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The purpose of this study is to examine the feasibility of conducting a pilot randomized controlled trial comparing mindfulness-based stress reduction with the health enhancement program on symptoms of urinary urge incontinence in older adult women, and to establish preliminary efficacy of these two approaches on symptoms of urinary urge incontinence.
The overarching goal of this research is to evaluate potential treatment options for older women with symptoms of urinary urge incontinence, with a specific focus on Mindfulness-Based Stress Reduction, a promising therapeutic approach in preliminary studies and one increasingly used to treat symptoms associated with brain-visceral interactions. Feasibility and preliminary efficacy will be tested in two randomized study arms: a Mindfulness-Based Stress Reduction intervention group and a Health Enhancement Program intervention comparison group.
This research study will explore the feasibility and preliminary efficacy of treating urinary urge incontinence in older adult women with mindfulness-based stress reduction in comparison to the health enhancement program through a randomized controlled pilot study. Feasibility determinants will include both research feasibility (recruitment, retention, treatment fidelity) and intervention feasibility (acceptability, tolerability, treatment adherence). Clinical outcomes to evaluate preliminary intervention efficacy will include severity of urinary urge incontinence symptoms, bother of urinary urge incontinence symptoms, perceived stress, and perceived level of self-efficacy of self-management of urinary urge incontinence symptoms. Preliminary efficacy of the intervention will also be evaluated with the Patient Global Impression of Improvement, a process measure that rates the patient's "response of a condition to a therapy" (Ryan, n.d., p. 1).
This combined pilot feasibility study and randomized controlled trial will evaluate specific factors crucial to the success of a large trial to evaluate the effect of Mindfulness-Based Stress Reduction on urinary urge incontinence in older adult women. Moore (2011) recommended that the pilot study design parallel the future larger study, particularly when evaluating feasibility in the pilot study. The capacity for hypothesis testing, or establishing causal inference is limited in a pilot study due to insufficient power; however, the information from efficacy testing is vital in informing future larger scale clinical trials. This study will serve as a necessary step for the development of effectiveness trials of Mindfulness-Based Stress Reduction in treatment of urinary urge incontinence in older adult women by informing and guiding evaluation, implementation, and dissemination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness-Based Stress Reduction | Experimental | 8 week manualized, standardized mindfulness-based stress reduction program taught by a certified Mindfulness-Based Stress Reduction instructor |
|
| Health Enhancement Program | Active Comparator | 8 week manualized, standardized health enhancement program, taught by a certified health education specialist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness-Based Stress Reduction | Behavioral | This experimental arm presents the actual Mindfulness-Based Stress Reduction program as developed in the late seventies and early eighties in its original eight week format |
| Measure | Description | Time Frame |
|---|---|---|
| Number of potential participants contacted | number of people who contacted PI during recruitment process, including the place they heard about the study | 10 weeks |
| number of enrolled participants completing the study | number of participants who attended at least five of nine classes number of excused absences number of unexcused absences | 12 weeks |
| percentage of course content delivered during intervention | weekly interventionist report on what was taught participants perception of course content delivered measured by a checklist of concepts covered in the weekly interventions at study completion | 44 weeks |
| positive or negative coded responses to the question "How did it go today?" | data coded from two participants' responses after each class in each arm | 8 weeks |
| number of participants who completed each week's homework practice | participants mark on homework practice log and submit weekly | 8 weeks |
| number of participants recruited for enrollment | potential participants who were interested in the study | 10 weeks |
| number of potential participants who are eligible to enroll | number of people who passed the screening process via calls or emails |
| Measure | Description | Time Frame |
|---|---|---|
| change in symptom severity | measured by the Incontinence Severity Index | 16 weeks, 6 months |
| change in symptom bother | measured by the Overactive Bladder questionnaire, short form |
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Inclusion Criteria:
The following eligibility criteria must be met for the potential participant to be considered for enrollment.
Exclusion Criteria:
The following exclusions are applied, as they could seriously limit participation or confound participant response to the intervention:
participants must self-identify as female to participate
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| Name | Affiliation | Role |
|---|---|---|
| Katarina F Felsted, MS | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84112 | United States |
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Two armed study with intervention and comparison groups running parallel to one another
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This is a blinded, randomized controlled trial. Participants are blinded to condition.
| Health Enhancement Program | Behavioral | This active comparison arm presents the official Health Enhancement Program in its eight week format as developed by MacCoon in 2009. |
|
| 10 weeks |
| consent rate | number of participants who are willing to sign consent document at enrollment interview; number who pass the Montreal Cognitive Assessment and are willing to sign consent document | 10 weeks |
| number of participants enrolled | number of people who enrolled into the study | 10 weeks |
| number of dropouts due to stated distress from or dislike of either intervention experience (as opposed to someone needing to withdraw due to a family emergency or illness) | participant self-report of what made the intervention challenging - why they were unable or unwilling to complete the course | 8 weeks |
| - number of minutes of homework practice each week | totaled from daily numbers reported by participant | 8 weeks |
| 16 weeks, 6 months |
| change in perceived stress | measured by the Perceived Stress Scale | 16 weeks, 6 months |
| change in perceived self-efficacy | measured by the Geriatric Self Efficacy Index for Urinary Incontinence | 16 weeks, 6 months |
| self report of rate and trajectory of change in participant impression of improvement | measured by the Patient Global Impression of Improvement | 16 weeks, 6 months |
| ID | Term |
|---|---|
| D053202 | Urinary Incontinence, Urge |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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