xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06001021</url>
    </required_header>
    <id_info>
      <org_study_id>UOG/ORIC/2022/393</org_study_id>
      <nct_id>NCT06001021</nct_id>
    </id_info>
    <brief_title>Cognitive Behavioral Couple Therapy for Perinatal Distress</brief_title>
    <official_title>The Effectiveness of Psychopharmacological Intervention Versus Cognitive Behavioural Couple Therapy and Their Combination in Perinatal Distressed Couples: A Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sameera Shafiq</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Gujrat</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The hypotheses of the study are&#xD;
  &#xD;
          -  There will be differences in perceived distress, dyadic coping strategies, social&#xD;
             support, quality of life, and well-being in couples at Pre- and Post-Test Levels during&#xD;
             the perinatal period in couples.&#xD;
  &#xD;
          -  There will be differences in psychopharmacology on total scores of perceived distress,&#xD;
             dyadic coping strategies, social support, quality of life, and well-being between the&#xD;
             experimental and wait list-placebo control groups.&#xD;
  &#xD;
          -  There will be differences in CBCT (condition: without Zikr) on total scores of perceived&#xD;
             distress, dyadic coping strategies, social support, quality of life, and well-being&#xD;
             between the experimental and wait list control group.&#xD;
  &#xD;
          -  There will be differences in CBCT (condition: with Zikr) on total scores of perceived&#xD;
             distress, dyadic coping strategies, social support, quality of life, and well-being&#xD;
             between the experimental and wait list-placebo control groups.&#xD;
  &#xD;
          -  There will be differences for combined psychopharmacology, and CBT (conditions: with&#xD;
             Zikr, without Zikr ) dimensions on total scores of perceived distress, dyadic coping&#xD;
             strategies, social support, quality of life, and well-being between experimental and&#xD;
             wait list-placebo control group.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The research questions of the study are&#xD;
  &#xD;
        • How effective will psychopharmacological treatment, CBCT, and combined medicine-CBCT&#xD;
        interventions be in reducing symptoms of distress and improving quality of life among couples&#xD;
        during the perinatal period through a randomized clinical trial?&#xD;
  &#xD;
          -  Will dyadic coping strategies, social support, quality of life, and well-being be&#xD;
             improved in couples at the post-test level as compared to the pre-test level by&#xD;
             therapeutic intervention through a randomized clinical trial?&#xD;
  &#xD;
          -  What impact this above-stated different mode of intervention will have on perceived&#xD;
             distress, dyadic coping strategies, social support, quality of life, and well-being&#xD;
             between experimental and wait list-placebo control groups?&#xD;
  &#xD;
        Procedures and Protocol&#xD;
  &#xD;
        The investigator will ask willing participants (screened for high risk) to select one of&#xD;
        their preferred treatment modes out of the following&#xD;
  &#xD;
          1. Medications (antidepressants and/or anxiolytics).&#xD;
  &#xD;
          2. Cognitive Behavioural Therapy without Zikr.&#xD;
  &#xD;
          3. Cognitive Behavioural Therapy with Zikr.&#xD;
  &#xD;
          4. Combination of medications and cognitive behavioral therapy.&#xD;
  &#xD;
          5. Combination of medications, cognitive behavioral therapy, and Zikr.&#xD;
  &#xD;
             A list of willing participants will be prepared. Each participant will have one in five&#xD;
             chances of getting the preferred treatment mode. There will be two groups (experimental&#xD;
             and control). To put people into one of the two groups, the investigator will select by&#xD;
             chance for instance by tossing a coin.&#xD;
  &#xD;
             Participants will not know to which group they actually belong. This information will be&#xD;
             recorded in the investigator's files, but the research assistant will not look at these&#xD;
             files until after the research is finished. This is the best way the investigators have&#xD;
             for testing without being influenced by what they think or hope might happen. The&#xD;
             investigator and research assistant will then compare which of the two has the best&#xD;
             results.&#xD;
  &#xD;
             The healthcare professionals (consultant gynecologists and investigator's research&#xD;
             assistant) will be looking after the participants very carefully during the study. If&#xD;
