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. 2020 May 11;2020(5):CD003689. doi: 10.1002/14651858.CD003689.pub4

Watkins 2007.

Study characteristics
Methods Study design: parallel design
Number of arms: 2
Experimental arm: motivational interviewing
Control arm: usual care
Participants Geographical location: UK
Setting: inpatient
Stroke criteria: all subtypes
Method of stroke diagnosis: via clinical signs and CT (97%)
Time since stroke: 5 to 28 days prior to randomisation
Inclusion criteria: 1) over 18 years
Exclusion criteria: 1) severe cognitive and communication problems; 2) moving out of the area after discharge; 3) already receiving psychiatric or clinical psychology intervention
Total number randomised in this study: 157
Number randomised to treatment group: 77 (69% men, mean age 70 years, SD 10)
Number randomised to control group: 80 (70% men, mean age 70 years, SD 10)
Total number included in final analysis: 157
Number included in treatment group for final analysis: 77
Number included in control group for final analysis: 80
Interventions Treatment: motivational interviewing
Treatment duration: treatment was up to 4 sessions, 1 per week, with same therapist
Administered by: nursing and psychology (non‐clinical) staff,
Supervision: by a clinical psychologist
Intervention fidelity: 16/204 did not receive any intervention sessions. 188/204 received at least one session. 42/204 received between 1‐3 sessions only
Control: usual care
Follow‐up: not reported
Outcomes Primary outcomes
  • Depression measured using the GHQ‐28


Secondary outcomes
  • Depression measured using the Yale Depression Screen

  • Activities of daily living measured using the BI

Notes Additional unpublished data provided by authors
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "A research nurse randomized patients (1:1 ratio) to either usual care (control) or MI (intervention) using minimization over sex, age (65 and 65 years), baseline function in activities of daily living (ADL; Barthel: 18 to 20; 11 to 17; 0 to 10),24 and location (acute stroke unit or not)." pp. 1957
Comments: method of sequence generation not reported.
Allocation concealment (selection bias) High risk Quote: "The same nurse then assigned intervention group patients to 1 of 4 therapists using an opaque sealed envelope in a pseudo‐randomized blocked design." pp. 1957
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "The therapists were not involved in the initial assessment of patients, randomization, or assignment of patients to therapists." pp. 1957
Comments: the same research nurse randomised and assigned patients to therapists
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "Surviving patients were sent a questionnaire. Patients not returning questionnaires within 2 weeks were telephoned by a second research nurse, blind to group allocation, and given the option of declining, having a further questionnaire posted, completing the questionnaire over the telephone, or receiving a home visit to assist." pp. 1958
Incomplete outcome data (attrition bias)
All outcomes Low risk Comments: Figure 1 shows the trial profile. Under analysis, it states that all participants were included in the analysis. Missing data were imputed
Selective reporting (reporting bias) Unclear risk Comments: no trial protocol available to compare with the publication
Other bias Low risk Comments: there was no statistically significant difference between the treatment and control group in baseline demographic characteristics