Kindness Matters: A RandomizedControlled Trial of a MindfulSelf-Compassion InterventionImproves Depression, Distress,and HbA1c Among PatientsWith DiabetesDOI: 10.2337/dc16-0416

OBJECTIVE

Mood difficulties are common among patients with diabetes and are linked topoor blood glucose control and increased complications. Evidence on psycholog-ical treatments that improve both mood and metabolic outcomes is limited.Greater self-compassion predicts better mental and physical health in bothhealthy and chronically ill populations. Thus, the purpose of this randomizedcontrolled trial (RCT) was to evaluate the effects of self-compassion training onmood and metabolic outcomes among patients with diabetes.

RESEARCH DESIGN AND METHODS

This RCT tested the effects of a standardized 8-week mindful self-compassion(MSC) program (n = 32) relative to a wait-list control condition (n = 31) amongpatients with type 1 and type 2 diabetes.Measures of self-compassion, depressivesymptoms, diabetes-specific distress, and HbA1c were taken at baseline (preinter-vention), at week 8 (postintervention), and at 3-month follow-up.

RESULTS

Repeated-measures ANOVA using intention to treat showed that MSC trainingincreased self-compassion and produced statistically and clinically significant re-ductions in depression and diabetes distress in the intervention group, with re-sults maintained at 3-month follow-up. MSC participants also averaged a clinicallyand statistically meaningful decrease in HbA1c between baseline and follow-upof >10 mmol/mol (nearly 1%). There were no overall changes for the wait-listcontrol group.

CONCLUSIONS

This initial report suggests that learning to be kinder to oneself (rather than beingharshly self-critical) may have both emotional and metabolic benefits amongpatients with diabetes.

1University of Auckland, Auckland, New Zealand2Waitemata District Health Board, Auckland,New Zealand

Corresponding author: Anna M. Friis, a.friis@auckland.ac.nz or annamfriis@gmail.com.

Received 26 February 2016 and accepted 27May 2016.

Clinical trial reg. no. ACTRN12615000946516,www.anzctr.org.au.

This article contains Supplementary Data onlineat http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc16-0416/-/DC1.

© 2016 by the American Diabetes Association.Readersmayuse this article as longas thework isproperly cited, the use is educational and not forprofit, and the work is not altered.

See accompanying article, p. XXX.

Anna M. Friis,1 Malcolm H. Johnson,1

Richard G. Cutfield,2 and

Nathan S. Consedine1

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Diabetes Care Publish Ahead of Print, published online June 22, 2016

Major depression is estimated to affectat least 12% of patients with diabetes(1), with subclinical mood symptomsand distress apparent in nearly one-third(31%) of those living with this chroniccondition (2). In addition to predicting ahigher negative affect, the emotionalburden of distress about managingone’s diabetes may be a qualitativelydifferent experience from depressionper se (3,4). Although both distress anddepression are linked to poor glycemiccontrol, evidence suggests that distressrather than depression may be a betterpredictor of metabolic outcomes (3,5).Of note, given the scale and impact ofmood disturbance among patients withdiabetes, evidence for psychological in-terventions that successfully treat de-pression and distress and, ideally,concurrently improve metabolic out-comes is limited.Several reasons exist to continue the

search for psychotherapeutic interven-tions to improve mental and physicalhealth outcomes among patients withdiabetes. A meta-analysis of random-ized controlled trials (RCTs) for treatingdepression in diabetes showed that psy-chotherapeutic treatments are moder-ately effective for depression and thatcognitive behavior therapy (CBT) in par-ticular had a small effect on glycemiccontrol (6). Although the number andsample sizes of studies included in thismeta-analysis were relatively small(10 of the 14 studies investigated sam-ples ranging from 13 to 60 participants),a more recent study of 87 adults withdepression and uncontrolled type 2 di-abetes found that CBT focused on ad-herence and depression improvedthese outcomes as well as glycemic con-trol (7). On the other hand, in their RCT,Hermanns et al. (8) found that diabetes-specific CBT reduced depression anddistress in a mixed sample (n = 214) ofpatients with type 1 and 2 diabetes buthad no between-group effect on HbA1c,and a large-scale meta-analysis and re-view showed no effects of psychologicalinterventions on glycemic controlamong adults with type 1 diabetes(9). Overall, the wide variation in meth-odologies and inclusion criteria, includ-ing the fact that most tr ia ls a lsoincluded other supportive treatmentssuch as diabetes education alongsidethe intervention, means that drawingconclusions about the efficacy of current

psychological treatment approachesand/or their metabolic effects remainsdifficult.

