behavior therapy

Project nature: promoting outdoor physical activity in children via primary care

Author/s: 
Georgia M Griffin, Carolina Nieto, Kirsten Senturia, Marshall Brown, Kimberly Garrett, Elizabeth Nguyen, Danette Glassy, Emily Kroshus, Pooja Tandon

Background

Families face a range of barriers in supporting their children’s active play in nature including family circumstances, environmental constraints, and behavioral factors. Evidence-based strategies to address these barriers are needed. We aimed to develop and pilot test a primary care-based family-centered behavioral intervention to promote active outdoor play in 4–10 year-old children.

Methods

Project Nature, a provider-delivered intervention that provides informational resources and an age-appropriate toy for nature play, was initially developed for children ages 0–3. With stakeholder input, we adapted existing materials for 4–10 year-olds and conducted usability testing at an urban clinic serving families from diverse backgrounds. Subsequently, we conducted a mix-methods pilot study to evaluate intervention feasibility and acceptability. Parents of 4–10 year-olds completed pre- and post-surveys (n = 22), and a purposive subset (n = 10) completed qualitative interviews. Post-intervention, pediatric providers (n = 4) were interviewed about their implementation experiences.

Results

The majority (82%) of parents liked the information provided and the remaining (18%) were neutral. Qualitatively, parents reported that: the toy provided a tangible element to help children and parents be active, they did not use the website, and they wished the intervention emphasized strategies for physical activity during cold and wet seasons. Providers felt the materials facilitated discussion about behavior change with families. There were no statistically significant changes in PA and outdoor time pre- and post-intervention.

Conclusions

Project Nature was welcomed by providers and families and may be a practical intervention to promote outdoor active play during well-child visits. Providing an age-appropriate nature toy seemed to be a critical component of the intervention, and may be worth the additional cost, time and storage space required by clinics. Building from these results, Project Nature should be revised to better support active outdoor play during suboptimal weather and evaluated to test its efficacy in a fully-powered trial.

Effect of Psychological and Medication Therapies for Insomnia on Daytime Functions: A Randomized Clinical Trial

Author/s: 
Charles M Morin, Si-Jing Chen, Hans Ivers, Simon Beaulieu-Bonneau, Andrew D Krystal, Bernard Guay, Lynda Bélanger, Ann Cartwright, Bryan Simmons, Manon Lamy, Mindy Busby, Jack D Edinger

Importance: Daytime functional impairments are the primary reasons for patients with insomnia to seek treatment, yet little is known about what the optimal treatment is for improving daytime functions and how best to proceed with treatment for patients whose insomnia has not remitted.

Objectives: To compare the efficacy of behavioral therapy (BT) and zolpidem as initial therapies for improving daytime functions among patients with insomnia and evaluate the added value of a second treatment for patients whose insomnia has not remitted.

Design, setting, and participants: In this sequential multiple-assignment randomized clinical trial conducted at institutions in Canada and the US, 211 adults with chronic insomnia disorder were enrolled between May 1, 2012, and December 31, 2015, and followed up for 12 months. Statistical analyses were performed on an intention-to-treat basis in April and October 2023.

Interventions: Participants were randomly assigned to either BT or zolpidem as first-stage therapy, and those whose insomnia had not remitted received a second-stage psychological therapy (BT or cognitive therapy) or medication therapy (zolpidem or trazodone).

Main outcomes and measures: Study outcomes were daytime symptoms of insomnia, including mood disturbances, fatigue, functional impairments of insomnia, and scores on the 36-item Short-Form Health Survey (SF-36) physical and mental health components.

Results: Among 211 adults with insomnia (132 women [63%]; mean [SD] age, 45.6 [14.9] years), 104 were allocated to BT and 107 to zolpidem at the first stage. First-stage treatment with BT or zolpidem yielded significant and equivalent benefits for most of the daytime outcomes, including depressive symptoms (Beck Depression Inventory-II mean score change, -3.5 [95% CI, -4.7 to -2.3] vs -4.3 [95% CI, -5.7 to -2.9]), fatigue (Multidimensional Fatigue Inventory mean score change, -4.7 [95% CI, -7.3 to -2.2] vs -5.2 [95% CI, -7.9 to -2.5]), functional impairments (Work and Social Adjustment Scale mean score change, -5.0 [95% CI, -6.7 to -3.3] vs -5.1 [95% CI, -7.2 to -2.9]), and mental health (SF-36 mental health subscale mean score change, 3.5 [95% CI, 1.9-5.1] vs 2.5 [95% CI, 0.4-4.5]), while BT produced larger improvements for anxiety symptoms relative to zolpidem (State-Trait Anxiety Inventory mean score change, -4.1 [95% CI, -5.8 to -2.4] vs -1.2 [95% CI, -3.0 to 0.5]; P = .02; Cohen d = 0.55). Second-stage therapy produced additional improvements for the 2 conditions starting with zolpidem at posttreatment in fatigue (Multidimensional Fatigue Inventory mean score change: zolpidem plus BT, -3.8 [95% CI, -7.1 to -0.4]; zolpidem plus trazodone, -3.7 [95% CI, -6.3 to -1.1]), functional impairments (Work and Social Adjustment Scale mean score change: zolpidem plus BT, -3.7 [95% CI, -6.4 to -1.0]; zolpidem plus trazodone, -3.3 [95% CI, -5.9 to -0.7]) and mental health (SF-36 mental health subscale mean score change: zolpidem plus BT, 5.3 [95% CI, 2.7-7.9]; zolpidem plus trazodone, 2.0 [95% CI, 0.1-4.0]). Treatment benefits achieved at posttreatment were well maintained throughout the 12-month follow-up, and additional improvements were noted for patients receiving the BT treatment sequences.

