A Cognitive Behavioral Group Approach to Enhance Adherence toHemodialysis Fluid Restrictions: A Randomized Controlled Trial
John Sharp, DClinPsy, Matt R. Wild, DClinPsy, Andrew I. Gumley, PhD, andChristopher J. Deighan, MD
Background: Adhering to fluid restrictions represents one of the most difficult aspects of the hemodialysisreatment regimen. This report describes a randomized controlled trial of a group-based cognitive behavioralntervention aimed at improving fluid-restriction adherence in patients receiving hemodialysis. It was hypothesizedhat the intervention would improve adherence, measured by means of interdialytic weight gain (IWG), withoutmpacting negatively on psychosocial functioning. Methods: Fifty-six participants receiving hemodialysis from 4enal outpatient settings were randomly assigned to an immediate-treatment group (ITG; n � 29) or deferred-reatment group (DTG; n � 27). Participants were assessed at baseline, posttreatment, and follow-up stages.reatment consisted of a 4-week intervention using educational, cognitive, and behavioral strategies to enhanceffective self-management of fluid consumption. Results: No significant difference in mean IWGs was foundetween the ITG and DTG during the acute-phase analysis (F1,54 � 0.03; P > 0.05). However, in longitudinal analysis,
here was a significant main effect for mean IWG (F1.76,96.80 � 9.10; P < 0.001) and a significant difference betweenaseline and follow-up IWG values (t55 � 3.85; P < 0.001), reflecting improved adherence over time. No adverseffects of treatment were indicated through measures of psychosocial functioning. Some significant changes werevidenced in cognitions thought to be important in mediating behavioral change. Conclusion: The current studyrovides evidence for the feasibility and effectiveness of applying group-based cognitive behavior therapy tonhance adherence to hemodialysis fluid restrictions. Results are discussed in the context of the study’sethodological limitations. Am J Kidney Dis 45:1046-1057.2005 by the National Kidney Foundation, Inc.
ATIENTS RECEIVING hemodialysis fre-quently show difficulty adhering to treat-
ent, which involves a complex and onerousehavioral regimen. Studies examining therevalence of nonadherence to hemodialysisherapy suggest that many patients do notuccessfully follow diet, fluid-intake, and medi-ation regimens, and that of these regimens,onadherence to fluid intake is among the mostommon.1,2 Previous reports estimated thatore than 50% of hemodialysis patients do not
From Psychological Medicine, Division of Communityased Sciences, University of Glasgow, Academic Centre,artnavel Royal Hospital; and Renal Unit, Glasgow Royal
nfirmary, Glasgow, Lanarkshire, UK.Received October 4, 2004; accepted in revised form
ebruary 9, 2005.Originally published online as doi:10.1053/j.ajkd.2005.02.032
n May 3, 2005.Address reprint requests to Matt R. Wild, DClinPsy, Psy-
hological Medicine, Division of Community Based Sci-nces, University of Glasgow, Academic Centre, Gartnaveloyal Hospital, 1055 Great Western Rd, Glasgow, Lanark-hire, G12 0XH, UK. E-mail: [email protected]
ollow the fluid-restriction regimen.3 The estab-ished association between adherence and pa-ient well-being4 suggests that the develop-
ent of strategies aimed at improvingdherence should be viewed as paramount inenal settings. An increasing amount of litera-ure is dedicated to the investigation of psycho-ogical interventions, and there has been dis-inct variation in the approaches adopted.5
raditionally, intervention studies have usedehavioral strategies in their quest for adher-nce enhancement. However, the demonstratedenefits of multifaceted interventions6,7 haverompted contemporary trials to integrate addi-ional psychotherapeutic techniques in the de-elopment of their intervention protocol.Cognitive theories of behavior change have
een applied to the treatment of almost everyhronic medical problem. These theories areased on the observation that people’s emotionalroblems are founded in a system of dysfunc-ional beliefs about themselves and the worldurrounding them.8,9 Underlying beliefs arehought to influence individuals’ thoughts. Hold-ng irrational beliefs often creates cognitive dis-
ortion that can lead to emotional disruption.
