Evaluation of an Online Gottman’s Psychoeducational Intervention to Improve Marital Communication among Iranian Couples

Amounting evidence indicates that insufficient knowledge of marital communication skills leads to destructive interactions and poor marital adjustments in couples, especially during stressful situations. Despite the high effectiveness of Gottman’s psychoeducational intervention, there is a lack of study on the online Gottman’s psychoeducation intervention (O-GPI) to improve marital communication and dyadic adjustments. The aim of this study was to evaluate the effectiveness of O-GPI on the improvement of marital communication patterns among Iranian couples. Method: The study followed a single-blind parallel group in a randomized controlled trial using an experimental longitudinal design, comprising 72 heterosexual couples living in Shiraz, Iran, with a 1–7-year marital age and no severe marital problems. The experimental group received eight consecutive O-GPIs via the Zoom platform, while the control group received information related to parenting skills via email. The outcome measures were the three patterns of communication: (i) constructive communication; (ii) demand–withdraw communication; and (iii) mutual avoidance communication—the screening measure was the dyadic adjustment scale. Results: The findings indicated that O-GPI could improve couples’ constructive communication significantly (45% for husbands and 40% wives) and decrease their total demand–withdrawal (51% for husbands and 65% wives) and mutual avoidance communication (60% for husbands and 62% wives). Limitations: Due to the homogenous nature of the sample, generalizations should be made with caution. Conclusions: This study demonstrates the feasibility and effectiveness of the online Gottman’s psychoeducational intervention to improve couples’ communication patterns.

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Impact of valganciclovir therapy on severe IRIS-Kaposi Sarcoma mortality: an open-label, parallel, randomized controlled trial.

10.1101/2021.10.24.21265453 ◽

2021 ◽

Author(s):

Patricia Volkow ◽

Leslie Chavez-Galan ◽

Lucero Ramon-Luing ◽

Judith Cruz-Velazquez ◽

Patricia Cornejo-Juarez ◽

...

Keyword(s):

Controlled Trial ◽

Kaposi Sarcoma ◽

Pulmonary Involvement ◽

Skin Lesions ◽

Attributable Mortality ◽

Control Group ◽

Open Label ◽

Parallel Group ◽

Pulmonary Lymph Node ◽

The Difference

High HHV-8 viral load (VL) in Kaposi Sarcoma (KS) has been associated with severe Immune reconstitution inflammatory syndrome (S-IRIS-KS), which can occur after initiating cART, and is linked with high mortality particularly in patients with pulmonary involvement. We investigate if valganciclovir initiated before cART decreases HHV-8 VL and assess if it reduces the incidence of S-IRIS-KS and its attributable mortality. Methods: Open-label parallel-group randomized clinical trial in AIDS cART naive patients with disseminated KS (DKS) as defined by at least two of the following: pulmonary, lymph-node or gastrointestinal involvement, lymphedema, or equal or more 30 skin lesions. In the experimental group (EG), patients were randomized to valganciclovir 900 mg BID four weeks before cART and continued until week-48; in the control group (CG), cART was initiated on week-0. Non-severe-IRIS-KS was defined as: increase in the number of lesions plus equal or more than one log10 HIV-VL decrease or equal or more than 50 cells/mm3 increase or equal or more than 2-fold rise in baseline CD4+ cells. S-IRIS-KS was defined as abrupt clinical worsening of KS lesions and/or fever after ruling out another infection following cART initiation, and at least three of the following: thrombocytopenia, anemia, hyponatremia, or hypoalbuminemia. Results: 40 patients were randomized and 37 completed the study. In the ITT analysis, the overall mortality did not differ between groups. In the per-protocol analyses, the difference showed a trend for higher S-IRIS-KS mortality in the CG 3/19 (15.7%), compared to EG 0/18 (p=0.07). The incidence of S-IRIS KS was significantly lower in the EG; two patients, one each had S-IRIS-KS episode (0.038 per 100 patient-days) compared to CG group, four patients developed 12 S-IRIS-KS episodes (0.21 per 100 patient-days); incidence rate of 0.09 (95% CI 0.02-0.5 p=0.006). Mortality in patients with pulmonary KS was significantly lower in EG, 3/4 in CG vs 0/5 in EG. S-IRIS-KS was associated with higher HHV-8-VL; IL6 and CRP; valganciclovir was protective. Of survivors at week 48, 82% achieved more than 80% remission. No difference was found between groups in the number of non-S-IRIS-KS events. Conclusions: Valganciclovir significantly reduced the episodes of S-IRIS-KS although attributable KS mortality was lower in the EG the difference was not significant (p=0.07). Mortality was significantly lower in EG patients with pulmonary KS.

