Anger and anxiety in patients with primary aldosteronism treated with amiloride hydrochloride or spironolactone or adrenalectomy

ANGER AND ANXIETY IN PATIENTS WITH PRIMARY ALDOSTERONISM TREATED WITH AMILORIDE HYDROCHLORIDE OR SPIRONOLACTONE OR ADRENALECTOMY Robin Sherill Armstrong RN, Dip App Sci (Nsg Edn), BHSc.(Nsg) Institute of Health and Biomedical Innovation School of Public Health Queensland University of Technology Thesis for Master of Applied Science (Research) 2007 Abstract Background In Primary Aldosteronism (PAL) excessive amounts of aldosterone cause sodium and water retention and, in many individuals, this leads to moderate to severely high blood pressure Although the chemistry and physiology are increasingly well understood, including the outcomes of treatment on physical health, there has been no systematic study of the psychological dimension of PAL Anecdotally, patients exhibit symptoms such as angry outbursts, irritability, anxiety and defensiveness, and partners of these patients sometimes mention poor anger control and brittle or unpredictable moods This thesis reports a systematic study of anger and anxiety among patients undergoing treatment for PAL Eighty-three patients were recruited over an 11-month period to a prospective, prepost design study to determine if treatment was associated with change in psychological state Method Participants completed the State-Trait Anger Expression Inventory (STAXI-2), State-Trait Anxiety Inventory (STAI) and Psychosocial Adjustment to Illness Scale (PAIS) questionnaires Adrenal Vein Sampling confirmed overproduction of aldosterone in one or both adrenal glands Patients with Aldosterone Producing Adenoma (APA) were offered adrenalectomy As per usual treatment protocols, patients with Bilateral Adrenal Hyperplasia (BAH) were prescribed spironolactone or amiloride depending predominantly on severity of blood pressure and potassium Robin S Armstrong M App Sci Thesis levels Post-test questionnaires were completed after 6-8 months Analysis was by mixed design (between-within subjects) ANOVA Participant numbers in the adrenalectomy group fell far short of expectations Fourteen past patients who had undergone unilateral adrenalectomy completed a retrospective semi-structured questionnaire This qualitative data was analysed to identify themes similar to quantitative data Results At baseline, ‘non-completers’ (ie those who did not complete the post-test; n=19), were significantly more angry than ‘completers’ (n=50) in State Anger (p< 01), Trait Anger (p< 05) and Anger Expression Index (p< 001) Trait Anxiety was also higher (p< 05), as was Psychological Distress (p< 05) Among those who participated at both interviews, there was small but statistically significant adverse treatment effect with higher scores for State Anger (p< 05), and Feeling Angry (p< 05) However for Trait Anger (p< 01), and of its sub-scales Angry Temperament (p< 05) and Angry Reaction (p< 01) there was a slight to moderate decrease in negative affect with treatment Psychological Distress scores also improved (p< 05) Across all ANOVAs, there were no significant interaction effects, suggesting that any treatment effect was equivalent for the two drugs Qualitatively collected data elucidated participants’ changes in approach to life and relationships since adrenalectomy Themes that emerged in the data included improved ability to cope with external stress, better control of emotions, more relaxed relationships and attitude to work, and a greater vitality and quality of life Robin S Armstrong M App Sci Thesis Generally the comments were consistent with the drug treatments; there was noticeable benefit, including perceived better anger control and less anxiety Conclusions Positive psychological effects of treatment observed in the two drug groups were triangulated with data from a qualitative study The combined evidence suggests that when excess circulating aldosterone is reduced (adrenalectomy), or blocked (spironolactone), or aldosterone’s salt and water retaining effects are minimised (amiloride), then nervous irritability and its subsequent psycho-behavioural manifestations are reduced The effect however is slight and the conclusions are weakened by an apparent attrition bias, and the absence of a control group Implications for further research are discussed Robin S Armstrong M App Sci Thesis Table of Contents Chapter 1: Introduction