Given the prevalence and health-relatedimplications of mood difficulties amongpatients with diabetes and the lack ofconclusive evidence for current psycho-logical interventions or their effects onglycemic indices, the search for behav-ioral interventions that can meet patientneeds on a broad scale must continue.One promising approach to improvingwell-being in clinical settings is the prac-tice of self-compassion, an ancient ideaarising alongside research into thehealth benefits associated with mindful-ness. Studies of mindfulness interven-tions among patients with diabetes haveshown consistent improvements in psy-chological outcomes, including depres-sion, but effects on metabolic controlhave been varied (10). Fundamentally,self-compassion–based treatments arebased on the notion that significant por-tions of psychological distress are createdby the tendency to be self-critical aboutactual or perceive failures. Self-compassionincorporates mindfulness as a core com-ponent (11) while also attempting toencourage a sense of common hu-manity (recognizing that everyone goesthrough difficult times) and self-kindness(responding to one’s suffering with gen-tleness and understanding instead ofjudgmentandcriticism).Unlikemindfulness,self-compassion directly trains the capacityfor active soothing and self-comforting intimes of suffering. Patients learn to treatthemselves in the same way they mighttreat distress in a beloved other, provid-ing gentle comfort and tending to theirown needs for self-care.

For a patient population in which therelentless demand for healthy bloodglucose control presents daily opportu-nities for failure and, thus, attacks onthe self, the practice of self-kindnessmay reduce psychological sufferingwith subsequent, flow-on metabolic be-nefits. Evidence in both healthy and pa-tient populations (12) has linked greaterself-kindness with better mood, and ameta-analysis of nearly 80 studies hasshown a large effect size (r = 0.47)in the relationshipbetweenself-compassionand well-being (13). Although evidencefrom diabetes is scanty, one studyfound that self-compassion predictedless diabetes-specific distress andbuffered the link between diabetes

distress and poor metabol ic out-comes (5).

Drawing from studies that showthat self-compassion can be increasedthrough training (14), the current in-vestigation tested whether an 8-weekgroup-based self-compassion interven-tion would improve psychological andphysical health outcomes among pa-tients with diabetes. We expected thatself-compassion would increase overthe training period and that the trainingwould reduce both depression anddiabetes-specific distress in the interven-tion arm.Wealso expected that these gainswould be sustained at 3-month follow-upand that self-compassion training wouldreduce HbA1c levels across the sametime period.

RESEARCH DESIGN AND METHODS

This RCT contrasted a standardizedmindful self-compassion (MSC) inter-vention with a wait-list (treatment-as-usual) control. Participants were63 patients with either type 1 or type 2diabetes. They were aged 18–70 years(mean 42.87, SD 14.30), fluent in En-glish, and able to attend a minimum ofsix of eight scheduled treatment ses-sions. Exclusion criteria were self-reported inability to read and writeEnglish. Participants were recruited be-tween July 2014 and September 2014at three hospital sites in Auckland,New Zealand. Recruitment was throughself-referral to the trial or following rec-ommendations from a patient’s physi-cian or diabetes nurse; the study waswidely advertised through numerous lo-cal diabetes centers. All participants pro-vided written informed consent.

ProcedureParticipants in the intervention condi-tion (n = 32) were assessed at baseline(T1), at week 8 (T2), and 3 months aftertraining had concluded (T3). Participantsin the wait-list control condition (n = 31)completed identical measurements atthe same three time points. Each timethey provided data, participants re-ceived $20 vouchers to cover the costsassociated with traveling to laboratoriesfor blood testing. Participants receivedan additional $20 voucher for each MSCsession they attended to cover transpor-tation and parking costs. Treatmentgroups began in August 2014 and werecompleted by October 2014.

