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. 2020 Jul 5;2020(7):CD012527. doi: 10.1002/14651858.CD012527.pub2

Clemow 2018.

Study characteristics
Methods Study design: RCT
Study grouping: parallel group
Unit of randomisation: individuals
Power (power & sample size calculation, level of power achieved): not specified
Imputation of missing data: imputation for psychosocial outcomes not specified; for blood pressure measures: multilevel, repeated‐measures regression analysis to generate full information maximum likelihood estimates of the group‐specific average change in systolic blood pressure (SBP) and diastolic blood pressure (DBP); per‐protocol analysis (i.e. only participants in IG who attended at least 6 sessions) and available‐case analysis (i.e. only participants in both groups who completed follow‐up assessments) + intention‐to‐treat analysis (n = 92)
Participants Country: USA
Setting: delivered in workplace (large urban medical centre)
Age: mean = 48.5 (SD = 8.7) years
Sample size (randomised): 92
Sex: 71 women, 21 men
Comorbidity (mean (SD) of respective measures in indicated, if available) at baseline: depression CES‐D: IG = 14.5 (8.7), CG = 11.2 (10.2); burnout, emotional exhaustion (MBI): IG = 19.2 (10.8), CG = 23.2 (12.6); burnout, depersonalisation: IG = 5.4 (5.2), CG = 4.2 (4.4); burnout, personal accomplishment: IG = 32.3 (9.7), CG = 31.5 (11.3)
Population description: employees (aged 18 – 70 years) of a large urban medical centre identified through workplace blood pressure (BP) screenings
Inclusion criteria: 1) employees of large urban medical centre; 2) aged 18 ‐ 70 years; 3) whose screening BP (average of 3 measurements) was ≥ 140 mm Hg SBP or 90 mm Hg (DBP) and whose average readings did not exceed 180/110 mm Hg at both screening and subsequent baseline evaluation
Exclusion criteria: 1) pregnancy; 2) end‐stage renal disease
Attrition (withdrawals and exclusions): 11 dropouts after randomisation (IG = 6, CG = 5; i.e. did not complete follow‐up assessment); 2 participants (in IG) later found to have been ineligible
Reasons for missing data: not specified (n = 11); average BP measurement computed in error ‐ actually below cut‐off (n = 2 ineligible after randomisation)
Interventions Intervention: LifeSkills workshop (stress and anger management intervention/workshop on cognitive‐behavioural coping skills) (n = 46)

  • delivery: face‐to‐face group setting (groups of 8 ‐ 10 participants) with video as adjunct to each session; individual consultation offered to participants who missed a session

  • providers: 3 doctoral‐level clinical or counselling psychologists trained according to guidelines used by Williams LifeSkills, Inc., to serve as group facilitators; receive ongoing supervision from the senior study clinician to ensure fidelity to the material; sessions followed the Williams LifeSkills Workshop manual and video; same facilitator works with the same group of participants throughout the course of the intervention

  • duration of treatment period and timing: 10 weekly 1‐hour sessions; group sessions conducted at mid‐day lunch breaks, during workday (between 12 noon ‐ 2.00 pm)

  • description:

    • workshop on cognitive‐behavioural coping skills; LifeSkills Workshop = structured cognitive‐behavioural group intervention that draws on cognitive‐behavioural techniques and stress reduction approaches

    • training is framed as training to increase a person’s resiliency for coping with stressful situations, rather than as treatment for a mental disorder

    • facilitator leads participants through each of several behavioural skills, modelling them as necessary

    • VIDEO developed as adjunct to each session, is integrated into each session, which standardises the presentation of material

    • SKILLS include: self‐monitoring, such as identification and evaluation of thoughts, feelings, and behaviours in response to stressful situations; problem‐solving; assertiveness in dealing with anger‐ and stress‐inducing events or demands, or both; deflection skills to reduce distress in stressful situations, such as breathing and muscle relaxation, distraction, and increasing distress tolerance; communication skills; and increasing empathy and building positive relationships

    • facilitators offer individual consultation to participants who missed a session

  • compliance: randomised participants attended with mean (SD) of 8.1 (1.8) group sessions, with 89.3% attending 7 or more sessions; n = 39/46 attended at least 6 sessions and completed follow‐up assessments (i.e. considered in per‐protocol analysis)

