Cognitive behavioural therapy for depression in women with PCOS: systematic review and meta-analysis.

Polycystic ovary syndrome (PCOS) is a common endocrine disorder with physical and psychological complaints, especially high depression scores. Cognitive behavioural therapy (CBT) is the first-line psychological treatment for depression. The objective of this study was to examine the effect of different types of CBT interventions and the effects on depression scores in women with PCOS. A literature search was performed in six databases up to July 2020. Studies published in English, in which depression scores were compared between groups during a CBT intervention in women with PCOS, were included. A total of 4854 studies were identified, of which eight studies were included in the systematic review and five in the meta-analysis. CBT ranged from 8 to 52 weeks and involved between 8 and 20 sessions. An overall Cohen's d effect size of 1.02 (95% confidence interval 0.02-2.02) was found in favour of CBT compared with standard care. To conclude, most psychological interventions applying CBT are effective in lowering depression scores in women with PCOS. These results should be interpreted with caution due to methodological differences and quality of the studies. More clinical trials are needed to assess how many sessions of CBT are necessary to treat depression in women with PCOS.

Improvements in PCOS characteristics and phenotype severity during a randomized controlled lifestyle intervention.

RESEARCH QUESTION: What is the effect of weight loss through different interventions (three-component lifestyle intervention with short message service [SMS+] versus three-component lifestyle intervention without SMS [SMS-] versus care as usual [CAU]) on polycystic ovary syndrome (PCOS) characteristics (ovulatory dysfunction, hyperandrogenism, polycystic ovarian morphology [PCOM]) and phenotype distribution? DESIGN: Analysis of secondary outcome measures of a randomized controlled trial. Women diagnosed with PCOS (n = 183), who wished to become pregnant, with a body mass index above 25 kg/m², were assigned to a 1-year three-component (cognitive behavioural therapy, diet, exercise) lifestyle intervention group, with or without SMS, or to CAU (advice to lose weight). RESULTS: The prevalence of biochemical hyperandrogenism was 30.9% less in the SMS- group compared with CAU after 1 year (P = 0.027). Within-group analyses revealed significant improvements in ovulatory dysfunction (SMS+: -39.8%, P = 0.001; SMS-: -30.5%, P = 0.001; CAU: -32.1%, P < 0.001), biochemical hyperandrogenism (SMS-: -27.8%, P = 0.007) and PCOM (SMS-: -14.0%, P = 0.034). Weight loss had a significantly favourable effect on the chance of having ovulatory dysfunction (estimate 0.157 SE 0.030, P < 0.001) and hyperandrogenism (estimate 0.097 SE 0.027, P < 0.001). CONCLUSIONS: All groups demonstrated improvements in PCOS characteristics, although these were more profound within the lifestyle intervention groups. Weight loss per se led to an amelioration of diagnostic characteristics and in the phenotype of PCOS. A three-component lifestyle intervention aimed at a 5-10% weight loss should be recommended for all women with PCOS before they become pregnant.

Introducing a value-based healthcare approach for women with premature ovarian insufficiency (POI): Recommendations for patient-centered outcomes in clinical practice.

OBJECTIVE: To establish a set of clinician and patient-reported outcome measures (PROMs) and present the initial findings of a value-based healthcare (VBHC) program in patients with premature ovarian insufficiency (POI). METHODS: Employing a four-phase approach, we identified the most crucial domains for patients with POI and translated these into PROMs. Prior to each visit, patients completed questionnaires to evaluate: depression (BDI-II), menopausal symptoms (GCS), work ability (WAS) and infertility (FertiQoL). During the visits, cardiovascular health assessments and dual-energy X-ray absorptiometry (DEXA) scans to measure bone mineral density were performed. Data at intake is presented, and comparisons are drawn between women using and those not using hormone replacement therapy (HRT). Patient-reported experience measures (PREMs) were evaluated by a questionnaire. RESULTS: A total of 267 POI patients completed the PROM questionnaires, of whom 58.1 % were using HRT at intake. Over half of the patients (53.5 %), had a BDI-II score of 14 or higher, indicating mild to severe depression. The mean total GCS score was 20.9 (SD 11.3). The median work ability score was 7.5 (IQR 6.0-8.0) and the mean FertiQoL score 63.9 (SD 15.7). Additionally, 22.7 % of patients presented with hypertension, 6.2 % with hypercholesterolemia, and almost 50 % had low bone mass. Patients rated the VBHC program with a mean of 8.6 (SD 1.2). CONCLUSIONS: These findings underscore the necessity of a multidisciplinary VBHC program incorporating standardized screening and psychological treatment. We advocate for the implementation of patient-centered outcomes for clinical practice, which have been found to be highly relevant by patients with POI.