idney Diseases, Vol 45, No 6 (June), 2005: pp 1046-1057
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onadherent hemodialysis patients are espe-ially likely to hold negative beliefs and attitudesegarding their treatment and consequently areore likely to engage in cognitive distortion.revious research suggests that such distorted
hinking styles may influence health-related be-avior.10
Cognitive behavior therapy (CBT) aims toelp patients identify dysfunctional cognitions,est them against reality, and alter them, therebymproving their emotional well-being and cop-ng behavior. A CBT approach may be particu-arly beneficial for patients who, on the basis ofxperiencing multiple failures in attempting toanage fluid-intake restrictions, have little or no
elief in their ability to cope adequately with theemands of the treatment regimen. Such individu-ls may have developed strong negative beliefsegarding their fluid management. Negativehoughts (eg, “My fluid restrictions are beyondy control.”) can result in negative feelings (eg,
adness, anger, hopelessness) and maladaptiveealth behaviors (eg, overdrinking), thereby rein-orcing these problematic beliefs. Assisting pa-ients to develop more realistic, self-helping be-iefs by using CBT could enable them to copeore effectively with fluid restrictions inherent
n the hemodialysis treatment regimen.Reviews of the existing literature suggest a
eed for improved methodological approaches inhe current field.5 Previous studies typically haveeen constrained by such methodological weak-esses as the use of small sample sizes and lackf control groups. Few studies have attempted topply a randomized controlled trial (RCT) de-ign to their investigation. Some reports haveighlighted the difficulties in adopting this de-ign in renal outpatient settings.11,12 It was pro-osed that the social nature of hemodialysis unitsay promote diffusion of treatment across groups.owever, through the adoption of alternative
xperimental design, it may be possible to circum-ent such difficulties. This would be worthwhileecause RCTs provide the best evidence on thefficacy of health care interventions.13
The present study reports on the effects of aewly developed cognitive behavioral interven-ion. The Glasgow University Liquid-Intake Pro-ram (GULP) aims to assist adult nonadherentemodialysis patients to improve their fluid re-
triction self-management. Through the adoption p
f an RCT design, the study sought to answer 3road research questions: (1) Is GULP effectiven improving adherence to hemodialysis fluidestrictions? (2) Are the foreseen improvementsn fluid-restriction adherence accompanied by aetrimental impact on quality of life and emo-ional well-being? (3) Does GULP impact onttributions and health beliefs thought to be influ-ntial in mediating adherence to fluid restric-ions?
METHODS
articipants, Settings, and LocationsParticipants were recruited from 4 National Health Ser-
ice outpatient hemodialysis units located in west and cen-ral Scotland, UK. Ethical approval was obtained from theelevant local research ethics committees. Renal nursingtaff identified patients with a history of problematic fluid-estriction adherence, defined as an average daily interdia-ytic weight gain (IWG) of 2.5 kg or greater. Inclusionriteria were: (1) confirmed diagnosis of end-stage renalisease, (2) receiving hemodialysis 3 times weekly for ateast 3 months, (3) at least 18 years of age, (4) living in aome setting, (5) willing to participate, (6) no severe cogni-ive disorders (eg, dementia), (7) no significant vision orearing impairments, (8) ability to speak and/or read En-lish, and (9) not currently receiving any additional psycho-herapeutic treatment from another source.
nterventionsGULP was conducted in a group format. Groups of
articipants were randomly assigned to an immediate-reatment group (ITG) or deferred-treatment group (DTG).articipation involved: (1) baseline prerandomization assess-ent, (2) 4-week treatment phase, (3) posttreatment assess-ent, and (4) follow-up assessment 10 weeks after treat-ent. The DTG received standard care for 4 weeks before
tarting treatment. The deferred entry to treatment conditionermitted experimental control in the form of both anxtended baseline and replication of the intervention effect.
