A web-based self-help intervention for partners of cancer patients based on Acceptance and Commitment Therapy: a protocol of a randomized controlled trial

BMC Public Health

Ernst T Bohlmeijer¹  Irma M Verdonck-de Leeuw³  Mariët Hagedoorn²  Karlein MG Schreurs⁴  Constance HC Drossaert¹  Nadine Köhle¹ 

[1] Department of Psychology, Health and Technology, University of Twente, Enschede, 7500 AE, The Netherlands;Department of Health Sciences, University Medical Center Groningen and University of Groningen, Groningen, 9700 AD, The Netherlands;Department of Otolaryngology/Head and Neck Surgery, VU University Medical Center, Amsterdam, 1007 MB, The Netherlands;Roessingh Research and Development, Enschede, 310 7500 AH, The Netherlands

关键词: Acceptance and Commitment Therapy;    Cost-effectiveness;    Effectiveness;    Web-based;    Self-help;    Partners;    RCT;    Distress;    Oncology;    Cancer;   

Others  :  1164167
DOI  :  10.1186/s12889-015-1656-y

 received in 2015-03-10, accepted in 2015-03-18,  发布年份 2015

【 摘 要 】

Background

There is a growing recognition that cancer not only affects the lives of the patients, but also the lives of their partners. Partners of cancer patients are highly involved in the illness trajectory by providing informal care and they often experience distress. However, supporting interventions for this group are scarce and existing interventions bear several limitations. On the basis of the need for theory- and evidence-based supportive interventions for partners of cancer patients, the web-based self-help intervention Hold on, for each other has been developed. This intervention is based on Acceptance and Commitment Therapy. The primary objective of the RCT is to investigate the (cost-) effectiveness of the intervention. Additional goals are (1) to examine if psychological flexibility, self-compassion, mastery, supportive behavior, posttraumatic growth and resilience are mediators of the intervention’s effects on the partners’ mental health; (2) to examine the moderating effects of the socio demographics (age, gender, education, working situation, family situation) and disease-related characteristics of the patients (sort of cancer, stage of disease, duration and treatment of cancer); and (3) to investigate to what extend participants are satisfied with the intervention, which parts of the intervention are mostly used, and how adherent the users are.

Methods/Design

A three-armed randomized controlled trial (RCT) will be conducted to compare two versions of the intervention Hold on, for each other with a waiting list control condition. Both intervention conditions contain the same content and differ only with regard to the form of professional support (personal support versus automatic support). Adult partners of cancer patients with mild to moderate depressive and anxiety symptoms, will be recruited through a multi-component strategy. Online measurements by self-assessment will be made on four measurement points (prior to randomization (baseline-measurement) and 3, 6 and 12 months after baseline).

Discussion

When proven effective, Hold on, for each other can be an invaluable contribution to the healthcare system and it could be offered to all partners of cancer patients who are in need for additional support.

Trial registration

Dutch Trial Register, trial registration number NTR4035 webcite, date of registration: 17 March 2013.