             there are anything participants are concerned about or that is bothering them about the&#xD;
             research they will talk to the researcher, research assistant, gynaecologist or staff.&#xD;
  &#xD;
             A placebo or inactive medicine looks like real medicine but it is not. It is a dummy or&#xD;
             pretend medicine. It has no effect on a person because it has no real medicine in it.&#xD;
             The investigator wants to know whether medicine is good, therefore some people will be&#xD;
             given the medicine and others will be given the pretend or a dummy medicine. For the&#xD;
             research to be good, it is important that participants do not know whether they have&#xD;
             been given real medicine or pretend or dummy medicine. This is one of the best ways the&#xD;
             investigator have for knowing what the medicine that are being tested really does. But&#xD;
             the participants given a placebo will be informed at the end of the study and will be&#xD;
             given treatment with medication as they are wait-list control. Participants will receive&#xD;
             psychopharmacological treatment according to the National Institute for Health and Care&#xD;
             Excellence (NICE) guidelines.&#xD;
  &#xD;
             Description of the Process&#xD;
  &#xD;
             During the research a couple has to make ten visits to attend ten sessions in the&#xD;
             hospital.&#xD;
  &#xD;
             • In the first visit, rapport will be built and pre-test assessment will be done in the&#xD;
             following two approaches&#xD;
  &#xD;
             Quantitative Approach&#xD;
  &#xD;
             • Indigenously developed Parental Perinatal Distress Scale (PPDS).&#xD;
  &#xD;
             • Multidimensional Scale for Perceived Social Support (MSPSS).&#xD;
  &#xD;
               -  Dyadic Coping Inventory (DCI).&#xD;
  &#xD;
               -  Flourishing Scale (FS).&#xD;
  &#xD;
               -  World Health Organization's Quality of Life Brief (WOLQOL-BREF)&#xD;
  &#xD;
             Qualitative Approach&#xD;
  &#xD;
             • In a qualitative approach, the semi-structured interviews will be conducted to explore&#xD;
             the present stressors and expectations, and perceptions about the effectivity of&#xD;
             treatments for perinatal distress among couples.&#xD;
  &#xD;
             Group 1 will be given medications or placebo for two weeks and/or for four to five weeks&#xD;
             maximum (as per requirement) by the consultant gynaecologist. They have to visit after&#xD;
             two weeks for post-test assessment. After treatment, the medicine will be tapered off to&#xD;
             stop the intake. As explained before, neither participant will know whether they have&#xD;
             received the medicine or the placebo. But in the end placebo participants will be&#xD;
             debriefed and will be continued with real medication.&#xD;
  &#xD;
             Group 2, Group 3, and Group 4 will continue the following 10 sessions (two sessions,&#xD;
             each one hour per week) of CBCT with the investigator.&#xD;
  &#xD;
             • In the second session, participants will be psycho-educated for perinatal period&#xD;
             distress, couples' physical and mental health and impact on the fetus-infant, the&#xD;
             prevalence of depression and anxiety, and the significance of identification.&#xD;
             Progressive muscle relaxation exercises will be carried out along with deep breathing.&#xD;
             Feedback on the session will be taken.&#xD;
  &#xD;
             • In the third session, participants will be psycho-educated on the theoretical model of&#xD;
             cognitive-behavioral couple therapy with some historical highlights and empirical&#xD;
             standing. A thought log will be given for homework. Feedback for deep breathing and&#xD;
             progressive muscle relaxation will be carried out.&#xD;
  &#xD;
             • In the fourth, fifth, sixth, seventh, eighth, and ninth session, feedback will be&#xD;
             taken on homework and session. Various techniques of Cognitive Behavioural Couple&#xD;
             Therapy will be applied based on the nature and contents of identified precipitating,&#xD;
             perpetuating, and present stressors. In addition, relevant techniques will be&#xD;
             incorporated from other modalities with eclecticism. Tasbeeh in Zikr will be given to&#xD;
             group 3 and group 5 who opted for it in the screening process.&#xD;
  &#xD;
             • On the tenth visit, feedback on the session and homework will be taken. post-test&#xD;
             assessment will be done in the following two approaches Group 5 will be exposed to one&#xD;