2 Self-Compassion Among Patients With Diabetes Diabetes Care

Treatment AllocationA trained researcher blind to the hy-potheses and study design and withoutparticipant contact used randomizationsoftware to allocate treatment assign-ments. Patients were told that theywould be participating in a programbased on evidence that learning to treatoneself with kindness and understand-ing when faced with difficult feelingsand circumstances could be good formental and physical health. They weretold that they might be allocated toeither a skills training workshop or await-list control. No further informationabout the MSC program was provided.

InterventionMSC is a protocol-standardized inter-vention aimed at increasingmindfulnessand self-compassion and reducing thesuffering associated with experientialavoidance (14). Sessions were deliveredto groups of 8–12 people during eightweekly sessions, each lasting 2.5 h. Ad-herence to the standard MSC protocolwas strict, without specific reference todiabetes as a particular source of suffer-ing. The intervention was deliveredby the first author, a New Zealand–registered health psychologist trained toteach the program according to manual-ized MSC protocols. Clinical supervisionwas conducted weekly through Skypeconference with MSC trainers across theintervention period. All participantsreceived a standardized e-mail 2 days af-ter each weekly session that summarizedthe week’s teachings and encouragedthem to practice what they had learnedduring the previous session.The central components of MSC are

formal meditation together with formaland informal self-compassion practicesaimed at developing the cognitive, be-havioral, and physical capacities tosoothe and comfort oneself when dis-tressed (see Supplementary Data).

Wait-list ConditionParticipants in the wait-list control condi-tion received medical treatment as usual.

AssessmentsAge, sex, ethnicity, and health statuswere assessed through self-report, aswere time since diagnosis and type ofdiabetes.

Outcome MeasuresSelf-compassion was assessed usingthe Self-Compassion Scale (SCS) (11), a

26-item, 5-point Likert scale question-naire comprising positive subscales ofself-kindness, common humanity, andmindfulness and negative subscales ofself-judgment, isolation, and overidenti-fication. Studies have demonstrated sat-isfactory psychometric properties (15).Factor analysis has confirmed the six-factorstructure of the scale and the single higher-order component of self-compassion. Reli-abilities for the aggregate total score in thecurrent study were T1 = 0.91, T2 = 0.91,and T3 = 0.93.

DepressionSymptoms of major depressive disorderwere assessed with the 9-item PatientHealth Questionnaire (PHQ-9) (16). Byusing a 2-week time window, respondersrated symptoms on a scale of 1 (not at all)to 4 (almost every day). A summed scorewas calculated. The PHQ-9 is widely usedand has excellent psychometric proper-ties. It was validated with patients withdiabetes in both primary and specializedoutpatient clinics (17). a-Reliabilities forthe current study are T1 = 0.81, T2 = 0.87,and T3 = 0.85.

Diabetes-specific distress is a com-mon condition and is consistently linkedto poor biobehavioral disease manage-ment (18). The 17-item Diabetes DistressScale (DDS) has a consistent factor struc-ture and good internal reliability and val-idity (18). The DDS contains items fromfour established domains of diabetes-related distress: emotional burden,physician-related distress, regimen-relateddistress, and interpersonal-relateddistress. A total score is calculated,with a mean item score of $3 consid-ered to be high distress and worthy ofclinical attention; higher scores on theDDS have been associated with greaterHbA1c (18). a-Reliabilities for the totalscale are T1 = 0.87, T2 = 0.90, and T3 =0.92.

Glycemic control (indicated by HbA1cvalues at the three time points) was as-sessed using values reported by Lab TestsAuckland Ltd., an accreditedmedical test-ing laboratory, by using the COBAS Inte-gra platform (Roche Diagnostics). HbA1creflects mean blood glucose levels overthe previous 2–3 months and is the stan-dard assessment of glycemia (19).

Sample Size CalculationThe sample size calculation, based on 2(group)3 3 (time) mixed-model repeated-measures ANOVA, was estimated from a

review and meta-analysis of psychologi-cal interventions among patients with di-abetes (5) in which the effects oftreatment on glycemic control were sub-stantially smaller than the moderateeffects found for depression. A priorianalyses with an f effect size of 0.25and a-probability of 0.05 suggested aminimum sample of 44 participants. Al-lowing for dropout and retention(20,21), 63 participants were recruited.The sample size calculations were per-formed with GPower 3.1 software.

