scholarly journals Effectiveness of Group Problem Management Plus (Group-PM+) for adults affected by humanitarian crises Nepal: study protocol for a cluster randomised controlled trial (c-RCT)

2019 ◽  
Author(s):  
E van 't Hof ◽  
Manaswi Sangraula ◽  
Nagendra P Luitel ◽  
Elizabeth L. Turner ◽  
Kedar Marahatta ◽  
...  
Keyword(s):  
Psychological Distress ◽  
Controlled Trial ◽  
General Health Questionnaire ◽  
Scale Up ◽  
Secondary Outcome ◽  
Psychological Interventions ◽  
Local Health ◽  
Family Meeting ◽  
Problem Management ◽  
Randomized Controlled

Abstract Background Globally, the lack of availability of psychological services for people exposed to adversities has led to the development of a range of scalable psychological interventions with features that enable better scale-up. Problem Management Plus (PM+) is a brief intervention of 5 sessions that can be delivered by non-specialists. It is designed for people in communities in low- and middle-income countries (LMIC) affected by any kind of adversity. Two recent randomized controlled trials in Pakistan and Kenya demonstrated the effectiveness of individually delivered PM+. A group version of PM+ has been developed to make the intervention more scalable and acceptable. This paper describes the protocol for a cluster randomized controlled trial (c-RCT) on locally adapted Group PM+ in Nepal. Methods: This c-RCT will compare Group PM+ to enhanced usual care (EUC) in participants with high levels of psychological distress recruited from the community. The study is designed as a two-arm, single-blind c-RCT that will be conducted in a community-based setting in Morang, a flood affected district in Eastern Nepal. Randomization will occur at ward level, the smallest administrative level in Nepal, with 72 enrolled wards allocated to Group PM+ or to EUC (ratio 1:1). Group PM+ consists of five approximately 2.5 hour sessions, in which participants are taught techniques to manage their stressors and problems, and is delivered by trained and supervised community psychosocial workers (CPSWs). EUC consists of a family meeting with (a) basic information on adversity and mental health, (b) benefits of getting support, (c) information on seeking services from local health facilities with mhGAP-trained staff. The primary outcome measure is levels of individual psychological distress at endline (equivalent to 20±1 weeks after baseline), measured by the General Health Questionnaire (GHQ-12). Secondary outcome measures include levels of functioning, depressive symptoms, post-traumatic stress disorder symptoms, levels of social support, somatic symptoms and ways of coping. We hypothesize that skills acquired will mediate any impact of the intervention. Discussion: This c-RCT will contribute to the growing evidence-base for transdiagnostic psychological interventions delivered by non-specialists for people in communities affected by adversity. If Group PM+ is proven effective the intervention manual will be released for use giving the opportunity to further adaptation and implementation of the intervention in diverse settings with communities that require better access to psychological interventions.

scholarly journals Effectiveness of Group Problem Management Plus (Group-PM+) for adults affected by humanitarian crises Nepal: study protocol for a cluster randomised controlled trial (c-RCT)

2019 ◽  
Author(s):  
E van 't Hof ◽  
Manaswi Sangraula ◽  
Nagendra P Luitel ◽  
Elizabeth L. Turner ◽  
Kedar Marahatta ◽  
...  
Keyword(s):  
Psychological Distress ◽  
Controlled Trial ◽  
General Health Questionnaire ◽  
Scale Up ◽  
Secondary Outcome ◽  
Psychological Interventions ◽  
Local Health ◽  
Post Traumatic Stress ◽  
Problem Management ◽  
Randomized Controlled