             of the two conditions. 50% of couples will get a placebo and 50% will receive routine&#xD;
             treatment care with no intervention. However, after the completion of the research, this&#xD;
             waitlist group (control) will be briefed and will be delivered with an intervention mode&#xD;
             of treatment of their choice as selected earlier.&#xD;
  &#xD;
             Quantitative Approach • Indigenously developed Parental Perinatal Distress Scale (PPDS).&#xD;
             • Multidimensional Scale for Perceived Social Support (MSPSS). • Dyadic Coping Inventory&#xD;
             (DCI).&#xD;
  &#xD;
               -  Flourishing Scale (FS).&#xD;
  &#xD;
               -  World Health Organization's Quality of Life Brief (WOLQOL-BREF) Qualitative&#xD;
                  Approach&#xD;
  &#xD;
               -  In a qualitative approach, the semi-structured interview will be conducted to&#xD;
                  explore the present stressors and expectations, and perceptions about effectivity&#xD;
                  of treatments for perinatal distress among couples.&#xD;
  &#xD;
             Duration The research takes place from 15th August, 2023 to 30th September, 2023.&#xD;
             Screening (for Major Depressive Disorder, Generalized Anxiety Disorder) with PPDS will&#xD;
             be carried out on the couples who visit the gynecological ward of the hospital in&#xD;
             August. After screening and signed informed consent, it will be necessary for&#xD;
             participants to come to the clinic/hospital for 10 days in total, for one hour each day&#xD;
             in September (two sessions per week, each for one hour).&#xD;
  &#xD;
             The investigator and the research assistant would like to meet with participants twice&#xD;
             in the upcoming month after the participant's last session visit for a final check-up in&#xD;
             follow-ups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 15, 2023</start_date>
    <completion_date type="Anticipated">October 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Factorial Assignment</intervention_model>
      <intervention_model_description>The first group receives psychopharmacological medication. The second group received CBCT (with or without Zikr). The third group receives a combination of psychopharmacological medication and CBCT The fourth group receives a combination of psychopharmacological medication, CBCT, and with or without Zikr.&#xD;
  The fifth group receives either a placebo or no CBCT intervention</intervention_model_description>
      <primary_purpose>Screening</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>Participants will be randomly assigned to any of the above-mentioned four arms. The outcome assessor (research assistant) will not be provided with information regarding the allocation of the participants to each group. Hence, the research assistant will be blind to getting the questionnaires filled.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Changes in the Scores of Parental Perinatal Distress Scale (PPDS)</measure>
      <time_frame>Pre-test Assessment in first week and post-test assessment in last week, with one month follow-up, through study completion, an average of 6 months.</time_frame>
      <description>The Generalized Anxiety Disorder and Major Depressive Disorder screening subscales of PPDS comprised of 8 and 14 items respectively, on a 0 to 3 scale. Scores range from 0 to 66, with higher scores indicating higher levels of perinatal anxiety and perinatal depression in couples.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in the Scores of Multidimensional Scale for Perceived Social Support (MSPSS)</measure>
      <time_frame>Pre-test Assessment in first week and post-test assessment in last week, with one month follow, through study completion, an average of 6 months.-up</time_frame>
      <description>MSPSS comprised of 12 items with 1 to 7 scoring categories. Scores range from 12 to 84, with higher scores indicating higher levels of social support for perinatal couples.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in the Scores of Dyadic Coping Inventory (DCI)</measure>
      <time_frame>Pre-test Assessment in first week and post-test assessment in last week, with one month follow-up, through study completion, an average of 6 months.</time_frame>
      <description>DCI comprised of 37 items with 1 to 5 scoring categories. Scores range from 37 to 185, with higher scores indicating higher levels coping in perinatal couples.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in the Scores of Flourishing Scale (FS)</measure>
      <time_frame>Pre-test Assessment in first week and post-test assessment in last week, with one month follow-up, through study completion, an average of 6 months.</time_frame>
