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Efficacy of Regular Exercise During Pregnancy on the Prevention of Postpartum Depression: The PAMELA Randomized Clinical Trial.

ABSTRACT: Importance:Interventions to reduce postpartum depression have mainly focused on enhancing screening to increase treatment rates among women. Preventive approaches are timely from a population health perspective, particularly in low- and middle-income countries where access to mental health services is limited. Objective:To assess the efficacy of regular exercise during pregnancy on the prevention of postpartum depression. Design, Setting, and Participants:This randomized clinical trial examines a prespecified secondary outcome of the Physical Activity for Mothers Enrolled in Longitudinal Analysis (PAMELA) Study, a parallel-group, randomized clinical trial. This trial was nested in the 2015 Pelotas (Brazil) Birth Cohort Study. Between August 27, 2014, and March 14, 2016, pregnant women between 16 and 20 weeks of gestation with no contraindications to exercise were randomized 1:2 to the intervention group or control group via computer-generated randomization using a block size of 9. Data were analyzed from March 7 to May 2, 2018. Interventions:Participants assigned to the intervention were engaged in a 16-week supervised exercise program including aerobic and resistance training delivered in 60-minute sessions 3 times per week. Main Outcomes and Measures:Postpartum depressive symptoms were assessed with the Edinburgh Postnatal Depression Scale 3 months after birth. A score of 12 or greater was defined as screening positive for postpartum depression. Primary analysis was performed on a complete case basis (90% of participants who had the primary end point ascertained). Results:A total of 639 participants (mean [SD] age, 27.1 [5.1] years; mean gestational age, 16.5 [1.5] weeks) were randomly assigned to the intervention group (n?=?213) or control group (n?=?426). Compliance with the protocol, defined as having engaged in at least 70% of exercise sessions, was low (40.4%). There was no significant difference in mean (SD) scores for postpartum depression between the intervention group (4.8 [3.7]) and the control group (5.4 [4.1]) (mean difference, -0.6; 95% CI, -1.3 to 0.1). There was also no significant difference in rates of postpartum depression between the intervention group (12 of 192 [6.3%]) and the control group (36 of 387 [9.3%]) (odds ratio, 0.65; 95% CI, 0.33-1.28). Instrumental variable analysis indicated that noncompliance may have attenuated the effect estimates obtained in the primary analysis. Conclusions and Relevance:Moderate-intensity exercise during pregnancy did not lead to significant reductions in postpartum depression. However, noncompliance to the intervention protocol was substantial and may have led to underestimations of the possible benefits of exercise. The point estimates for this study are in the same direction as the previous randomized clinical trial on this topic. Future studies on how to promote regular exercise during pregnancy to improve compliance, particularly targeting young and less educated women, are warranted before further trials are undertaken. Trial Registration:ClinicalTrials.gov Identifier: NCT02148965.

SUBMITTER: Coll CVN

PROVIDER: S-EPMC6324311 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:ImportanceLow-income and minority mothers experience a disproportionate incidence of depression and lack access to treatment services. Development of prevention strategies in accessible community-based venues is a potentially important public health strategy.ObjectiveTo determine the efficacy of a depression prevention strategy embedded in Head Start.Design, setting, and participantsThis randomized clinical trial was performed from February 15, 2011, through May 9, 2016, at 6 Head Start agencies serving families at or below the federal poverty level. Participants included mothers with depressed mood, anhedonia, or depression history but who were not in a current major depressive episode. Participants were followed up for 12 months with masked outcome assessments. Final follow-up was completed on May 9, 2016.InterventionsParticipants were randomized to a problem-solving education (PSE) intervention (n = 111) or usual Head Start services (n = 119).Main outcomes and measuresPrimary outcomes were problem-solving skills and depressive symptoms. To capture the chronicity and intensity of symptoms, the Quick Inventory of Depressive Symptoms was administered bimonthly, and rates of clinically significant symptom elevations were compared across groups. Secondarily, the presence of a major depressive episode was assessed using the Structured Clinical Interview for DSM-IV Axis I Disorders.ResultsAmong the 230 participants, 152 (66.1%) were Hispanic, with a mean (SD) age of 31.4 (7.3) years. An intention-to-treat analysis among 223 participants contributing follow-up data found no differences in problem-solving skills across groups. The mean (SD) number of depressive symptom elevations among the PSE participants was 0.84 (1.39) compared with 1.12 (1.47) among the usual service participants (adjusted incident rate ratio [aIRR], 0.60; 95% CI, 0.41-0.90). In analyses stratified according to baseline depressive symptoms, PSE exerted a preventive effect among those with lower-level baseline symptoms, with a mean (SD) of 0.39 (0.84) elevations among PSE participants compared with 0.88 (1.37) among usual service participants (aIRR, 0.39; 95% CI, 0.21-0.75). However, no difference was observed among those with higher-level baseline symptoms (mean [SD] elevations, 2.06 [1.92] for PSE and 2.00 [1.91] for usual service; aIRR, 1.10; 95% CI, 0.67-1.80). Analysis of symptom scores followed the same pattern, with an adjusted mean reduction of 1.33 (95% CI, 0.36-2.29) among participants with lower-level baseline symptoms.Conclusions and relevanceThe PSE intervention is efficacious in preventing depressive symptom episodes and performs optimally among those with initial low-level symptoms. Additional effectiveness studies in Head Start are necessary to develop meaningful public health programs.Trial registrationclinicaltrials.gov Identifier: NCT01298804.

