained psychologist.	Other	Combined Intervention
Placebo and No InterventionControl waitlist group will be provided with either a placebo by a consultant gynaecologist or no intervention by a trained psychologist	Other	Control (Placebo and No Intervention)

Primary outcome

The Sum of Scores of Major Depressive Disorder Subscale and Generalized Anxiety Disorder Subscale
Time frame: 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 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.
The Sum of Scores on Multidimensional Scale for Perceived Social Support (MSPSS)
Time frame: 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 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.
The Sum of Scores on Dyadic Coping Inventory (DCI)
Time frame: 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.
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.
The Sum of Scores on Flourishing Scale (FS)
Time frame: 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 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.
The Sum of Scores on Each Subscale of World Health Organization Quality of Life (WHOQOL-BREF)
Time frame: 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.
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.

2 secondary outcomes

Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time frame: 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
Time frame: 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).

Results and safety

Results posted to the registry on 13 Aug 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Psychopharmacological Intervention	16	14
CBCT Intervention	16	16
CBCT Intervention With Zikr	16	16
Combined Intervention Without Zikr	16	8
Combined Intervention With Zikr	16	10
Control Arm (Placebo)	8	6
Control Arm (No Intervention)	8	8

Primary outcome: The Sum of Scores of Major Depressive Disorder Subscale and Generalized Anxiety Disorder Subscale

Time frame: 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.. Mean (Standard Deviation). Unit: score on a scale

Measure	Psychopharmacological Intervention n = 14	CBCT Without Zikr Intervention n = 16	CBCT With Zikr Intervention n = 16	Combined Intervention Without Zikr n = 8	Combined Intervention With Zikr n = 10	Placebo Comparator n = 6	No Intervention n = 8
Value	18.14 (2.03)	17.31 (2.33)	15.62 (2.47)	8.62 (1.50)	9.50 (1.35)	53.33 (2.87)	60.12 (4.12)

Psychopharmacological Intervention vs CBCT Without Zikr Intervention vs CBCT With Zikr Intervention vs Combined Intervention Without Zikr vs Combined Intervention With Zikr vs Placebo Comparator vs No Intervention: Mean Difference (Final Values): -35.55 (90% CI -38.90 to -32.19), p = 0.000, ANCOVA

Population analysed: 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.

Primary outcome: The Sum of Scores on Multidimensional Scale for Perceived Social Support (MSPSS)

Measure	Psychopharmacological Intervention n = 14	CBCT Without Zikr Intervention n = 16	CBCT With Zikr Intervention n = 16	Combined Intervention Without Zikr n = 8	Combined Intervention With Zikr n = 10	Placebo Comparator n = 6	No Intervention n = 8
Value	22.14 (1.40)	38.31 (4.40)	47.00 (2.00)	79.00 (3.20)	80.50 (2.63)	18.66 (3.32)	18.62 (1.59)

Psychopharmacological Intervention vs CBCT Without Zikr Intervention vs CBCT With Zikr Intervention vs Combined Intervention Without Zikr vs Combined Intervention With Zikr vs Placebo Comparator vs No Intervention: Mean Difference (Final Values): 23.96 (90% CI 19.59 to 28.32), p = 0.000, ANCOVA

Population analysed: 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.

Primary outcome: The Sum of Scores on Dyadic Coping Inventory (DCI)

Measure	Psychopharmacological Intervention n = 14	CBCT Without Zikr Intervention n = 16	CBCT With Zikr Intervention n = 16	Combined Intervention Without Zikr n = 8	Combined Intervention With Zikr n = 10	Placebo Comparator n = 6	No Intervention n = 8
Value	105.42 (2.97)	153.25 (1.77)	155.93 (3.83)	161.37 (3.24)	162.40 (4.90)	41.16 (1.16)	40.25 (1.48)

Psychopharmacological Intervention vs CBCT Without Zikr Intervention vs CBCT With Zikr Intervention vs Combined Intervention Without Zikr vs Combined Intervention With Zikr vs Placebo Comparator vs No Intervention: Mean Difference (Final Values): 86.89 (90% CI 78.33 to 95.46), p = 0.00, ANCOVA

Population analysed: 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.

Primary outcome: The Sum of Scores on Flourishing Scale (FS)

Measure	Psychopharmacological Intervention n = 14	CBCT Without Zikr Intervention n = 16	CBCT With Zikr Intervention n = 16	Combined Intervention Without Zikr n = 8	Combined Intervention With Zikr n = 10	Placebo Comparator n = 6	No Intervention n = 8
Value	19.78 (3.40)	38.56 (1.89)	38.31 (2.33)	52.37 (2.97)	50.80 (2.57)	9.83 (1.60)	9.50 (1.51)

Psychopharmacological Intervention vs CBCT Without Zikr Intervention vs CBCT With Zikr Intervention vs Combined Intervention Without Zikr vs Combined Intervention With Zikr vs Placebo Comparator vs No Intervention: Mean Difference (Final Values): 22.26 (90% CI 19.41 to 25.12), p = 0.000, ANCOVA