Sexual function in women with premature ovarian insufficiency (POI): Systematic review and meta-analysis.

Premature ovarian insufficiency (POI) is a rare condition characterized by loss of ovarian function before the age of 40. POI seems associated with mood disorders and sexual dysfunction. However, there is a lack of high-quality evidence relating to the impact of POI on sexual function. Therefore, we conducted a systematic review and meta-analysis to evaluate sexual function in women with POI compared to women without the condition. The following online databases were systematically searched up to January 2023: EMBASE, Medline (Ovid), Web of Science, Cochrane, PsychInfo, and Google Scholar. Random effects models were used for analyses, with data reported as Hedges' g and 95 % confidence interval, and the risk of heterogeneity was evaluated. The protocol of this study was registered with PROSPERO (CRD42023437203). A total of 10 studies were included in the systematic review and 5 studies involving 352 women with POI were included in the meta-analysis. Eight of the ten studies concluded that women with POI have reduced sexual function. An overall medium Hedges' g effect size of -0.72 was found (ranging between -0.20 and -1.29) in favor of control women, with moderate heterogeneity (I2 = 64 %). Stratified studies of women on systemic hormone replacement therapy (HRT) showed an even higher Hedges' g effect size, of -0.82 (95 % CI -1.18, -0.47). In conclusion, sexual function in women with POI is reduced compared with control women. Sexual function should be discussed with women with POI and they should be offered psychosexual counseling.

Translation of the Modified Polycystic Ovary Syndrome Questionnaire (mPCOSQ) and the Polycystic Ovary Syndrome Quality of Life Tool (PCOSQOL) in Dutch and Flemish Women with PCOS.

This study aims to determine the test-retest reliability and to confirm the domain structures of the Dutch version of the modified polycystic ovary syndrome questionnaire (mPCOSQ) and the Polycystic Ovary Syndrome Quality of Life Scale (PCOSQOL) in Dutch and Flemish women with Polycystic Ovary Syndrome (PCOS). PCOS patients were contacted with a request to complete both questionnaires (including additional demographic questions) online in their home environment on T0 and on T1. The study was approved by the Ethics Committee of Erasmus Medical Centre and of Ghent University Hospital. In this study, 245 participants were included between January and December 2021. The mPCOSQ has excellent internal consistency (α: 0.95) and a high to excellent Intraclass Correlation Coefficient (ICC) for all six domains (ICC: 0.88-0.96). The PCOSQOL demonstrates excellent internal consistency (α: 0.96) and ICC (ICC: 0.91-0.96) for all four domains. The original six-factor structure of the mPCOSQ is partly confirmed. An extra domain is added to the PCOSQOL which included coping items. Most women have no preference for one of the two questionnaires (55.9%). In conclusion, The Dutch mPCOSQ and PCOSQOL are reliable and disease-specific QoL measures for women with PCOS. Both questionnaires are recommended for clinical practice.

Pregnancy Outcomes in Women with PCOS: Follow-Up Study of a Randomized Controlled Three-Component Lifestyle Intervention.

Women with polycystic ovary syndrome (PCOS) and excess weight often present with reproductive derangements. The first-line treatment for this population is a multi-component lifestyle intervention. This follow-up study of a randomized controlled trial based on data from the Dutch Perinatal registry was conducted to study the effect of a one-year three-component (cognitive behavioral therapy, healthy diet, and exercise) lifestyle intervention on pregnancy outcomes in women with PCOS and overweight or obesity. Women diagnosed with PCOS, a BMI ≥ 25 kg/m², and a wish to conceive were randomized to either three-component lifestyle intervention (LSI, n = 123), and care as usual (CAU, n = 60) where they were encouraged to lose weight autonomously. Conception resulting in live birth was 39.8% (49/123) within LSI and 38.3% (23/60) within CAU (p = 0.845). In total, 58.3% conceived spontaneously. Gestational diabetes (LSI: 8.2% vs. CAU: 21.7%, p = 0.133), hypertensive disorders (LSI: 8.2% vs. CAU 13.0%, p = 0.673), and preterm birth (LSI: 12.2% vs. CAU: 17.4%, p = 0.716) rates were all lower in LSI compared to CAU. This follow-up study showed no significant differences in conception resulting in live birth rates between LSI and CAU. Nonetheless, a large proportion eventually conceived spontaneously. Moreover, after LSI, the number of uneventful pregnancies was lower compared to care as usual.

The Effect of Tailored Short Message Service (SMS) on Physical Activity: Results from a Three-Component Randomized Controlled Lifestyle Intervention in Women with PCOS.