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Evaluation of the Effectiveness of a Psychoeducational Intervention in Treatment-Naïve Patients with Antidepressant Medication in Primary Care: A Randomized Controlled Trial

The Scientific World JOURNAL ◽

10.1155/2015/718607 ◽

2015 ◽

Vol 2015 ◽

pp. 1-11 ◽

Cited By ~ 3

Author(s):

R. Casañas ◽

R. Catalán ◽

R. Penadés ◽

J. Real ◽

S. Valero ◽

...

Keyword(s):

Primary Care ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Antidepressant Medication ◽

Psychoeducational Intervention ◽

Control Group ◽

Intention To Treat ◽

Symptoms Of Depression ◽

Randomized Controlled ◽

Treatment Naïve

Background. There is evidence supporting the effectiveness of psychoeducation (PE) in patients with symptoms of depression in primary care (PC), but very few studies have assessed this intervention in antidepressant-naïve patients. The aim of this study is to assess the effectiveness of a PE program in these patients, since the use of antidepressant (AD) medication may interfere with the effects of the intervention.Methods. 106 participants were included, 50 from the PE program (12 weekly 1.5-hour sessions) and 56 from the control group (CG) that received the usual care. Patients were assessed at baseline and at 3, 6, and 9 months. The main outcome measures were the Beck Depression Inventory (BDI) and remission based on the BDI. The analysis was carried out on an intention-to-treat basis.Results. The PE program group showed remission of symptoms of 40% (P=0.001) posttreatment and 42% (P=0.012) at 6 months. The analysis only showed significant differences in the BDI score posttreatment (P=0.008; effect size Cohen’sd′=0.55).Conclusions. The PE intervention is an effective treatment in the depressive population not treated with AD medication. Before taking an AD, psychoeducational intervention should be considered.

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Effectiveness of a Walking Program Involving the Hybrid Assistive Limb Robotic Exoskeleton Suit for Improving Walking Ability in Stroke Patients: Protocol for a Randomized Controlled Trial (Preprint)

10.2196/preprints.14001 ◽

2019 ◽

Author(s):

Hideo Tsurushima ◽

Masafumi Mizukami ◽

Kenichi Yoshikawa ◽

Tomoyuki Ueno ◽

Yasushi Hada ◽

...

Keyword(s):

Controlled Trial ◽

Gait Disturbance ◽

Controlled Study ◽

Control Group ◽

Walking Ability ◽

Stroke Patients ◽

Robotic Exoskeleton ◽

Walking Program ◽

Parallel Group ◽

Hybrid Assistive Limb

BACKGROUND Gait disturbance often occurs in stroke survivors. Recovery of walking function is challenging, as some gait disturbance due to hemiparesis often remains even after rehabilitation therapy, presenting a major obstacle towards regaining activities-of-daily-living performance and achieving social reintegration. OBJECTIVE This study aims to clarify the effectiveness of a walking program involving the wearable Hybrid Assistive Limb (HAL-TS01) robotic exoskeleton for improving walking ability in stroke patients with hemiparesis and stagnant recovery despite ongoing rehabilitation. METHODS This is a multicenter, randomized, parallel-group, controlled study (HAL group, n=27; control group, n=27). The study period includes preintervention observation (until stagnant recovery), intervention (HAL-based walking therapy or conventional rehabilitation; 5 weeks), and postintervention observation (2 weeks). Following provision of informed consent and primary registration, the patients undergo conventional rehabilitation for preintervention observation, during which the recovery of walking ability is monitored to identify patients with stagnant recovery (based on weekly assessments using the 10-meter maximum walking speed [MWS] test). Patients with an MWS of 30-60 m/minute and insufficient weekly improvement in MWS undergo secondary registration and are randomly assigned to undergo HAL-based walking therapy (HAL group) or conventional rehabilitation (control group). The primary outcome is the change in MWS from baseline to the end of the 5-week intervention. RESULTS This study began in November 2016 and is being conducted at 15 participating facilities in Japan. CONCLUSIONS Assessments of walking ability vary greatly and it is difficult to define the threshold for significant differences. To reduce such variability, our study involves conducting conventional rehabilitation to the point of saturation before starting the intervention. Stagnation in the recovery of walking ability despite conventional rehabilitation highlights the limits of current medical care. The present study may bring evidence that HAL-based therapy can overcome such limitations and induce added recovery of walking ability, which would promote the use of HAL technology in the clinical setting. CLINICALTRIAL UMIN Clinical Trials Registry UMIN000024805; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028545

