Self-efficacy and resilience in severe aphasia - an exploratory cross-sectional study of two psychosocial factors and their relation to functional communication.

PURPOSE: Self-efficacy and resilience are important for various aspects of rehabilitation outcome after stroke. However, little is known about how these factors are affected and related to communication outcome in stroke survivors with aphasia. The purpose was to investigate self-efficacy and resilience, and associations to language and functional communication, in people with severe post-stroke aphasia. MATERIALS AND METHODS: 37 participants with severe aphasia rated their self-efficacy and resilience, using adapted versions of the existing instruments DLSES and CD-RISC. In addition, linguistic ability, executive function and functional communication were assessed. RESULTS: Participants rated their self-efficacy and resilience as expected based on reports in the literature; somewhat lower than general populations and at similar levels as clinical populations. There were no association between self-efficacy, resilience and linguistic ability. In the sample as a whole, there were no associations between self-efficacy, resilience and functional communication. However, when results were stratified by executive function, associations emerged in the group with stronger executive function. CONCLUSIONS: People with severe aphasia have decreased self-efficacy and resilience compared to general populations, but not necessarily in proportion to their language impairment. Among participants with relatively spared executive functions there were indications of an association between self-efficacy, resilience and functional communication.

The constructs self-efficacy and resilience are related to several outcomes after stroke.Self-efficacy and resilience can be assessed in many people with severe aphasia, provided that materials and administration procedure are adequately adapted.There are indications of an association between functional communication and self-efficacy and resilience.Integrating activities to increase self-efficacy and resilience in aphasia rehabilitation may be beneficial to treatment outcomes regarding functional communication.

Evaluation of the group intervention "Let's Get Organized" for improving time management, organisational, and planning skills in people with mild intellectual disability.

BACKGROUND: Limited time management skills cause problems in daily life for people with mild intellectual disability (ID) and "Let's Get Organized" (LGO) is a promising manual-based occupational therapy group intervention aiming to support management skills. AIMS/OBJECTIVES: To evaluate the applicability of the Swedish version of LGO-S by i) exploring enhancements in time management skills, satisfaction with daily occupations, and aspects of executive functioning in people with time-management difficulties and mild ID, and ii) describing clinical experiences of using the LGO-S for people with mild ID. MATERIAL AND METHODS: Twenty-one adults with mild ID were included. Data were collected pre-/post-intervention and at 3- and 12-month follow-ups with: Swedish version of Assessment of Time Management Skills (ATMS-S), Satisfaction with Daily Occupation (SDO-13), and Weekly Calendar Planning Activity (WCPA-SE). There were few follow-up participants (n = 6-9). RESULTS: Significant change in time management skills that maintained at 12-months follow-ups. Significant increase in regulation of emotions at 12-month follow-up. Results at 12-months follow-up indicated sustainability in outcomes as measured by ATMS-S. A non-significant positive trend was observed in other outcomes between pre- and post-intervention. CONCLUSIONS AND SIGNIFICANCE: LGO-S seems applicable for improving skills in time management, organisation and planning also for people with mild ID.

Efficacy of a school-based intervention to influence attitudes about future parenting among Swedish youth with intellectual disability: An RCT study.

BACKGROUND: The study aim was to investigate the efficacy of an intervention designed to provide a basis for informed choices about future parenthood to special upper secondary school students with intellectual disabilities. METHODS: A randomised trial with a waiting list control group was used. In total, 108 special upper secondary school students with mild or moderate intellectual disabilities, age 16-21 years, provided informed consent and participated. The intervention included education using the Parenting Toolkit and a Real Care Baby simulator. The analyses included 91 students (intervention group n = 46, 24F/22M; control group n = 45, 26F/19M). RESULTS: The result showed that intervention group changed their attitudes to future parenting, from 'do not know' to 'know', significantly more than control group. The intervention increased knowledge levels in the intervention group. CONCLUSIONS: The intervention group showed increased ability to make informed choices and decisions about parenthood.

What do people respond to when rating executive function? - a cognitive interviewing investigation of BRIEF-A informant ratings in severe aphasia.

