The Effectiveness of the Unified Protocol for Emotional Problems of Women with Breast Cancer: A Randomized Clinical Trial

Document Type : Original Article


1 Department of Clinical Psychology, Faculty of Medicine, Zahedan University of Medical Sciences, Sistan and Balouchestan, Iran

2 Department of Psychology, Faculty of Medicine, Islamic Azad University of Medical Sciences, Tehran, Iran

3 Department of Clinical Psychology, Islamic Azad University, Kermanshah, Iran

4 Department of Psychology, Islamic Azad University South Tehran Branch, Tehran, Iran


Introduction: The results of many studies have confirmed the existence of different emotional problems in women with breast cancer. So far, no study has been carried out on the effectiveness of the unified protocol. Therefore, the current research aimed at studying the effectiveness of this protocol on emotional problems of women who suffer from breast cancer.
Method: This study was a quasi-experimental study with a control group. The treatment lasted for 12 sessions (each session 60 min). The population included all women with breast cancer in Kermanshah. Sampling was done by convenience sampling. In this study, 40 women with breast cancer were divided into two control (20) and experimental (20) groups. The control group only received medication while the experimental group received a unified protocol along with medication. The participants were examined during pre-test, post-test and follow-up assessments. The assessments were done using the Depression, Anxiety and Stress Scale (DASS-21), The Emotion Regulation Questionnaire (ERQ), Acceptance & Action Questionnaire (AAQ-II), and Work and Social Adjustment Scale (WSAS). The data were analyzed via SPSS-24. Mean, standard deviation and repeated measures analysis were used to analyze the data.
Results: The results of repeated measures analysis indicated that the unified protocol leads to significant improvements in the variables of the study (P<0.01). The effect size of this treatment on the variables was medium and higher. The highest size effect belonged to reappraisal, suppression, acceptance and action, depression, stress, anxiety and socio-occupational adaptation.
Conclusion:  The unified protocol led to a decrease in the emotional problems, an improvement in emotion regulation and acceptance towards this illness in women with breast cancer. The therapeutic implications have been discussed.