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The Effects of the Dietary Approaches to Stop Hypertension (DASH) Diet on Metabolic Syndrome in Hospitalized Schizophrenic Patients: A Randomized Controlled Trial

Nutrients ◽

10.3390/nu11122950 ◽

2019 ◽

Vol 11 (12) ◽

pp. 2950 ◽

Cited By ~ 1

Author(s):

Tamara Sorić ◽

Mladen Mavar ◽

Ivana Rumbak

Keyword(s):

Metabolic Syndrome ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Dash Diet ◽

Randomized Controlled ◽

Parallel Group ◽

Schizophrenic Patients ◽

The Relationship

The relationship between the Dietary Approaches to Stop Hypertension (DASH) diet and metabolic syndrome (MetS) in people with schizophrenia is unknown and remains to be investigated. Therefore, we have conducted a three-month parallel-group randomized controlled trial. Sixty-seven hospitalized schizophrenic patients with MetS [n = 33 in the intervention group (IG) and n = 34 in the control group (CG)] completed the intervention. The IG followed the DASH diet with the caloric restriction of approximately 1673.6 kJ/day (400 kcal/day) when compared to the standard hospital diet followed by the CG. Simultaneously, both groups participated in a nutrition counseling program. Anthropometric and biochemical parameters and blood pressure were measured at the baseline and after three months, while nutrient intakes during the intervention were assessed using three non-consecutive 24-hour dietary recalls. The analyses were carried out based on the per-protocol approach. At three months, the MetS prevalence significantly decreased in both the IG and the CG (75.8%, p = 0.002, and 67.7%, p = 0.0003, respectively; odds ratio = 0.9; 95% confidence interval = 0.43–1.87). No significant differences in the prevalence of MetS and its features were found between the groups.

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A Randomised Controlled Trial of Pharmacist Medication Histories and Supplementary Prescribing on Medication Errors in Postoperative Medications

Anaesthesia and Intensive Care ◽

10.1177/0310057x1103900613 ◽

2011 ◽

Vol 39 (6) ◽

pp. 1064-1070 ◽

Cited By ~ 30

Author(s):

S. B. Marotti ◽

R. K. Kerridge ◽

M. D. Grimer

Keyword(s):

Hospital Stay ◽

Controlled Trial ◽

Control Group ◽

History Taking ◽

Medication History ◽

Parallel Group ◽

Supplementary Prescribing ◽

Randomised Controlled ◽

The Impact ◽

Parallel Group Trial

Errors in the management of regular medications at the time of hospital admission are common. This randomised controlled three-arm parallel-group trial examined the impact of pharmacist medication history taking and pharmacist supplementary prescribing on unintentional omissions of postoperative medications in a large perioperative service. Participants included elective surgical patients taking regular medications with a postoperative hospital stay of one night or more. Patients were randomly assigned, on admission, to usual care (n=120), a pharmacist medication history only (n=120) or pharmacist medication history and supplementary prescribing (n=120). A medication history involved the pharmacist interviewing the patient preoperatively and documenting a medication history in the medical record. In the supplementary prescribing group the patients’ regular medicines were also prescribed on the inpatient medication chart by the pharmacist, so that dosing could proceed as soon as possible after surgery without the need to wait for medical review. The estimate marginal mean number of missed doses during a patients hospital stay was 1.07 in the pharmacist supplementary prescribing group, which was significantly less than both the pharmacist history group (3.30) and the control group (3.21) (P <0.001). The number of medications charted at an incorrect dose or frequency was significantly reduced in the pharmacist history group and further reduced in the prescribing group (P <0.001). We conclude that many patients miss doses of regular medication during their hospital stay and preoperative medication history taking and supplementary prescribing by a pharmacist can reduce this.

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Effectiveness of One-Way Text Messaging on Attendance to Follow-Up Cervical Cancer Screening Among Human Papillomavirus–Positive Tanzanian Women (Connected2Care): Parallel-Group Randomized Controlled Trial (Preprint)

10.2196/preprints.15863 ◽

2019 ◽

Author(s):

Ditte S Linde ◽

Marianne S Andersen ◽

Julius Mwaiselage ◽

Rachel Manongi ◽

Susanne K Kjaer ◽

...