The intervention protocol was administered in a groupormat (3 to 8 people) for hour-long sessions once weeklyor 4 weeks. Ten groups, including 5 ITGs and 5 DTGs, wereacilitated by an appropriately supervised trainee clinicalsychologist (J.S.) in renal outpatient settings. In view of thearget population (patients who have difficulty adhering toreatment) and to minimize the risk for dropout, the interven-ion was designed to be brief and time limited. Educationalomponents included conveying information relating to themportance of fluid restrictions. Behavioral techniques werehared to allow patients to acquire relevant self-monitoringkills, including controlling their environment, goal setting,nd self-regulation. Cognitive components were included toncourage patients to identify associations between theirhoughts, emotions, and behaviors. Patients were requestedo complete thought records between sessions. This allowed
atients to identify and gain insight into their own cognitive
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istortions and the impact of these thinking errors on theirehavior. Patients were asked to evaluate the rationality andccuracy of their beliefs in an attempt to modify thoughtsdentified as maladaptive. Strategies were introduced to helpatients manage the physiological symptoms of stress. Allatients received a muscular relaxation tape for daily prac-ice. The importance of effective social support networksas discussed. Suggestions were given on how to interact
ppropriately with others regarding the management of fluidonsumption and gain optimal social support from signifi-ant others.
The intervention was highly structured and formatted tollow for replication between groups. The therapist wasuided by a facilitator’s manual to achieve this. Sessionsere led by a therapist, although participants were encour-
ged to contribute throughout. Participants received a treat-ent manual, recording sheets, and an audiotape for home-
ased practice. Full details of the treatment procedures arevailable from the authors.
utcomesThe primary outcome measure with respect to the efficacy
f GULP was IWG. Using regularly calibrated electroniccales that were zeroed before each use, renal nursing staffitnessed and recorded predialysis and postdialysis weighteasurements of ITG participants during a 14-week period
nd DTG participants during an 18-week period. Emotionalunctioning was measured by using the Hospital Anxiety andepression Scale (HADS).14 The HADS is a well-estab-
ished, standardized, 14-item, self-report questionnaire. Itsmission of somatic items makes it an appropriate measureor a chronically ill population. The measure rates theatient’s experience of anxiety- (7 items; score range, 0 to1) and depression-related (7 items; score range, 0 to 21)ymptoms within the past week. A lower score indicatesetter emotional well-being.The Short-Form 36 (version 2) Health Survey (SF-
6)15 measures 8 health concepts: physical functioning,ole limitations caused by physical health problems, bodilyain, general health, vitality, social functioning, roleimitations caused by personal or emotional problems,nd mental health. A higher score indicates better health-elated quality of life. On individual visual analoguecales, participants were requested to rate questions relat-ng to health beliefs and attributions associated with fluidestrictions. These items were adapted from Friend et al.16
ealth belief questions were: “To what extent do youelieve excessive fluid consumption is hazardous to yourealth?,” “To what extent is it important for you to avoidxcessive drinking?,” and “To what extent do you believehat restricting fluid intake will help you in preservingood health?” The attribution questions were: “Whatercentage of the time do you feel that you successfullydhere to your fluid restrictions?,” “What percentage ofhe time do you feel that your adherence is due to yourwn efforts?,” and “In general, how difficult is it for youo resist fluid intake?” Patients self-completed all second-
ry measures within the dialysis unit. e
ample SizeCohen17 recommends a 0.80 level of power. However, the
urrent study represents a pilot investigation of a newlyeveloped treatment. To establish the feasibility of thentervention, the current study was more tolerant of making
potential type II error. Based on 0.70 power to detect aignificant difference (P � 0.05, 1 sided), 19 participantsere required for a control group and 22 participants wereeeded for an intervention group. This calculation was basedn SDs from baseline data extracted from Christensen etl.11 Within-group variance may have changed posttreat-ent. To compensate for any discrepancy, 5 additional
articipants were added to each group. Furthermore, someevel of attrition was anticipated during the study. Therefore,he study sought to recruit approximately 30 participants forach group (60 in total).