This analysis of secondary outcome measures of a randomized controlled trial was conducted to study the effect of a one-year three-component (cognitive behavioural therapy, diet, exercise) lifestyle intervention (LSI), with or without additional Short Message Service (SMS) support, on physical activity and aerobic capacity in overweight or obese women with polycystic ovary syndrome (PCOS). Women diagnosed with PCOS and a BMI > 25 kg/m2 were randomly assigned to LSI with SMS support (SMS+, n = 60), LSI without SMS support (SMS-, n = 63) or care as usual (CAU, n = 60) in order to lose weight. Based on results from the International Physical Activity Questionnaire (IPAQ), we found a significant within-group increase after one year for SMS+ in the high physical activity category (+31%, p < 0.01) and sitting behaviour decreased (Δ -871 min/week, p < 0.01). Moreover, the peak cycle ergometer workload increased within SMS+ (Δ +10 watts, p < 0.01). The SMS+ group also demonstrated a significantly different increase in walking metabolic equivalent of task minutes (METmin)/week compared with CAU after one year (Δ 1106 METmin/week, p < 0.05). Apart from this increase in walking activity, no other between-group differences were found in this trial. Overall, based on within-group results, SMS support seemed to help with improving physical activity and aerobic capacity and decreasing sedentary behaviour.

Improved Physical and Mental Health After a Combined Lifestyle Intervention with Cognitive Behavioural Therapy for Obesity.

Background: Obesity is a multifactorial, chronic, progressive disease associated with decreased health-related quality of life, comorbidities, and increased mortality risk. Lifestyle interventions, focusing on dietetics, physical exercise, and behavioral therapy, are a cornerstone of therapy. Despite this very multidisciplinary treatment approach, the definition of treatment success is often based only on a weight loss of ≥ 5%. However, the heterogeneous nature of obesity may necessitate a more comprehensive approach to assessing treatment effects. Objectives: Here, we describe changes in physiological, psychological, and behavioral health after a multidisciplinary combined lifestyle intervention (CLI). Additionally, we investigated whether these changes were related to weight loss. Methods: This prospective observational longitudinal study comprised 96 adults with obesity (73 women, 81 Caucasian) participating in a CLI at the Obesity Center CGG, Erasmus University Medical Center, Rotterdam, the Netherlands. The 1.5-year intervention comprised multidisciplinary professional guidance towards a healthy diet, increased physical activity, and included cognitive behavioral therapy. Physiological health outcomes, psychological well-being, eating behavior, and physical activity were assessed after ten weeks and 1.5 years and compared to baseline. Results: An average of 5.2% weight loss (-6.0 kg) was accompanied by a mean 9.8% decrease in fat mass (-5.9 kg; both P < 0.001) and significant improvements in metabolism, hormonal status, and immune parameters (all P < 0.05). Moreover, we observed decreased psychopathology, increased quality of life, and decreased disordered eating (all P < 0.05). Weight loss correlated with most metabolic changes (all P < 0.05) but not with most psychological/behavioral changes. Conclusions: Combined lifestyle intervention in patients with obesity was accompanied by significant improvements in body weight and body composition along with cardiometabolic, endocrine, immunological, psychological, and behavioral improvements. Interestingly, most changes in psychological and behavioral health occurred independently of weight loss. Obesity treatment success should be evaluated based on a combination of physical and patient-reported outcomes rather than weight loss alone.

Changes in eating behavior through lifestyle treatment in women with polycystic ovary syndrome (PCOS): a randomized controlled trial.

BACKGROUND: Eating behaviors like emotional eating, external eating and restrained eating play an important role in weight gain and weight loss in the general population. Improvements in eating behavior are important for long-term weight. This has not yet been studied in women with Polycystic Ovary Syndrome (PCOS). The aim of this study is to examine if a three-component lifestyle intervention (LI) is effective for improving disordered eating behavior in women with PCOS. METHODS: Women diagnosed with PCOS (N = 183), with a body mass index (BMI) > 25 kg/m2 and trying to achieve a pregnancy were either assigned to 1 year of 20 group sessions of cognitive behavioral therapy (CBT) combined with nutritional advice and exercise with or without additional feedback through Short Message Service (SMS) or Care As Usual (CAU), which includes the advice to lose weight using publicly available services. RESULTS: The Eating Disorder Examination Questionnaire (EDEQ) scores worsened in CAU (47.5%) and improved in the LI (4.2%) at 12 months. The difference between the LI and CAU was significant (P = 0.007) and resulted in a medium to large effect size (Cohen's d: - 0.72). No significant differences were observed in EDEQ scores between LI with SMS compared to LI without SMS (Cohen's d: 0.28; P = 0.399). Also, weight loss did not mediate the changes in eating behavior. An overall completion rate of 67/183 (36.6%) was observed. CONCLUSIONS: A three-component CBT lifestyle program resulted in significant improvements in disordered eating behavior compared to CAU. Changes in disordered eating behavior are important for long-term weight loss and mental health. TRIAL REGISTRATION: NTR, NTR2450. Registered 2 August 2010, https://www.trialregister.nl/trial/2344.