Keyword(s):

Cervical Cancer ◽

Cancer Screening ◽

Cervical Cancer Screening ◽

Controlled Trial ◽

Intervention Group ◽

Text Messages ◽

Control Group ◽

Randomized Controlled ◽

Parallel Group

BACKGROUND Rapid human papillomavirus (HPV) DNA testing is an emerging cervical cancer screening strategy in resource-limited countries, yet it requires follow-up of women who test HPV positive. OBJECTIVE This study aimed to determine if one-way text messages improved attendance to a 14-month follow-up cervical cancer screening among HPV-positive women. METHODS This multicenter, parallel-group randomized controlled trial was conducted at 3 hospitals in Tanzania. Eligible participants were aged between 25 and 60 years, had tested positive to a rapid HPV test during a patient-initiated screening, had been informed of their HPV result, and had a private mobile phone with a valid number. Participants were randomly assigned in a 1:1 ratio to the intervention or control group through an incorporated algorithm in the text message system. The intervention group received one-way text messages, and the control group received no text messages. The primary outcome was attendance at a 14-month health provider-initiated follow-up screening. Participants were not blinded, but outcome assessors were. The analysis was based on intention to treat. RESULTS Between August 2015 and July 2017, 4080 women were screened for cervical cancer, of which 705 were included in this trial—358 women were allocated to the intervention group, and 347 women were allocated to the control group. Moreover, 16 women were excluded before the analysis because they developed cervical cancer or died (8 from each group). In the intervention group, 24.0% (84/350) women attended their follow-up screening, and in the control group, 23.8% (80/335) women attended their follow-up screening (risk ratio 1.02, 95% CI 0.79-1.33). CONCLUSIONS Attendance to a health provider-initiated follow-up cervical cancer screening among HPV-positive women was strikingly low, and one-way text messages did not improve the attendance rate. Implementation of rapid HPV testing as a primary screening method at the clinic level entails the challenge of ensuring a proper follow-up of women. CLINICALTRIAL ClinicalTrials.gov NCT02509702; https://clinicaltrials.gov/ct2/show/NCT02509702. INTERNATIONAL REGISTERED REPORT RR2-10.2196/10.2196/15863

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Comparison of binocular game and patching in treating mild to moderate anisometropic amblyopia: a study protocol for a randomized controlled trial

Trials ◽

10.1186/s13063-021-05735-2 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Mohammad Etezad Razavi ◽

Marzieh Najjaran ◽

Jaber Mohseni ◽

Shokoufeh Aalaei

Keyword(s):

Clinical Trials ◽

Study Protocol ◽

Randomized Clinical Trials ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Medical Sciences ◽

Treatment Needs ◽

Parallel Group ◽

Research Designs

Abstract Background Amblyopia, as a neurodevelopmental preventable visual disorder, affects approximately 1.1 % in Asia. A binocular approach to treating amblyopia has been recently proposed. Whether the binocular playing game treatment is comparable to patching treatment needs further randomized clinical trials. To address this, the present research, designs, develops, and evaluates a new binocular game to treat amblyopia. Methods This study has been designed as a non-inferiority, randomized, two parallel-group, controlled trial. Forty-four patients between 4 and 12 years diagnosed with amblyopia will be randomly assigned to the control and intervention groups. In the intervention group, amblyopia treatment is provided with red-green anaglyphic glasses and a red filter placed in front of the amblyopic eye, along with a game to be played for 30 min twice a day. Those in the control group will receive patch therapy according to amblyopia treatment study protocol. The primary outcome is to change visual acuity in the amblyopic eye from the baseline to 3 months after randomization. Ethics and dissemination The Ethics Committee of Mashhad University of Medical sciences’ approval date was February 28, 2018, with a reference code of IR.MUMS.fm.REC.1396.783. Thus far, the recruitment of participants has not been completed and is scheduled to end in September 2021. The results will be disseminated in a peer-reviewed journal. Trial registration Iranian Registry of Clinical Trials IRCT20180217038768N1. Registered on 22 April 2019.