Project description:ImportancePostpartum depression (PPD) is one of the most common medical complications during and after pregnancy, negatively affecting both mother and child.ObjectiveTo demonstrate the efficacy and safety of zuranolone, a neuroactive steroid γ-aminobutyric acid receptor-positive allosteric modulator, in PPD.Design, setting, and participantsThis phase 3, double-blind, randomized, outpatient, placebo-controlled clinical trial was conducted between January 2017 and December 2018 in 27 enrolling US sites. Participant were women aged 18 to 45 years, 6 months or fewer post partum, with PPD (major depressive episode beginning third trimester or ≤4 weeks postdelivery), and baseline 17-item Hamilton Rating Scale for Depression (HAMD-17) score of 26 or higher. Analysis was intention to treat and began December 2018 and ended March 2019.InterventionsRandomization 1:1 to placebo:zuranolone, 30 mg, administered orally each evening for 2 weeks.Main outcomes and measuresPrimary end point was change from baseline in HAMD-17 score for zuranolone vs placebo at day 15. Secondary end points included changes from baseline in HAMD-17 total score at other time points, HAMD-17 response (≥50% score reduction) and remission (score ≤7) rates, Montgomery-Åsberg Depression Rating Scale score, and Hamilton Rating Scale for Anxiety score. Safety was assessed by adverse events and clinical assessments.ResultsOf 153 randomized patients, the efficacy set comprised 150 patients (mean [SD] age, 28.3 [5.4] years), and 148 (98.7%) completed treatment. A total of 76 patients were randomized to placebo, and 77 were randomized to zuranolone, 30 mg. Zuranolone demonstrated significant day 15 HAMD-17 score improvements from baseline vs placebo (-17.8 vs -13.6; difference, -4.2; 95% CI, -6.9 to -1.5; P = .003). Sustained differences in HAMD-17 scores favoring zuranolone were observed from day 3 (difference, -2.7; 95% CI, -5.1 to -0.3; P = .03) through day 45 (difference, -4.1; 95% CI, -6.7 to -1.4; P = .003). Sustained differences at day 15 favoring zuranolone were observed in HAMD-17 response (odds ratio, 2.63; 95% CI, 1.34-5.16; P = .005), HAMD-17 score remission (odds ratio, 2.53; 95% CI, 1.24-5.17; P = .01), change from baseline for Montgomery-Åsberg Depression Rating Scale score (difference, -4.6; 95% CI, -8.3 to -0.8; P = .02), and Hamilton Rating Scale for Anxiety score (difference, -3.9; 95% CI, -6.7 to -1.1; P = .006). One patient per group experienced a serious adverse event (confusional state in the zuranolone group and pancreatitis in the placebo group). One patient in the zuranolone group discontinued because of an adverse event vs none for placebo.Conclusions and relevanceIn this randomized clinical trial, zuranolone improved the core symptoms of depression as measured by HAMD-17 scores in women with PPD and was generally well tolerated, supporting further development of zuranolone in the treatment of PPD.Trial registrationClinicalTrials.gov Identifier: NCT02978326.

Project description:Background Approximately 13–19% of postpartum women experience postpartum depression and a majority report at least some stress during the postpartum phase. Traditional interventions such as psychotherapy and antidepressant medications are often not feasible or desirable. The purpose of this study was to examine two low cost, brief, accessible interventions designed to prevent postpartum depression and perceived stress among women at high risk. Methods Participants (n = 450) who were on average four weeks postpartum, had a history of depression before pregnancy, and exercised less than 60 min per week were randomly assigned to one of the following three conditions: (1) 6-month telephone-based exercise intervention; (2) 6-month telephone-based wellness/support intervention (e.g., healthy eating, sleep, and perceived stress); or (3) usual care. Results Overall, 2.4% of participants met criteria for depression at 6 months and 3.6% at 9 months with no differences between groups. At 6 months following randomization, median symptoms of depression were significantly lower among wellness participants compared to usual care participants (b = − 1.00, SE = 0.46, p = .03). Perceived stress at 6 months post-randomization was significantly lower among exercise vs. usual care participants (b = − 2.00, SE = .98, p = .04) and exercise vs. wellness participants (b = − 2.20, SE = 1.11, p = .04). Conclusions The wellness intervention was efficacious for preventing symptoms of depression; however, postpartum depression that met the diagnostic criteria was surprisingly low in all conditions among this at risk sample of postpartum women. Exercise interventions may have a protective effect on perceived stress among women at risk for postpartum depression. Practitioners should consider integrating exercise and wellness interventions into postpartum care. Trial registration Clinical Trials Number: NCT01883479 (06/21/2013).