and Literature Review 12 Rationale for the study 18 Evolution of the quantitative study 19 Objectives 22 Chapter 2: Method (Study 1) 23 Rationale for this study 23 Null Hypothesis 25 Design 25 Sample 25 Measurement 33 Procedures 38 Statistical analysis 40 Ethical considerations 41 Chapter 3: 42 Results (Study 1) Discussion 57 Conclusion 61 Chapter 4: Qualitative inquiry into the effects of adrenalectomy (Study 2) Patient perceptions of behavioural, emotional, physical And lifestyle change, 6-24 months post-adrenalectomy for aldosterone producing adenoma: A qualitative study Introduction 63 Method 64 Analysis 69 Results 71 Discussion (Study 2) 81 Robin S Armstrong M App Sci Thesis Chapter 5: Conclusion The combined quantitative and qualitative study 85 Reference list 88 Appendix 1: Psychometric Analysis - modified STAI – Form Y 96 Appendix 2: Qualitative Study questionnaire Robin S Armstrong M App Sci Thesis 112 List of Tables and Figures Chapter 2: Method (Study 1) Table 2.1: Descriptive characteristics of participants in spironolactone and amiloride groups at baseline _30 Table 2.2: Concomittant medication use by participants in spironolactone and amiloride groups at baseline 32 Table 2.3: Scale and sub-scale definitions taken from STAXI-2 Professional Manual (Spielberger, 1996). _ 35 Chapter 3: Results (Study 1) Table 3.1: Comparison at baseline of mean State Anger and Mean State Anxiety scores of participants who subsequentlydid complete (completers) and did not complete (non-completers) the post-test questionnaire 42 Table 3.2: Comparison at baseline of mean Trait Anger and mean Trait Anxiety scores of participants who subsequently did complete (completers) and did not complete (non-completers) the post-test questionnaire 43 Table 3.3: Comparison at baseline of mean Anger Expression and mean Anger control scores of participants who subsequently did complete (completers) and did not complete (non-completers) the post test questionnaire _44 Table 3.4: Comparison of mean PAIS baseline scores for participants who did or did not complete the post-test questionnaire _45 Table 3.5: Comparison of treatment groups spironolactone and amiloride at baseline. _46 Table 3.6: Variables significantly differing by gender at baseline _47 Table 3.7: Post-test differences in scores that were significantly different at baseline, grouped by gender and treatment group _47 Table 3.8: Mixed between-within analysis of variance (ANOVA) State Anger and State Anxiety. _49 Figure 3.1: Change in mean State Anger scores from pre-test to post-test. 49 Figure 3.2: Change in mean Feeling Angry scores from pre-test to post-test _50 Table 3.9: Mixed between-within analysis of variance (ANOVA) Trait Anger, Anger Expression, Anger Control and Trait Anxiety _ 51 Figure 3.3: Change in mean Trait Anger scores pre-test to post-test. 52 Robin S Armstrong M App Sci Thesis Figure 3.4: Change in mean Angry Temperament scores pre-test to post-test. _52 Figure 3.5: Change in mean Angry reaction scores pre-test to post-test. _ 53 Table 3.10: Mixed between-within analysis of variance (ANOVA) Psychosocial Adjustment to Illness Scale (PAIS) _53 Figure 3.6: Change in mean (PAIS) Psychological Distress scores pre-test to post-test 55 Table 3.11: Mixed between-within analysis of variance (ANOVA) Serum Potassium and Systolic Blood Pressure. _56 Chapter : Qualitative enquiry into the effects of adrenalectomy Table 4.1: Participant perceptions of their ability to cope with external stress. 73 Table 4.2: Participant perceptions of their improved emotional control 75 Table 4.3: Participant perceptions of positive changes in their spouse/partner, family and social relationships, and work. _76 Table 4.4: Participant perceptions of improvement in their vitality and quality of life. _78 Table 4.5: Participant perceptions of most important physical change _ 79 Table 4.6: Participant blood pressure and medications. 