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Strength-Based Flourishing Intervention to Promote Resilience in Individuals With Physical Disabilities in Disadvantaged Communities: A Randomized Controlled Trial

Research on Social Work Practice ◽

10.1177/1049731520959445 ◽

2020 ◽

Vol 31 (1) ◽

pp. 53-64

Author(s):

He Bu ◽

Wenjie Duan

Keyword(s):

Physical Disabilities ◽

Controlled Trial ◽

Intervention Group ◽

Cost Effective ◽

Repeated Measure ◽

Control Group ◽

Parallel Group ◽

Strength Based ◽

Post Hoc ◽

People With Physical Disabilities

Purpose: The current study developed a strength-based flourishing intervention (SFI) and examined its efficacy on fostering the resilience of people with physical disabilities in poor areas, using a randomized (1:1) parallel-group controlled, and single-blind trial. Method: A total of 51 participants ( M age = 42.16, standard deviation = 8.42; 43.14% males; 29 for the intervention group, whereas 22 for the control group) completed preintervention, postintervention, and 3-month follow-up tests. Results: The 2 × 3 mixed repeated measure analyses and post hoc analyses revealed a significant main group effect ( F = 4.46, p = .04) and a short-term effect (i.e., 3 month; F = 6.35, p = .02) of the SFI. The results indicated that the SFI could significantly promote resilience in the intervention group. However, the effects of the intervention did not immediately appear. Discussion: The SFI could assist in providing research-based and cost-effective health services to promote flourishing and resilience in vulnerable populations.

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Marital Satisfaction and Communication in Fundamentalist Protestant Marriages

Psychological Reports ◽

10.2466/pr0.1996.78.3.979 ◽

1996 ◽

Vol 78 (3) ◽

pp. 979-985 ◽

Cited By ~ 5

Author(s):

Thomas S. Snow ◽

William C. Compton

Keyword(s):

Marital Satisfaction ◽

Religious Affiliation ◽

Communication Patterns ◽

Dyadic Adjustment ◽

Marital Communication ◽

Dyadic Adjustment Scale

Marital satisfaction and communication patterns were studied in homogamous fundamentalist Protestant couples, i.e., both partners have the same religious affiliation, heterogamous fundamentalist couples, i.e., each partner has a different religious affiliation, and couples who were not fundamentalist Protestant. A total of 78 couples completed the Dyadic Adjustment Scale and the Marital Communication Inventory. Analyses indicated that importance of religion in a person's life rather than religious affiliation was a predictor of both satisfaction and communication patterns. Implications for further research were discussed.

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Design of a Mobile Application and Evaluation of Its Effects on Psychological Parameters of Covid-19 Inpatients: A Protocol for a Randomized Controlled Trial

Frontiers in Psychiatry ◽

10.3389/fpsyt.2021.612384 ◽

2021 ◽

Vol 12 ◽

Author(s):

Shokoufeh Aalaei ◽

Farnaz Khoshrounejad ◽

Lahya Afshari Saleh ◽

Mahnaz Amini

Keyword(s):

Mobile Application ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Care Providers ◽

Psychological Conditions ◽

Parallel Group ◽

High Prevalence ◽

Group A ◽

Discharge From Hospital

Background: Panic of the disease and the associated concerns can lower the quality of life and physical performance. As long as the COVID-19 pandemic is ever on the rise, the psychological pandemic of the disease is on the rise, too. The high prevalence of COVID-19 has further increased physicians' work pressure. Patients' needs are not met adequately by physicians. It seems essential to use aids to monitor patients' needs and serve them properly. Thus, in the present research, suggestions are made on how to evaluate patients' physical and psychological conditions during the treatment via a mobile application.Methods and Analysis: The present research is a randomized, two parallel-group, controlled trial. One-hundred-twelve inpatients diagnosed with the coronavirus will be assigned randomly to the control and intervention groups. In the intervention group, a mobile application will be provided to educate patients, establish two-way interactions between patients and care providers and record patients' symptoms. Those in the control group will receive the usual care. The primary outcome is the change to the depression anxiety stress scales-21 (DASS-21) score from the baseline to 2 weeks after discharge from hospital. It will be measured at the baseline, at the time of discharge, and two weeks later.Ethics and Dissemination: The Ethics committee of Mashhad University of Medical Sciences' approval date was 2020-04-19 with IR.MUMS.REC.1399.118 reference code. Thus far, participants' recruitment has not been completed and is scheduled to end in March 2021. The results will be disseminated in a peer-reviewed journal.Trial Registration: IRCT20170922036314N4 (https://www.irct.ir/trial/47383).

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