PURPOSE: Executive dysfunction is common in persons with severe aphasia. Assessing these functions in this population is challenging. Informant ratings, such as the BRIEF-A, might be a useful alternative to neuropsychological tests. However, research has shown weak relationships between tests and ratings. The aim of this study was to understand how significant others of people with severe aphasia interpret and respond to questions about executive function in the informant report version of BRIEF-A. METHODS: Eleven significant others were interviewed about a subset of the BRIEF-A items, using cognitive interviewing. Interviews were subjected to thematic analysis. RESULTS: There was variation in the interpretation of the items of BRIEF-A which frequently corrupted the items' relation to what it was intended to measure. Further, informants wavered between considering the person with aphasias' ability or actual performance and many had lowered their expectations. The language problems caused by the aphasia affected the validity of some items. CONCLUSIONS: The quantitative results of BRIEF-A informant ratings should be interpreted with caution, since it is unclear to what extent the responses represent executive function. The use of informant ratings does not solve the problem with aphasia being a confounding factor in assessment of executive function.IMPLICATIONS FOR REHABILITATIONAssessing executive function in people with severe aphasia is important but challenging.Quantitative results of informant ratings of executive function, such as BRIEF-A, in this population should be interpreted with caution, since it is unclear to what extent the ratings represent executive function.Using informant ratings does not solve the problem of the aphasia being a confounding factor, since the aphasia impacts on the validity of some of the items.

Test-retest reliability of Picture My Participation in children with intellectual disability in South Africa.

BACKGROUND: Picture My Participation (PmP) is a promising instrument for measuring the participation in everyday situations of children with intellectual disability (ID), particularly in low- and middle-income countries. AIM: To explore test-retest reliability of PmP by comparing two repeated measurements of children with ID in an urban context in South Africa. METHODS: A picture-supported interview with 31 children with ID, aged 7-17 years, was conducted twice, two weeks apart. The children rated their participation, operationalised as attendance and involvement, in 20 everyday activities. Analyses were completed for total scores, for the four subcomponents and at item level. RESULTS: Test-retest agreement at an item level for both attendance and involvement showed slight/fair agreement for most activities (Kappa = 0.01-0.40), and moderate agreement for some activities (Kappa = 0.41-0.60). Moderate agreement was shown for the total scale and at component level (ICC = 0.5-0.75), except for (firstly) attendance of and involvement in 'Family Activities' (ICC = 0.26 for attendance, 0.33 for involvement), and (secondly) involvement in 'Personal Activities' (ICC = 0.33). CONCLUSION: The result indicates that PmP can reliably be used at component level and as a screening tool for intervention planning to identify participation and participation restrictions in children with ID.

One-year follow-up after the time management group intervention Let's Get Organized.

BACKGROUND: Time management skills are essential to maintain occupations in everyday life. People with neurodevelopmental or mental disorders often experience persistent difficulties with managing time and organizing daily life, consequently, there is a need to establish interventions with sustainable results. AIM: The aim was to perform a one-year post-intervention follow-up after the intervention Let's Get Organized (LGO-S) for people with neurodevelopmental or mental disorders. METHODS: The study is a one-year follow-up of a single group pre-test-post-test design. Thirty-eight persons with difficulties in time management due to neurodevelopmental or mental disorders participated. Instruments to collect data were Assessment of Time Management Skills; Weekly Calendar Planning Activity and the Satisfaction with Daily Occupations instrument. Wilcoxons's signed-rank test was used to compare data over time. RESULTS: There were no significant differences in the participants' outcomes between post-intervention and one-year follow-up in time management skills and regulation of emotions, satisfaction with daily occupations, and global satisfaction. A significant improvement could be seen in the subscale organization and planning at the one-year follow-up compared to post-intervention. CONCLUSIONS: Improvements in time management skills, organization, and planning, regulation of emotions, and satisfaction with daily occupations after the LGO-S can be maintained in the long term.

The utility of goal attainment scaling in evaluating a structured water dance intervention for adults with profound intellectual and multiple disabilities.

BACKGROUND: Adults with profound intellectual and multiple disabilities (PIMD) have problems to be actively involved in essential life activities that affect their health. The aim of this study was to explore the utility of goal attainment scaling (GAS) in evaluating an intervention for adults with PIMD, and to describe how the GAS goals were set according to the International Classification of Functioning, Disability and Health (ICF) domains of body function as well as activity and participation. METHOD: As part of an aquatic intervention (Structured water dance), 28 adults with PIMD received GAS goals which were adapted to their individual needs and which the intervention could affect. RESULT: Twenty of the goals were formulated within the ICF Activity/Participation domain and eight within the Body Functions domains. On average, participants improved by 1.25 levels on the five-level GAS scales. CONCLUSION: GAS can be a useful tool for setting and evaluating individualized and meaningful goals, in body functions as well as in activity and participation, related to a healthpromoting activity for adults with PIMD.