80 Appendix 1:Psychometric analysis of State-Trait Anxiety Inventory (STAI) Table 1.1: Pre-test State Anxiety modified 8-item form 97 Table 1.2: Pre-test Trait Anxiety modified 8-item form 98 Table 1.3: Post-test State Anxiety modified 8-item form _ 98 Table 1.4: Post-test Trait Anxiety modified 8-item form _ 99 Table 1.5: Pre-test State Anxiety – same items used in modified version from participants who completed the 20-item form-Y. 100 Table 1.6: Pre-test State Anxiety – 20-item form-Y. _ 101 Table 1.7: Pre-test Trait Anxiety – same items used in modified version from participants who completed the 20-item form-Y. 102 Table 1.8: Pre-test Trait Anxiety –20-item form-Y 103 Table 1.9: Post-test State Anxiety – same items used in modified version from participants who completed the 20-item form-Y. 104 Table 1.10: Post-test State Anxiety – 20-item form-Y. _105 Robin S Armstrong M App Sci Thesis Table 1.11: Post-test Trait Anxiety – same items used in modified version from participants who completed the 20-item form-Y. 106 Table 1.12: Post-test Trait Anxiety – 20-item form-Y. _107 Table 1.13: Correlation of 8-item modified scale total score with PAIS (vii) Psychological Distress score and correlation of 20-item version with PAIS (vii) Psychological distress score 108 Figure 1.1: Total score correlation of pre-test State Anxiety 1-8 with matched PAIS (vii) item Psychological Distress. 109 Figure 1.2: Total score correlation of pre-test Trait Anxiety 1-8 with matched PAIS (vii) item Psychological Distress. 110 Figure 1.3: Total score correlation of post-test State Anxiety 1-8 with matched PAIS (vii) item Psychological Distress. 111 Figure 1.4: Total score correlation of post-test Trait Anxiety 1-8 with matched PAIS (vii) item Psychological Distress. 112 Robin S Armstrong M App Sci Thesis Statement of Original Authorship “The work contained in this thesis has not been submitted for a degree or diploma at any other higher education institution To the best of my knowledge and belief, this thesis contains no material previously published or written by another person except where due reference is made.” Signed: ……………………………………… Robin S Armstrong RN, Dip App Sci (Nsg Edn) BHSc (Nursing) Date: ………………………………………… Robin S Armstrong M App Sci Thesis 10 POST-TEST STATE ANXIETY Appendix Table 1.9: Post-test State Anxiety same items used in modified version from participants who completed the 20- item Form-Y (cases N=38) STAI StateItem Mean Cronbach’s Alpha if item deleted I feel calm 1.76 887 810 I am tense 1.71 899 684 I feel upset 1.34 904 610 I feel frightened 1.26 900 704 I feel nervous 1.53 896 706 I am relaxed 1.89 898 697 I am worried 1.63 892 754 I feel confused 1.29 894 779 Cronbach’s Alpha - 908 Robin S Armstrong Item total Correlation Mean = 0.718 M App Sci Thesis 104 Appendix Table 1.10: Post-test – State Anxiety 20 Item Form-Y (cases N=37) STAI StateItem Mean Cronbach’s Alpha if item deleted Item total Correlation I feel calm 1.76 949 885 I feel secure 1.49 951 826 I am tense 1.68 953 618 I feel strained 1.62 951 751 I feel at ease 1.84 951 806 I feel upset 1.30 954 592 I am presently worried over possible misfortunes 1.57 953 636 I feel satisfied 1.84 955 517 I feel frightened 1.27 953 669 I feel comfortable 1.57 951 809 I feel self-confident 1.89 952 741 I feel nervous 1.49 953 674 I am jittery 1.32 954 570 I feel indecisive 1.59 952 688 I am relaxed 1.89 951 796 I feel content 1.81 953 671 I am worried 1.62 952 712 I feel confused 1.30 951 806 I feel steady 1.78 953 652 I feel pleasant 1.70 952 710 Cronbachs’ Alpha - 954 Chronbachs’ Alpha = 0.902 for 8-item version and 0.908 for items within the 20- item form are similar to the 20-item value 0.954 above Robin S Armstrong M App Sci Thesis 105 POST-TEST TRAIT ANXIETY Appendix Table 1.11: Post-test Trait Anxiety same items used in modified version from participants who completed the 20- item Form-Y (cases N=37) STAI Trait Item Mean Cronbach’s Alpha if item deleted I feel nervous and restless 1.68 852 697 I feel satisfied with myself 1.84 844 759 I feel that difficulties are piling up so that I cannot overcome them 1.54 858 656 I feel like a failure 1.30 861 632 I have disturbing thoughts 1.38 865 593 I lack self-confidence 1.70 877 458 I feel secure 1.54 848 722 I worry too much about something that really does not matter 1.84 861 625 Cronbach’s Alpha - 874 Robin S Armstrong Item total Correlation Mean = 0.643 M App Sci Thesis 106 Appendix Table 1.12: Post-test Trait Anxiety 20-item Form-Y (cases N=36) STAI Trait Item Mean Cronbach’s Alpha if item deleted Item total Correlation I feel pleasant 1.69 914 757 I feel nervous and restless 1.67 915 758 I feel satisfied with myself 1.83 914 739 I wish I could be as happy as others seem to be 1.89 950 000 I feel like a failure 1.31 918 612 I feel rested 2.50 918 554 I feel calm, cool and collected 2.22 912 795 I feel that difficulties are piling