  • integrity of delivery: involvement of developers of intervention in study restricted to ensure treatment fidelity through training and initial supervision of the clinician who subsequently trained and supervised the clinicians who delivered the intervention; weekly sessions are audio‐recorded to monitor treatment fidelity and to allow for supervision of the facilitators; facilitators receive ongoing supervision from the senior study clinician to ensure fidelity to the material

  • economic information: USD 125 for completing the trial

  • theoretical basis: sessions followed the Williams LifeSkills Workshop manual and video (Riley 2017); draws on cognitive‐behavioural techniques and stress reduction approaches


Control: TAU (minimally enhanced) (n = 46)

  • delivery: brochure (self‐help materials)

  • providers: self‐help/self‐guided

  • duration of treatment period and timing: not specified

  • description: enhanced usual care: self‐help materials for BP reduction and physician referral; brochure on BP control developed by National Heart, Lung, and Blood Institute, containing information about hypertension and suggestions for making lifestyle changes to reduce BP; with participants’ permission, their BP readings were sent to their physicians, along with the 2‐page JNC 7 (joint national committee on prevention, detection, evaluation, and treatment of high blood pressure; JNC 7 report) reference card summarising guidelines for the management of high BP; no group meetings

  • compliance: not specified for TAU group; n = 41/46 completed follow‐up assessments (i.e. considered in per‐protocol analysis)

  • integrity of delivery: not specified

  • economic information: USD 125 for completing the trial

  • theoretical basis: not specified
Outcomes Outcomes collected and reported:

  • SPB ‐ automated device

  • DBP ‐ automated device

  • hostility ‐ Cook‐Medley Hostility Scale

  • burnout, emotional exhaustion ‐ MBI

  • burnout, depersonalization ‐ MBI

  • burnout, personal accomplishment ‐ MBI

  • work strain, skill discretion ‐ Karasek Job Content Questionnaire

  • work strain, decision‐making authority ‐ Karasek Job Content Questionnaire

  • work strain, job demands ‐ Karasek Job Content Questionnaire

  • assertiveness, passive behaviour ‐ PAA

  • assertiveness, aggressive ‐ PAA

  • assertiveness, assertive ‐ PAA

  • social support, belonging ‐ ISEL

  • social support, appraisal ‐ ISEL

  • social support, tangible ‐ ISEL

  • ruminative responses, depressive rumination RRS

  • ruminative responses, reflection ‐ RRS

  • ruminative responses, brooding ‐ RRS

  • John Henryism

  • depression ‐ CES‐D

  • perceived stress ‐ Perceived Stress Scale ‐ not reported


Time points measured and reported: 1) pre‐intervention; 2) 2‐month follow‐up (i.e. 2 months/approximately 60 days post‐intervention); BP also assessed at screening (to test eligibility)
Adverse events: not specified
Notes Contact with authors: We contacted the authors to obtain the means and SDs for perceived stress in both groups at each time point. We also asked for the means and SDs for all outcomes at 2‐month follow‐up (instead of change scores); no response received to 2 inquiries
Study start/end date: start of data collection in 2003; see trial registration: until August 2006
Funding source: funding provided by NIH grant #HL67584 from the National Heart, Lung, and Blood Institute; funded with a Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) through Williams LifeSkills, Inc, Durham, North Carolina
Declaration of interest: Redford B. Williams and Virginia P. Williams are founders and major stockholders in Williams LifeSkills, Inc. Their involvement in the project, as noted in the Methods section, was limited to treatment fidelity and initial training and initial supervision in the intervention. They also assisted in the editing of the manuscript. Otherwise, the design and conduct of the study, the data collection and analyses, and interpretation of results occurred independently of the developers of the intervention. The other authors have no conflicts to disclose.
Ethical approval needed/obtained for study: approved by IRB at Columbia University Medical Center
Comments by study authors: trial is registered at clinicaltrials.gov (Identifier NCT01262066)
Miscellaneous outcomes by the review authors: not relevant
Correspondence: Lynn P. Clemow, Department of Medicine, Center for Behavioral Cardiovascular Health, Columbia University Medical Center, New York, NY, USA; Department of Family and Community Medicine, Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, USA; clemowlp@rwjms.rutgers.edu
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "Those who agreed to participate were randomly assigned to one of two groups: intervention (LifeSkills workshop) or minimally enhanced usual care."
Quote: "Randomization was done by calling an off‐site person holding the randomization envelopes, using random‐sized randomization blocks provided by the study statistician (J.E.S.), in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines [43]."
Quote: "No significant differences were observed between the intervention and control groups on demographic and clinical characteristics at baseline (Table 1)."
Quote: "Baseline psychosocial characteristics did not vary between treatment and control groups (Table 3)."
Quote: "At baseline, SBP and DBP were similar between the two groups."
Judgement comment: insufficient information about random sequence generation to permit judgement of ‘Low risk’ or ‘High risk’ (exact method of random sequence generation is not described); RCT and verified baseline comparability of groups for sociodemographic and clinical characteristics (Table 1; all Ps > 0.08) and outcome variables (Table 2: physiological outcomes: SBP, DBP: Ps > 0.35; Table 3, subjective outcomes) on the basis of analysis
Allocation concealment (selection bias) Low risk Quote: "Randomization was done by calling an off‐site person holding the randomization envelopes, using random‐sized randomization blocks provided by the study statistician (J.E.S.), in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines [43]."
Judgement comment: Participants and investigators enrolling participants could not foresee assignment (allocation by off‐site person holding randomisation envelopes).
Blinding of participants and personnel (performance bias)
Objective outcomes Low risk Quote: "First, research staff were not blinded to participant group assignment."
Judgement comment: no blinding of study personnel (also face‐to‐face intervention); blinding of participants unclear, but the review authors judge that the outcome is not likely to be influenced by lack of blinding
Blinding of participants and personnel (performance bias)
Subjective outcomes High risk Quote: "First, research staff were not blinded to participant group assignment."
Judgement comment: no blinding of study personnel (also face‐to‐face intervention); blinding of participants unclear, but the outcome is likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias)
Objective outcomes Low risk Quote: "First, research staff were not blinded to participant group assignment."
Quote: "However, we attempted to mitigate the potential influence of this problem by using automated BP measurements, which are blinded to group assignment and less susceptible to bias than manual BP measurements."
Judgement comment: research staff not blinded in general; therefore, probably also no blinding of outcome assessment, but the review authors judge that the outcome measurement is not likely to be influenced by lack of blinding
Blinding of outcome assessment (detection bias)
Subjective outcomes High risk Quote: "First, research staff were not blinded to participant group assignment."
Judgement comment: research staff not blinded in general; therefore, probably also no blinding of outcome assessment, and the outcome measurement is likely to be influenced by lack of blinding
Incomplete outcome data (attrition bias)
All outcomes Low risk Quote: "Fig 1 | CONSORT diagram."
Quote: "Eleven participants dropped out after randomization (six in the intervention group and five in the usual care control group). Two participants, both in the intervention group, were later found to have been ineligible because their average BP measurements were computed in error and were actually below the cutoff."
Quote: "An intent‐to‐treat analysis was performed on all randomized participants. A multilevel, repeated‐measures regression analysis was performed to generate full information maximum likelihood estimates of the group‐specific average change in SBP and DBP between baseline and the 2‐month posttreatment assessments and to estimate and test the differential change between the intervention and usual care groups. Consistent with intent‐to‐treat principles, all participants who were randomized, including two participants who were subsequently deemed ineligible (described below), were included in the analysis"
Quote: "All 92 participants who were randomized were included in the analysis."
Quote: "In secondary analyses, we repeated the previous analyses after restricting the sample to those who completed the protocol (i.e., those in the control group who completed the follow‐up assessment [n = 41] and those in the intervention group who attended at least six sessions and completed the follow‐up assessment [n = 39])."
Judgement comment: reasons for missing outcome data are unlikely to be related to true outcome with relative balance in missing data between groups (dropouts: IG: n = 6, CG: n = 5); per‐protocol analysis (i.e. only participants who attended at least 6 sessions in IG) and available‐case analysis (i.e. only participants who completed follow‐up assessment) as well as intention‐to‐treat analysis
Selective reporting (reporting bias) High risk Judgement comment: trial registration (NCT01262066) available; several reported outcomes (psychosocial variables) were not prespecified; PRE‐SPECIFIED: change in mean office blood pressure, covarying hostility and hostility x time (hostility assessed via Cook‐Medley questionnaire); REPORTED: (diastolic/systolic) blood pressure; hostility; depression; burnout (emotional exhaustion, depersonalisation, personal accomplishment), work strain (skill discretion, decision‐making authority, job demands), assertiveness (passive behaviour, aggressive, assertive), social support (belonging, appraisal, tangible), ruminative response (depressive rumination, reflection, brooding); perceived stress is prespecified in the report, but not reported