Abstract Background Globally, the lack of availability of psychological services for people exposed to adversities has led to the development of a range of scalable psychological interventions with features that enable better scale-up. Problem Management Plus (PM+) is a brief intervention of 5 sessions that can be delivered by non-specialists. It is designed for people in communities in low- and middle-income countries (LMIC) affected by any kind of adversity. Two recent randomized controlled trials in Pakistan and Kenya demonstrated the effectiveness of individually delivered PM+. A group version of PM+ has been developed to make the intervention more scalable and acceptable. This paper describes the protocol for a cluster randomized controlled trial (c-RCT) on locally adapted Group PM+ in Nepal. Methods: This c-RCT will compare Group PM+ to enhanced usual care (EUC) in participants with high levels of psychological distress recruited from the community. The study is designed as a two-arm, single-blind c-RCT that will be conducted in a community-based setting in Morang, a flood affected district in Eastern Nepal. Randomization will occur at ward level, the smallest administrative level in Nepal, with 72 enrolled wards allocated to Group PM+ or to EUC (ratio 1:1). Group PM+ consists of five approximately 2.5 hour sessions, in which participants are taught techniques to manage their stressors and problems, and is delivered by trained and supervised community psychosocial workers (CPSWs). EUC consist of a meeting with (a) basic information on adversity and mental health, (b) benefits of getting support, (c) information on seeking services from local health facilities with mhGAP-trained staff. The primary outcome measure is levels of individual psychological distress 20 weeks after baseline, measured by the General Health Questionnaire (GHQ-12). Secondary outcome measures include levels of functioning, depressive symptoms, post-traumatic stress disorder symptoms, levels of social support, somatic symptoms and ways of coping. We hypothesize that skills acquired will mediate any impact of the intervention. Discussion: This c-RCT will contribute to the growing evidence-base for transdiagnostic psychological interventions delivered by non-specialists for people in communities affected by adversity. If Group PM+ is proven effective the intervention manual will be released for use giving the opportunity to further adaptation and implementation of the intervention in diverse settings with communities that require better access to psychological interventions.

scholarly journals Brief videoconferencing psychological intervention for reducing COVID-19 related distress: study protocol for a randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Dharani Keyan ◽  
Katie Dawson ◽  
Suzanna Azevado ◽  
Srishti Yadav ◽  
Jenny Tran ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Study Protocol ◽  
Sleep Problems ◽  
Psychological Intervention ◽  
Controlled Trial ◽  
General Health Questionnaire ◽  
Trial Registration ◽  
World Health ◽  
Randomized Controlled

Abstract Background Globally COVID-19 has had a profound impact on the psychological wellbeing of millions of people, and there is an urgent imperative to address elevated levels of distress during the COVID-19 pandemic. The World Health Organization (WHO) has developed Problem Management Plus (PM+), a low intensity psychological intervention for adults experiencing psychological distress. This paper outlines the study protocol for a trial that tests the effectiveness of an adapted version of PM+ to reduce distress associated with COVID-19. Methods A single-blind, parallel, randomized controlled trial will be carried out for distressed people across Australia. via video conferencing on a small group basis. Following informed consent, adults that screen positive for levels of psychological distress (General Health Questionnaire-12 (GHQ-12 score ≥ 3) and have access to videoconferencing platform will be randomised to an adapted version of gPM+ (n = 120) or enhanced treatment as usual (ETAU) (n = 120). The primary outcome will be reduction in psychological distress including anxiety and depression at 2-months post treatment. Secondary outcomes include worry, sleep problems, anhedonia, social support, and stress in relation to COVID-19. Discussion The trial aims assess whether an adapted version of videoconferencing PM+ that is specifically designed to target COVI-19 related distress will result in reduced distress relative to enhanced usual care. Trial registration This trial was prospectively registered on the ANZCTR on 14/4/20 (ACTRN12620000468921).

scholarly journals Effectiveness of Group Problem Management Plus, a brief psychological intervention for adults affected by humanitarian disasters in Nepal: A cluster randomized controlled trial

PLoS Medicine ◽  
2021 ◽  
Vol 18 (6) ◽  
pp. e1003621
Author(s):  
Mark J. D. Jordans ◽  
Brandon A. Kohrt ◽  
Manaswi Sangraula ◽  
Elizabeth L. Turner ◽  
Xueqi Wang ◽  
...  
Keyword(s):  
Psychological Distress ◽  
Functional Impairment ◽  
Psychological Treatment ◽  
Controlled Trial ◽  
Depression Symptoms ◽  
Ptsd Symptoms ◽  
Problem Management ◽  
Humanitarian Emergencies ◽  
Randomized Controlled ◽  
Cluster Randomized

