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Cognitive-behavioral therapy for post COVID-19 condition: A pilot randomized controlled trial.

BACKGROUND: The post COVID-19 condition (PCC) is a disabling condition with urgent need for effective treatments. This pilot randomized controlled trial examined the feasibility and efficacy of a cognitive-behavioral therapy (CBT) for PCC in a parallel-group design. METHODS: N = 53 individuals with PCC were randomized to CBT (n = 27) or 16-week wait-list control (WLC) condition (n = 26). One participant allocated to WLC was excluded after randomization, resulting in an intention-to-treat (ITT) sample of N = 52 participants (CBT: n = 27, age: M = 48.59, SD = 11.52, 77.8% female; WLC: n = 25, Age: M = 48.44, SD = 9.81, 60% female). CBT comprised eight group and five individual sessions addressing cognitive and behavioral factors of symptom maintenance (treatment duration if completed: M = 14 weeks, SD = 1 week). Primary outcomes included fatigue (FSS), overall somatic symptom burden (PHQ-15), and respiratory and cardiovascular symptoms (SBQ™-LC "Breathing" and "Circulation"), assessed at pre-, post-assessment, and follow-up. RESULTS: Participants receiving CBT showed a significant medium-sized reduction in fatigue directly after treatment compared to the WLC condition (d = -0.58, p = .045), whereas the WLC group showed a significant increase in overall somatic symptoms (d = 0.60, p = .027). Results for respiratory symptoms were mixed, showing inconsistent patterns across analyses. Retrospectively assessed feasibility and treatment satisfaction were good, with few adverse effects reported. CONCLUSIONS: This pilot trial suggests the feasibility and preliminary efficacy of CBT for PCC. Larger RCTs with active control groups should confirm these findings.

Humans↗

Vaginoscopic versus conventional approaches to outpatient diagnostic hysteroscopy: a two-centre randomized prospective study.

BACKGROUND: To compare the tolerability and feasibility of the transvaginal and standard approaches in outpatient diagnostic hysteroscopy. METHODS: This randomized prospective trial was carried out in two centres to compare the transvaginal (n = 200) and conventional (n = 200) approaches during outpatient hysteroscopy. Patients were randomized by a computer-generated list. The main outcome measure was pain during the examination, measured on a visual analogue scale (VAS) graded from 0 to 10 (0 = lowest, 10 = highest). Secondary criteria were ease of instrument passage through the cervix, investigation quality and its duration. For data analysis, we used the chi-squared test or Fischer's exact test for qualitative variables and the Mann-Whitney U-test for quantitative variables. RESULTS: Median VAS was rated at 0.5 for the vaginoscopic and 2 for the standard (P < 0.0001) approaches. The approaches did not differ significantly in investigation quality, procedure duration or ease of cervical passage (although the latter was more often easy transvaginally). CONCLUSIONS: The transvaginal approach is better tolerated than the conventional technique in outpatient diagnostic hysteroscopy.

Female↗

Biofeedback-assisted relaxation therapy in neurocardiogenic syncope: a pilot study.

This controlled pilot study explored the effects of biofeedback assisted relaxation (BFRT) in neurocardiogenic syncope. Twenty-two patients who completed a 2-week pretest, were randomized to either treatment or wait list control, followed by a 2-week posttreatment/control period. Treatment comprised electromyograph and thermal biofeedback, autogenic and progressive relaxation, and symptom-specific recommendations. Significant differences (p < .05) between groups were observed in the headache index and loss of consciousness, favoring the BFRT group. Both groups decreased state anxiety and depression. The Millon Behavioral Health Inventory was used to assess patients' coping style and adjustment to illness. The majority of the adult participants evidenced illness overreaction, preoccupation with illness, depressive feelings, and tendencies to nonadherence to therapy. BFRT is of potential benefit to patients with neurocardiogenic syncope, but further study is necessary to define the influence of coping style on outcome.

Adolescent↗

Age analysis of cognitive-behavioral group therapy for chronic pain outpatients.

This study explored the effectiveness, in terms of age of the client, of a 10-week cognitive-behavioral group therapy (stress inoculation training) for chronic pain. A total of 69 outpatients between the ages of 27 and 80 (M = 52.74 years, SD = 14.40) with diverse types of chronic pain were assigned randomly to immediate or wait-list-delayed therapy. Self-report measures of pain, activities, coping, and the use of medications and other physical pain control techniques were obtained at baseline, during therapy, and at 1- and 6-month follow-up. Treatment decreased the degree to which pain interfered with activity, increased ability to cope with pain, and decreased use of some medications and other physical treatments. It had little effect on perceived pain intensity. Gains were maintained through 6-month follow-up. Age was unrelated to outcome. Stress inoculation training appears to be an effective method of ameliorating the interference of chronic pain with the daily activities of life for adults of all ages.