up so that I cannot overcome them 1.56 917 685 I worry too much about something that really does not matter 1.83 916 640 I am happy 1.72 913 793 I have disturbing thoughts 1.36 917 698 I lack self-confidence 1.69 920 446 I feel secure 1.56 915 723 I make decisions easily 1.92 915 716 I feel inadequate 1.61 920 457 I am content 1.72 912 840 Some unimportant thought runs through my mind and bothers me 1.56 916 701 I take disappointments so keenly that I can’t put them out of my mind 1.75 916 659 I am a steady person 1.83 914 728 I get in a state of tension or turmoil as I think over my recent concerns and interests 1.61 915 708 Cronbachs’ Alpha - 921 Chronbachs’ Alpha = 0.908 for 8-item version and 0.874 for items within the 20- item form are reasonably similar to the 20-item value 0.921 above Robin S Armstrong M App Sci Thesis 107 External validity of scale External validity for the 8-item modified scale was determined by Pearson’s product moment correlation coefficient (Pearson’s r) which explores the strength of the relationship between two continuous variables to Psychosocial Adjustment to Illness Scale) used in this study This comparison is particularly valid for this comparison because the data were collected at the same time points as the State and Trait Anxiety data Appendix Table 1.13: Correlation of 8-item modified scale total score with PAIS (vii) Psychological Distress score and correlation of 20-item version with PAIS (vii) Psychological Distress score Data collection point Pearson’s r 8-item modified scale Pearson’s r 20-item original version Pre-test State Anxiety 912** 631** Pre-test Trait Anxiety 837** 712** Post-test State Anxiety 921** 733** Post-test Trait Anxiety 827** 327* ** correlation is significant at the 0.01 level (2-tailed) * correlation is significant at the 0.05 level (2-tailed) In this study there was significant (p < 01) relationship between each 8-item score and the PAIS Psychological distress score for the same data collection point Visual representations of these relationships are depicted in following scatterplots (Figures 1.1, 1.2, 1.3 and 1.4) Robin S Armstrong M App Sci Thesis 108 Appendix Figure 1.1: Total score correlation of pre-test State Anxiety 1- (cases N=17) with matched PAIS Psychological Distress item (cases N=17) Correlation: PAIS psych distress (item vii) & STAI State pre-test items 18 12 paisvii psych distress 10 10 15 20 total state score 1-8 Robin S Armstrong M App Sci Thesis 109 Appendix Figure 1.2: Total score correlation of pre-test Trait Anxiety 1- (cases N=17) with matched PAIS Psychological Distress item (cases N=17) Correlation PAIS psych distress (item vii) & STAI Trait pre-test items 18 12 paisvii psych distress 10 10 15 20 25 30 35 trait total score 1-8 Robin S Armstrong M App Sci Thesis 110 Appendix Figure 1.3: Total score correlation of post-test State Anxiety 1- (cases N=17) with matched PAIS Psychological Distress item (cases N=17) Correlation: PAIS psych distress (item vii) & STAI State post-test items 1-8 pais vii psych distress 12.5 10 7.5 2.5 12 15 18 21 total state score 1-8 Robin S Armstrong M App Sci Thesis 111 Appendix Figure 1.4: Total score correlation of post-test Trait 1- (cases N=17) with matched PAIS Psychological Distress item (cases N=17) Correlation: PAIS psych distress (item vii) & STAI Trait post-test items 18 paisvii psych distress 12.5 10 7.5 2.5 10 15 20 25 trait total score 1-8 Robin S Armstrong M App Sci Thesis 112 Appendix ID CODE: ……………… SCHOOL OF PUBLIC HEALTH QUT and the HYPERTENSION UNIT GREENSLOPES PRIVATE HOSPITAL DATE: ……………… 6-24 MONTHS POST-ADRENALECTOMY SUB-STUDY In the to 24 months since you have had your adrenal gland removed … 1.0 Have you noticed any changes in your relationships with others at work? Yes /No 1.1 If you have answered “yes” please describe _ 1.2 Do you feel that these changes are in the main related to the removal of your adrenal gland? Yes / No 1.3 Please state the reasons for your response _ In the 6-24 months since you have had your adrenal gland removed… 2.0 Have you noticed any change in your relationship with your spouse or person you feel closest to? Yes / No 2.1 If you have answered “yes” please describe _ 2.2 Do you feel that these changes are in the main related to the removal of your adrenal gland? Yes / No 2.3 Please state the reasons for your response In the 6-24 months since you have had your adrenal gland