  1. Schmidt ME, Scherer S, Wiskemann J, Steindorf K. Return to work after breast cancer: The role of treatment‐related side effects and potential impact on quality of life. European journal of cancer care. 2019;28(4):e13051.
  2. WHO. Cancer Fact Sheet 1st February 2015.2015.
  3. Moghadamfar N, Amraei R, Asadi F, Amani O. The efficacy of Acceptance and Commitment Therapy (ACT) on hope and psychological well-being in women with breast cancer under chemotherapy. Iranian J Psychiatric Nurs. 2018;6(5):1-8.
  4. Haji-Seyed-Sadeghi M, Zarani F, Mazaheri-Nejad-Fard G, Heidari M. Effectiveness of Training Mindfulness on Psychological Well-being, Coping Strategy and Family Function among Women Suffering from Breast Cancer. International Journal of Behavioral Sciences. 2020;13(4):153-8.
  5. Shaw L-K, Sherman KA, Fitness J, Australia BCN. Women's experiences of dating after breast cancer. Journal of psychosocial oncology. 2016;34(4):318-35.
  6. Gozashti MA, Daboui P, Moradi S. Effectiveness of group poetry therapy in reducing psychological problems and improving quality of life in patients with breast cancer. Journal of Mazandaran University of Medical Sciences. 2017;26(144):98-107.
  7. Carroll AJ, Baron SR, Carroll RA. Couple-based treatment for sexual problems following breast cancer: A review and synthesis of the literature. Supportive Care in Cancer. 2016;24(8):3651-9.
  8. Uwayezu MG, Gishoma D, Sego R, Mukeshimana M, Collins A. Anxiety and depression among cancer patients: prevalence and associated factors at a Rwandan referral hospital. Rwanda Journal of Medicine and Health Sciences. 2019;2(2):118-25.
  9. Lengacher CA, Reich RR, Paterson CL, Ramesar S, Park JY, Alinat C, et al. Examination of broad symptom improvement resulting from mindfulness-based stress reduction in breast cancer survivors: a randomized controlled trial. Journal of clinical oncology. 2016;34(24):2827.
  10. Derry HM, Jaremka LM, Bennett JM, Peng J, Andridge R, Shapiro C, et al. Yoga and self‐reported cognitive problems in breast cancer survivors: a randomized controlled trial. Psycho‐Oncology. 2015;24(8):958-66.
  11. Pouy S, Peikani FA, Nourmohammadi H, Sanei P, Tarjoman A, Borji M. Investigating the effect of mindfulness-based training on psychological status and quality of life in patients with breast cancer. Asian Pacific journal of cancer prevention: APJCP. 2018;19(7):1993.
  12. Ghorbani v, Z Z, Omidi A SM. Efficacy of acceptance and commitment therapy (ACT) on depression, pain acceptance, and psychological flexibility in married women with breast cancer: a pre- and post-test clinical trial. Trends Psychiatry Psychother. 2021.
  13. Barlow DH, Farchione TJ, Sauer-Zavala S, Latin HM, Ellard KK, Bullis JR, et al. Unified protocol for transdiagnostic treatment of emotional disorders: Therapist guide: Oxford University Press; 2017.
  14. Faller H, Schuler M, Richard M, Heckl U, Weis J, Küffner R. Effects of psycho-oncologic interventions on emotional distress and quality of life in adult patients with cancer: systematic review and meta-analysis. Journal of Clinical Oncology. 2013;31(6):782-93.
  15. Tatrow K, Montgomery GH. Cognitive behavioral therapy techniques for distress and pain in breast cancer patients: a meta-analysis. Journal of behavioral medicine. 2006;29(1):17-27.
  16. Newby JM, McKinnon A, Kuyken W, Gilbody S, Dalgleish T. Systematic review and meta-analysis of transdiagnostic psychological treatments for anxiety and depressive disorders in adulthood. Clinical psychology review. 2015;40:91-110.
  17. Pearl SB, Norton PJ. Transdiagnostic versus diagnosis specific cognitive behavioural therapies for anxiety: A meta-analysis. Journal of anxiety disorders. 2017;46:11-24.
  18. Mohammadpour M, Sadeghi K, Foroughi A, Amiri S, Pouyanfard S, Parvizifard A, et al. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders: Treatment of Comorbid Psychopathology Accompanying a Generalized Anxiety Disorder. International Journal of Behavioral Sciences. 2018;12(3):125-31.
  19. Ito M, Okumura Y, Horikoshi M, Kato N, Oe Y, Miyamae M, et al. Japan Unified Protocol Clinical Trial for Depressive and Anxiety Disorders (JUNP study): study protocol for a randomized controlled trial. BMC psychiatry. 2016;16(1):71.
  20. Barlow DH, Allen LB, Choate ML. Toward a unified treatment for emotional disorders. Behavior therapy. 2004;35(2):205-30.
  21. Mansell W, Harvey A, Watkins E, Shafran R. Conceptual foundations of the transdiagnostic approach to CBT. Journal of Cognitive Psychotherapy. 2009;23(1):6-19.
  22. McManus F, Shafran R, Cooper Z. What does a transdiagnostic approach have to offer the treatment of anxiety disorders? British Journal of Clinical Psychology. 2010;49(4):491-505.
  23. Barlow DH, Sauer-Zavala S, Carl JR, Bullis JR, Ellard KK. The nature, diagnosis, and treatment of neuroticism: Back to the future. Clinical Psychological Science. 2014;2(3):344-65.
  24. Barlow DH, Farchione TJ, Bullis JR, Gallagher MW, Murray-Latin H, Sauer-Zavala S, et al. The unified protocol for transdiagnostic treatment of emotional disorders compared with diagnosis-specific protocols for anxiety disorders: A randomized clinical trial. JAMA psychiatry. 2017;74(9):875-84.
  25. Mohammadpour M, Bavafa A, Foroughi A, Pouyanfard S, Elahi A, Jaberghaderi N. Generalized Anxiety Disorder and Comorbid Symptoms of Sleep: The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. Journal of Sleep Sciences. 2018;3(3-4):80-9.
  26. Bentley KH, Sauer-Zavala S, Cassiello-Robbins CF, Conklin LR, Vento S, Homer D. Treating suicidal thoughts and behaviors within an emotional disorders framework: Acceptability and feasibility of the unified protocol in an inpatient setting. Behavior modification. 2017;41(4):529-57.
  27. Barlow D, Ellard K, Fairholme C, Farchione C, Boisseau C, Allen L, et al. The unified protocol for transdiagnostic treatment of emotional disorders: Client workbook. 2011.
  28. Lovibond PF, Lovibond SH. The structure of negative emotional states: Comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behaviour research and therapy. 1995;33(3):335-43.
  29. jokar b, samani s. Evaluation of the validity and reliability of depression, anxiety, and stress scale. Journal of Social Sciences and Humanities of Shiraz University. 2007;8(4):65-78.
  30. Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. Journal of personality and social psychology. 2003;85(2):348.
  31. 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. Behavior therapy. 2011;42(4):676-88.
  32. abbasi i, fata l, molodi r, zarabi h. Psychometric evaluation of the Persian version of the accaptance and action Questionnaire-II. Journal of Psychology Models and Methods. 2012;2(10):65-80.
  33. Mundt JC, Marks IM, Shear MK, Greist JM. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. The British Journal of Psychiatry. 2002;180(5):461-4.
  34. Mohammadi A, Birashk B, Gharraee B. Comparison of the Effect of Group Transdiagnostic Treatment and Group Cognitive Therapy on Emotion Regulation. Iranian Journal of Psychiatry & Clinical Psychology. 2013;19(3).
  35. González Fernández S, Fernández Rodríguez C, Paz Caballero MD, Pérez Álvarez M. Treating anxiety and depression of cancer survivors: Behavioral activation versus acceptance and commitment therapy. Psicothema, 30. 2018.
  36. Hayes SC, Barnes‐Holmes D. Relational operants: Processes and implications: A response to Palmer's review of relational frame theory. Journal of the Experimental Analysis of Behavior. 2004;82(2):213-24.
  37. 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. Cognitive and Behavioral Practice. 2012;19(4):508-17.
  38. Mazaheri M, Daghaghzadeh H, Afshar H, Mohammadi N. The effectiveness of the unified protocol on emotional dysregulation and cognitive emotion regulation strategies in patients with psychosomatic disorders. International Journal of Body, Mind and Culture. 2014:73-82.
  39. Khakpoor S, Saed O, Armani Kian A. Emotion regulation as the mediator of reductions in anxiety and depression in the Unified Protocol (UP) for transdiagnostic treatment of emotional disorders: double-blind randomized clinical trial. Trends in psychiatry and psychotherapy. 2019;41(3):227-36.
  40. Feros DL, Lane L, Ciarrochi J, Blackledge JT. Acceptance and Commitment Therapy (ACT) for improving the lives of cancer patients: a preliminary study. Psycho‐oncology. 2013;22(2):459-64.