Structural validity and internal consistency of Picture My Participation: A measure for children with disability.

BACKGROUND: Picture My Participation (PMP) intended to measure participation, defined as attendance and involvement in everyday situations, of children with disabilities, particularly in low- and middle-income settings. OBJECTIVES: To explore structural validity of PMP by identifying possible subcomponents in the attendance scale and examining internal consistency of the total score and each subcomponent. METHOD: A picture-supported interview was conducted with 182 children, 7-18 years, with and without intellectual disability (ID). Frequency of attendance in 20 activities was rated on a four-point Likert scale (never, seldom, sometimes and always). RESULTS: An exploratory principal component analysis extracted four subcomponents: (1) organised activities, (2) social activities and taking care of others, (3) family life activities and 4) personal care and development activities. Internal consistency for the total scale (alpha = 0.85) and the first two subcomponents (alpha = 0.72 and 0.75) was acceptable. The two last subcomponents alpha values were 0.57 and 0.49. CONCLUSION: The four possible subcomponents of PMP can be used to provide information about possible domains in which participation and participation restrictions exist. This study provided further psychometric evidence about PMP as a measure of participation. The stability and the utility of these subcomponents needed further exploration.

Children in South Africa with and without Intellectual Disabilities' Rating of Their Frequency of Participation in Everyday Activities.

In a low-and middle-income country (LMIC) such as South Africa, not much is known about how children with intellectual disabilities (ID) participate in everyday activities, as no studies to date have compared their participation to peers without ID from the same background. Using a newly developed, contextually valid measure of participation, Picture my Participation (PmP), 106 children with (73) and without ID (33), rated their frequency of participation in activities of daily living. Previous international research has established that children with ID tend to participate less frequently than children without ID in everyday activities outside of the school setting. However, much of this research is based on proxy ratings from caregivers rather than children with ID themselves. There is a growing body of evidence that suggests children with disabilities have uniquely different views of their own participation than their caregivers. The existing research evidence is also delimited to studies conducted predominantly in high income contexts (HICSs). Since it is universally acknowledged that participation patterns are affected by the environment, it is important to evaluate the generalizability of the current evidence to LMICs. The current study found that there were many similar patterns of participation between the two groups although significant differences were noted in social, community, leisure and self-care activities. We compare these results to findings from studies conducted in HICs and find that there are similarities but also differences across contexts. This study highlights the importance of gaining a child's perspective of participation and understanding how intellectual disability can affect participation relative to peers without ID in LMICS.

Structured Water Dance Intervention (SWAN) for adults with profound intellectual and multiple disabilities: study protocol.

BACKGROUND: People with profound intellectual and multiple disabilities (PIMD) have a combination of severe intellectual disability, extensive physical impairment, sensory impairments and medical health problems. There is, however, a lack of evidence-based physical and health-promoting interventions for people with PIMD. OBJECTIVE: Structured Water Dance Intervention (SWAN) is a new method developed to fill this gap. This paper reports a protocol for an intervention study which aims to evaluate SWAN with regard to its effects on physiological, psychological and social health-related variables as well as its cost-effectiveness and potential for implementation in health care. METHODS: The evaluation of SWAN is performed in a multi-center randomized crossover study. Data is collected through cortisol measurement, physiological assessments, proxy ratings, video observations and interviews. CONCLUSIONS: This is the first attempt to evaluate rigorously an innovative intervention for people with PIMD, a group that is rarely considered for health promotion interventions. This study will provide important information about the efficacy, cost-effectiveness and potential to implement SWAN in health care.

Measuring executive function in people with severe aphasia: Comparing neuropsychological tests and informant ratings.

BACKGROUND: Knowledge about patients' executive function is important in the rehabilitation of language and communication in stroke patients with aphasia. Due to linguistic demands, most neuropsychological tests are unsuitable for this population, and it might seem appealing to use informant report of executive function as a substitute. OBJECTIVE: To investigate the relationships between scores on a neuropsychological test and informant ratings of executive function, as well as between the informant ratings and the functional communication ability, in people with severe aphasia after stroke. METHODS: Thirty-eight people with severe aphasia and their significant others participated. Executive function was tested with parts of the neuropsychological screening instrument CLQT and rated by significant others (informants) using BRIEF-A. Functional communication was assessed with a standardised test and rated by significant others. RESULTS: Results revealed few correlations between CLQT and BRIEF-A. There was no correlation between informant ratings on BRIEF-A and scores on the measures of functional communication. CONCLUSIONS: Informant ratings of executive function do not measure the same construct as, and cannot be used as a substitute for, standardised neuropsychological tests. Informant ratings of executive function do not seem to provide information that is relevant to the understanding of functional communication in people with severe aphasia.