Background Globally, 235 million people are impacted by humanitarian emergencies worldwide, presenting increased risk of experiencing a mental disorder. Our objective was to test the effectiveness of a brief group psychological treatment delivered by trained facilitators without prior professional mental health training in a disaster-prone setting. Methods and findings We conducted a cluster randomized controlled trial (cRCT) from November 25, 2018 through September 30, 2019. Participants in both arms were assessed at baseline, midline (7 weeks post-baseline, which was approximately 1 week after treatment in the experimental arm), and endline (20 weeks post-baseline, which was approximately 3 months posttreatment). The intervention was Group Problem Management Plus (PM+), a psychological treatment of 5 weekly sessions, which was compared with enhanced usual care (EUC) consisting of a family psychoeducation meeting with a referral option to primary care providers trained in mental healthcare. The setting was 72 wards (geographic unit of clustering) in eastern Nepal, with 1 PM+ group per ward in the treatment arm. Wards were eligible if they were in disaster-prone regions and residents spoke Nepali. Wards were assigned to study arms based on covariate constrained randomization. Eligible participants were adult women and men 18 years of age and older who met screening criteria for psychological distress and functional impairment. Outcomes were measured at the participant level, with assessors blinded to group assignment. The primary outcome was psychological distress assessed with the General Health Questionnaire (GHQ-12). Secondary outcomes included depression symptoms, posttraumatic stress disorder (PTSD) symptoms, “heart–mind” problems, social support, somatic symptoms, and functional impairment. The hypothesized mediator was skill use aligned with the treatment’s mechanisms of action. A total of 324 participants were enrolled in the control arm (36 wards) and 319 in the Group PM+ arm (36 wards). The overall sample (N = 611) had a median age of 45 years (range 18–91 years), 82% of participants were female, 50% had recently experienced a natural disaster, and 31% had a chronic physical illness. Endline assessments were completed by 302 participants in the control arm (36 wards) and 303 participants in the Group PM+ arm (36 wards). At the midline assessment (immediately after Group PM+ in the experimental arm), mean GHQ-12 total score was 2.7 units lower in Group PM+ compared to control (95% CI: 1.7, 3.7, p < 0.001), with standardized mean difference (SMD) of −0.4 (95% CI: −0.5, −0.2). At 3 months posttreatment (primary endpoint), mean GHQ-12 total score was 1.4 units lower in Group PM+ compared to control (95% CI: 0.3, 2.5, p = 0.014), with SMD of −0.2 (95% CI: −0.4, 0.0). Among the secondary outcomes, Group PM+ was associated with endline with a larger proportion attaining more than 50% reduction in depression symptoms (29.9% of Group PM+ arm versus 17.3% of control arm, risk ratio = 1.7, 95% CI: 1.2, 2.4, p = 0.002). Fewer participants in the Group PM+ arm continued to have “heart–mind” problems at endline (58.8%) compared to the control arm (69.4%), risk ratio = 0.8 (95% CI, 0.7, 1.0, p = 0.042). Group PM+ was not associated with lower PTSD symptoms or functional impairment. Use of psychosocial skills at midline was estimated to explain 31% of the PM+ effect on endline GHQ-12 scores. Adverse events in the control arm included 1 suicide death and 1 reportable incidence of domestic violence; in the Group PM+ arm, there was 1 death due to physical illness. Study limitations include lack of power to evaluate gender-specific effects, lack of long-term outcomes (e.g., 12 months posttreatment), and lack of cost-effectiveness information. Conclusions In this study, we found that a 5-session group psychological treatment delivered by nonspecialists modestly reduced psychological distress and depression symptoms in a setting prone to humanitarian emergencies. Benefits were partly explained by the degree of psychosocial skill use in daily life. To improve the treatment benefit, future implementation should focus on approaches to enhance skill use by PM+ participants. Trial registration ClinicalTrials.gov NCT03747055.

scholarly journals Internet-Based Cognitive Behavioral Therapy for Psychological Distress Associated With the COVID-19 Pandemic: A Pilot Randomized Controlled Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Victoria Aminoff ◽  
Malin Sellén ◽  
Elise Sörliden ◽  
Mikael Ludvigsson ◽  
Matilda Berg ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Psychological Distress ◽  
Alcohol Use ◽  
Psychological Treatment ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Symptom Profile