【 授权许可】

   
2015 Kohle et al.; licensee BioMed Central.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Lund L, Ross L, Petersen MA, Groenvold M. The interaction between informal cancer caregivers and health care professionals: a survey of caregivers’ experiences of problems and unmet needs. Support Care Cancer. 2014:1–15 [Epub ahead of print].
• [2]Applebaum AJ, Breitbart W: Care for the cancer caregiver: a systematic review. Palliat Support Care 2013, 11(03):231-252. doi:10.1017/S1478951512000594
• [3]Stenberg U, Ruland CM, Miaskowski C: Review of the literature on the effects of caring for a patient with cancer. Psycho Oncol 2010, 19(10):1013-1025.
• [4]Northouse LL, Katapodi MC, Song L, Zhang L, Mood DW: Interventions with family caregivers of cancer patients, meta-analysis of randomized trials. CA Cancer J Clin 2010, 60(5):317-339. doi:10.3322/caac.20081
• [5]Ussher JM, Perz J, Hawkins Y, Brack M: Evaluating the efficacy of psycho-social interventions for informal carers of cancer patients: a systematic review of the research literature. Health Psychol Rev 2009, 3(1):85-107.
• [6]Pitceathly C, Maguire P: The psychological impact of cancer on patients’ partners and other key relatives: a review. Eur J Cancer 2003, 39(11):1517-1524.
• [7]Donnelly JM, Kornblith AB, Fleishman S, Zuckerman E, Raptis G, Hudis CA, et al.: A pilot study of interpersonal psychotherapy by telephone with cancer patients and their partners. Psycho Oncol 2000, 9(1):44-56.
• [8]Sinfield P, Baker R, Ali S, Richardson A: The needs of carers of men with prostate cancer and barriers and enablers to meeting them: a qualitative study in England. Eur J Cancer Care 2012, 21(4):527-534. doi:10.1111/j.1365-2354.2012.01341.x
• [9]Tang W, Chan C, So W, Leung D: Web-based interventions for caregivers of cancer patients: a review of literatures. Asia Pac J Oncol Nurs 2014, 1(1):9-15. doi:10.4103/2347-5625.135811
• [10]Eysenbach G: What is e-health? J Med Internet Res 2001, 3(2):e20.
• [11]Griffiths F, Lindenmeyer A, Powell J, Lowe P, Thorogood M: Why are health care interventions delivered over the internet? A systematic review of the published literature. J Med Internet Res 2006, 8(2):e10.
• [12]Feros DL, Lane L, Ciarrochi J, Blackledge JT: Acceptance and Commitment Therapy (ACT) for improving the lives of cancer patients: a preliminary study. Psycho Oncol 2013, 22(2):459-464.
• [13]Hayes SC, Luoma JB, Bond FW, Masuda A, Lillis J: Acceptance and commitment therapy: model, processes and outcomes. Behav Res Ther 2006, 44(1):1-25.
• [14]Rost AD, Wilson K, Buchanan E, Hildebrandt MJ, Mutch D: Improving psychological adjustment among late-stage ovarian cancer patients: examining the role of avoidance in treatment. Cogn Behav Pract 2012, 19(4):508-517.
• [15]Manne SL, Ostroff J, Winkel G, Grana G, Fox K: Partner unsupportive responses, avoidant coping, and distress among women with early stage breast cancer: patient and partner perspectives. Health Psychol 2005, 24(6):635.
• [16]Manne SL, Ostroff JS, Norton TR, Fox K, Goldstein L, Grana G: Cancer‐related relationship communication in couples coping with early stage breast cancer. Psycho Oncol 2006, 15(3):234-247.
• [17]Masuda A, Twohig MP, Stormo AR, Feinstein AB, Chou Y-Y, Wendell JW: The effects of cognitive defusion and thought distraction on emotional discomfort and believability of negative self-referential thoughts. J Behav Ther Exp Psy 2010, 41(1):11-17.
• [18]Roemer L, Orsillo SM, Salters-Pedneault K: Efficacy of an acceptance-based behavior therapy for generalized anxiety disorder: evaluation in a randomized controlled trial. J Consult Clin Psych 2008, 76(6):1083.