Adult↗

Dance and movement program improves quality-of-life measures in breast cancer survivors.

A pilot research study was conducted at 2 cancer centers in Connecticut to determine the effect of a dance and movement program on quality of life and shoulder function in breast cancer survivors treated within the prior 5 years. Thirty-five women completed the trial that included a 12-week intervention, using The Lebed Method, Focus on Healing Through Movement and Dance. The study design was a randomized control trial with a wait list control group crossover to active treatment in weeks 13 to 25, with the treatment group receiving the program in weeks 1 to 12, and no program in weeks 13 to 25. Outcome measures were the Breast Cancer Quality of Life (FACT-B), Shoulder range of motion (ROM), and Body Image Scale. FACT-B significantly improved in the intervention group at 13 weeks from 102.0 +/- 15.8 to 116.7 +/- 16.9, compared to the wait list group 108.1 +/- 16.4 to 107.1 +/- 21.3 (time x group effect, P = .008). During the crossover phase, the FACT-B score increased in the wait list group and was stable in the treatment group. The overall effect of the training at 26 weeks was significant (time effect, P = .03), and the order of training was also significant (P = .015). Shoulder ROM increased in both groups at 13 weeks--15 degrees and 8 degrees in the intervention and wait list groups (Time effect, P = .03; time x group, P = .58). Body Image improved similarly in both groups at 13 weeks (time effect, P = .001; time x group, P = .25), and at 26 weeks. There was no significant effect of the order of training for these outcome measures. A dance movement program that addressed the physical and emotional needs of women following treatment for breast cancer substantially improved a breast cancer-specific quality-of-life measure. Larger studies are justified to determine the acceptability of this therapy as part of the continuum of care for breast cancer survivors.

Adult↗

How should patients with unstable angina and non-ST-segment elevation myocardial infarction be managed? A meta-analysis of randomized trials.

PURPOSE: Patients with unstable angina or non-ST-segment elevation myocardial infarction (MI) may be managed with either an "invasive" or "conservative" strategy. It is unclear which of these strategies is superior. METHODS: We identified studies with MEDLINE and EMBASE searches (1966-September 2003) and by reviewing reference lists. Studies were included if they were randomized controlled trials comparing management strategies for patients in the early post-unstable angina/non-ST-segment elevation MI period and had follow-up data for at least 3 months. RESULTS: Seven trials that randomized a total of 9212 patients were included. The pooled odds ratio (OR) for all-cause mortality was 0.96 (95% confidence interval [CI]: 0.72 to 1.27). The occurrence of fatal or nonfatal re-infarction was reduced with an invasive strategy (OR 0.73; 95% CI: 0.61 to 0.88) as was readmission to hospital (OR 0.67; 95% CI: 0.48 to 0.94). The endpoints of nonfatal MI and the composite of death or nonfatal MI showed nonsignificant trends favoring an invasive strategy. Trials that included a higher proportion of patients with ST-segment depression on admission and trials in which a larger proportion of patients underwent revascularization showed a greater magnitude of benefit for an invasive strategy. CONCLUSION: For patients with unstable angina/non-ST-segment elevation MI, an invasive strategy reduces rates of fatal or nonfatal re-infarction and hospital readmission, but not all-cause mortality, when compared with a noninvasive strategy. These results suggest that an invasive management strategy should be considered for all patients with unstable angina/non-ST-segment elevation MI and perhaps in particular those with ST-segment depression.

Angina, Unstable↗

Black Americans' perceptions of cancer. A study utilizing the Health Belief Model.

The purpose of this study was to determine black adults' knowledge and perceptions of cancer by utilizing the Health Belief Model. The subjects were obtained by randomly selecting 11 churches from a list of 33. There were 769 black adults who responded to the survey (64 percent response rate). Mean age of respondents was 44.3 years, SD = 14.7. Only 29 percent were able to correctly identify all seven of the American Cancer Society warning signs; 13 percent were unable to identify any warning signs. One in four believed it was likely they would develop cancer sometime in their life, and 42 percent believed blacks were more susceptible to cancer than whites. Forty-one percent believed most people who get cancer will die from it. Perceived barriers to treatment included cost and pain. A large number of significant differences (P < .01) were found when responses were examined in relation to the sex, educational level, and age of the subjects.