Background: The COVID-19 pandemic has been associated with various negative psychological consequences. This is a challenge for the society as regular psychological services cannot be offered to the same extent as before the pandemic. In addition to the requirement of social distancing, there is a need to adjust psychological treatment components like exposure to avoid increasing the spread of the infection. Internet-delivered cognitive behavior therapy (ICBT) has an established evidence base for a range of psychiatric problems and has been suggested as one possible approach to deal with the situation. This study aimed to conduct a randomized controlled pilot trial during the summer of 2020 with a broad focus on psychological distress and a treatment approach that tailors the intervention based on symptom profile and preferences.Methods: Following the advertisement and interview, we included 52 participants with elevated levels of psychological distress. They were randomly allocated to either a 7-week-long individually tailored ICBT (n = 26) or a wait-list control condition (n = 26). Measures of depression and quality of life were used as primary outcomes. We also included secondary outcome measures of anxiety, insomnia, trauma, stress, anger, and alcohol use. For screening, we used the CoRonavIruS Health Impact Survey (CRISIS).Results: Overall moderate to large between-group effects were found at post-treatment in favor of the treatment on measures of both depression [Beck Depression Inventory (BDI); Cohens d = 0.63; Patient Health Questionnaire (PHQ-9): d = 0.62] and anxiety [Generalized Anxiety Disorder-7-item scale (GAD-7); d = 0.82]. This was also observed for stress symptoms [Perceived Stress Scale (PSS-14); d = 1.04]. No effects were seen on measures of quality of life, insomnia, symptoms of post-traumatic stress, and anger. There was an effect on alcohol use [Alcohol Use Disorder Identification Test (AUDIT); d = 0.54], which was not of clinical relevance.Conclusion: Individually tailored ICBT shows initial promise as a way to reduce psychological problems in association with the COVID-19 pandemic. A possible limitation was that the trial was conducted when the effects of the pandemic were decreasing and when fewer people were affected by the restrictions (e.g., the summer of 2020).

Study Protocol for a Randomized Controlled Trial: Peer to Peer Group Problem Management Plus (PM+) for Adult Syrian Refugees in Turkey

2019 ◽  
Author(s):  
Ersin Uygun ◽  
Zeynep Ilkkursun ◽  
Marit Sijbrandij ◽  
A. Tamer Aker ◽  
Richard Bryant ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Posttraumatic Stress ◽  
Functional Impairment ◽  
Peer Group ◽  
Controlled Trial ◽  
Syrian Refugees ◽  
Problem Management ◽  
Randomized Controlled

Abstract Background: A large proportion of Syrians have been exposed to potentially traumatic events, multiple losses, breakdown of supportive social networks and many of them have sought refuge in host countries where they also face post migration living difficulties such as discrimination or/and integration problems. These adversities may put Syrian refugees at high risk for common mental disorders. In response to this, the World Health Organization (WHO) developed a transdiagnostic scalable psychological intervention called Problem Management Plus (PM+) to reduce psychological distress among populations exposed to adversities. PM+ has been adapted for Syrian refugees and can be delivered by non-specialist peer lay persons in the community. Methods: A randomized controlled trial (RCT) will be conducted with 380 Syrian refugees in Turkey. After providing informed consent, participants with high levels of psychological distress (scoring >15 on the Kessler-10 Psychological Distress Scale (K10)) and functional impairment (scoring >16 on the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)) will be randomly assigned to Group PM+/Enhanced Care As Usual (Group PM+/E-CAU) (n = 190) or enhanced-care-as-usual (E-CAU) (n = 190). Outcome assessments will take place 1-week after the 5 th session (post assessment), 3 months after the 5 th session and 12 months after baseline assessment. The primary outcome is psychological distress as measured by the Hopkins Symptom Checklist (HSCL-25). Secondary outcomes include functional impairment, posttraumatic stress symptoms, self-identified problems, as well as health system and productivity costs. A process evaluation will be conducted to explore the feasibility, challenges and success of the intervention with 25 participants including participants, facilitators, policy makers and mental health professionals. Discussion: The treatment manual of the Syrian-Arabic Group PM+ and training materials will be made available through the WHO once the effectiveness and cost-effectiveness of group PM+ has been established. Keywords: Cognitive behavioural therapy, depression, anxiety, posttraumatic stress, refugee, mental health, group interventions, task shifting, trans-diagnostic

scholarly journals Protocol for a Randomized Controlled Trial: Peer to Peer Group Problem Management Plus (PM+) for Adult Syrian Refugees in Turkey

2020 ◽  
Author(s):  
Ersin Uygun ◽  
Zeynep Ilkkursun ◽  
Marit Sijbrandij ◽  
A. Tamer Aker ◽  
Richard Bryant ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Posttraumatic Stress ◽  
Functional Impairment ◽  
Peer Group ◽  
Controlled Trial ◽  
Syrian Refugees ◽  
Problem Management ◽  
Randomized Controlled