Test-retest reliability of the Swedish version of the Weekly Calendar Planning Activity - a performance-based test of executive functioning.

Purpose: The Weekly Calendar Planning Activity is a performance test aiming to examine how subtle problems with executive functioning influence the performance of multi-step activities in daily life. The purpose of this study was to explore the Swedish version of the Weekly Calendar Planning Activity, regarding test-retest reliability and possible learning effects.Material and methods: Twenty-four adults with psychiatric, neurodevelopmental or mild intellectual disorders and with difficulties in executive functioning performed the test on three separate occasions, with two weeks apart. Test-retest reliability was determined using intraclass correlation coefficients. Possible learning effects were evaluated. The smallest detectable change was calculated to determine the precision of individual scores.Results and conclusion: The intraclass correlation coefficients between the first two test occasions were weak (0.42-0.66), but were acceptable to excellent (0.65-0.91) between test occasions 2 and 3. There was a considerable amount of random variation in the results, but little systematic variation, indicating no or possibly a small learning effect in the total number of accurately recorded appointments. This variation indicates a need to use two consecutive baseline measurements when the Swedish version of the Weelky Calendar Planning Acitivity is used as an outcome measure. Together, our results suggest that the Swedish version of the Weelky Calendar Planning Acitivity is a useful performance-based measure of how subtle problems in executive functioning affects activity performance.Implications for rehabilitationExecutive functioning is crucial for managing daily life, and ecologically valid tests are needed to measure such functioning.The Weekly Calendar Planning Activity is a new performance-based test using a task that is relevant to daily life.The outcomes obtained in the Weekly Calendar Planning Activity are highly useful in clinical practice.The day-to-day variation in the Weekly Calendar Planning Activity results warrants the need for two consecutive baseline measurements when it is used to measure change.

Content validity and usefulness of Picture My Participation for measuring participation in children with and without intellectual disability in South Africa and Sweden.

Background: Participation comprises attendance and involvement in everyday situations. Picture My Participation (PmP) is an instrument intended to measure participation in children with disabilities, particularly in low and middle income countries.Aim: To investigate content validity and usefulness of PmP for measuring participation in children with intellectual disability (ID) in South Africa and Sweden.Methods: A picture supported interview with 149 children, 6-18 years, with and without ID. Twenty everyday activities were provided. The three most important activities were selected by the child. Attendance was rated on all activities. Involvement was rated on the most important.Results: All activities were selected as important by at least one child with ID in both countries. There were similarities in perceived importance between the children with and without ID from South Africa. The children from South Africa with ID were the only subgroup that used all scale points for rating attendance and involvement.Conclusion: The 20 selected activities of PmP were especially relevant for children with ID in South Africa. The usefulness of the scales was higher for the children with ID in both countries. PmP is promising for assessing participation across different settings but psychometrical properties and clinical utility need further exploration.

Pilot Study of Let's Get Organized: A Group Intervention for Improving Time Management.

IMPORTANCE: There is a need for evidence-based occupational therapy interventions to enhance time management in people with time management difficulties. OBJECTIVE: To pilot test the first part of the Let's Get Organized (LGO) occupational therapy intervention in a Swedish context by exploring enhancements of time management skills, aspects of executive functioning, and satisfaction with daily occupations in people with time management difficulties because of neurodevelopmental or mental disorders. DESIGN: One-group pretest-posttest design with 3-mo follow-up. SETTING: Outpatient psychiatric and habilitation settings. PARTICIPANTS: Fifty-five people with confirmed or suspected mental or neurodevelopmental disorder and self-reported difficulties with time management in daily life. INTERVENTION: Swedish version of Let's Get Organized (LGO-S) Part 1, with structured training in the use of cognitive assistive techniques and strategies using trial-and-error learning strategies in 10 weekly group sessions of 1.5 hr. OUTCOMES AND MEASURES: Time management, organization and planning, and emotional regulation were measured with the Swedish version of the Assessment of Time Management Skills (ATMS-S). Executive functioning was measured with the Swedish version of the Weekly Calendar Planning Activity, and satisfaction with daily occupations was assessed with the Satisfaction With Daily Occupations measure. RESULTS: Participants displayed significantly improved time management, organization and planning skills, and emotional regulation, as well as satisfaction with daily occupations. Aspects of executive functioning were partly improved. ATMS-S results were sustained at 3-mo follow-up. CONCLUSION AND RELEVANCE: LGO-S Part 1 is a promising intervention for improving time management skills and satisfaction with daily occupations and should be investigated further. WHAT THIS ARTICLE ADDS: This study shows that LGO-S Part 1 is feasible for use in psychiatric and habilitation outpatient services. The results are promising for improved time management skills, organization and planning skills, and satisfaction with daily occupations and need to be confirmed in further studies.