• [19]Teasdale JD, Segal ZV, Williams JMG, Ridgeway VA, Soulsby JM, Lau MA: Prevention of relapse/recurrence in major depression by mindfulness-based cognitive therapy. J Consult Clin Psych 2000, 68(4):615.
• [20]Ma SH, Teasdale JD: Mindfulness-based cognitive therapy for depression: replication and exploration of differential relapse prevention effects. J Consult Clin Psych 2004, 72(1):31.
• [21]Shapiro SL, Brown KW, Biegel GM: Teaching self-care to caregivers: effects of mindfulness-based stress reduction on the mental health of therapists in training. Train Educ Prof Psychol 2007, 1(2):105.
• [22]Neff KD, Kirkpatrick KL, Rude SS: Self-compassion and adaptive psychological functioning. J Res Pers 2007, 41(1):139-154.
• [23]Neff KD. Self-compassion for caregivers: If you’re a caregiver, you need self-compassion. Psychology Today. 2011. https://www.psychologytoday.com/blog/the-power-self-compassion/201105/self-compassion-caregivers. Accessed 02/18/2015 2015.
• [24]Kelders SM: Understanding adherence to web-based interventions. Universiteit Twente, Enschede, the Netherlands; 2012.
• [25]Zigmond AS, Snaith RP: The hospital anxiety and depression scale. Acta Psychiatr Scand 1983, 67(6):361-370.
• [26]Julian LJ. Measures of Anxiety. Arthritis Care Res. 2011;63(11). doi:10.1002/acr.20561.
• [27]Sheehan D, Lecrubier Y, Sheehan KH, Janavs J, Weiller E, Keskiner A, et al.: The validity of the Mini International Neuropsychiatric Interview (MINI) according to the SCID-P and its reliability. Eur Psychiat 1997, 12(5):232-241.
• [28]Leon AC, Olfson M, Portera L, Farber L, Sheehan DV: Assessing psychiatric impairment in primary care with the Sheehan Disability Scale. Int J Psychiat Med 1997, 27(2):93-105.
• [29]Rush AJ: American Psychiatric A, Task Force for the Handbook of Psychiatric M: Handbook of psychiatric measures. American Psychiatric Association, Washington, DC; 2000.
• [30]Keyes CL: Mental illness and/or mental health? Investigating axioms of the complete state model of health. J Consult Clin Psych 2005, 73(3):539.
• [31]Lamers S, Westerhof GJ, Bohlmeijer ET, ten Klooster PM, Keyes CL: Evaluating the psychometric properties of the mental health continuum‐short form (MHC‐SF). J Clin Psychol 2011, 67(1):99-110.
• [32]Robinson BC: Validation of a caregiver strain index. J Gerontol 1983, 38(3):344-348.
• [33]Ware JE Jr, Sherbourne CD: The MOS 36-item short-form health survey (SF-36): I. Conceptual framework and item selection. Med Care 1992, 6:473-483.
• [34]Vander Zee K, Sanderman R, Heyink J, de Haes H: Psychometric qualities of the rand 36-item health survey 1.0: A multidimensional measure of general health status. Int J Behav Med 1996, 3(2):104-122. doi:10.1207/s15327558ijbm0302_2
• [35]Brooks R: EuroQol: the current state of play. Health Policy 1996, 37(1):53-72. http://dx.doi.org/10.1016/0168-8510(96)00822-6
• [36]Jacobs N, Kleen M, De Groot F, A-Tjak J: Het meten van experiëntiële vermijding. De nederlandstalige versie van de Acceptance and Action Questionnaire-II (AAQ-II). Gedragstherapie 2008, 41:349-361.
• [37]Bond FW, Hayes SC, Baer RA, Carpenter KM, Guenole N, Orcutt HK, et al.: Preliminary psychometric properties of the Acceptance and Action Questionnaire–II: A revised measure of psychological inflexibility and experiential avoidance. Behav Therapy 2011, 42(4):676-688.
• [38]McCracken LM, Zhao‐O’Brien J: General psychological acceptance and chronic pain: there is more to accept than the pain itself. Eur J Pain 2010, 14(2):170-175.
• [39]Fledderus M, Bohlmeijer ET, Smit F, Westerhof GJ: Mental health promotion as a new goal in public mental health care: a randomized controlled trial of an intervention enhancing psychological flexibility. Am J Public Health 2010, 100(12):2372.