Statistical AnalysesThe Consolidated Standards of Report-ing Trials (CONSORT) guidelines forrandomized trials were followed, and in-tention-to-treat analyses were con-ducted with SPSS Statistics 20 software(IBM Corporation). Individual missingvalues were imputed by using themeans of the relevant subscale for theSCS and DDS or the total scale mean forthe PHQ-9. For missing HbA1c values (n =6 of 189), the most recently recordedvalue was carried forward. For the fourparticipants who withdrew from thestudy, measurements from the timepoint before withdrawal were carriedforward for analysis, and all multivariateassumptions were met. As a furthercheck, per-protocol analyses were con-ducted, revealing a very similar patternof results for both biological and sub-jective outcomes. Independent sam-ples t tests and x2 analyses were usedto test for possible group differences indemographic and clinical variables atbaseline (T1).

A series of 2 (group) 3 3 (time) mixed-model ANOVAs tested the expectations that1) randomization to the self-compassiontraining would increase self-compassionas well as reduce depression, distress,and HbA1c relative to the wait-list con-trol and 2) these gains would be main-tained at 3-month follow-up. Effectsizes are reported as partial h2 (hp

2) co-efficients. To further interpret any time-by-group interactions, a series of t testsexamined possible differences betweenbaseline and postintervention (T1 andT2), between postintervention and3-month follow-up (T2 and T3), and be-tween baseline and 3-month follow-up(T1 and T3).

Clinically Meaningful ImprovementClinically meaningful improvements inoutcomes were defined as reductions

care.diabetesjournals.org Friis and Associates 3

between T1 and T3 of 1) at least 5 pointson the baseline PHQ-9 score (22), 2) atleast 1 point on the DDS mean (23), and3) at least 0.5% (5.5 mmol/mol) in HbA1cscores (24). x2 analyses were used totest between-group differences in theproportion of participants showing clin-ically significant improvement.

RESULTS

Recruitment and AttritionAs indicated in the CONSORT diagram(Fig. 1), 84 patients indicated an initialinterest in participation. Of these, 71were randomized (15% noneligible),and 63 ultimately provided data forthe study (32 in the MSC condition,31 in the wait-list control [89% of eli-gible]). x2 analysis showed no group dif-ferences in attrition: Of the 63 participantswho provided baseline data, 4 withdrew(2 from each condition).

Baseline CharacteristicsTable 1 provides an overview of thestudy sample, stratified by group. Nodifferences were found between thetwo groups at baseline in demographicor diabetes-specific characteristicsother than time since diagnosis. How-ever, between-group differences wereseen at baseline on psychological andclinical metrics; PHQ-9, DDS, and HbA1cscores were greater and SCS scores werelower in the MSC group than in the wait-list control group. A greater proportionof intervention participants had clinicallysignificant diabetes distress, but no dif-ferences between groups were found inthe proportion with clinically significantdepression (Table 2). Because of thesebaseline differences, primary analyseswere replicated by ANCOVA in whichbaseline values were covaried and T2and T3 values entered as repeatedmeasures. Results were essentiallyunchanged.

Changes in Self-CompassionThe ANOVA showed a main effect oftime (F[2,60] = 13.07, P , 0.001, hp

2 =0.30) but not of group (F[1,61] = 0.02,P. 0.05); however, there was an interac-tion between time and group (F[2,60] =0.06, P = 0.001, hp

2 = 0.21). Plot inspec-tion, confirmed with t tests (Table 3),showed that self-compassion increasedin the MSC group between T1 and T2,with gains maintained at T3. No changeswere found in the wait-list control groupat any time (Fig. 2).

