BMC Cancer | |
U-CARE: Internet-based stepped care with interactive support and cognitive behavioral therapy for reduction of anxiety and depressive symptoms in cancer - a clinical trial protocol | |
Susanne Mattsson1  Sven Alfonsson1  Maria Carlsson1  Peter Nygren2  Erik Olsson1  Birgitta Johansson2  | |
[1] Department of Public Health and Caring Sciences, Uppsala University, Box 564, SE-751 22 Uppsala, Sweden | |
[2] Department of Oncology, Radiology and Radiation Science, Uppsala University, Uppsala, Sweden | |
关键词: Psychosocial support; Internet; Depression; Anxiety; Cancer; | |
Others : 1079576 DOI : 10.1186/1471-2407-13-414 |
|
received in 2013-03-20, accepted in 2013-09-10, 发布年份 2013 | |
【 摘 要 】
Background
Approximately 20–30% of patients with cancer experience a clinically relevant level of emotional distress in response to disease and treatment. This in itself is alarming but it is even more problematic because it is often difficult for physicians and nurses to identify cancer patients who experience clinically relevant levels of anxiety and depression symptoms. This can result in persistent distress and can cause human suffering as well as costs for individuals and to the community.
Methods
Applying a multi-disciplinary and design-oriented approach aimed at attaining new evidence-based knowledge in basic and applied psychosocial oncology, this protocol will evaluate an intervention to be implemented in clinical practice to reduce cancer patient anxiety and depression. A prospective randomized design will be used.
The overarching goal of the intervention is to promote psychosocial health among patients suffering from cancer by means of self-help programmes delivered via an Internet platform. Another goal is to reduce costs for individuals and society, caused by emotional distress in response to cancer.
Following screening to detect levels of patient distress, patients will be randomized to standard care or a stepped care intervention. For patients randomized to the intervention, step 1 will consist of self-help material, a chat forum where participants will be able to communicate with each other, and a Frequently Asked Questions (FAQ) section where they can ask questions and get answers from an expert. Patients in the intervention group who still report symptoms of anxiety or depression after access to step 1 will be offered step 2, which will consist of cognitive behavioral therapy (CBT) administered by a personal therapist. The primary end point of the study is patients’ levels of anxiety and depression, evaluated longitudinally during and after the intervention.
Discussion
There is a lack of controlled studies of the psychological and behavioral processes involved in this type of intervention for anxiety and depressive disorders. Since anxiety and depressive symptoms are relatively common in patients with cancer and the availability of adequate support efforts is limited, there is a need to develop evidence-based stepped care for patients with cancer, to be delivered via the Internet.
Trial registration
ClinicalTrials.gov Identifier: NCT01630681
【 授权许可】
2013 Mattsson et al.; licensee BioMed Central Ltd.
【 预 览 】
Files | Size | Format | View |
---|---|---|---|
20141202190114516.pdf | 265KB | download | |
Figure 1. | 24KB | Image | download |
【 图 表 】
Figure 1.
【 参考文献 】
- [1]National board OHAW: Cancer incidence in Sweden 2011. Stockholm: National board of health and welfare; 2011. [Official statistics of Sweden, statistics health and medical care]
- [2]Johansson B, Brandberg Y, Hellbom M, Persson C, Petersson L, Berglund G, Glimelius B: Health-related quality of life and distress in cancer patients: results from a large randomised study. Br J Cancer 2008, 99(12):1975-1983.
- [3]Fann J, Thomas-Rich A, Katon W, Cowley D, Pepping M, McGregor B, Gralow J: Major depression after breast cancer: a review of epidemiology and treatment. Gen Hosp Psychiatry 2008, 30(2):112-126.
- [4]Strong V, Waters R, Hibberd C, Rush R, Cargill A, Storey D, Walker J, Wall L, Fallon M, Sharpe M: Emotional distress in cancer patients: the Edinburgh cancer centre symptom study. Br J Cancer 2007, 96(6):868-874.
- [5]Fröjd C, Larsson G, Lampic C, von Essen L: Health related quality of life and psychosocial function among patients with carcinoid tumours. A longitudinal, prospective, and comparative study. Health and Quality of Life Outcomes 2007, 5(1):18. BioMed Central Full Text
- [6]Arving C, Glimelius B, Brandberg Y: Four weeks of daily assessments of anxiety, depression and activity compared to a point assessment with the hospital anxiety and depression scale. Qual Life Res 2008, 17(1):95-104.
