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      Guided internet-administered self-help to reduce symptoms of anxiety and depression among adolescents and young adults diagnosed with cancer during adolescence (U-CARE: YoungCan): a study protocol for a feasibility trial

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          Abstract

          Introduction

          A subgroup of adolescents and young adults diagnosed with cancer during adolescence reports elevated levels of anxiety and depressive symptoms and unmet needs for psychological support. Evidence-based psychological treatments tailored for this population are lacking. This protocol describes a feasibility study of a guided-internet-administered self-help programme (YoungCan) primarily targeting symptoms of anxiety and depression among young persons diagnosed with cancer during adolescence and of the planned study procedures for a future controlled trial.

          Methods/analysis

          The study is an uncontrolled feasibility trial with a pre-post and 3-month follow-up design. Potential participants aged 15–25 years, diagnosed with cancer during adolescence, will be identified via the Swedish Childhood Cancer Registry. 30 participants will be included. Participants will receive YoungCan, a 12-week therapist-guided, internet-administered self-help programme consisting primarily of cognitive–behavioural therapy organised into individually assigned modules targeting depressive symptoms, worry and anxiety, body dissatisfaction and post-traumatic stress. Interactive peer support and psychoeducative functions are also available. Feasibility outcomes include: recruitment and eligibility criteria; data collection; attrition; resources needed to complete the study and programme; safety procedures; participants' and therapists' adherence to the programme; and participants' acceptability of the programme and study methodology. Additionally, mechanisms of impact will be explored and data regarding symptoms of anxiety, depression, post-traumatic stress, body dissatisfaction, reactions to social interactions, quality of life, axis I diagnoses according to the Mini International Neuropsychiatric Interview and healthcare service use will be collected. Exploratory analyses of changes in targeted outcomes will be conducted.

          Ethics/dissemination

          This feasibility protocol was approved by the Regional Ethical Review Board in Uppsala, Sweden (ref: 2016/210). Findings will be disseminated to relevant research, clinical, health service and patient communities through publications in peer-reviewed and popular science journals and presentations at scientific and clinical conferences.

          Trial registration number

          ISRCTN97835363.

          Related collections

          Most cited references36

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          Emerging adulthood. A theory of development from the late teens through the twenties.

          J Arnett (2000)
          Emerging adulthood is proposed as a new conception of development for the period from the late teens through the twenties, with a focus on ages 18-25. A theoretical background is presented. Then evidence is provided to support the idea that emerging adulthood is a distinct period demographically, subjectively, and in terms of identity explorations. How emerging adulthood differs from adolescence and young adulthood is explained. Finally, a cultural context for the idea of emerging adulthood is outlined, and it is specified that emerging adulthood exists only in cultures that allow young people a prolonged period of independent role exploration during the late teens and twenties.
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            Cognitive behavior therapy via the Internet: a systematic review of applications, clinical efficacy and cost-effectiveness.

            Internet-based cognitive behavior therapy (ICBT) is a promising treatment that may increase availability of cognitive behavior therapy (CBT) for psychiatric disorders and other clinical problems. The main objective of this study was to determine the applications, clinical efficacy and cost-effectiveness of ICBT. The authors conducted a systematic review to identify randomized controlled trials investigating CBT delivered via the internet for adult patient populations. Searches to identify studies investigating cost-effectiveness of ICBT were also conducted. Evidence status for each clinical application was determined using the American Psychologist Association criteria for empirically supported treatments. Of 1104 studies reviewed, 108 met criteria for inclusion, of which 103 reported on clinical efficacy and eight on cost-effectiveness. Results showed that ICBT has been tested for 25 different clinical disorders, whereas most randomized controlled trials have been aimed at depression, anxiety disorders and chronic pain. Internet-based treatments for depression, social phobia and panic disorder were classified as well-established, that is, meeting the highest level of criteria for evidence. Effect sizes were large in the treatment of depression, anxiety disorders, severe health anxiety, irritable bowel syndrome, female sexual dysfunction, eating disorders, cannabis use and pathological gambling. For other clinical problems, effect sizes were small to moderate. Comparison to conventional CBT showed that ICBT produces equivalent effects. Cost-effectiveness data were relatively scarce but suggested that ICBT has more than 50% probability of being cost effective compared with no treatment or to conventional CBT when willingness to pay for an additional improvement is zero. Although ICBT is a promising treatment option for several disorders, it can only be regarded as a well-established treatment for depression, panic disorder and social phobia. It seems that ICBT is as effective as conventional CBT for respective clinical disorder, that is, if conventional CBT works then ICBT works. The large effects and the limited therapist time required suggest that the treatment is highly cost effective for well-established indications.
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              Feasibility, reliability and validity of a questionnaire on healthcare consumption and productivity loss in patients with a psychiatric disorder (TiC-P)

              Background Patient self-report allows collecting comprehensive data for the purpose of performing economic evaluations. The aim of the current study was to assess the feasibility, reliability and a part of the construct validity of a commonly applied questionnaire on healthcare utilization and productivity losses in patients with a psychiatric disorder (TiC-P). Methods Data were derived alongside two clinical trials performed in the Netherlands in patients with mental health problems. The response rate, average time of filling out the questionnaire and proportions of missing values were used as indicators of feasibility of the questionnaire. Test-retest analyses were performed including Cohen’s kappa and intra class correlation coefficients to assess reliability of the data. The construct validity was assessed by comparing patient reported data on contacts with psychotherapists and reported data on long-term absence from work with data derived from registries. Results The response rate was 72%. The mean time needed for filling out the first TiC-P was 9.4 minutes. The time needed for filling out the questionnaire was 2.3 minutes less for follow up measurements. Proportions of missing values were limited (< 2.4%) except for medication for which in 10% of the cases costs could not be calculated. Cohen’s kappa was satisfactory to almost perfect for most items related to healthcare consumption and satisfactory for items on absence from work and presenteeism. Comparable results were shown by the ICCs on variables measuring volumes of medical consumption and productivity losses indicating good reliability of the questionnaire. Absolute agreement between patient-reported data and data derived from medical registrations of the psychotherapists was satisfactory. Accepting a margin of +/− seven days, the agreement on reported and registered data on long-term absence from work was satisfactory. The validity of self-reported data using the TiC-P is promising. Conclusions The results indicate that the TiC-P is a feasible and reliable instrument for collecting data on medical consumption and productivity losses in patients with mild to moderate mental health problems. Additionally, the construct validity of questions related to contacts with psychotherapist and long-term absence from work was satisfactory.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2017
                27 January 2017
                : 7
                : 1
                : e013906
                Affiliations
                [1 ]Clinical Psychology in Healthcare, Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden
                [2 ]Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
                [3 ]Pediatric Oncology, Department of Women's and Children's Health, Uppsala University, Uppsala, Sweden
                [4 ]Clinical Education Development and Research (CEDAR), Psychology, College of Life and Environmental Sciences, University of Exeter, Exeter, UK
                Author notes
                [Correspondence to ] Malin Ander; malin.ander@ 123456kbh.uu.se
                Article
                bmjopen-2016-013906
                10.1136/bmjopen-2016-013906
                5278290
                28132011
                0dd7efc8-b747-4054-92fe-ca4b995a527f
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

                This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/

                History
                : 16 August 2016
                : 1 November 2016
                : 4 January 2017
                Funding
                Funded by: Barncancerfonden, http://dx.doi.org/10.13039/501100006313;
                Award ID: PR2013-0039
                Categories
                Mental Health
                Protocol
                1506
                1712
                1719
                1717

                Medicine
                adolescence,cognitive behavioural therapy,feasibility study,neoplasms,psychological treatment

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