andomizationTo compensate for any effects of treatment diffusion, it
as decided to randomize shifts, rather than individuals.hifts, or clusters, were allocated on an individual basis toither the ITG or DTG according to an automated computer-enerated randomization procedure. All clusters had anqual probability of assignment to each group. No restrictionn randomization was used. Allocation concealment wasnsured because recruitment of participants was performedn ignorance of the group to which the cluster would bessigned.
lindingThe present study is an open nonblind trial. As active
ecipients of the intervention, participants could not begnorant of treatment administration. The evaluator was notlinded to treatment allocation. The primary outcome mea-ure, IWG, was a routine objective measure calculated byenal nursing staff independent of the trial. Secondary out-ome measures were self-rated assessments and question-aires. Therefore, selection of outcome measures enabledhe minimization of observer bias.
ata AnalysisIndependent t-tests and Pearson chi-square analysis
ere used to determine whether any significant differ-nces existed between the 2 groups for continuous andategorical variables, respectively. All analyses were con-ucted according to the intention-to-treat principle. Inde-endent t-tests found no systematic differences betweenarticipants with complete data and participants withissing data on all primary and secondary outcomeeasures at prerandomization assessment. Missing dataere estimated through inputation of randomized groupedian for the appropriate assessment stage. Descriptive
tatistics were generated related to sample characteristicsnd variables of interest.
Acute-phase analysis consisted of conducting 1-waynalysis of variance for primary and secondary outcomeeasures, with and without adjustment for corresponding
aseline covariates. Longitudinal analysis of treatment
ffect combined data obtained at baseline, posttreatment,
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nd follow-up from the ITG and DTG. Repeated-easures analyses of variance were used to analyze
ongitudinal effects of treatment for each dependent vari-ble. When a main effect was identified, differencesetween assessment periods were investigated by usingaired-samples t-tests. The use of multiple tests increasedhe probability of a type I error. There was no adjustmento compensate for this increased error rate. For purposes
Fig 1. Flow diagram ofrial.
f the current pilot investigation, an inflated type II error F
ate was deemed acceptable to identify important primarynd secondary outcomes for additional research.
RESULTS
articipant Flow and Baseline Data
Participant flow and retention are shown in
ig 1. From November 2003 through March
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004, a total of 10 clusters (n � 56) wereandomly assigned to the ITG (5 clusters, n �9) or DTG (5 clusters, n � 27).
Characteristics of randomized participants ataseline are listed in Table 1. Baseline analysishowed no significant differences between theTG and DTG for sex, age, marital status, occu-ational status, education, time on dialysisherapy, baseline IWG, and all HADS subscales.rom the SF-36, no significant differences werehown, with the exception of Role–Emotionalt54 � 2.52; P � 0.05). No significant differencesere shown in Health Beliefs A and B. A signifi-
ant difference was shown in Health Belief Ct54 � 2.18; P � 0.05). No significant differencesere shown in Attributions A and C. A signifi-
ant difference was shown in Attribution Bt54 � 2.15; P � 0.05). Baseline differencesetween groups were taken into account in theepeated-measures analysis by using baselinealues as covariates when appropriate.
utcomes and Estimation
Dependent variables were participant’s weeklyean IWGs, HADS scores, SF-36 scores, and
elf-ratings of Attributions and Health Beliefs.or ease of comparison, outcome data relating to
he primary outcome measure IWG are shown inig 2.
cute-Phase Analysis
The acute-phase analysis investigated datarom week 0 to week 4. This period related to thereatment phase for the ITG, whereas the DTGerved as a between-group no-treatment control.esults are reported as a summary of the change
rom week 0 to week 4 and mean differencewith 95% confidence interval) in this changeetween the 2 groups in Table 2. Week 4, thereas no significant difference in IWGs between
he ITG and DTG (F1,54 � 0.03; P � 0.05).omparison of adjusted means continued to beonsignificant (F1,53 � 0.87; P � 0.05). Forecondary outcomes, 1-way analyses of varianceound no significant differences between treat-ent groups at week 4, with the exception of theF-36 subscale Mental Health (F1,54 � 6.51;� 0.05). After adjustment for appropriate base-
ine covariates, analysis of covariance foundignificant differences on the SF-36 subscales
ental Health (F1,53 � 12.93; P � 0.01), Role– a
motional (F1,53 � 18.78; P � 0.01), and Attri-ution C (F1,53 � 8.01; P � 0.01).