Abstract Background: A large proportion of Syrians have been exposed to potentially traumatic events, multiple losses, breakdown of supportive social networks and many of them have sought refuge in host countries where they also face post migration living difficulties such as discrimination or/and integration problems. These adversities may put Syrian refugees at high risk for common mental disorders. In response to this, the World Health Organization (WHO) developed a transdiagnostic scalable psychological intervention called Problem Management Plus (PM+) to reduce psychological distress among populations exposed to adversities. PM+ has been adapted for Syrian refugees and can be delivered by non-specialist peer lay persons in the community. Methods: A randomized controlled trial (RCT) will be conducted with 380 Syrian refugees in Turkey. After providing informed consent, participants with high levels of psychological distress (scoring >15 on the Kessler-10 Psychological Distress Scale (K10)) and functional impairment (scoring >16 on the WHO Disability Assessment Schedule 2.0 (WHODAS 2.0)) will be randomly assigned to Group PM+/Enhanced Care As Usual (Group PM+/E-CAU) (n = 190) or enhanced-care-as-usual (E-CAU) (n = 190). Outcome assessments will take place 1-week after the 5 th session (post assessment), 3 months after the 5 th session and 12 months after baseline assessment. The primary outcome is psychological distress as measured by the Hopkins Symptom Checklist (HSCL-25). Secondary outcomes include functional impairment, posttraumatic stress symptoms, self-identified problems, as well as health system and productivity costs. A process evaluation will be conducted to explore the feasibility, challenges and success of the intervention with 25 participants including participants, facilitators, policy makers and mental health professionals. Discussion: The treatment manual of the Syrian-Arabic Group PM+ and training materials will be made available through the WHO once the effectiveness and cost-effectiveness of group PM+ has been established. Keywords: Cognitive behavioural therapy, depression, anxiety, posttraumatic stress, refugee, mental health, group interventions, task shifting, trans-diagnostic

scholarly journals Internet-based interpersonal psychotherapy for stress, anxiety, and depression in prenatal women: study protocol for a pilot randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Katherine S. Bright ◽  
Muhammad Kashif Mughal ◽  
Abdul Wajid ◽  
Marie Lane-Smith ◽  
Lindsay Murray ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Pregnant Women ◽  
Sample Size ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Interpersonal Psychotherapy ◽  
Secondary Outcome ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Abstract Background Psychological distress, defined as depression, anxiety and perceived stress, during pregnancy is common, with 15–25% of women experiencing clinically significant levels of such distress. Despite the far-reaching impact of prenatal psychological distress on mothers and their children, and that women are receptive to screening, few providers routinely screen for prenatal psychological distress and less than one in five women will receive the mental health care that they require. There is a lack of certainty regarding the most effective treatments for prenatal psychological distress. No online interpersonal psychotherapy (IPT) trials have been conducted that focus on improving psychological distress in prenatal women. The purpose of this pilot randomized controlled trial is to evaluate the perspectives of pregnant women on the feasibility and acceptability of online IPT (e-IPT) delivered during pregnancy. Methods A pilot randomized controlled trial design with repeated measures will evaluate the feasibility and acceptability of e-IPT for pregnant women compared to routine prenatal care. Qualitative interviews with 15–30 individuals in the intervention group will provide further data on the feasibility and acceptability of the intervention. Assessment of feasibility will include the ease of accessing and completing the intervention. Women will also be asked about what barriers there were to starting and completing the e-IPT. Assessment of acceptability will inquire about the perception of women regarding the intervention and its various features. A sample size of 160 consenting pregnant women aged 18 years and older will be enrolled and randomized into the experimental (e-IPT) or control (routine care) condition. The secondary outcome measures include: depression, anxiety and stress symptoms; self-efficacy; self-mastery; self-esteem; relationship quality (spouse, immediate family members); coping; and resilience. All participants will complete the aforementioned measures at baseline during pregnancy (T1), 3 months postrandomization (T2), at 8 months of pregnancy (T3), and 3 months postpartum (T4). Discussion The results of this pilot randomized controlled trial will provide data on the feasibility and acceptability of the intervention and identify necessary adaptations. This study will allow for optimization of full trial processes and inform the evaluation strategy, including sample size calculations for the full randomized controlled trial. Trial registration ClinicalTrials.gov, NCT01901796. Registered on 18 December 2014.

