The Effectiveness of Psychopharmacological Intervention Versus Cognitive Behavioral Couple Therapy and Their Combination in Perinatal Distressed Couples: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- The Sum of Scores of Major Depressive Disorder Subscale and Generalized Anxiety Disorder Subscale
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participants will be randomly assigned to any of the above six arms by random number generation via online calculator.net. The outcome assessor (research assistant) will not be provided with information regarding the allocation of the participants to each group. Hence, the research assistant and participants will be blind to getting the questionnaires filled.
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The fourth month of pregnancy till the seventh month of the antenatal period.
- •One week after delivery/birth till one year of a child in the postnatal period.
- •Screened by PPDS as high-risk couples (for the level of severe symptomology) for Major Depressive Disorder (cut-off score 29 to 42) and/or Generalized Anxiety Disorder (cut-off score 17 to 24), and their Comorbidity.
- •Dose requirements in any one of the antidepressant and/or anxiolytic, such as escitalopram (5-10 mg), sertraline (12.5-25 mg), and/or alprazolam (0.25-0.50 mg) per day.
- •Wives accompanied by their husbands.
- •Willingness to participate as a couple in the study.
- •No physical disorder is present and/or no medication use.
- •No psychiatric disorder history or presence
- •No psychotropic medication use (presence or history)
- •No disability is present.
排除标准
- •Unwilling couples to participate in the study.
- •Wife and/or couple is in an emergency.
- •Wife and/or couple has unstable mental health.
- •Wife accompanied by close relatives other than a spouse.
- •Wife in the first week of delivery.
- •Dose requirements in any one of the antidepressant and/or anxiolytic, such as escitalopram (above10 mg), sertraline (above 25 mg), and/or alprazolam (above 0.50 mg) per day.
- •Couples screened with depressive disorder and/or anxiety disorder having psychotic features.
- •Couples screened with depressive disorder and/or anxiety disorder having suicidal ideation.
- •Couples screened with depressive disorder and/or anxiety disorder having mania/hypomanic features.
- •Couples having diabetes.
- •Couples having cardiovascular disorders.
- •Presence or history of any physical or psychiatric disorder and/or use of medications
- •Any intellectual, visual, or hearing disability present in either spouse of a couple.
研究组 & 干预措施
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.
干预措施: Psychopharmacological Intervention (Drug)
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.
干预措施: Cognitive Behavioral Couple Therapy (Behavioral)
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.
干预措施: Psychopharmacological Intervention (Drug)
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.
干预措施: Cognitive Behavioral Couple Therapy (Behavioral)
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.
干预措施: Combination of Psychopharmacological Intervention and CBCT (Other)
Control (Placebo and No Intervention)
This group will receive a placebo from a gynecologist or no intervention from a trained psychologist.
干预措施: Placebo and No Intervention (Other)
结局指标
主要结局
The Sum of Scores of Major Depressive Disorder Subscale and Generalized Anxiety Disorder Subscale
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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)
时间窗: 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.
次要结局
- Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0(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(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).)
研究者
Sameera Shafiq
Lecturer
University of Gujrat