ongitudinal Analysis of Treatment Effect
Data combined from both groups produced aignificant main effect for mean IWGF1.76,96.80 � 9.10; P � 0.001). Within-groupWG means were compared. Differences be-ween baseline and posttreatment IWG valuesere nonsignificant (t55 � 1.12; P � 0.05).ifferences between baseline and follow-up
WG values were significant (t55 � 3.85; P �.001), reflecting improved adherence overime. There were no main effects for any of theADS subscales or those from the SF-36.here was a main effect for Health Belief A
F1.36,74.71 � 13.61; P � 0.001). Differencesetween baseline and posttreatment ratingst55 � 3.77; P � 0.001) and baseline andollow-up ratings (t55 � 3.97; P � 0.001) wereignificant. There was a main effect for Healthelief B (F1.46,80.24 � 12.41; P � 0.001).ifferences between baseline and posttreat-ent ratings (t55 � 4.69; P � 0.001) and
aseline and follow-up ratings (t55 � 3.39; P0.01) were both significant. Again, a main
ffect for Health Belief C was shown (F1.24,68.18
8.68; P � 0.01), with differences betweenaseline and posttreatment ratings (t55 � 2.80;� 0.01) and baseline and follow-up ratings
t55 � 3.18; P � 0.01; significant). No signifi-ant main effects for Attributions were ob-erved, with the exception of Attribution BF1.75,96.37 � 3.41; P � 0.05). Differencesetween baseline and posttreatment ratings (t55
2.42; P � 0.05) were significant; however,ifferences between baseline and follow-upatings (t55 � 0.17; P � 0.05) were nonsignifi-ant.
The study considered gains of 2.5 kg orreater to indicate problematic fluid-intake ad-erence. At baseline assessment, 100% of pa-ients were classified as nonadherent with fluid-ntake restrictions. At posttreatment assessment,1 participants (19.6%) were classified as ad-erent. At follow-up assessment, 21 partici-ants (37.5%) had achieved an IWG less than.5 kg.Means � SDs of all dependent variables acrossassessment periods (baseline, posttreatment,
nd follow-up) are listed in Table 3. Levels of
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Table 1. Baseline Characteristics by Randomized Treatment Group
Health beliefs* (%)Question A 77.62 � 21.92 85.93 � 17.20Question B 76.69 � 23.49 83.33 � 21.40Question C 84.48 � 20.50 68.74 � 32.61
Attributions† (%)Question A 53.83 � 30.30 54.63 � 22.62Question B 74.31 � 25.27 59.78 � 25.29Question C 66.03 � 26.40 67.59 � 24.42
NOTE. Data expressed as number of participants (percent) for categorical data and mean � SD for continuous data.*Health beliefs: question A, “To what extent do you believe that excessive fluid consumption is hazardous to your health?”;
uestion B, “To what extent is it important for you to avoid excessive drinking?”; and question C, “To what extent do youelieve that restricting fluid intake will help you in preserving good health?”†Attributions: question A, “What percentage of the time do you feel that you successfully adhere to your fluid restrictions?”;
uestion B, “What percentage of the time do you feel that your adherence is due to your own efforts?”; and question C, “In
eneral, how difficult is it for you to resist fluid intake?”
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robability are offered when significant differ-nces were found.
ncillary Analyses
Information elicited from patient evaluationorms showed the feasibility of the approach. Noignificant logistical problems were encountereduring the trial. Overall, GULP was well appreci-ted by participants, with a mean rating of5.36 � 22.80 on a scale of 0 to 100. With regardo the program length, 15 participants (26.8%)hought the intervention was “too short,” 27articipants (48.2%) believed it was “just right,”nd 4 participants (7.1%) considered the grouptoo long.” No participant believed the grouppeed of progression was “too slow,” 32 partici-ants (57.1%) believed the speed of progressionas “just right,” and 14 participants (25%) be-
ieved it was “too fast.” Most patients (n � 27;8%) reported spending less than 30 minutes pereek on homework assignments.