Project description:To compare the efficacy of behavior activation (BA) + low vision rehabilitation (LVR) with supportive therapy (ST) + LVR to prevent depressive disorders in patients with age-related macular degeneration (AMD).Single-masked, attention-controlled, randomized, clinical trial with outcome assessment at 4 months.Patients with AMD and subsyndromal depressive symptoms attending retina practices (n = 188).Before randomization, all subjects had 2 outpatient LVR visits, and were then randomized to in-home BA+LVR or ST+LVR. Behavior activation is a structured behavioral treatment that aims to increase adaptive behaviors and achieve valued goals. Supportive therapy is a nondirective, psychological treatment that provides emotional support and controls for attention.The Diagnostic and Statistical Manual IV defined depressive disorder based on the Patient Health Questionnaire-9 (primary outcome), Activities Inventory, National Eye Institute Vision Function Questionnaire-25 plus Supplement (NEI-VFQ), and NEI-VFQ quality of life (secondary outcomes).At 4 months, 11 BA+LVR subjects (12.6%) and 18 ST+LVR subjects (23.4%) developed a depressive disorder (relative risk [RR], 0.54; 95% CI, 0.27-1.06; P = 0.067). In planned adjusted analyses the RR was 0.51 (95% CI, 0.27-0.98; P = 0.04). A mediational analysis suggested that BA+LVR prevented depression to the extent that it enabled subjects to remain socially engaged. In addition, BA+LVR was associated with greater improvements in functional vision than ST+LVR, although there was no significant between-group difference. There was no significant change or between-group difference in quality of life.An integrated mental health and low vision intervention halved the incidence of depressive disorders relative to standard outpatient LVR in patients with AMD. As the population ages, the number of persons with AMD and the adverse effects of comorbid depression will increase. Promoting interactions between ophthalmology, optometry, rehabilitation, psychiatry, and behavioral psychology may prevent depression in this population.

Project description:BackgroundSpecialized, individualized exercise programs that increase self-efficacy (SE) are essential for the development and maintenance of regular exercise. The objective of this study is to examine the effect of customized exercise programs (CEPs) implemented by physical therapists in improving exercise-related SE and promoting behavioral changes among elderly individuals who do not exercise regularly compared with commonly prescribed exercises.MethodsIn this randomized controlled study, the sampling frame consisted of participants in an annual town-sponsored medical check-up. The inclusion criteria were no regular exercise and age of 65-74 years at enrollment. The subjects in the intervention group (CEP group) were instructed to perform individualized exercises prescribed based on an original algorithm. Data collection was performed at baseline and 3, 6, 9, and 12 months after exercise instruction. The primary outcome was SE for exercise at the last time point. Secondary outcomes were SE for exercise, stage of change in exercise behavior, knee pain, and low back pain at each evaluation time point.ResultsFifty subjects (CEP group n = 26; control group n = 24) were randomized. In the CEP group, 25 of 26 subjects were analyzed at 3 months, 26 of 26 subjects were analyzed at 6 and 9 months, and 25 of 26 subjects were analyzed at 12 months. In the control group, 23 of 24 subjects were analyzed at 3, 6, 9, and 12 months. SE for exercise improved 24.0% (CEP group 30.8%; control group 16.7%) compared to baseline. No significant differences were observed in the primary outcome. SE for exercise was significantly lower at 9 and 12 months compared with baseline in the control group. Stage of change for exercise behavior was significantly higher at 3 months compared with baseline in the CEP group and at 6 months in the control group. Knee pain was worse at 3 months compared with baseline in the control group.ConclusionsThis study suggested that exercise instruction with CEPs contributes to the maintenance of SE for exercise and is useful for changing exercise behavior in elderly individuals who do not regularly exercise.Trial registrationUMIN000027240 , registered on 03/05/2017.

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Efficacy of Regular Exercise During Pregnancy on the Prevention of Postpartum Depression: The PAMELA Randomized Clinical Trial.

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