- [7]van Scheppingen C, Schroevers MJ, Smink A, van der Linden YM, Mul VE, Langendijk JA, Coyne JC, Sanderman R: Does screening for distress efficiently uncover meetable unmet needs in cancer patients? Psycho-Oncology 2011, 20(6):655-663.
- [8]Hodges L, Humphris G, Macfarlane G: A meta-analytic investigation of the relationship between the psychological distress of cancer patients and their carers. Social Sci & Med 2005, 60(1):1-12.
- [9]Vodermaier A, Linden W, MacKenzie R, Greig D, Marshall C: Disease stage predicts post-diagnosis anxiety and depression only in some types of cancer. Br J Cancer 2011, 105(12):1814-1817.
- [10]Hagedoorn M, Sanderman R, Bolks HN, Tuinstra J, Coyne JC: Distress in couples coping with cancer: a meta-analysis and critical review of role and gender effects. Psychological Bull 2008, 134(1):1.
- [11]Parker PA, Baile WF, Moor C, Cohen L: Psychosocial and demographic predictors of quality of life in a large sample of cancer patients. Psycho-Oncology 2002, 12(2):183-193.
- [12]Berglund A, Holmberg L, Tishelman C, Wagenius G, Eaker S, Lambe M: Social inequalities in non-small cell lung cancer management and survival: a population-based study in central Sweden. Thorax 2010, 65(4):327-333.
- [13]Pinquart M, Duberstein P: Depression and cancer mortality: a meta-analysis. Psychol Med 2010, 40(11):1797-1810.
- [14]Vodermaier A, Linden W, Siu C: Screening for emotional distress in cancer patients: a systematic review of assessment instruments. JNCI J Natl Cancer Inst 2009, 101(21):1464.
- [15]Murray E, Burns J, See TS, Lai R, Nazareth I: Interactive health communication applications for people with chronic disease. Cochrane Database Syst Rev 2005, 4:12-23.
- [16]Winzelberg AJ, Classen C, Alpers GW, Roberts H, Koopman C, Adams RE, Ernst H, Dev P, Taylor CB: Evaluation of an internet support group for women with primary breast cancer. Cancer 2003, 97(5):1164-1173.
- [17]Høybye M, Dalton SO, Deltour I, Bidstrup P, Frederiksen K, Johansen C: Effect of internet peer-support groups on psychosocial adjustment to cancer: a randomised study. Br J Cancer 2010, 102(9):1348-1354.
- [18]Spek V, Cuijpers P, Nyklícek I, Riper H, Keyzer J, Pop V: Internet-based cognitive behaviour therapy for symptoms of depression and anxiety: a meta-analysis. Psychol Med 2007, 37(03):319-328.
- [19]Carlson L, Angen M, Cullum J, Goodey E, Koopmans J, Lamont L, MacRae J, Martin M, Pelletier G, Robinson J: High levels of untreated distress and fatigue in cancer patients. Br J Cancer 2004, 90(12):2297-2304.
- [20]Thalén-Lindström A, Larsson G, Glimelius G, Johansson B: Anxiety and depression in oncology patients; a longitudinal study of a screening, assessment and psychosocial support intervention. Acta Oncologica Jan 2013 2013, 52(1):118-127.
- [21]Bower P, Gilbody S: Stepped care in psychological therapies: access, effectiveness and efficiency. Narrative literature review. Br J Psychiatry 2005, 186:11-17.
- [22]Fann J, Fan M, Unützer J: Improving primary care for older adults with cancer and depression. J Gen Internal Med 2009, 24:417-424.
- [23]van’t Veer-Tazelaar PJ, van Marwijk HWJ, van Oppen P, van Hout HPJ, van der Horst HE, Cuijpers P, Smit F, Beekman ATF: Stepped-care prevention of anxiety and depression in late life: a randomized controlled trial. Archives Gen Psychiatry 2009, 66(3):297.
- [24]Marks I, Mataix-Cols D, Kenwright M, Cameron R, Hirsch S, Gega L: Pragmatic evaluation of computer-aided self-help for anxiety and depression. Br J Psychiatry 2003, 183(1):57.
- [25]Myhr G, Payne K: Cost-effectiveness of cognitive-behavioural therapy for mental disorders: implications for public health care funding policy in Canada. Canadian J Psychiatry 2006, 51(10):662.