DISCUSSION
Participation in GULP resulted in no signifi-ant improvement in adherence, measured byeans of IWG, during the 4-week treatment
hase. The ITG and DTG showed minimal mean
hanges between baseline and posttreatment. Al- o
hough no significant improvements were madeuring the treatment phase, there was a signifi-ant reduction in IWG from baseline to 10-weekollow-up. GULP purposefully was designed toe a short intervention, comprising only 4 treat-ent sessions. It is reasonable to speculate this
id not permit a protracted period for patients tostablish significant treatment gains. For ex-mple, the program may not have been of suffi-ient duration for participants to apply the knowl-dge and consolidate the skills acquired throughreatment within 4 weeks. It is reasonable toonclude that the ongoing decreases in IWGfter treatment cessation were attributable to theevelopment and refinement of effective cogni-ive and behavioral management strategies. Aimilar effect was shown by Christensen et al.11
his cohort study compared a group receiving aelf-regulation intervention with a no-treatmentontrol. Although no significant group differ-nces were found after treatment, IWGs betweenhe treatment and control groups were signifi-antly different at an 8-week follow-up assess-ent. As in the current study, decreased IWG
evels were not only maintained after treatment,ut continued to improve. However, the signifi-ant finding evidenced at follow-up in the study
Fig 2. Line graph show-ing effects on IWG of immedi-ate treatment and deferredtreatment across the experi-mental period.
f Christensen et al11 was, in part, a function of
Table 2. Acute-Phase Analysis: Comparison Between the ITG and DTG of Primary and Secondary Outcome Measures at Week 0 and Week 4
NOTE. Data expressed as mean � SD and mean change (95% confidence interval).Abbreviation: NS, not significant.*Improvement indicated by negative change score on IWG and HADS subscales and positive change score on SF-36 subscales.†Health beliefs: question A, “To what extent do you believe that excessive fluid consumption is hazardous to your health?”; question B, “To what extent is it important for you
to avoid excessive drinking?”; and question C, “To what extent do you believe that restricting fluid intake will help you in preserving good health?”‡Attributions: question A, “What percentage of the time do you feel that you successfully adhere to your fluid restrictions?”; question B, “What percentage of the time do you
feel that your adherence is due to your own efforts?”; and question C, “In general, how difficult is it for you to resist fluid intake?”
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ncreasing IWG levels within the control groupnd not solely attributable to gains establishedhrough treatment.
The hemodialysis treatment regimen has beenhown to affect social and psychological function-ng.18 It is possible that more intensive manage-ent could lead to increased feelings of burden
nd subsequent negative effects on psychologi-al well-being and quality of life. Thus, benefitsf improved adherence would have to be weighedgainst their negative impact on psychologicalell-being and quality of life. Conversely, no
hange in psychosocial measures could be vieweds a positive outcome. There were no significantithin-group differences between any of theADS subscales or any of the 8 SF-36 subscales.
Table 3. Longitudinal Comparison of Primary aPosttreatment, and Fol
ealth beliefs* (%)Question A 81.63 � 20.89 90.30 �Question B 79.89 � 22.56 90.18 �Question C 76.89 � 27.92 86.58 �
ttributions† (%)Question A 54.21 � 26.63 59.98 �Question B 67.30 � 26.10 73.41 �Question C 66.79 � 25.25 62.45 �
NOTE. Data expressed as mean � SD.Abbreviation: NS, not significant.*Health beliefs: question A, “To what extent do you believ
uestion B, “To what extent is it important for you to avoielieve that restricting fluid intake will help you in preservin†Attributions: question A, “What percentage of the time d
uestion B, “What percentage of the time do you feel thateneral, how difficult is it for you to resist fluid intake?”
he findings suggest that participation in GULP e
nd improvement in self-management do notmpact negatively on psychosocial functioning.