Adult↗

Treatment of tinnitus in the elderly: a controlled trial of cognitive behavior therapy.

The aim of the study was to investigate the effects of cognitive behavioral therapy (CBT) in elderly people with tinnitus (<65 years). Thirty-seven patients were called in for a structured interview. Following exclusion, twenty-three participated in the trial. All participants underwent medical ear, nose, and throat (ENT) examination, audiometry, and tinnitus matchings. A randomized controlled design with a waiting list control group was used. A CBT treatment package was delivered in six weekly two hour group sessions. Outcome was measured using validated self-report inventories and daily diary ratings of annoyance, loudness and sleep quality for one week pretreatment, post-treatment. A three month follow-up was included at which time all participants had received treatment, but in a shorter format for the control group. Results showed statistically significant reductions of tinnitus-related distress. Thus, CBT was better than no treatment, but the particular aspects of CBT that contributed to the effects can not be established. In conclusion, the findings give some support for the use of group CBT for elderly people with tinnitus.

Aged↗

Pre-ovarian block versus paracervical block for oocyte retrieval.

BACKGROUND: A pre-ovarian block (POB) technique can be used for pain relief during oocyte retrieval in IVF. The local anaesthetic is deposited in the vaginal wall and between the vaginal wall and the peritoneal surface near the ovary using ultrasound guidance. The aim of this study was to test whether analgesia with POB resulted in improved pain relief compared to paracervical block (PCB). METHODS: A prospective, randomized, multicentre study of POB versus PCB (10 ml of 1% lidocaine each) with 183 patients randomized to POB (n = 96) or PCB (n = 87) was performed. Randomization (via a computer-generated list) was balanced for age, previously completed IVF cycles, degree of anxiety, estimated number of follicles, BMI, premedication and centre. Pain was measured using a visual analogue scale (VAS, 0-100 mm) and given as median values. The primary end-point of this study was overall VAS pain score for both sides during the oocyte retrieval procedure. RESULTS: Overall pain during the entire oocyte retrieval was 22 (POB) and 16 (PCB) (P = 0.42). No differences were found in degree of anxiety, premedication, dose of alfentanil, fertilization rate, number of good-quality embryos or clinical pregnancy rate. CONCLUSIONS: No differences were found in overall pain experienced during the entire oocyte retrieval procedure with POB compared to PCB.

Adult↗

The role of client choice and target selection in self-management therapy for depression in older adults.

In a study designed to maximize the effectiveness of treatment by allowing participants to select the target of treatment, 40 depressed older adults were randomly assigned to a waiting-list control condition or to conditions in which the target of treatment was either chosen or assigned. All participants received self-management therapy and the choice was between changing behavior or changing cognition. It was found that individually administered self-management therapy was effective in treating depression for older adults. There were no differences in outcome between versions of self-management therapy that targeted behavioral or cognitive change. Among those who completed treatment, there were no differences in outcome between those who received a choice and those who did not. Individuals who were given a choice of treatment options, however, were less likely to drop out of treatment prematurely.

Aged↗

Low dose prednisolone administration in routine ICSI patients does not improve pregnancy and implantation rates.

BACKGROUND: Glucocorticoids have been used in conjunction with zona dissection to improve pregnancy and implantation rates in IVF patients. The aim of this prospective randomized study was to evaluate the effect of low-dose prednisolone in addition to the standard protocol, on pregnancy and implantation rates in routine ICSI patients before and after embryo replacement. METHODS: A total of 313 patients in 360 consecutive cycles (patients <39 years old and with three or less than three ICSI attempts) performed at our centre were randomly assigned by computer-generated list to receive either prednisolone (10 mg/day in two divided doses), starting on the first day of ovarian stimulation and continuing for 4 weeks (group A), or no treatment (group B). RESULTS: The mean age, number of previously failed IVF attempts, basal FSH levels and the mean rank of trials were comparable between groups A and B. The mean (+/- SD) number of metaphase II oocytes retrieved (11.9 +/- 5.5 versus 12.0 +/- 5.1), 2-pronuclei fertilization rate (67.2 versus 65.8%), the pregnancy and the implantation rates were not different between the study and control groups (49.0 and 23.6% versus 50.0 and 23.3% respectively). CONCLUSION: Low-dose prednisolone treatment in addition to the standard protocol before and after embryo replacement does not appear to have a significant effect on pregnancy or implantation rates.