scholarly journals An internet-based self-help intervention for people with psychological distress due to COVID-19: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Noemi Anja Brog ◽  
Julia Katharina Hegy ◽  
Thomas Berger ◽  
Hansjörg Znoj
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
The Self ◽  
Randomized Controlled ◽  
Self Help ◽  
Parallel Group ◽  
Related Quality ◽  
Health Related

Abstract Background The coronavirus-19 (COVID-19) has reached pandemic status and is affecting countries all over the world. The COVID-19 pandemic is accompanied by various stressors that require adjustment in everyday life and possibly changes in personal future prospects. While some individuals cope well with these challenges, some develop psychological distress including depressive symptoms, anxiety, or stress. Internet-based self-help interventions have proven to be effective in the treatment of various mental disorders such as depression and anxiety. Based on that, we developed an internet-based self-help program for individuals with psychological distress due to the situation surrounding the COVID-19 pandemic. The 3-week self-help program consists of 6 modules comprising texts, videos, figures, and exercises. Participants can request guidance within the self-help program (guidance on demand). The primary aim of this study is to evaluate the efficacy and feasibility of the self-help program compared to a waiting control condition. Methods The design is a parallel group randomized controlled trial. Participants are allocated to a 3-week self-help intervention plus care as usual or a 3-week waiting period with only care as usual. There are follow-ups after 6 weeks and 18 weeks. At least 80 participants with COVID-19 pandemic related psychological distress will be recruited. Primary outcome are depressive symptoms. Secondary outcomes include anxiety and chronic stress, suicidal experiences and behavior, health-related quality of life, generalized optimism and pessimism, embitterment, optimistic self-beliefs, emotion regulation skills, loneliness, resilience, and the satisfaction with and usability of the self-help program. Discussion To the best of our knowledge, this is one of the first studies investigating the efficacy of an internet-based self-help program for psychological distress due to the situation surrounding the COVID-19 pandemic. Thus, the results of this study may give further insight into the use of internet-based self-help programs in pandemic-related psychological distress. Trial registration ClinicalTrials.gov NCT04380909. Retrospectively registered on 8 May 2020.

scholarly journals Does regular strength training cause urinary incontinence in overweight inactive women? A randomized controlled trial

2021 ◽  
Author(s):  
Kari Bø ◽  
Lene Anette H. Haakstad ◽  
Gøran Paulsen ◽  
Anne Mette Rustaden
Keyword(s):  
Randomized Controlled Trial ◽  
Urinary Incontinence ◽  
Strength Training ◽  
Short Form ◽  
Controlled Trial ◽  
Secondary Outcome ◽  
Control Group ◽  
Randomized Controlled ◽  
Sum Score ◽  
New Onset

Abstract Introduction and hypothesis Urinary incontinence (UI) is common in women who exercise. We aimed to investigate new onset UI in formerly inactive, overweight or obese women (BMI > 25) participating in three different strength training modalities compared with a non-exercising control group. Methods This was a secondary analysis of an assessor blinded randomized controlled trial investigating the effect of 12 weeks of three strength training concepts for women on muscle strength and body composition. None of the programs included pelvic floor muscle training. International Consensus on Incontinence Questionnaire Urinary Incontinence Short Form (ICIQ-UI-SF) was used to investigate primary outcome; new onset UI, and secondary outcome; ICIQ-UI-SF sum score. Suissa and Shuster’s exact unconditional test was used to analyze difference in new onset UI. Difference in ICIQ-UI-SF sum score is presented as mean with 95% CI. Results At baseline 40 out of 128 (31.2%) participants reported UI. Three out of 27, 2 out of 17, 2 out of 23, and 0 out of 21 women in the three training and control groups respectively had new onset UI. There were no statistically significant differences in new onset UI across the groups or when collapsing new onset UI in the intervention groups compared with the controls (7 out of 67 vs 0 out of 21), p = 0.124. After the intervention the control group reported worse ICIQ-UI-SF sum score than any of the training groups; mean difference − 6.6 (95% CI: −11.9, −1.27), p = 0.012, but there was no difference in change from baseline to 12 weeks between the groups p = 0.145). Conclusions There was no statistically significant change in UI after strength training.

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