      <description>FS comprised of 8 items with 1 to 7 scoring categories. Scores range from 8 to 56, with higher scores indicating better wellbeing in perinatal couples.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in the Scores of WHOQOL-BREF</measure>
      <time_frame>Pre-test Assessment in first week and post-test assessment in last week, with on month follow-up, through study completion, an average of 6 months.</time_frame>
      <description>WHOQOL-BREF comprised of 26 items with 1 to 5 scoring categories. Scores range from 26 to 130, with higher scores indicating better quality of life in perinatal couples.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes in Blood Concentration (either ng/ml or mg/L) Level for escitalopram, sertraline, and alprazolam</measure>
      <time_frame>Post-test assessment in last week of the trial, follow up 6 months, through study completion, an average of 6 months..</time_frame>
      <description>The main adverse events for escitalopram and sertraline are nausea/vomiting, and weight gain, sedation, and headache. Based on the safety/coverage ratio among agents with ≥20% adverse event coverage, the safest profile emerged for escitalopram and included sertraline as well (Solmi et al, 2020). Adverse events such as sedation have been reported for alprazolam 2 mg otherwise considered safety and tolerability profile indicating low potential for abuse (Wilbraham et al, 2020). Blood concentration (either ng/ml or mg/L) for escitalopram, sertraline, and alprazolam will be measured (conditioned to the availability of tests in diagnostic laboratory of Gujrat, Pakistan).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
      <time_frame>Post-test assessment in last week of the trial, follow up 6 months, through study completion, an average of 6 months.</time_frame>
      <description>The side-effects of escitalopram, sertraline, and alprazolam with 5-10 mg, 12.5-25 mg, and 0.25-0.50 mg doses, are classified as Grade 1 level in CTCAE v4.0 because they settle down within two to three weeks of continued medication. Yazdy et al (2014) have identified the risk of clubfoot with the escitalopram in first trimester. Pinheiro et al, 2015 have posited sertraline a safe medicine during postpartum period. Lee et al, 2022 have indicated that 1 mg alprazolam use during pregnancy is associated with adverse effects of low birth weight and spontaneous abortion. Amenorrhea and galactorrhorea have been reported in a female case study who was consuming 5 to 6 mg of alprazolam per day in addition to 3 mg of alprazolam XR (Petric et al, 2011). Therefore the present study has restricted the dose of alprazolam upto 0.50 mg. The frequency of cases (rate, number) with low birth weighted infants, abortions, amenorrhea and galactorrhea will be recorded (if any).</description>
    </primary_outcome>
    <number_of_arms>5</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Perinatal Depression</condition>
    <condition>Perinatal Anxiety</condition>
    <arm_group>
      <arm_group_label>Psychopharmacological Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cognitive Behavioral Couple Therapy (CBCT) Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Combined Intervention</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This group will receive Medicine (prescribed by a consultant gynecologist) and CBCT intervention (with or without Zikr) from a trained psychologist in CBT.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control (Placebo and No Intervention)</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>This group will receive a placebo from a gynecologist or no intervention from a trained psychologist.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Other</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>This group will receive no intervention from a trained psychologist.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Psychopharmacological Intervention</intervention_name>
      <description>Escitalopram 5-10 mg in antenatal period; Sertraline 12.5-25 mg in postnatal period) and/or Benzodiazepine (Alprazolam, 0.25-0.50 mg).</description>
      <arm_group_label>Combined Intervention</arm_group_label>
      <arm_group_label>Psychopharmacological Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Cognitive Behavioral Couple Therapy</intervention_name>
      <description>CBCT intervention from a trained psychologist in CBT.</description>
      <arm_group_label>Cognitive Behavioral Couple Therapy (CBCT) Intervention</arm_group_label>
      <arm_group_label>Combined Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Combination of Psychopharmacological Intervention and CBCT</intervention_name>
      <description>Medication will be prescribed by a consultant gynecologist and CBCT (conditions: with or without Zikr) will be provided by a trained psychologist.</description>