Adult↗

Weight loss in obese Mexican Americans treated for 1-year with orlistat and lifestyle modification.

OBJECTIVE: To evaluate the effectiveness of a culturally appropriate lifestyle intervention combined with orlistat in producing weight loss with obese Mexican-American women. SUBJECTS: Mexican-American women (N=108), aged 21-65 y, with a body mass index (BMI) > or =27 kg/m(2) were randomized to 1 y of treatment with orlistat and a culturally tailored lifestyle modification intervention (OLM; n=56) or a wait-list control group (WLC; n=52). DESIGN: A randomized, controlled, open-label 12-month study. Orlistat was dosed at 120 mg, three times per day. The OLM intervention included behavior modification, a low-fat (< or =30% of total daily calories) diet, and moderate physical activity (> or =150 min/week). MEASUREMENT: Primary outcomes included changes in body weight (kg), BMI, waist circumference, blood pressure, glucose, and lipids. RESULTS: A total of 72 (37 OLM, 35 WLC) and 66 participants (32 OLM, 34 WLC) completed the 6- and 12-month follow-ups, respectively. Repeated-measures ANOVA demonstrated a significant time x treatment interaction (Wilks' lambda=12.61; P<0.001), indicating that OLM-treated patients achieved significant weight loss relative to the WLC group during the study (mean percentage weight loss+/-s.e.m.; -8.1%+/-1.2 vs -1.6%+/-0.7 at 6 months and -8.8%+/-1.5 vs -0.2%+/-1.0 at 12 months, respectively). OLM-treated patients also experienced significant reductions in waist circumference, low-density-lipoprotein, and total cholesterol. CONCLUSIONS: This study demonstrates the effectiveness of an intervention combining orlistat and lifestyle modification with Mexican-American women, a population with substantial risk for obesity.

Adult↗

Prolongation of follicular phase by delaying hCG administration results in a higher incidence of endometrial advancement on the day of oocyte retrieval in GnRH antagonist cycles.

BACKGROUND: Prolongation of follicular phase by delaying hCG administration has been reported to result in a significantly lower ongoing pregnancy rate that did not seem to be due to an embryonic factor. The aim of this prospective randomized study was to assess the effect of delaying hCG administration on endometrial histology. METHODS: Ten oocyte donors underwent endometrial biopsy on the day of oocyte retrieval and endometrial histology was assessed by Noyes' criteria. Ovarian stimulation was performed with recombinant (r)FSH and daily GnRH antagonist starting on day 6 of stimulation. Patients were randomized by a computer-generated list to receive 10 000 IU of hCG either as soon as > or =3 follicles > or =17 mm were present on ultrasound (early-hCG group, n = 5) or 2 days after this criterion was met (late-hCG group, n = 5). RESULTS: When hCG was delayed, endometrial advancement was present in all samples examined (median advancement 3 days, range 2-3 days). On the contrary, no secretory changes were observed when the follicular phase was not prolonged (difference in the proportion of patients with advancement between the early-hCG and the late-hCG group: 100%, 95% CI: 38-100). CONCLUSIONS: Prolongation of follicular phase by delaying hCG administration results in a higher incidence of endometrial advancement on the day of oocyte retrieval in GnRH antagonist cycles.

Adult↗

Effects of home-based daily exercise therapy on joint mobility, daily activity, pain, and depression in patients with ankylosing spondylitis.

We investigated the effects of home-based daily exercise on joint mobility, functional capacity, pain, and depression in patients with ankylosing spondylitis (AS). The patients were randomly assigned to a wait-list control group or to an exercise-therapy group. The exercise-therapy group performed a 20-min exercise program once per day for 8 consecutive weeks. After 8 weeks, compared with the control group, the exercise group showed improvements in joint mobility (cervical flexion, extension, shoulder flexion, abduction, hip abduction, and knee flexion), finger-floor distance, and functional capacity. Pain and depression scores were significantly lower after the exercise program in the exercise group than in the control group. These findings indicate that exercise therapy increases joint mobility and functional capacity, and decreases pain and depression in patients with AS. Home-based exercise, which is easily accessible to patients, might be an effective intervention for AS.

Activities of Daily Living↗

A comparison of individual and group cognitive-behavioural treatment for female pathological gambling.

