A randomized clinical trial: Efficacy of group-based acceptance and commitment therapy program for breast cancer patients with high fear of progression.

BACKGROUND: Fear of progression (FOP) is a common and significant concern among cancer patients, encompassing worries about cancer progression during active treatment. Elevated levels of FOP can be dysfunctional. This study aims to assess the efficacy of an Acceptance and Commitment Therapy (ACT)-based intervention on FOP, anxiety sensitivity (AS), and quality of life (QOL) in breast cancer patients. METHODS: A clinical trial was conducted involving 80 stage I-III active-treatment breast cancer patients with a score greater than 34 on the Fear of Progression Questionnaire-Short Form scale. These patients were randomly assigned in a 1:1 ratio to either an intervention group, which received weekly 70-min sessions of 5-ACT-bsed group-therapy, or a control group that received usual treatment. Variables including FOP, AS, QOL, and ACT-related factors were assessed using ASQ, QLQ-C30, Cognitive Fusion Questionnaire, and Acceptance and Action Questionnaire-II at three time points: baseline, post-intervention, and 3-month follow-up. The efficacy of the intervention was evaluated using mixed model analysis across all time-points. RESULTS: The fidelity and acceptability of the ACT-based manual were confirmed using significant methods. A significant reduction in FOP was observed only in the ACT group at post-intervention (P-valueACT < 0.001; Cohen dACT = 1.099). Furthermore, the ACT group demonstrated a more significant reduction in FOP at follow-up. Furthermore, all secondary and ACT-related variables, except for the physical symptoms subscale, showed significant improvement in the ACT group compared to the control group. CONCLUSIONS: Our ACT-based manual showed promise for reducing FOP, AS, and improving QOL, and ACT-related variables in breast cancer patients 3 months following the intervention.

Can integrating religiosity and spirituality into postpartum care improve the quality of life in women with preeclampsia.

Background: Women with a history of preeclampsia frequently have a lower level of physical well-being and emotional problems. Objective: This study aimed to determine the effect of integrating religiosity and spirituality into postpartum care can improve the quality of life in women with preeclampsia. Methods: This study was a randomized controlled clinical trial conducted on 40 women with preeclampsia. All eligible participants were allocated to two control and intervention groups using a random blocking method. Data were collected using Mother-Generated Index (MGI) in pre-intervention and 6 weeks later and analyzed using descriptive statistics, Chi-square test, and independent t-tests. The significance level was p < 0.05. Results: The mean, Standard deviation (SD) of the total score of MGI before intervention in the intervention group was 5.35 (1.09) which increased to 8.00 (0.50) 6 weeks after intervention. In the control group, the pre-test score of MGI was 5.81 (0.97) which increased to 6.69 (1.37) after 6 weeks of follow-up. The difference between the two groups was statistically significant after the intervention based on an independent t-test (p = 0.001).The mean (SD) of five subscales included Feelings toward herself, Feelings toward the child, Feelings toward her husband and others, Feelings toward sex, and Physical health status after intervention in the intervention group statistically significantly increased compared to the control group (p < 0.011). Conclusion: The integration of spiritual counseling with the educational content of postpartum care had a positive impact on improving the postpartum QoL of women with preeclampsia. For better conclusions, a study with a large sample size needed to be conducted in the future. Clinical Trial Registration: https://en.irct.ir/user/trial/50832/view, identifier IRCT20150731023423N16.

The Efficacy of Integrating Spirituality into Prenatal Care on Pregnant Women's Sleep: A Randomized Controlled Trial.