      <arm_group_label>Combined Intervention</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo and No Intervention</intervention_name>
      <description>Control waitlist group will be provided with either a placebo by a consultant gynaecologist or no intervention by a trained psychologist</description>
      <arm_group_label>Control (Placebo and No Intervention)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  The fourth month of pregnancy till the seventh month of the antenatal period.&#xD;
  &#xD;
            -  One week after delivery/birth till one year of a child in the postnatal period.&#xD;
  &#xD;
            -  Screened by PPDS as high-risk couples (for the level of severe symptomology) for Major&#xD;
               Depressive Disorder (cut-off score 29 to 42) and/or Generalized Anxiety Disorder&#xD;
               (cut-off score 17 to 24), and their Comorbidity.&#xD;
  &#xD;
            -  Dose requirements in any one of the antidepressant and/or anxiolytic, such as&#xD;
               escitalopram (5-10 mg), sertraline (12.5-25 mg), and/or alprazolam (0.25-0.50 mg) per&#xD;
               day.&#xD;
  &#xD;
            -  Wives accompanied by their husbands.&#xD;
  &#xD;
            -  Willingness to participate as a couple in the study.&#xD;
  &#xD;
            -  No physical disorder is present.&#xD;
  &#xD;
            -  No disability is present.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Unwilling couples to participate in the study.&#xD;
  &#xD;
            -  Wife and/or couple is in an emergency.&#xD;
  &#xD;
            -  Wife and/or couple has unstable mental health.&#xD;
  &#xD;
            -  Wife accompanied by close relatives other than a spouse.&#xD;
  &#xD;
            -  Wife in the first week of delivery.&#xD;
  &#xD;
            -  Dose requirements in any one of the antidepressant and/or anxiolytic, such as&#xD;
               escitalopram (above10 mg), sertraline (above 25 mg), and/or alprazolam (above 0.50 mg)&#xD;
               per day.&#xD;
  &#xD;
            -  Couples screened with depressive disorder and/or anxiety disorder having psychotic&#xD;
               features.&#xD;
  &#xD;
            -  Couples screened with depressive disorder and/or anxiety disorder having suicidal&#xD;
               ideation.&#xD;
  &#xD;
            -  Couples screened with depressive disorder and/or anxiety disorder having&#xD;
               mania/hypomanic features.&#xD;
  &#xD;
            -  Couples having diabetes.&#xD;
  &#xD;
            -  Couples having cardiovascular disorders.&#xD;
  &#xD;
            -  Any intellectual, visual, or hearing disability present in either spouse of a couple.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Couples (wives and husbands)</gender_description>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Sameera Shafiq Lecturer, PhD Scholar, MPhil</last_name>
      <phone>+923345116648</phone>
      <email>sameerashafiq@yahoo.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Gujrat</name>
        <address>
          <city>Gujrat</city>
          <country>Pakistan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Pakistan</country>
    </location_countries>
    <reference>
      <citation>Langan R, Goodbred AJ. Identification and Management of Peripartum Depression. Am Fam Physician. 2016 May 15;93(10):852-8.</citation>
      <PMID>27175720</PMID>
    </reference>
    <reference>
      <citation>Schoretsanitis G, Westin AA, Stingl JC, Deligiannidis KM, Paulzen M, Spigset O. Antidepressant transfer into amniotic fluid, umbilical cord blood &amp; breast milk: A systematic review &amp; combined analysis. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Apr 20;107:110228. doi: 10.1016/j.pnpbp.2020.110228. Epub 2021 Jan 2.</citation>
      <PMID>33358964</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>33449825</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>35361275</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>32394557</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>25171134</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>31745991</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>25589155</PMID>
    </reference>
    <reference>
      <citation>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. Erratum In: Front Pharmacol. 2022 Aug 05;13:934265.</citation>
      <PMID>35548333</PMID>
    </reference>
    <reference>
      <citation>Petric D, Peitl MV, Peitl V. High doses alprazolam induced amenorrhoea and galactorrhoea. Psychiatr Danub. 2011 Mar;23(1):123-4.</citation>
      <PMID>21448116</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>20666955</PMID>
    </reference>
    <reference>
      <citation>Bodenmann G. Dyadic coping inventory: Test manual. Bern, Switzerland: Huber. 2008.</citation>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>30283370</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>29951429</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
