Cognitive Behavioral Couple Therapy for Perinatal Distress

Sponsor

Sameera Shafiq (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06001021

Collaborator

(none)

Enrollment

Location

Arms

2.5

Anticipated Duration (Months)

31.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Perinatal Depression Perinatal Anxiety	Drug: Psychopharmacological Intervention Behavioral: Cognitive Behavioral Couple Therapy Other: Combination of Psychopharmacological Intervention and CBCT Other: Placebo and No Intervention	N/A

Detailed Description

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

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. 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

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 interventionThe 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

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.

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

Aug 15, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Changes in the Scores of Parental Perinatal Distress Scale (PPDS) [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.]
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.
Changes in the Scores of Multidimensional Scale for Perceived Social Support (MSPSS) [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]
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.
Changes in the Scores of Dyadic Coping Inventory (DCI) [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.]
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.
Changes in the Scores of Flourishing Scale (FS) [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.]
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.
Changes in the Scores of WHOQOL-BREF [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.]
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.
Changes in Blood Concentration (either ng/ml or mg/L) Level for escitalopram, sertraline, and alprazolam [Post-test assessment in last week of the trial, follow up 6 months, through study completion, an average of 6 months..]
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).
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [Post-test assessment in last week of the trial, follow up 6 months, through study completion, an average of 6 months.]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 45 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

The fourth month of pregnancy till the seventh month of the antenatal period.
One week after delivery/birth till one year of a child in the postnatal period.
Screened by PPDS as high-risk couples (for the level of severe symptomology) for Major Depressive Disorder (cut-off score 29 to 42) and/or Generalized Anxiety Disorder (cut-off score 17 to 24), and their Comorbidity.
Dose requirements in any one of the antidepressant and/or anxiolytic, such as escitalopram (5-10 mg), sertraline (12.5-25 mg), and/or alprazolam (0.25-0.50 mg) per day.
Wives accompanied by their husbands.
Willingness to participate as a couple in the study.
No physical disorder is present.
No disability is present.

Exclusion Criteria:

Unwilling couples to participate in the study.
Wife and/or couple is in an emergency.
Wife and/or couple has unstable mental health.
Wife accompanied by close relatives other than a spouse.
Wife in the first week of delivery.
Dose requirements in any one of the antidepressant and/or anxiolytic, such as escitalopram (above10 mg), sertraline (above 25 mg), and/or alprazolam (above 0.50 mg) per day.
Couples screened with depressive disorder and/or anxiety disorder having psychotic features.
Couples screened with depressive disorder and/or anxiety disorder having suicidal ideation.
Couples screened with depressive disorder and/or anxiety disorder having mania/hypomanic features.
Couples having diabetes.
Couples having cardiovascular disorders.
Any intellectual, visual, or hearing disability present in either spouse of a couple.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Gujrat	Gujrat		Pakistan

Sponsors and Collaborators

Sameera Shafiq

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Sameera Shafiq, Lecturer, University of Gujrat

ClinicalTrials.gov Identifier:

NCT06001021

Other Study ID Numbers:

UOG/ORIC/2022/393

First Posted:

Aug 21, 2023

Last Update Posted:

Aug 21, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sameera Shafiq, Lecturer, University of Gujrat

Cognitive Behavioral Couple Therapy

Pharmacological Phenomena

Additional relevant MeSH terms:

Depression

Study Results

No Results Posted as of Aug 21, 2023