• [40]Neff KD, Vonk R: Self-compassion versus global self-esteem: two different ways of relating to oneself. J Pers 2009, 77(1):23-50. doi:10.1111/j.1467-6494.2008.00537.x
• [41]Raes F, Pommier E, Neff KD, Van Gucht D: Construction and factorial validation of a short form of the self‐compassion scale. Clin Psychol Psychother 2011, 18(3):250-255.
• [42]Tedeschi RG, Calhoun LG: The Posttraumatic Growth Inventory: measuring the positive legacy of trauma. J Trauma Stress 1996, 9(3):455-471.
• [43]Cann A, Calhoun LG, Tedeschi RG, Taku K, Vishnevsky T, Triplett KN, et al.: A short form of the Posttraumatic Growth Inventory. Anxiety Stress Coping 2010, 23(2):127-137.
• [44]Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J: The brief resilience scale: assessing the ability to bounce back. Int J Behav Med 2008, 15(3):194-200.
• [45]Buunk BP, Berkhuysen MA, Sanderman R, Nieuwland W: Actieve betrokkenheid, beschermend bufferen en overbescherming. Meetinstrumenten voor de rol van de partner bij hartrevalidatie. [The role of the partner in heart disease: Active engagement, protective buffering, and overprotection]. Gedrag Gezondheid 1996, 24(6):304-313.
• [46]Hagedoorn M, Dagan M, Puterman E, Hoff C, Meijerink WJHJ, Delongis A, et al.: Relationship satisfaction in couples confronted with colorectal cancer: the interplay of past and current spousal support. J Behav Med 2011, 34(4):288-297. doi:10.1007/s10865-010-9311-7
• [47]Pearlin LI, Schooler C: The structure of coping. J Health Soc Behav. 1978, 19:2-21.
• [48]Larsen DL, Attkisson CC, Hargreaves WA, Nguyen TD: Assessment of client/patient satisfaction: development of a general scale. Eval Program Plann 1979, 2(3):197-207.
• [49]Hakkaart-van Roijen L, Van Straten A, Donker M, Tiemens B: Trimbos/iMTA questionnaire for costs associated with psychiatric illness (TIC-P). Institute for Medical Technology Assessment. Erasmus University Rotterdam Trimbos, Rotterdam, the Netherlands.; 2002.
• [50]Koopmanschap MA: PRODISQ: a modular questionnaire on productivity and disease for economic evaluation studies. Expert Rev Pharmacoecon Outcomes Res 2005, 5(1):23-28. doi:10.1586/14737167.5.1.23
• [51]Lipsey MW, Wilson DB: The efficacy of psychological, educational, and behavioral treatment: confirmation from meta-analysis. Am Psychol 1993, 48(12):1181.
• [52]Preacher KJ, Hayes AF: SPSS and SAS procedures for estimating indirect effects in simple mediation models. Behav Res Meth Instrum Comput 2004, 36(4):717-731.
• [53]Preacher KJ, Hayes AF: Asymptotic and resampling strategies for assessing and comparing indirect effects in multiple mediator models. Behav Res Methods 2008, 40(3):879-891.
• [54]Bohlmeijer ET, Fledderus M, Rokx T, Pieterse ME: Efficacy of an early intervention based on acceptance and commitment therapy for adults with depressive symptomatology: Evaluation in a randomized controlled trial. Behav Res Ther 2011, 49(1):62-67.
• [55]McMillan SC, Small BJ, Weitzner M, Schonwetter R, Tittle M, Moody L, et al.: Impact of coping skills intervention with family caregivers of hospice patients with cancer. Cancer 2006, 106(1):214-222.
• [56]Bultz BD, Speca M, Brasher PM, Geggie PH, Page SA: A randomized controlled trial of a brief psychoeducational support group for partners of early stage breast cancer patients. Psycho Oncol 2000, 9(4):303-313.
• [57]Scott JL, Halford WK, Ward BG: United we stand? The effects of a couple-coping intervention on adjustment to early stage breast or gynecological cancer. J Consult Clin Psychol 2004, 72(6):1122.