Changes in Depressive SymptomsThe ANOVA testing for changes in depres-sive symptoms showed an effect fortime (F[2,60] = 12.40, P , 0.001, hp

2 =0.29). As with the SCS scores, there wasno main effect for group (F[1,61] = 2.40,P . 0.05), but there was a significanttime-by-group interaction (F[2,60] = 7.07,P , 0.05, hp

2 = 0.19). Plot inspectionconfirmed by t tests (Table 3) showedthat the intervention reduced depres-sion scores in the MSC group betweenT1 and T2, with results maintained at T3.There were no changes in depressionscores in the wait-list control groupbetween any time point (Fig. 2).

Changes in Diabetes DistressThe ANOVA showed effects for bothtime (F[2,60] = 27.30, P , 0.001, hp

2 =0.48) and group (F[1,61] = 3.92, P = 0.05,hp

2 = 0.06) as well as an interaction be-tween time and group (F[2,60] = 12.24,P , 0.001, hp

2 = 0.29). Plot inspection,confirmed with t tests (Table 3), showedthat the intervention reduced distress inthe MSC group between T1 and T2, withimprovements maintained at T3. Al-though there were no changes evidentin the wait-list control group betweenT1 and T2, there was an overall reductionin distress scores between T1 and T3(Fig. 2).

Changes in HbA1c

Results showed an effect for t ime(F[2,60] = 13.25, P , 0.001, hp

2 = 0.31)but not group (F[1,61] = 2.66, P. 0.05).The general reduction in HbA1c overtime was qualified by an interaction be-tween time and group (F[2,60] = 5.1,P , 0.05, hp

2 = 0.15). Inspection ofthe interaction plot, confirmed byt tests (Table 3), showed that althoughHbA1c did not change between T1 and T2in the MSC group, scores reducedby.10 mmol/mol (nearly 1%) betweenT1 and T3. There was no change overallbetween T1 and T3 for thewait-list controlgroup (Fig. 2).

Clinically Significant ChangeAnalyses demonstrated group differ-ences in the proportion of participantsshowing clinically meaningful improve-ment between T1 and T3. In the MSCgroup, 20 (62.5%) participants record-ed a clinically meaningful decrease inPHQ-9 depression scores comparedwith 5 (16.1%) in the wait-list controlgroup (x2 [1, n = 63] = 12.28, P , 0.001,

w = 20.47). Equally, 15 (46.9%) partici-pants in the MSC group recorded clini-cally meaningful reductions in distresscompared with 3 (9.7%) in the wait-listcontrol group (x2 [1, n = 63] = 8.93, P ,0.05, w = 20.41). For HbA1c, 21 (65.6%)participants in theMSC group recorded aclinically meaningful decrease comparedwith 9 (29%) in the wait-list controlgroup (x2 [1, n = 63] = 7.05, P, 0.05, w =20.37).

CONCLUSIONS

To our knowledge, this report repre-sents the first investigation into the pos-sible utility of self-compassion trainingin improving mood and metabolicoutcomes among patients with type 1and type 2 diabetes. As expected, the8-week MSC intervention increasedself-compassion, a finding consistentwith a prior RCT of the MSC protocoland other evidence suggesting thatself-compassion can be learned (14).The current study extends these findingsto a diabetes population, a difficult-to-treat patient group among whomharsh self-criticism is not only com-mon (25) but also a likely correlate ofmood and behavioral self-managementdifficulties. As such, finding that theintervention showed the expectedbenefits in terms of reducing depres-sion and diabetes-specific distress isimportant. Perhaps most notably andconsistent with our final hypothesis,self-compassion training also reducedHbA1c, suggesting that theMSC interven-tion affected both subjective and objec-tive metrics, an extension of most priorpsychosocial RCTs among patients withdiabetes (26).

Given the absence of compassion-specific studies among patients with di-abetes, this discussion considers thesefindings in relation to prior studies thatincorporated aspects of mindfulness oracceptance, a class of psychosocial in-tervention that may also engender com-passion alongside acceptance of difficultthoughts and feelings (4,27). We considerpossible explanations for the benefits ofself-compassion, evaluate the clinical pos-sibilities for compassion-based therapiesin diabetes, and offer directions for futureresearch and clinical practice.