The current study aimed to determine the differential efficacy of a cognitive-behavioural treatment program for female pathological gamblers delivered in individual and group format. Fifty-six female pathological gamblers with electronic gaming machine gambling problems were randomly assigned to the control (waiting list) group or one of the treatment groups (individual or group treatment). Treatment comprised a 12-session program including financial limit setting, alternative activity planning, cognitive correction, problem solving, communication training, relapse prevention, and imaginal desensitisation. Treatment outcome was evaluated with conceptually related measures within the areas of gambling behaviour and psychological functioning. While individual and group treatment formats generally produced comparable outcomes in terms of gambling behaviour and psychological functioning, group treatment failed to produce superior outcomes to the control group in relation to several measures of psychological functioning. Moreover, by the completion of the six-month follow-up, 92% of the gamblers allocated to individual treatment compared with 60% allocated to group treatment no longer satisfied the diagnostic criteria for pathological gambling. These findings suggest that some caution should be employed when delivering cognitive-behavioural treatment in a group format until further research is conducted to establish its efficacy.

Adult↗

Follicular growth during contraceptive pill or vaginal ring treatment depends on the day of ovulation in the pretreatment cycle.

BACKGROUND: The aim of this study was to investigate whether the day of ovulation and the duration of a pretreatment cycle were related to the degree of follicular growth during subsequent contraceptive treatment. METHODS: This randomized, open-label study was performed in 40 healthy female volunteers, who were randomized by a computer-generated list after stratification for the ovulation day in a pretreatment cycle. They received two cycles of NuvaRing (21 subjects) or a combined oral contraceptive (COC) containing 30 microg ethinylestradiol and 150 microg levonorgestrel (19 subjects). Follicular diameter and serum hormone concentrations (FSH, LH, 17beta-estradiol, progesterone) were measured every third day. Data from treatment day 20 onwards were used for analysis. RESULTS: In the NuvaRing users, subjects with short cycles and early ovulations in the pretreatment cycle developed larger follicles during treatment than subjects with longer cycles and late ovulations. In the COC users, subjects with early ovulations in the pretreatment cycle developed larger follicles during treatment. CONCLUSIONS: The degree of follicular growth during treatment with a combined hormonal contraceptive is influenced by the duration of the pretreatment cycle and particularly by the duration of the follicular phase.

Adolescent↗

A randomized double-blind comparison of two single doses of mifepristone for emergency contraception.

BACKGROUND: Previous trials have shown the potential of 10 mg of mifepristone in emergency contraception. The aim of this trial was to investigate whether 10 mg of mifepristone has the same efficacy as 25 mg. METHODS: This double-blind, randomized trial was carried out in 10 family planning institutes and hospitals in China. Women who met recruitment criteria and requested emergency contraception within 120 h of a single act of unprotected coitus were randomized using a computer-generated list to either 10 or 25 mg of mifepristone within each centre. RESULTS: Among 3052 women enrolled, the outcome was known for 3030 women, 1516 in the 10 mg group and 1514 in the 25 mg group. Seventeen pregnancies occurred in each group, giving a pregnancy rate of 1.1%. The relative risk of pregnancy for women treated with 10 mg mifepristone compared with those treated with 25 mg was 1.0 (95% CI: 0.51-1.95) and equivalence was demonstrated within a two-fold margin. Both doses prevented 85-86% of pregnancies expected to have occurred if no treatment had been given. The pregnancy rate nearly doubled if women had further acts of intercourse. Efficacy decreased with treatment delay. Side-effects were uncommon and mild. CONCLUSIONS: A dose of 10 mg of mifepristone is sufficient for emergency contraception. Earlier treatment is preferable, although the method can be used effectively for up to 5 days after intercourse.

Adult↗

The chlamydia screening studies: rationale and design.

BACKGROUND: Screening has been recommended to reduce the prevalence and morbidity associated with genital chlamydia infection in the United Kingdom. METHODS: We describe the rationale and study design of the Chlamydia Screening Studies (ClaSS), a collaborative project designed to evaluate screening outside genitourinary medicine clinics. A non-selective, active screening approach in 16-39 year olds randomly sampled from 27 general practice lists in the Bristol and Birmingham areas formed the basis of interlinked studies: a case-control study was used to investigate factors to improve the targeting of screening; participants with chlamydia were invited to enroll in a randomised controlled trial to evaluate partner notification conducted in primary care; and laboratory based studies were used to assess the best specimens and tests. We also explored psychosocial effects of screening and partner notification and modelled the cost effectiveness of the programme. CONCLUSION: Results from four pilot practices show that mailing of specimens for chlamydia testing is feasible but that it is difficult to achieve high response rates with postal screening. The high prevalence of asymptomatic infection in men suggests that efforts to screen men for chlamydia should be strengthened.

Adolescent↗