The Relationship Between Intelligence Quotient and Aspects of Everyday Functioning and Participation for People Who Have Mild and Borderline Intellectual Disabilities.

BACKGROUND: This study explored the relationship between intelligence quotient (IQ) and aspects of everyday functioning/participation in individuals (age 16-40) who have a mild/borderline intellectual disability (IQ 55-85). METHOD: Correlations were examined between IQ and (i) self-rated (n = 72) ability, participation as performance (how often an activity is performed), important participation restriction (not/seldom performing an activity perceived as important) and general well-being and (ii) proxy-rated (n = 41) ability and participation as performance. RESULTS: No significant correlations between IQ and any of the explored measures were found. However, the effect sizes of the correlations between IQ and ability were considered as small but not negligible. CONCLUSIONS: The results support the notion that IQ is a poor predictor of general aspects of everyday functioning in persons with mild/borderline intellectual disability. The result indicates that self-ratings partly generate other information than proxy ratings which may be important for assessments of supportive requirements and diagnosis.

Simplified bipartite concepts of functioning and disability recommended for interdisciplinary use of the ICF.

PURPOSE: To argue for and propose bipartite concepts of functioning and disability, to tally with the structure of the ICF classification list, concepts of social models and clinical needs. METHOD: The ICF concepts are discussed in relation to the history of ideas regarding disability concepts and the needs for such concepts in interdisciplinary rehabilitation. RESULTS: Bipartite concepts are presented; they refer to actual functioning, simply body functions/structures and participation, including functioning in standardized environments. Participation refers to actually performed "activities", with "activities" simply denoting things that people may do. Bipartite concepts are congruent with the ICF classification and the structure of social models of disability, suitable for clinical and interdisciplinary use and easy to understand. The issue of standardized environments represents a methodological issue rather than the conceptual issue of defining functioning and disability. An individual perspective on activity and activity limitations, i.e. the middle part of the tripartite ICF concept, is somewhat similar to concepts of traditional language that were regarded as too generalizing already in 1912, when the interactional concept of "disability in a social sense" was introduced in rehabilitation practices. CONCLUSION: Bipartite concepts of functioning and disability are recommended for interdisciplinary use of the ICF. IMPLICATIONS FOR REHABILITATION: The ICF classification is useful, but the ICF concept of activities in an individual perspective is confusing. We suggest a use of the term "activities" simply to denote things that people may do and "participation" to denote actually performed activities. Estimations of ability should be explicit about how they are related to environmental factors.

How are the activity and participation aspects of the ICF used? Examples from studies of people with intellectual disability.

INTRODUCTION: Interdisciplinary differences regarding understanding the International Classification of Functioning, Disability and Health (ICF) concepts activity/participation may hinder its unifying purpose. In the ICF model, functioning (and disability) is described as a tripartite concept: 1) Body structures/functions, 2) Activities, and 3) Participation. Activities refer to an individual perspective on disability that does not tally with the basic structure of social models. OBJECTIVE: To review how activity and participation are actually used in studies of intellectual disability (ID). CONCLUSION: Based on 16 papers, four different usages of activity/participation were found. 1) Theoretical reference to tripartite ICF concept with attempts to use it. 2) Theoretical reference to tripartite ICF concept without actual use of activities. 3) "Atheoretical" approach with implicit focus on participation. 4) Theoretical reference to bipartite concept with corresponding use of terms. The highlighted studies have in common a focus on participation. However, the usage of the term "activity" differs both within and between studies. Such terminology will probably confuse interdisciplinary communication rather than facilitating it. Also, the use of an explicit underlying theory differs, from references to a tripartite to references to a bipartite concept of disability. This paper is focused on ID, but the discussed principles regarding the ICF and interdisciplinary disability theory are applicable to other diagnostic groups within rehabilitation practices.