- [26]Sabariego C, Brach M, Herschbach P, Berg P, Stucki G: Cost-effectiveness of cognitive-behavioral group therapy for dysfunctional fear of progression in cancer patients. Eur J Health Econ 2011, 12(5):489-497.
- [27]Zigmond A, Snaith R: The hospital anxiety and depression scale. Acta Psychiatr Scand 1983, 67(6):361-370.
- [28]Puhan MA, Frey M, Büchi S, Schünemann HJ: The minimal important difference of the hospital anxiety and depression scale in patients with chronic obstructive pulmonary disease. Health and Quality of Life Outcomes 2008, 6(1):46. BioMed Central Full Text
- [29]Bjelland I, Dahl AA, Haug TT, Neckelmann D: The validity of the hospital anxiety and depression scale-an updated literature review. J Psychosomatic Res 2002, 52(2):69-78.
- [30]Andersson G, Kaldo-Sandström V, Ströma L: Internet administration of the hospital anxiety and depression scale in a sample of tinnitus patients. J Psychosom Res 2003., 55(Issue 3)
- [31]Svanborg P, Åsberg M: A new self rating scale for depression and anxiety states based on the comprehensive psychopathological rating scale. Acta Psychiatr Scand 1994, 89(1):21-28.
- [32]Svanborg P, Asberg M: A comparison between the beck depression inventory (BDI) and the self-rating version of the Montgomery asberg depression rating scale (MADRS). J Affective Disord 2001, 64(2–3):203.
- [33]Montgomery SA, Asberg M: A new depression scale designed to be sensitive to change. Br J Psychiatry 1979, 134(4):382.
- [34]Spielberger CD, Gorsuch RL, Lushene RE: The state-trait anxiety inventory. Palo Alto, Calif: Consulting Psychologists Press Inc; 1970.
- [35]Kvaal K, Ulstein I, Nordhus IH, Engedal K: The Spielberger state‒trait anxiety inventory (STAI): the state scale in detecting mental disorders in geriatric patients. Int J Geriatric Psychiatry 2005, 20(7):629-634.
- [36]Weathers F, Litz B, Herman D, Huska J, Keane T: The PTSD checklist: reliability, validity, and diagnostic utility. Paper presented at the Annual Meeting of the International Society for. San Antonio, TX: Traumatic Stress Studies; 1993.
- [37]American Psychiatric Association: Diagnostic and Statistical Manual of Mental Disorders. Fourth edition. Washington, DC: American Psychiatric Association; 2000. Text Revision
- [38]Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, Haes JCJM: The European organization for research and treatment of cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. JNCI J Natl Cancer Inst 1993, 85(5):365.
- [39]Sprangers M, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, Franzini L, Williams A, De Haes H, Hopwood P: The European organization for research and treatment of cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol 1996, 14(10):2756.
- [40]van Andel G, Bottomley A, Fosså SD, Efficace F, Coens C, Guerif S, Kynaston H, Gontero P, Thalmann G, Akdas A: An international field study of the EORTC QLQ-PR25: a questionnaire for assessing the health-related quality of life of patients with prostate cancer. Eur J Cancer 2008, 44(16):2418-2424.
- [41]Whistance R, Conroy T, Chie W, Costantini A, Sezer O, Koller M, Johnson C, Pilkington S, Arraras J, Ben-Josef E: Clinical and psychometric validation of the EORTC QLQ-CR29 questionnaire module to assess health-related quality of life in patients with colorectal cancer. Eur J Cancer 2009, 45(17):3017-3026.
- [42]The EQG: EuroQol-a new facility for the measurement of health-related quality of life. Health Policy 1990, 16(3):199-208.
- [43]Blackwell E, de Leon CFM, Miller GE: Applying mixed regression models to the analysis of repeated-measures data in psychosomatic medicine. Psychosom Med 2006, 68(6):870-878.
- [44]Holsti OR: Content analysis for the social sciences and humanities. 1969.
- [45]Arving C, Sjoden PO, Bergh J, Hellbom M, Johansson B, Glimelius B, Brandberg Y: Individual psychosocial support for breast cancer patients: a randomized study of nurse versus psychologist interventions and standard care. Cancer nursing 2007, 30(3):E10-E19.
- [46]Wright JH, Wright AS, Albano AM, Basco MR, Goldsmith LJ, Raffield T, Otto MW: Computer-assisted cognitive therapy for depression: maintaining efficacy while reducing therapist time. Am J Psychiatry 2005, 162(6):1158-1164.