OBJECTIVE: The study is aimed at determining the efficacy of spiritual content counselling on improving the sleep quality and insomnia severity of pregnant women. METHODS: This randomized controlled trial was carried out on 40 pregnant women recruited at five health centres of Abhar, Iran, 2020. The eligible women were allocated into two intervention and control groups according to the randomized blocking method. Group counselling with spiritual content was carried out in eight sessions at 16 to 20 weeks of gestation. The control group only received routine care. Data were collected using the Pittsburgh Sleep Quality Index (PSQI) and the Insomnia Severity Index (ISI) questionnaires in three stages, before the intervention, at 28, and 36 weeks of gestation. Statistical analysis was performed using repeated measure ANOVA test, chi-square, and independent t-tests. P < 0.05 was considered significant statistical level. RESULTS: In the counselling group, the mean (SD) of a total score of sleep quality before the intervention was 9.45 (2.30) which decreased to 5.40 (1.56) in 36 weeks of gestational age, while in the control group was increased from 9.26 (2.15) to 11.47 (1.54). After the intervention based on the repeated measure ANOVA test, the mean total score of the insomnia severity, sleep quality, and its components decreased statistically in the second and third trimesters compared to the first trimester in the intervention group compared to the control group (P = 0.001). CONCLUSION: The results showed that counselling with spiritual content could effectively ameliorate sleep quality and reduce insomnia severity in pregnant women. It seems that the approach is an acceptable basis to design intervention programs in this field that can be considered by midwives. Clinical Trial Registry and Registration Number. The study was registered at the Iranian Registry of Clinical Trials under the IRCT20150731023423N15.

The effect of midwifery led counseling based on Gamble's approach on childbirth fear and self-efficacy in nulligravida women.

BACKGROUND: Studies show that childbirth fear is a common problem among Iranian women. Therefore, most Iranian women prefer caesarean section for giving birth. This study investigated the effectiveness of a psychoeducational intervention by midwives (birth emotions - looking to improve expectant fear (BELIEF)) on decreasing childbirth fear and self-efficacy among first-time pregnant women who were afraid of giving birth. METHODS: A number of 80 pregnant women participated in the study. They had received a score of ≥66 on the Wijma delivery expectancy/experience questionnaire. They were randomly assigned into two groups: intervention (n = 40) and control groups (n = 40). The intervention group received two face-to-face counseling sessions based on the BELEF protocol in the 24th and 34th weeks of pregnancy. Between these two sessions, it also received eight telephone-counseling sessions once a week. The control group only received the prenatal routine care. The outcome measures were childbirth fear, childbirth self-efficacy, and childbirth preference. RESULTS: The intervention group showed significantly more reduction in childbirth fear and more increase in childbirth self-efficacy compared to the control group. In addition, more women in the intervention group reported that they preferred to give normal vaginal birth than women in the control group. CONCLUSION: The BELIEF protocol could be an effective approach in reducing childbirth fear and increasing childbirth self-efficacy among first-time pregnant women who are afraid of giving birth. TRIAL REGISTRATION NUMBER: IRCT20101219005417N3, Date of Registration: 19-12-2018.

Adjunctive Raloxifene and Isradipine Improve Cognitive Functioning in Patients With Schizophrenia: A Pilot Study.

BACKGROUND: Cognitive impairment is the most important feature of schizophrenia leading to severe functional disability. To identify pathways that improve pathophysiological neurocognition in schizophrenia is a current challenge for the development of goal-directed clinical interventions. In the present study, we investigated the effects of raloxifene (a selective estrogen modulator) and isradipine (a voltage-gated L-type calcium channel blocker) on cognitive deficits in patients with schizophrenia. METHOD: We designed a double-blind, randomized, parallel, placebo-controlled trial. We randomized 60 patients with schizophrenia into 3 groups including isradipine 5 mg, raloxifine 60 mg, and placebo for 6 consequent weeks, all in the same shape capsules, 2 times a day, along with treatment as usual. The initial and final results of blood tests, electrocardiograms, and cognitive tests in specific domains, such as attention, processing speed, executive function, and verbal memory were evaluated. RESULTS: Our findings revealed a remarkable association between adjunctive raloxifene treatment and the alleviation of verbal memory deficits. Isradipine treatment significantly improved the verbal memory and attention dysfunction in some variables of the Stroop test, compared with the placebo. However, no effect was observed in processing speed and executive function deficits. CONCLUSIONS: To the best of our knowledge, this study provides the first evidence that isradipine is a novel therapy option improving verbal memory and attention, both related to its activity in the hippocampus and the cerebellum. Further investigations are necessary to elucidate the mechanisms of action for both drugs in schizophrenia.