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was assessed on week 11 and week 12 (follow-ups) through the study period (2 and half months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Psychopharmacological Intervention	0 of 14 (0%)	3 of 14 (21.4%)	0 of 14
CBCT Without Zikr Intervention	0 of 0	0 of 0	0
CBCT With Zikr Intervention	0 of 0	0 of 0	0
Combined Intervention Without Zikr	0 of 8 (0%)	2 of 8 (25%)	0 of 8
Combined Intervention With Zikr	0 of 10 (0%)	2 of 10 (20%)	0 of 10
Placebo Comparator	0 of 0	0 of 0	0
No Intervention	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27175720Langan R, Goodbred AJ. Identification and Management of Peripartum Depression. Am Fam Physician. 2016 May 15;93(10):852-8.
Background: PubMed 33358964Schoretsanitis G, Westin AA, Stingl JC, Deligiannidis KM, Paulzen M, Spigset O. Antidepressant transfer into amniotic fluid, umbilical cord blood & breast milk: A systematic review & combined analysis. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Apr 20;107:110228. doi: 10.1016/j.pnpbp.2020.110228. Epub 2021 Jan 2.
Background: PubMed 33449825Nishimura A, Furugen A, Umazume T, Kitamura S, Soma M, Noshiro K, Takekuma Y, Sugawara M, Iseki K, Kobayashi M. Benzodiazepine Concentrations in the Breast Milk and Plasma of Nursing Mothers: Estimation of Relative Infant Dose. Breastfeed Med. 2021 May;16(5):424-431. doi: 10.1089/bfm.2020.0259. Epub 2021 Jan 15.
Background: PubMed 35361275Saito J, Tachibana Y, Wada YS, Yakuwa N, Kawasaki H, Suzuki T, Sago H, Yamatani A, Murashima A. Transfer of brotizolam, periciazine, and sulpiride in cord blood and breast milk, and alprazolam in breast milk: a case report. J Pharm Health Care Sci. 2022 Apr 1;8(1):10. doi: 10.1186/s40780-022-00241-2.
Background: PubMed 32394557Solmi M, Fornaro M, Ostinelli EG, Zangani C, Croatto G, Monaco F, Krinitski D, Fusar-Poli P, Correll CU. Safety of 80 antidepressants, antipsychotics, anti-attention-deficit/hyperactivity medications and mood stabilizers in children and adolescents with psychiatric disorders: a large scale systematic meta-review of 78 adverse effects. World Psychiatry. 2020 Jun;19(2):214-232. doi: 10.1002/wps.20765.
Background: PubMed 25171134Yazdy MM, Mitchell AA, Louik C, Werler MM. Use of selective serotonin-reuptake inhibitors during pregnancy and the risk of clubfoot. Epidemiology. 2014 Nov;25(6):859-65. doi: 10.1097/EDE.0000000000000157.
Background: PubMed 31745991Wilbraham D, Berg PH, Tsai M, Liffick E, Loo LS, Doty EG, Sellers E. Abuse Potential of Lasmiditan: A Phase 1 Randomized, Placebo- and Alprazolam-Controlled Crossover Study. J Clin Pharmacol. 2020 Apr;60(4):495-504. doi: 10.1002/jcph.1543. Epub 2019 Nov 20.
Background: PubMed 25589155Pinheiro E, Bogen DL, Hoxha D, Ciolino JD, Wisner KL. Sertraline and breastfeeding: review and meta-analysis. Arch Womens Ment Health. 2015 Apr;18(2):139-146. doi: 10.1007/s00737-015-0499-y. Epub 2015 Jan 15.
Background: PubMed 35548333Lee H, Koh JW, Kim YA, Chun KC, Han JY, Hwang JH, Choi JS, Joo SH, Kwon HY. Pregnancy and Neonatal Outcomes After Exposure to Alprazolam in Pregnancy. Front Pharmacol. 2022 Apr 25;13:854562. doi: 10.3389/fphar.2022.854562. eCollection 2022.
Background: PubMed 21448116Petric D, Peitl MV, Peitl V. High doses alprazolam induced amenorrhoea and galactorrhoea. Psychiatr Danub. 2011 Mar;23(1):123-4.
Background: PubMed 20666955Akhtar A, Rahman A, Husain M, Chaudhry IB, Duddu V, Husain N. Multidimensional scale of perceived social support: psychometric properties in a South Asian population. J Obstet Gynaecol Res. 2010 Aug;36(4):845-51. doi: 10.1111/j.1447-0756.2010.01204.x.
BackgroundBodenmann G. Dyadic coping inventory: Test manual. Bern, Switzerland: Huber. 2008.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Sum of Scores of Major Depressive Disorder Subscale and Generalized Anxiety Disorder Subscale (time frame: 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 study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06001021, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.