      <PMID>35320244</PMID>
    </reference>
    <reference>
      <citation>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.</citation>
    </reference>
    <reference>
      <citation>Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.</citation>
      <PMID>9626712</PMID>
    </reference>
    <reference>
      <citation>Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.</citation>
      <PMID>2280326</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 13, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 13, 2023</last_update_submitted>
    <last_update_submitted_qc>August 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Gujrat</investigator_affiliation>
      <investigator_full_name>Sameera Shafiq</investigator_full_name>
      <investigator_title>Lecturer</investigator_title>
    </responsible_party>
    <keyword>Cognitive Behavioral Couple Therapy</keyword>
    <keyword>Pharmacological Phenomena</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Depression</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06001021
  org study id: UOG/ORIC/2022/393
  nct id: NCT06001021
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The hypotheses of the study are
  
          -  There will be differences in perceived distress, dyadic coping strategies, social
             support, quality of life, and well-being in couples at Pre- and Post-Test Levels during
             the perinatal period in couples.
  
          -  There will be differences in psychopharmacology on total scores of perceived distress,
             dyadic coping strategies, social support, 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
             distress, dyadic coping strategies, social support, 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
             distress, dyadic coping strategies, social support, 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 distress, dyadic coping
             strategies, social support, quality of life, and well-being between experimental and
             wait list-placebo control group.
  The research questions of the study are
  
        • How effective will psychopharmacological treatment, CBCT, and combined medicine-CBCT
        interventions be in reducing symptoms of distress and improving quality of life among couples
        during the perinatal period through a randomized clinical trial?
  
          -  Will dyadic coping strategies, social support, quality of life, and well-being be
             improved in couples at the post-test level as compared to the pre-test level by
             therapeutic intervention through a randomized clinical trial?
  
          -  What impact this above-stated different mode of intervention will have on perceived
             distress, dyadic coping strategies, social support, quality of life, and well-being
             between experimental and wait list-placebo control groups?
  
        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
  
          1. Medications (antidepressants and/or anxiolytics).
  
          2. Cognitive Behavioural Therapy without Zikr.
  
          3. Cognitive Behavioural Therapy with Zikr.
  
          4. Combination of medications and cognitive behavioral therapy.
  
          5. 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. There will be two groups (experimental
             and control). To put people into one of the two groups, the investigator will select by
             chance for instance by tossing a coin.
  
             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
             for testing without being influenced by what they think or hope might happen. 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 will be informed at the end of the study and will be
             given treatment with medication as they are wait-list control. 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, and Group 4 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 5 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, this
             waitlist group (control) will be briefed and will be delivered with an intervention mode
             of treatment of their choice as selected earlier.
  
             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 present stressors and expectations, 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 each day
             in 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.
  allocation: Randomized
  intervention model: Factorial Assignment
  intervention model description: The first group receives psychopharmacological medication. The second group received CBCT (with or without Zikr). The third group receives a combination of psychopharmacological medication and CBCT The fourth group receives a combination of psychopharmacological medication, CBCT, and with or without Zikr.