First, the finding that the MSC pro-gram reduced depression adds to theoverall evidence for psychosocial inter-ventions among patients with diabetes

4 Self-Compassion Among Patients With Diabetes Diabetes Care

(6–9) aswell as is consistent with severalmindfulness-based RCTs (4,20,21) anduncontrolled studies (28,29). However,although mindfulness is a foundationof MSC, self-compassion is broader inscope than mindfulness alone, concur-rently emphasizing self-kindness (ratherthan self-criticism) and common hu-manity (compared with isolation), qual-ities also associated with well-being(13). A recent pilot study among breastcancer survivors (another group in which

mood disorders are common) of an8-week cognitively based compassion in-tervention also reported reduced de-pression after sessions emphasizingself-kindness and common humanity(30), providing preliminary evidence forthe efficacy of this type of training.

Second, that the training reduced di-abetes distress is likewise consistentwith prior mindfulness interventions(4,20,21). Although diabetes-relatedtopics were not explicitly referred to

during theMSC program, all participantswere patients with diabetes. As such,the emphasis on mindful acceptance ofdifficulty as being normal (i.e., “otherpeople in my situation feel like this”)and active soothing of stressed or un-comfortable emotional states (“may Ibe kind to myself in this moment”) likelyelicited diabetes-related thoughts, withthe MSC practices then proving helpfulin reducing the associated distress. Thisinterpretation is consistent with the

follow-up due to life

8-week

Figure 1—CONSORT diagram showing the flow of participants with diabetes through each stage of the MSC RCT.

care.diabetesjournals.org Friis and Associates 5

findings of Gregg et al. (4) in which mind-fulness and acceptance training reduceddifficult diabetes-related thoughts andfeelings. In contrast, a problem-solvingapproach (i.e., attempting to solve theproblems eliciting distress) largely failedto find between-group differences in dis-tress (23).Third, the current finding that the

MSC training resulted in reduced HbA1c

is among a very small number of psycho-social RCTs to record this critical result(4,8,9). Although the interaction be-tweenmental health andmetabolic out-comes among patients with diabetes iscomplex (9) and the impact of depres-sion reduction to improve glycemic con-trol still controversial (31), these resultsare consistent with preliminary evi-dence from studies suggesting that

psychological factors buffer biologicalsystems from the negative effects ofdiabetes distress (5).

One possible explanation for this pat-tern of benefit is found in data regardingthe physiological and autonomic process-esbelieved tounderlie self-compassion. Itmay be that actively soothing oneselfwhen distressed reduces stress responsesthat are linked to blood glucose levels(32). Evidence suggests that brief self-compassion exercises reduce cortisol(33), and a greater ability to self-soothehas been linked to greater heart rate var-iability (34), a measure of autonomic flex-ibility. Furthermore, cross-sectional datashow that self-compassion is associatedwith lower interleukin-6 (35), perhapsimplyinga linkwith inflammatoryprocess-es that, in turn, are also linked to bothstress (36) and HbA1c (37).

Hence, although the current data areclearly preliminary and do not directlyilluminate the mechanisms at play,they are consistent with the notionthat self-compassion deactivates threatsystems (associated with the release ofcortisol and adrenalin) and activates themammalian self-soothing system associ-ated with the release of oxytocin andopiates (38). Thus, learning to be kinderto oneself when stress or sufferingarises (i.e., active self-soothing in theface of stress and difficult emotions)may be linked to particular physiologicalprocesses that are in themselves linkedto HbA1c.

Study Limitations and StrengthsThese contributions noted, the data arelimited in some important ways. First,the findings are generalizable only tothose who volunteered for the RCT. Al-though attrition was low for a longitudi-nal study of this kind (20,21) no formalanalyses of selectivity were possible,and larger, more representative trialsare warranted.