The current trial gave limited attention toechanisms underlying the evidenced adherence
nhancement. It could be speculated that themprovement in fluid-restriction adherence likelyas a result of a change in attitudes and beliefs
egarding hemodialysis treatment. Significant dif-erences from baseline to posttreatment and fromaseline to follow-up were evidenced in all 3easures of health beliefs. Changes were all in
he desired direction, with participants generallyhowing a tendency to hold more functional andccurate beliefs regarding fluid restrictions inemodialysis. No measures of attributions signifi-antly changed from baseline to follow-up. Friend
ondary Outcome Measures Between Baseline,Assessment Periods
xcessive fluid consumption is hazardous to your health?”;ssive drinking?”; and question C, “To what extent do youhealth?”el that you successfully adhere to your fluid restrictions?”;herence is due to your own efforts?”; and question C, “In
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nvolved when predicting stability and changesn fluid-restriction adherence. Although attribu-ions may be important in maintaining adher-nce, a patient’s beliefs are likely to motivatehange. By extension, the initial focus of adher-nce-enhancement interventions should seek toodify patients’ health beliefs, which may be
onstraining their commitment to change. Earlyessions of GULP placed a significant emphasisn education of the importance of fluid restric-ion.
Although modification of beliefs may haveeen responsible for some behavioral change, its unlikely that all improvement can be attributedo this. There are a number of rewards inherent inffective self-management. For example, hemo-ialysis patients typically enjoy close relation-hips with nursing staff, with whom they haveegular contact. Improvement in adherence isikely to receive social rewards, the most basicevel representing verbal praise. In addition, therere a number of tangible health benefits frommproved adherence. These may have includedecreased cramps, a reduction in symptomaticypotensive episodes, increased activity levels,nd a shorter time on dialysis. Previous interven-ion studies based on behavioral paradigms haveelied on using both social and tangible rewardso foster behavior change. However, it frequentlyas logistically difficult to maintain these contin-encies over time. Consequently, IWG ofteneturned to pretreatment levels. The current studyid not rely exclusively on external schedules ofeinforcement to promote change. Instead, changeas propagated by the acquisition of knowledge,odification of dysfunctional cognitions, and
evelopment of self-management skills.To date, few research studies have evaluated
he effects of CBT with regard to improvingdherence to fluid restrictions. Therefore, integrat-ng the current findings into the existing litera-ure was somewhat constrained. However, re-ults and findings of the current trial can beelated to the wider psychological literature ondherence to treatment. For example, a meta-nalysis investigating the effectiveness of inter-entions to improve patient adherence to medicalegimens concluded that multicomponent inter-entions were more effective than single-compo-ent interventions.5 To date, the majority of
tudies of fluid-restriction adherence have used i
ingle-focused strategies, typically behavioral.ULP represents a multicomponent treatmentackage and, consistent with the literature, anpproach that is more likely to successfully en-ance adherence. The majority of previous stud-es in this field were characterized by their use ofehavioral interventions that often failed to showong-term maintenance of gains.5 Nevertheless,any of these studies showed considerable prom-
se. Results from the current study lend supporto previous research showing the effectiveness ofsychological treatments for improving adher-nce.