  The fifth group receives either a placebo or no CBCT intervention
  primary purpose: Screening
  masking: Double (Participant, Outcomes Assessor)
  masking description: Participants will be randomly assigned to any of the above-mentioned four arms. The outcome assessor (research assistant) will not be provided with information regarding the allocation of the participants to each group. Hence, the research assistant will be blind to getting the questionnaires filled.
  measure: Changes in the Scores of Parental Perinatal Distress Scale (PPDS)
  time frame: Pre-test Assessment in first week and post-test assessment in last week, with one month follow-up, through study completion, an average of 6 months.
  description: The Generalized Anxiety Disorder and Major Depressive Disorder screening subscales of PPDS comprised of 8 and 14 items respectively, on a 0 to 3 scale. Scores range from 0 to 66, with higher scores indicating higher levels of perinatal anxiety and perinatal depression in couples.
  measure: Changes in the Scores of Multidimensional Scale for Perceived Social Support (MSPSS)
  time frame: Pre-test Assessment in first week and post-test assessment in last week, with one month follow, through study completion, an average of 6 months.-up
  description: MSPSS comprised of 12 items with 1 to 7 scoring categories. Scores range from 12 to 84, with higher scores indicating higher levels of social support for perinatal couples.
  measure: Changes in the Scores of Dyadic Coping Inventory (DCI)
  time frame: Pre-test Assessment in first week and post-test assessment in last week, with one month follow-up, through study completion, an average of 6 months.
  description: DCI comprised of 37 items with 1 to 5 scoring categories. Scores range from 37 to 185, with higher scores indicating higher levels coping in perinatal couples.
  measure: Changes in the Scores of Flourishing Scale (FS)
  time frame: Pre-test Assessment in first week and post-test assessment in last week, with one month follow-up, through study completion, an average of 6 months.
  description: FS comprised of 8 items with 1 to 7 scoring categories. Scores range from 8 to 56, with higher scores indicating better wellbeing in perinatal couples.
  measure: Changes in the Scores of WHOQOL-BREF
  time frame: Pre-test Assessment in first week and post-test assessment in last week, with on month follow-up, through study completion, an average of 6 months.
  description: WHOQOL-BREF comprised of 26 items with 1 to 5 scoring categories. Scores range from 26 to 130, with higher scores indicating better quality of life in perinatal couples.
  measure: Changes in Blood Concentration (either ng/ml or mg/L) Level for escitalopram, sertraline, and alprazolam
  time frame: Post-test assessment in last week of the trial, follow up 6 months, through study completion, an average of 6 months..
  description: The main adverse events for escitalopram and sertraline are nausea/vomiting, and weight gain, sedation, and headache. Based on the safety/coverage ratio among agents with ≥20% adverse event coverage, the safest profile emerged for escitalopram and included sertraline as well (Solmi et al, 2020). Adverse events such as sedation have been reported for alprazolam 2 mg otherwise considered safety and tolerability profile indicating low potential for abuse (Wilbraham et al, 2020). Blood concentration (either ng/ml or mg/L) for escitalopram, sertraline, and alprazolam will be measured (conditioned to the availability of tests in diagnostic laboratory of Gujrat, Pakistan).
  measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
  time frame: Post-test assessment in last week of the trial, follow up 6 months, through study completion, an average of 6 months.
  description: The side-effects of escitalopram, sertraline, and alprazolam with 5-10 mg, 12.5-25 mg, and 0.25-0.50 mg doses, are classified as Grade 1 level in CTCAE v4.0 because they settle down within two to three weeks of continued medication. Yazdy et al (2014) have identified the risk of clubfoot with the escitalopram in first trimester. Pinheiro et al, 2015 have posited sertraline a safe medicine during postpartum period. Lee et al, 2022 have indicated that 1 mg alprazolam use during pregnancy is associated with adverse effects of low birth weight and spontaneous abortion. Amenorrhea and galactorrhorea have been reported in a female case study who was consuming 5 to 6 mg of alprazolam per day in addition to 3 mg of alprazolam XR (Petric et al, 2011). Therefore the present study has restricted the dose of alprazolam upto 0.50 mg. The frequency of cases (rate, number) with low birth weighted infants, abortions, amenorrhea and galactorrhea will be recorded (if any).
