Watkins 2007.
Study characteristics | ||
Methods | Study design: parallel design Number of arms: 2 Experimental arm: motivational interviewing Control arm: usual care |
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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 |
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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 |
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Outcomes | Primary outcomes
Secondary outcomes
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Notes | Additional unpublished data provided by authors | |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 |