Second, although participants werenot recruited based on mood problems,more than one-half (52.38%) reportedclinically significant depression andnearly one-third (30.16%) reported clin-ically relevant distress at baseline, ratesnotably higher than those reportedamong patients with diabetes in general(20). Consequently, it is possible thatpatients with more distress differen-tially volunteered for the trial and/orthat benefits are more pronounced

Table 1—Baseline characteristics of the sample

Demographic MSC (n = 32) Wait-list (n = 31) Total (n = 63)

Age (years) 42.16 (14.70) 46.65 (16.44) 44.37 (15.62)

SexMale 12 (37.50) 8 (25.81) 20 (31.75)Female 20 (62.50) 23 (74.19) 43 (68.25)

EthnicityNew Zealand European 20 (62.50) 26 (83.88) 46 (73.02)Maori 0 1 (3.22) 1 (1.59)Asian 2 (6.25) 3 (9.67) 5 (7.94)Other Pacific 1 (3.12) 0 3 (4.76)Other European 7 (21.88) 1 (3.22) 8 (12.70)

Type of diabetesType 1 26 (81.25) 20 (64.51) 46 (73)Type 2 3 (9.37) 6 (19.35) 9 (14.3)Type 2 on insulin 3 (9.37) 5 (16.13) 8 (12.7)

Time since diagnosis (years)* 19.90 (13.58) 13.46 (9.94) 16.84 (12.32)

Data are mean (SD) or n (%). *Significant differences between groups, P , 0.05.

Table 2—Primary outcomes at T1, T2, and T3

Measure (range) T1 T2 T3

SCS* (0–5)MSC 2.52 (0.57) 3.10 (0.50) 3.21 (0.72)Wait-list 2.88 (0.60) 3.12 (0.64) 3.08 (0.59)

PHQ9* (0–27)MSC 14.01 (4.52) 9.16(6.50) 7.88 (4.62)Wait-list 9.74 (6.06) 7.30 (5.02) 9.32 (6.50)

DDS17** (0–6)MSC 3.16 (0.88) 2.33 (0.86) 2.10 (0.84)Wait-list 2.35 (0.63) 2.29 (0.85) 2.10 (0.89)

ClinicalHbA1c*MSC

mmol/mol 74.25 (15.11) 71.44 (18.34) 64.03 (16.25)% 8.94 (1.38) 8.69 (1.68) 8.0 (1.49)

Wait-listmmol/mol 64.06 (13.32) 66.03 (14.20) 62.32 (12.41)% 8.01 (1.22) 8.19 (1.14) 7.85 (1.36)

DepressedPHQ $ 12MSC 20 (62.5) 11 (34.4) 6 (18.8)Wait-list 13 (41.93) 7 (22.6) 7 (22.6)

Distressed**MSC 16 (50.00) 8 (25.0) 0 (0)

DDS $ 3Wait-list 3 (9.70) 6 (19.4) 0 (0)

Data are mean (SD) or n (%) (depressed and distressed measures). *Significant differencesbetween groups at baseline, P , 0.05. **Significant differences between groups at baseline,P , 0.001.

6 Self-Compassion Among Patients With Diabetes Diabetes Care

among people with greater levels ofdistress and depression (and poorer gly-cemic control). In addition, we note afailure of randomization with between-

group baseline differences in the keyclinical markers of depression, distress,and HbA1c as well as in self-compassion.Although the analytic approach should

accommodate such differences, findingsmust nonetheless be interpreted withcaution because they may be limitedto those with more room to improve in

Table 3—Results of t tests between T1 and T2, T2 and T3, and overall differences between T1 and T3 for MSC and wait-listcontrol groups separately

Measure T1 and T2 Difference T2 and T3 Difference T1 and T3 Difference

SCSMSC t(31) = 4.70** 0.58 (0.12) t(31) = 0.88 0.11 (0.14) t(31) = 5.10** 0.70 (0.14)Wait-list t(30) = 1.93 0.25 (0.13) t(30) = 21.92 20.24 (0.12) t(30) = 0.14 0.01 (0.10)

PHQ9MSC t(31) = 23.85* 24.86 (1.27) t(31) = 20.95 1.3 (1.35) t(31) = 25.92** 26.14 (1.04)Wait-list t(30) = 21.96 22.44 (1.25) t(30) = 1.74 2.03 (1.17) t(30) = 20.38 20.41 (1.10)

DDS17MSC t(31) = 4.56** 0.83 (0.18) t(31) = 21.12 20.23 (1.18) t(31) = 27.23** 21.06 (0.15)Wait-list t(30) = 20.36 20.06 (0.17) t(30) = 20.90 20.19 (0.21) t(30) = 22.11* 20.25 (0.20)