Conclusions and relevance: In this randomized clinical trial of adults with insomnia disorder, BT and zolpidem produced improvements for various daytime symptoms of insomnia that were no different between treatments. Adding a second treatment offered an added value with further improvements of daytime functions.

Trial registration: ClinicalTrials.gov Identifier: NCT01651442.

Nonsurgical Treatments for Urinary Incontinence in Women: A Systematic Review Update

Author/s: 
Balk, Ethan, Adam, Gaelen P., Kimmel, Hannah, Rofeberg, Valerie, Saeed, Iman, Jeppson, Peter, Trikalinos, Thomas

Introduction. About 17 percent of adult women have had urinary incontinence (UI), classified as stress, urgency, or mixed. Stress UI is associated with an inability to retain urine with activities that increase intraabdominal pressure. Urgency UI is associated with the sudden, compelling urge to void. Mixed UI occurs when both are present.

Methods. We updated the Agency for Healthcare Research and Quality's 2012 systematic review with new literature searches in MEDLINE®, the Cochrane Central Trials Registry, the Cochrane Database of Systematic Reviews, and Embase® from 2011 through December 4, 2017. We included UI outcomes (cure, improvement, satisfaction), quality of life, and adverse events. For UI outcomes, we conducted network meta-analyses, combining direct and indirect comparisons across studies. Quality of life and adverse event outcomes are narratively described.

Results. We identified 233 eligible studies, of which 140 reported on UI outcomes, 96 on quality of life, and 127 on adverse events. Studies evaluated 16 categories of interventions with 53 specific interventions. Fourteen intervention categories have been evaluated for UI outcomes; all except hormones and periurethral bulking agents were more effective to achieve at least one favorable UI outcome than no treatment (variable strength of evidence [SoE]). Among 1st or 2nd line interventions for stress UI, behavioral therapy (BT, alone and in combination with hormones) was more effective than either alpha agonists or hormones to achieve cure or improvement (moderate SoE); alpha agonists were more effective than hormones to achieve improvement (moderate SoE). Among treatments used as 1st or 2nd line interventions for urgency UI, BT was significantly more effective than anticholinergics to achieve cure or improvement (high SoE). Among 3rd line interventions for stress UI, intravesical pressure release, but not periurethral bulking agents, was more effective than no treatment (variable SoE). Neuromodulation, which is commonly used for treatment of urgency UI, is more effective than no treatment of stress UI for cure, improvement, and satisfaction (high SoE). Among studies of women with only stress UI, indirect evidence suggests that intravesical pressure release is more effective to achieve improvement than combination BT and neuromodulation, and triple combination neuromodulation, hormones, and BT may be more effective than either periurethral bulking or combination neuromodulation and BT (all low SoE). Among treatments used as 3rd line interventions for urgency UI, both neuromodulation and onabotulinum toxin A (BTX) are more effective than no treatment (high SoE), and BTX may be more effective than neuromodulation to achieve cure (low SoE). BT, neuromodulation, and anticholinergics resulted in better quality of life than no treatment (low SoE). Urinary tract infections (UTIs) were reported in 11 percent of women receiving transcutaneous electrical nerve stimulation and erosion in 1.6 percent of women with the periurethral bulking agent macroplastique (low SoE). Dry mouth was the most commonly reported adverse event for the anticholinergic oxybutynin (36%) and the alpha agonist duloxetine (13%) (high SoE). BTX was associated with UTIs (36%) and urinary retention (10% to 20%) (moderate SoE). Constitutional adverse events (e.g., nausea, insomnia, fatigue) were common with duloxetine (moderate SoE).

Conclusions. Network meta-analyses demonstrated that most nonpharmacological and pharmacological interventions are more likely than no treatment to improve UI outcomes and quality of life. BT, alone or in combination with other interventions, is generally more effective than 2nd line (pharmacological) therapies alone for both stress and urgency UI. Common adverse events with pharmacological treatments include dry mouth, nausea, and fatigue. BTX is associated with urinary infections and retention. Periurethral bulking agents are associated with erosion and need for surgical removal. Large gaps remain in the literature regarding head-to-head comparisons of individual interventions.

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