As part of their systematic review, Sharp et al5
oted the absence of studies investigating theffectiveness of interventions using an RCT de-ign. The current study’s use of an RCT designermits more confidence in the findings of thistudy and confirms previous findings relating tohe effectiveness of psychological intervention,n which external validity was limited.19 How-ver, although the observed improvement in ad-erence is encouraging, findings should be inter-reted with caution. A statistically significanteduction in IWG during the trial was clearlyhown. However, it is questionable whether thiseduction was clinically significant. The baselineeasure of mean IWG was 3.56 � 0.91 kg. At
ollow-up assessment, this mean value had de-reased to 2.96 � 1.09 kg. Although this repre-ents a statistically significant change, this values still clearly in excess of the predefined criteriaf 2.5 kg thought to be indicative of problematicdherence. Within the literature, what representslinically significant weight gain remains un-lear. Previous studies have varied considerablyn their estimations. Identified definitions of de-ired weight gain vary between 1,20 2,21,22 and 3g.16 Most commonly, average IWGs greaterhan 2.5 kg are considered to reliably indicateroblematic adherence.23,24 Despite mean IWGontinuing to exceed the defined criteria, anyeduction in IWG can be considered beneficialecause it represents a decrease in cardiovascu-ar stress.25 Furthermore, at follow-up assess-ent, IWG was continuing to decrease. It is
ncertain whether continued long-term monitor-ng of IWG would have shown a pattern ofecline at less than the 2.5-kg level. The naturef the current study, with a strict time frame
mposed on trial completion, did not permit a
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SHARP ET AL1056
ollow-up assessment exceeding 10 weeks. Aollow-up of at least 6 months would be morenformative with regard to long-term effects ofULP. However, it should be noted that althoughean IWG continued to exceed 2.5 kg, clinically
ignificant improvements in IWG were made in7.5% of participants.One of the principal reasons for fluid consump-
ion is to quench thirst. Thirst is controlled bylasma osmolality, which, in turn, is determinedargely by serum sodium concentration. Thirstnd therefore fluid consumption hence are af-ected by excessive dietary salt intake. Duringhe program, patients were advised to limit saltntake. However, dietary sodium intake was notormally assessed. Measurement of this variableotentially could have shown objective informa-ion relating to patients’ efforts to manage di-tary aspects of their treatment.
An additional limitation relates to the failureo assess treatment fidelity. Measuring fidelity tosychological intervention would require atten-ion to the therapist’s behaviors and multipletructural and administrative characteristics ofhe program. The current study did not havedequate resources available to formally mea-ure fidelity.
Because of such limited resources, the indi-idual responsible for data collection also admin-stered the intervention. This represented a poten-ial source of bias. However, primary andecondary measures used in the current studyrguably were resistant to such bias. IWG is anbjective measure with little potential for report-ng error. Similarly, the SF-36 and HADS assess-ents are objective, standardized, self-report in-
truments. Such measures would be unlikely tooster observer bias.
A methodological limitation regarding sampleize calculation has been identified. Sample sizealculation was based on a study that computedWG during a 2-week period. The current studysed 1-week mean IWG.Throughout the course of the trial, patients
requently commented on the lack of informationhey received before starting hemodialysisherapy. No formal assessment of patient knowl-dge was conducted. However, it was clear thathere were significant discrepancies between pa-ient’s knowledge of hemodialysis treatment.
early all patients were aware of the recommen- 1
ation to reduce fluid consumption. However,ew patients were able to expound a satisfactoryxplanation of why these restrictions were ad-ised. An interesting extension of the currenttudy could involve an investigation of patientnowledge relating to fluid restriction at thenset of hemodialysis therapy. Entering into aife-changing treatment of a chronic illness ingnorance of the major adaptations required doesot offer a good prognosis for effective manage-ent. Without sound understanding of the ratio-
ale of treatment, effective self-care and mainte-ance of motivation would be unlikely.dministration of an informative program, dis-
ussing reasons for fluid restrictions and effec-ive means of management, before patients startedemodialysis therapy could prove beneficial forong-term self-regulation of behavior.
To summarize, GULP is a promising CBTntervention designed to assist hemodialysis pa-ients to manage their fluid restriction more effec-ively. GULP had a beneficial effect on adher-nce to fluid restrictions during the trial period.reatment seemed acceptable, with a low rate ofarticipant attrition. However, long-term fol-ow-up to evaluate whether any treatment gainschieved are sustained over time would be pref-rable. Results from this pilot investigation war-ant further implementation and evaluation. Fu-ure development of GULP would allow accesso psychological treatment for dialysis popula-ions that struggle with adherence to fluid restric-ions.
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