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

Kerr 2018.

Study characteristics
Methods Study design: parallel design
Number of arms: 2
Experimental arm: individual motivational interviewing
Control arm: usual care
Participants Geographical location: Australia
Setting: inpatient
Stroke criteria: acute presentation after acute stroke (cerebral infarction/intracerebral haemorrhage)
Method of stroke diagnosis: confirmed by neurologist in the medical notes
Time since stroke: not reported
Inclusion criteria: 1) acute presentation after acute stroke (cerebral infarction/intracerebral haemorrhage; 2) cognitively alert
Exclusion criteria: 1) mental health conditions, including depressive symptoms requiring professional support within 1 month; 2) severe communication problems e.g. significant dysphasia or aphasia; 3) myocardial infarction; 4) concurrent neurological disease/trauma; 5) subarachnoid haemorrhage
Depression criteria: depression score not an entry criteria.
Total number randomised in this trial: 28
Number randomised to treatment group: 14 (85.7% men, mean age 69.14, SD 10.91)
Number randomised to control group: 14 (50% men, mean age 71.95, SD 13.14)
Total number included in final analysis: 25
Number included in treatment group for final analysis: 12
Number included in control group for final analysis: 13
Interventions Treatment: 3 x 30‐minute sessions of motivational interviewing. The purpose of Session 1 was to set the agenda and encourage the patient to talk about adjustment to stroke. In Session 2, the patient was encouraged to identify realistic goals for recovery and identify barriers to achieving goals. In Session 3, the goal was to identify any ambivalence the patient had about achieving goals; support the patient's optimism and self‐efficacy, and assist identification of solutions to solve problems. Participants were encouraged to summarise their goals and commitment and clarify any information from the first 2 sessions
Treatment duration: 3 months
Administered by: trained facilitators
Supervision: by a psychologist
Intervention fidelity: unclear
Control: usual care
Follow‐up: 3 months
Outcomes Primary outcomes
  • Depression measured using the HADS and the PHQ‐9

  • Anxiety measured using the HADS


Secondary outcomes
  • Quality of life measured using the QoL Index

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "A computer‐generated block randomization list equally divided all numbers between 1 and 60 into either treatment or control groups." pp. 3
Allocation concealment (selection bias) High risk Quote: "Allocation to the intervention or control arms was concealed from participants until after recruitment and baseline data collection. Envelopes were prepared by the Principal Investigator and stored in a locked cupboard in the ward. The envelopes were numbered sequentially, indicating the order in which participants were enrolled into the study (e.g. the first participant received the envelope labelled 'Number 1', the second participant received the envelope 'Number 2', etc.). A note in the envelope indicated the allocation (to intervention or control group), concealed by coloured paper to protect the identity of the allocation group. The project manager opened the randomization envelopes after baseline data collection." pp. 3
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote: "Allocation to the intervention or control arms was concealed from participants until after recruitment and baseline data collection." pp. 3
Comments: blinding of personnel not reported
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote: "The research assistant, a nurse with significant research experience, was employed to collect data at the 2 follow‐up time points. Although intentionally blinded, the research assistant may have become aware of the allocation in conversation with the participant." pp. 5
Incomplete outcome data (attrition bias)
All outcomes High risk Comments: per protocol analysis reported in Table 1 and 2. 10/48 participants were not included in the analysis. (8 dropped out; 2 unable to participate; 1 died, 1 developed aphasia)
Selective reporting (reporting bias) Unclear risk Comments: no trial protocol available to compare with the publication
Other bias Low risk Quote: "Patients were broadly similar for age, gender, nationality, and marital status. Capacity to perform activities of daily living were similar, according to the Modified Barthel Index.” pp. 6
Comments: no other bias detected