Lifestyle treatment in women with polycystic ovary syndrome: predictors of weight loss and dropout.

BACKGROUND: Polycystic ovary syndrome (PCOS) affects 5%-10% of women in their reproductive years. Most women with PCOS struggle with obesity during their entire life. Knowing which determinants contribute to a successful lifestyle change is important to optimize treatment options for women with PCOS. OBJECTIVE: This analysis of secondary outcome measures aimed to determine factors of ≥5% weight loss and dropout in all arms of the study and separately in the lifestyle intervention (LI) and control (care as usual [CAU]) groups. STUDY DESIGN: Women diagnosed with PCOS (N = 183) and a Body Mass Index (BMI) above 25 kg/m2 were included. Participants were assigned to (1) 20 lifestyle sessions involving cognitive behavioral therapy (CBT), (2) 20 lifestyle sessions involving CBT with additional short message service (SMS), or (3) to control (CAU). A generalized linear regression was performed to identify determinants of ≥5% weight loss. Logistic regression was performed to identify determinants of dropout. All models were corrected by including baseline weight as a covariate. RESULTS: LI (OR 4.906, p = .001) was associated with ≥5% weight loss, while higher depression scores (OR 0.549, p = .013) had a negative association. Restraint eating was a positive factor for ≥5% weight loss in LI but a negative in CAU. Higher baseline weight (OR 1.033, p = .006), LI with SMS (OR 4.424, p = .002), and higher levels of androstenedione (OR 1.167, p = .026) were associated with dropout. CONCLUSIONS: Depression and eating behavior were associated with ≥5% weight loss. Women with PCOS should be screened for depression and eating behavior before a LI.

Dietary and/or physical activity interventions in women with overweight or obesity prior to fertility treatment: protocol for a systematic review and individual participant data meta-analysis.

INTRODUCTION: Dietary and/or physical activity interventions are often recommended for women with overweight or obesity as the first step prior to fertility treatment. However, randomised controlled trials (RCTs) so far have shown inconsistent results. Therefore, we propose this individual participant data meta-analysis (IPDMA) to evaluate the effectiveness and safety of dietary and/or physical activity interventions in women with infertility and overweight or obesity on reproductive, maternal and perinatal outcomes and to explore if there are subgroup(s) of women who benefit from each specific intervention or their combination (treatment-covariate interactions). METHODS AND ANALYSIS: We will include RCTs with dietary and/or physical activity interventions as core interventions prior to fertility treatment in women with infertility and overweight or obesity. The primary outcome will be live birth. We will search MEDLINE, Embase, Cochrane Central Register of Controlled Trials and trial registries to identify eligible studies. We will approach authors of eligible trials to contribute individual participant data (IPD). We will perform risk of bias assessments according to the Risk of Bias 2 tool and a random-effects IPDMA. We will then explore treatment-covariate interactions for important participant-level characteristics. ETHICS AND DISSEMINATION: Formal ethical approval for the project (Venus-IPD) was exempted by the medical ethics committee of the University Medical Center Groningen (METc code: 2021/563, date: 17 November 2021). Data transfer agreement will be obtained from each participating institute/hospital. Outcomes will be disseminated internationally through the collaborative group, conference presentations and peer-reviewed publication. PROSPERO REGISTRATION NUMBER: CRD42021266201.

Metabolic health during a randomized controlled lifestyle intervention in women with PCOS.