removed… 3.0 Have you noticed any change in your relationships with your family? Yes / No Robin S Armstrong M App Sci Thesis 113 3.1 If you have answered “yes” please describe _ 3.2 Do you feel that these changes are in the main related to the removal of your adrenal gland? Yes / No 3.3 Please state the reasons for your response In the 6-24 months since you have had your adrenal gland removed… 4.0 Have you noticed any changes in your social relationships? Yes / No 4.1 If you have answered “yes” please describe _ 4.2 Do you feel that these changes are in the main related to the removal of your adrenal gland? Yes / No 4.3 Please state the reasons for your response _ In the 6-24 months since you have had your adrenal gland removed… 5.0 Has your spouse or person you feel closest to, noticed any change in your relationship with them? Yes / No 5.1 If you have answered “yes” please describe 6.0 Has your spouse or person you feel closest to noticed any change in your relationships at work? Yes / No 6.1 If you have answered “yes” please describe _ Robin S Armstrong M App Sci Thesis 114 7.0 Has your spouse or person you feel closest to noticed any change in your relationships with the family? Yes / No 7.1 If you have answered “yes” please describe 8.0 Has your spouse or person you feel closest to noticed any change in your relationships socially? Yes / No 8.1 If you have answered “yes” please describe _ In the 6-24 months since you have had your adrenal gland removed… 9.0 Have you noticed any changes (for better or worse) in your physical health? Yes / No 9.1 If you have answered “yes” please describe up to physical changes (noting whether this change is for the better or the worse) beginning with the most important to you 1. _ _ 2. _ _ _ _ 3. _ _ _ _ 4. _ 5. _ Robin S Armstrong M App Sci Thesis 115 In the 6-24 months since you have had your adrenal gland removed… 10.0 Have you noticed any change in the consistency of your moods? Yes / No 10.1 If you answered “yes” please describe 11.0 Has your spouse or person to whom you feel closest noticed any change in the consistency of your moods? Yes / No 11.1 If you have answered ‘yes’ please describe 12.0 Have you noticed any change in the intensity of your emotional reactions? Yes / No 12.1 If you answered “yes” please describe 13.0 Has your spouse or person to whom you feel closest noticed any change in the intensity of your emotional reactions? Yes / No 13.1 If you answered “yes” please describe 14.0 Have you noticed any difference in the way you approach your day? For example, you feel less or more “pressured” or “driven” since you have had your adrenal gland removed? Please describe Robin S Armstrong M App Sci Thesis 116 In the 6-24 months since you have had your adrenal gland removed… 15.0 Have you noticed any difference in (i) the level of anger that you feel or (ii) how often you feel angry? Please describe (i) ii) 15.1 Have you noticed any change in the way/s in which you express your anger? Please describe In the 6-24 months since you have had your adrenal gland removed… 16.0 Have you noticed any difference in (i) the level of anxiety that you feel or (ii) how often you feel anxious? Please describe (i) ii) 16.1 Is there a difference in the types of things you get anxious about? Please describe Please not write your name on this document, it is coded for confidentiality IF YOU DO NOT HAVE ENOUGH ROOM TO WRITE ALL THAT YOU WISH, PLEASE NUMBER THE QUESTION YOU ARE REFERRING TO AND CONTINUE ON THE BACK OF THE PAGES Thankyou 17.0 Please include a record of 2-3 days of home blood pressure measurements done within the last month Robin S Armstrong M App Sci Thesis 117 18.0 Please include a list of all of the medications that you are currently taking for any condition at all Thankyou Robin S Armstrong M App Sci Thesis 118 ... clinical coordinator role in the Hypertension Unit included liaising and providing information regarding Fludrocortisone Suppression Test (FST) procedures Information regarding upcoming bookings... primary aldosteronism treated with amiloride hydrochloride, spironolactone or adrenalectomy Chapter 1: Introduction and literature review The aim of this study was to examine anger, anxiety and quality... treatment with amiloride hydrochloride and before and after 6-8 months treatment with spironolactone (Study 1, Chapter 3) To examine patient perceptions of changes following adrenalectomy in order