Important aspects of participation and participation restrictions in people with a mild intellectual disability.

PURPOSE: This study explored a possibility to assess the concepts of participation and participation restrictions in the International Classification of Functioning, Disability and Health (ICF) by combining self-ratings of the perceived importance with the actual performance of different everyday activities in people with a mild intellectual disability. METHOD: Structured interviews regarding 68 items from the ICF activity/participation domain were conducted (n = 69). The items were ranked by perceived importance, performance and by combined measures. Furthermore, the measures were related to a single question about subjective general well-being. RESULTS: Rankings of performance highlighted about the same items as "important participation", while rankings of low performance addressed quite different items compared with "important participation restriction". Significant correlations were found between subjective general well-being and high performance (r = 0.56), high performance/high importance (important participation) (r = 0.56), low performance (r = -0.56) and low performance/high importance (important participation restriction; r = -0.55). CONCLUSIONS: The results support the clinical relevance of the ICF and the studied selection of 68 items. Although performance only may sometimes be a relevant aspect, knowledge about the relationship between the perceived importance and the actual performance is essential for clinical interventions and for research aiming to understand specific needs regarding participation. IMPLICATIONS FOR REHABILITATION: The concepts of participation and participation restriction are highly relevant in people with a mild intellectual disability. Self-rated performance might be sufficient to assess participation at a group level. In clinical practices, the relationship between the perceived importance and the actual performance of an activity is essential to assess.

International Classification of Functioning, Disability and Health categories explored for self-rated participation in Swedish adolescents and adults with a mild intellectual disability.

OBJECTIVE: To explore internal consistency and correlations between perceived ability, performance and perceived importance in a preliminary selection of self-reported items representing the activity/participation component of the International Classification of Functioning, Disability and Health (ICF). DESIGN: Structured interview study. SUBJECTS: Fifty-five Swedish adolescents and adults with a mild intellectual disability. METHODS: Questions about perceived ability, performance and perceived importance were asked on the basis of a 3-grade Likert-scale regarding each of 68 items representing the 9 ICF domains of activity/participation. RESULTS: Internal consistency for perceived ability (Cronbach's alpha for all 68 items): 0.95 (values for each domain varied between 0.57 and 0.85), for performance: 0.86 (between 0.27 and 0.66), for perceived importance: 0.84 (between 0.27 and 0.68). Seventy-two percent of the items showed correlations >0.5 (mean=0.59) for performance vs perceived importance, 41% >0.5 (mean=0.47) for perceived ability vs performance and 12% >0.5 (mean=0.28) for perceived ability vs perceived importance. CONCLUSION: Measures of performance and perceived importance may have to be based primarily on their estimated clinical relevance for describing aspects of the ICF participation concept. With a clinimetric approach, parts of the studied items and domains may be used to investigate factors related to different patterns and levels of participation, and outcomes of rehabilitation.

Effects of gut-directed hypnotherapy on IBS in different clinical settings-results from two randomized, controlled trials.

OBJECTIVES: Gut-directed hypnotherapy has been found to be effective in irritable bowel syndrome (IBS). However, randomized, controlled studies are rare and few have been performed outside highly specialized research centers. The objective of this study was to study the effect of gut-directed hypnotherapy in IBS in different clinical settings outside the traditional research units. METHODS: The study population included IBS patients refractory to standard management. In study 1, patients were randomized to receive gut-directed hypnotherapy (12 sessions, 1 h/week) in psychology private practices or supportive therapy, whereas patients were randomized to receive gut-directed hypnotherapy in a small county hospital or to serve as waiting list controls in study 2. Gastrointestinal symptom severity and quality of life were evaluated at baseline, at 3 months follow-up and after 1 year. RESULTS: We randomized 138 IBS patients refractory to standard management, 90 in study 1 and 48 in study 2. In both the studies, IBS-related symptoms were improved at 3 months in the gut-directed hypnotherapy groups (P<0.05), but not in the control groups (ns). In study 1, a significantly greater improvement of IBS-related symptom severity could be detected in the gut-directed hypnotherapy group than in the control group (P<0.05), and a trend in the same direction was seen in study 2 (P=0.17). The results seen at 3 months were sustained up to 1 year. CONCLUSIONS: Gut-directed hypnotherapy is an effective treatment alternative for patients with refractory IBS, but the effectiveness is lower when the therapy is given outside the highly specialized research centers.