CONTEXT: Women with polycystic ovary syndrome (PCOS) have an increased risk of metabolic syndrome (MetS). Both PCOS and MetS are associated with excess weight. OBJECTIVE: To examine the effect of a three-component lifestyle intervention (LSI) with or without short message service (SMS+ or SMS-, respectively) on the prevalence and severity of MetS and metabolic parameters, compared to care as usual (CAU). DESIGN: Randomized controlled trial. METHODS: Women diagnosed with PCOS and a BMI >25 kg/m2 (n = 183) were either assigned to a 1-year three-component (cognitive behavioural therapy, diet, and exercise) LSI, with or without SMS support, or to CAU which provided weight-loss advice only. Main outcome measures included changes in the prevalence of MetS, the continuous MetS severity z-score (cMetS z-score), metabolic parameters, and the impact of weight loss. RESULTS: After 1 year, the decrease in the cMetS z-score was greater in the SMS+ group than the CAU group (-0.39, P = 0.015). The prevalence of MetS changed with -21.6% (P = 0.037), -16.5% (P = 0.190), and +7.0% (P = 0.509) in both LSI groups and CAU group, respectively. A post hoc analysis for both LSI groups combined vs CAU resulted in a MetS difference of -25.9% (P = 0.046). Moreover, weight loss per se resulted in significantly favourable effects on all metabolic parameters. CONCLUSIONS: This three-component LSI was more successful in improving metabolic health compared to CAU. Therefore, we recommend this intervention to women with PCOS and excess weight, provided that a clinically relevant weight loss is being pursued.

Weight Reduction Through a Cognitive Behavioral Therapy Lifestyle Intervention in PCOS: The Primary Outcome of a Randomized Controlled Trial.

OBJECTIVE: Long-term weight loss is important and difficult to achieve for many women with polycystic ovary syndrome (PCOS). Lifestyle interventions (LS) in PCOS have shown moderate short-term effects. Three-component LS that combine nutrition advice, exercise, and cognitive behavioral therapy have not been tested in long-term interventions. METHODS: Women (N = 183) with PCOS who were trying to conceive and had BMI > 25 kg/m2 were assigned to 20 group sessions of cognitive behavioral therapy combined with nutrition advice and exercise (LS with or without Short Message Service [SMS] via mobile phone) or care as usual (CAU). RESULTS: More weight loss was observed in LS than in CAU (P < 0.001). Adding SMS was even more effective (P = 0.017). In CAU, 13 of 60 (21.8%) succeeded in achieving a 5% weight loss, as did 32 of 60 (52.8%) in LS without SMS and 54 of 63 (85.7%) in LS with SMS. The odds of achieving a 5% weight loss were 7.0 (P < 0.001) in LS compared with CAU. More than 18 of 60 (29.0%) of the women in CAU gained weight versus 5 of 60 (8.5%) and 2 of 63 (3.1%) in LS without or with SMS, respectively. The overall dropout rate was 116 of 183 (63.4%). CONCLUSIONS: A three-component LS program resulted in reasonable weight loss in women with PCOS. Adding SMS resulted in more weight loss.

Long-term effects of a three-component lifestyle intervention on emotional well-being in women with Polycystic Ovary Syndrome (PCOS): A secondary analysis of a randomized controlled trial.

Many women with Polycystic Ovary Syndrome (PCOS) report high depression rates. The relationship between PCOS and these high depression rates is unclear. Two-component lifestyle interventions have revealed short-term effects on depression scores in this group of women. In general, 3-component interventions including diet, exercise, and cognitive behavioral therapy (CBT) are more effective in the long-term to improve emotional well-being. This has not yet been studied in women with PCOS. This study examined the effect of 20 CBT lifestyle (LS) sessions combined with a healthy diet and physical therapy with or without 9 months additional feedback through Short Message Service (SMS) via mobile phone, compared to care as usual (CAU, involving advice to lose weight). In this secondary analysis, 155 women with PCOS and a BMI above 25 kg/m2 were eligible. Depression scores decreased significantly in the LS programme compared to CAU (P = 0.045). In both the LS programme without SMS (P = 0.036) and the LS programme with SMS (P = 0.011) depression scores decreased while no change was observed in CAU (P = 0.875). Self-esteem scores improved significantly in the LS programme compared to CAU (P = 0.027). No differences in body image scores were observed in LS participants compared to CAU (P = 0.087), although body image improved significantly in both the LS without SMS (P = 0.001) and with SMS (P = 0.008) study arms. We found no significant mediating role by androgens in the relationship between LS participants and emotional well-being. Only weight-loss mediated the relationship between LS and self-esteem. To conclude, a three-component lifestyle intervention programme with or without additional SMS resulted in significant improvements in depression and self-esteem compared to CAU, in women with PCOS, obesity, and a wish to achieve a pregnancy. Testosterone, androstenedione, DHEA, insulin, HOMA-IR, and cortisol did not mediate this effect. Weight loss mediated the effects on self-esteem but not on depression and body-image. This suggests that lifestyle treatment independent of weight loss can reduce depression and body-image, but both lifestyle treatment and weight loss can improve self-esteem. Thus, a three-component lifestyle intervention based on CBT could prove successful in improving mood in women with PCOS who are overweight or obese and attempting to become pregnant.