HbA1cMSC t(31) = 21.47 22.81 (1.91) t(31) = 23.63* 27.41 (2.04) t(31) = 24.65** 210.22 (2.20)mmol/mol% t(31) = 21.47 20.26 (0.18) t(31) = 23.63* 20.68 (0.19) t(31) = 24.65** 0.94 (1.14)

Wait-listmmol/mol t(30) = 1.58 1.20 (1.25) t(30) = 23.27* 23.71 (1.14) t(30) = 21.20 21.74 (1.45)% t(30) = 1.58 0.18 (0.11) t(30) = 23.27* 20.34 (0.10) t(30) = 21.20 20.16 (0.13)

Data are mean (SE) unless otherwise indicated. *P , 0.05. **P , 0.001.

Figure 2—Mean difference scores in outcome measures of self-compassion (A), diabetes distress (B), depression (C), and HbA1c (D) for each groupbetween T1 and T2 (baseline and postintervention), T2 and T3 (postintervention and 3-month follow-up), and T1 and T3 (baseline to 3-month follow-up).

care.diabetesjournals.org Friis and Associates 7

terms of greater baseline levels of de-pression and distress, among whomhigher HbA1c can be expected (2).Finally, the absence of an active con-

trol group means nonspecific factors, in-cluding group support or simplymeetingwith a teacher and fellow patients withdiabetes in a supportive way over a pe-riod of 8 weeks, may be responsible forthe observed effects. Caution musttherefore be applied in attributing theseresults to the effects of the MSC inter-vention specifically, and findings mustagain be considered preliminary. Not-withstanding these limitations, this firstRCTof a stand-alonepsychological interven-tion (i.e., without the inclusion of diabetes-specific education or material) founddifferences in both psychological andphysiological metrics (HbA1c) in whatis a typically hard-to-treat population.Offsetting these limitations, however,

is a low dropout rate (6.30%), which isunusual for distressed patients with dia-betes where levels of;30% dropout arecommon (20,21,39). Participants wereclearly motivated to attend the MSC ses-sions and to stay involved in the programuntil completion. Wait-list control partic-ipants were also motivated to attendsessions, with nearly two-thirds subse-quently taking part in the MSC programimmediately following the conclusion ofthe experimental protocol.

Future DirectionsLiving with diabetes involves relentlessself-care responsibilities that can beunderstandably overwhelming for pa-tients. Opportunities for negative self-evaluation and self-criticism of failuresin diabetes self-management abound.Although some evidence exists for theeffectiveness of mindfulness-based inter-ventions in this patient group, developingthe capacity to actively soothe andcomfort oneself during suffering (i.e.,self-compassion) may also be useful inmitigating the harmful effects of self-criticism. Such benefits might conceivablyextend to other chronically ill populationsin which issues with self-regulation andmood are common. Randomized trialswith large sample sizes, an active controlgroup, and longer-term follow-up of bothpsychological andmetabolic outcomes us-ing easily replicable protocols are needed.In summary, these data show that a

standardized, 8-week self-compassion in-tervention improves both mental health

andmetabolic outcomes in patients withdiabetes. The increased capacity to bekind and understanding to oneself inthe face of difficult feelings may be animportant focus for training as part ofreducing the suffering linked to depres-sion and distress and improving the keyclinical marker of effective diabetesmanagement: HbA1c.

Funding. This study was made possible withthe support of the New Zealand Society for theStudy of Diabetes and the New Zealand Dia-betes Foundation.Duality of Interest. No potential conflicts ofinterest relevant to this article were reported.Author Contributions. A.M.F. contributed tothe data research andwriting of themanuscript.M.H.J. and N.S.C. contributed to the data anal-ysis and review and editing of the manuscript.R.G.C. provided clinical supervision. A.M.F. is theguarantor of this work and, as such, had fullaccess to all the data in the study and takesresponsibility for the integrity of the data andthe accuracy of the data analysis.Prior Presentation. Parts of this study werepresented in abstract form at the 2nd Interna-tional Conference on Mindfulness, Rome, Italy,11–12 May 2016.

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