  arm group label: Psychopharmacological Intervention
  arm group type: Experimental
  description: 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.
  arm group label: Cognitive Behavioral Couple Therapy (CBCT) Intervention
  arm group type: Experimental
  description: 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.
  arm group label: Combined Intervention
  arm group type: Experimental
  description: This group will receive Medicine (prescribed by a consultant gynecologist) and CBCT intervention (with or without Zikr) from a trained psychologist in CBT.
  arm group label: Control (Placebo and No Intervention)
  arm group type: Placebo Comparator
  description: This group will receive a placebo from a gynecologist or no intervention from a trained psychologist.
  arm group label: Other
  arm group type: No Intervention
  description: This group will receive no intervention from a trained psychologist.
  intervention type: Drug
  intervention name: Psychopharmacological Intervention
  description: Escitalopram 5-10 mg in antenatal period; Sertraline 12.5-25 mg in postnatal period) and/or Benzodiazepine (Alprazolam, 0.25-0.50 mg).
  arm group label: Combined Intervention
  arm group label: Psychopharmacological Intervention
  intervention type: Behavioral
  intervention name: Cognitive Behavioral Couple Therapy
  description: CBCT intervention from a trained psychologist in CBT.
  arm group label: Cognitive Behavioral Couple Therapy (CBCT) Intervention
  arm group label: Combined Intervention
  intervention type: Other
  intervention name: Combination of Psychopharmacological Intervention and CBCT
  description: Medication will be prescribed by a consultant gynecologist and CBCT (conditions: with or without Zikr) will be provided by a trained psychologist.
  arm group label: Combined Intervention
  intervention type: Other
  intervention name: Placebo and No Intervention
  description: Control waitlist group will be provided with either a placebo by a consultant gynaecologist or no intervention by a trained psychologist
  arm group label: Control (Placebo and No Intervention)
  criteria: 
  gender: All
  gender based: Yes
  gender description: Couples (wives and husbands)
  minimum age: 19 Years
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sameera Shafiq Lecturer, PhD Scholar, MPhil
  phone: +923345116648
  email: sameerashafiq@yahoo.com
  facility: 
  country: Pakistan
  citation: Langan R, Goodbred AJ. Identification and Management of Peripartum Depression. Am Fam Physician. 2016 May 15;93(10):852-8.
  PMID: 27175720
  citation: 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.
  PMID: 33358964
  citation: 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.
  PMID: 33449825
  citation: 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.
  PMID: 35361275
  citation: 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.
  PMID: 32394557
  citation: 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.
  PMID: 25171134
  citation: 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.
  PMID: 31745991
  citation: 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.
  PMID: 25589155
  citation: 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. Erratum In: Front Pharmacol. 2022 Aug 05;13:934265.
  PMID: 35548333
  citation: Petric D, Peitl MV, Peitl V. High doses alprazolam induced amenorrhoea and galactorrhoea. Psychiatr Danub. 2011 Mar;23(1):123-4.
  PMID: 21448116
  citation: 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.
  PMID: 20666955
  citation: Bodenmann G. Dyadic coping inventory: Test manual. Bern, Switzerland: Huber. 2008.
  citation: 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.
  PMID: 30283370
  citation: 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.
  citation: 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.
  PMID: 29951429
  citation: 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.
  PMID: 35320244
  citation: 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.
  citation: Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.
  PMID: 9626712
  citation: Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.
  PMID: 2280326
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Gujrat
  investigator full name: Sameera Shafiq
  investigator title: Lecturer
  mesh term: Depression
  sharing ipd: No