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

1. Characteristics of dropout studies.

Study ID Methods Participants Interventions Outcomes Notes
Bramanti 1989 Study design: parallel design
Number of arms: 2
Experimental arm: protirelin tartrate
(TRH‐T)
Control arm:
placebo Geographical location: Italy
Setting: unclear
Number of participants: 30
Stroke criteria: acute stroke
Method of stroke diagnosis: not reported
Inclusion criteria: not reported
Exclusion criteria: not reported
Depression criteria: not reported
Number included in treatment group: unclear (63% male, mean age 72.2, SD not reported of the overall cohort)
Number included in control group: unclear (63% men, mean age 72.2, SD not reported of the overall cohort) Treatment: protirelin tartrate (TRHT) 2 mg/day
Control: placebo
Duration: 2 weeks
Follow‐up: none
  • Depression measured using the HDRS

Results not available in format suitable for the review
Downes 1995 Study design: parallel design
Number of arms: 3
Experimental arm 1: information + counselling
Experimental arm 2: information pack
Control arm: usual
care Geographical location: UK
Setting: outpatient
Number of participants: 62
Stroke criteria: not reported
Method of stroke diagnosis: not reported
Inclusion criteria: 1) lived at home; 2) had an informal carer; 3) stroke increase mRS; 4) post‐stroke mRS score of 2 to 5
Exclusion criteria: 1) not living at home; 2) not having an informal carer; 3) having no increase in disability or change in lifestyle/dependency
Depression criteria: HADS score > 11
Number included in treatment group 1: 22 (50% men, age not reported)
Number included in treatment group 2: 22 (55% men, age not reported)
Number included in control group: 18 (44% men, age not reported)
Treatment 1: information plus counselling. Egan's problem‐solving approach, individual is helped to explore concerns, clarify problems, set goals, and take appropriate action. Protocol discussed first and formulated into a counsellor/client contract. Information pack containing information on physical, cognitive, behavioural and emotional effects of stroke, carer well‐being, and local services.
Treatment 2: information only: information pack containing information on physical, cognitive,behavioural, and emotional effects of stroke, carer well‐being, and local services.
Control: usual care, no visit(s) or information pack provided
Duration: information session consisted of 1 visit and provision of the information pack. Counselling consisted of up to 8 counselling sessions over 4 to 6 months
Administered by: nurse counsellor
Supervision: unclear
Follow‐up: none
  • Depression measured using the HADS‐ Depression

  • Anxiety measured using the HADS‐ Anxiety

Unable to isolate
outcome data for non‐depressed participants at randomisation
Friedland 1992 Study design: parallel design
Number of arms: 2
Experimental arm: psychoeducational support
Control arm:
usual care
Geographical location: Canada
Setting: outpatient
Number of participants: 88
Stroke criteria: all subtypes
Method of stroke diagnosis: via clinical signs
Inclusion criteria: 1) completed formal inpatient rehabilitation and a period of rehabilitation provided by a home care programme
Exclusion criteria: 1) history of psychiatric admission, 2) previously on antidepressant medication, 3) aphasia with limited ability to communicate verbally
Depression criteria: unclear
Number included in treatment group: 48 (44% men, mean age 69 years, SD 11)
Number included in control group: 40 (44% men, mean age 69 years, SD 11)
Treatment: psychoeducational, with participant and members of their support team; work to improve social support, establish new supports, emotional support offered
Control: usual care, no visits
Duration: treatment continued for 6 to 12 sessions over approximately 3 months
Administered by: specially trained social support intervention therapist
Supervision: unclear
Follow‐up: 6 months (3 months post intervention)
  • Depression (difference in scores at end of treatment) measured using the GHQ‐28

Results not available
Graffingo 2003 Study design:
parallel design
Number of arms: 2
Experimental arm: sertraline (SSRI)
Control arm:
matched placebo
Geographical location: unclear
Setting: unclear
Number of participants: unclear
Stroke criteria: unclear
Method of stroke diagnosis: unclear
Inclusion criteria: unclear
Exclusion criteria: unclear
Depression criteria: unclear
Number included in treatment group: unclear
Number included in control group: unclear
Treatment: sertraline (SSRI)
Control: matched placebo
Duration: unclear
Follow‐up: unclear
  • Depression: unclear what measure was used

Results not available
Hadidi 2014 Study design: parallel design
Number of arms: 2
Experimental
arm: problem‐solving therapy (PST)
Control arm: weekly telephone calls Geographical location: USA
Setting: inpatient
Number of participants: 22
Stroke criteria: first time diagnosis of ischaemic stroke < 48 hours
Method of stroke diagnosis: not reported
Inclusion criteria: 1) Mini‐Cog score of 3; ≥ 50 years of age; 2) able to read and write in English
Exclusion criteria: 1) previous history of mental health problems; 2) diagnosis of severe aphasia as identified by a speech pathologist; 3) haemorrhagic stroke or transient ischaemic
attack; 4) medical instability requiring transfer to critical care
Depression criteria: CES‐D score measured at baseline but patients recruited regardless of their CES‐D score. If CES‐D score > 10,
or suicidal ideation the primary physician was notified
Number included in treatment group: 11 (18% men, mean age 73)
Number included in control group: 11 (45% men, mean age 69)
Treatment: one‐on‐one problem solving therapy sessions lasting 1‐2 hours. Therapy entails providing patient information on impact and guidance to enable the patient to: identify and define the problem; brainstorm all potential solutions; select the most appropriate and feasible solution; create and implement a SMART (Specific, Measureable,
Achievable, Realistic and Timely) goal; evaluate and re‐view progress in follow‐up sessions
Administered by: a doctoral nursing student who received PST training through a 13‐ module online program adapted from a standard 3‐day in person training
Supervision: principal investigator who had undergone in person PST training
Intervention fidelity: not reported
Control: weekly telephone calls to assess CES‐D and FIM scores
Duration: once per week for 10 weeks
Follow‐up: 3 months
  • Depression measured using the CES‐D

  • Impairment measured using the FIM

  • Leaving the trial early

Unable to isolate outcome data for non‐ depressed participants at randomisation
Kim 2017 Study design:
parallel design
Number of arms: 2
Experimental arm:
escitalopram (SSRI)
Control arm: placebo
Geographical location: South Korea
Setting: inpatient
Number of participants: 478
Stroke criteria: ischaemic stroke or intracerebral haemorrhage
Method of stroke diagnosis: confirmed by MRI or CT
Inclusion criteria: 1) > 20 years, 2) had an acute ischaemic stroke or intracerebral haemorrhage within the previous 21 days, 3) mRS score of 2 or greater at the time of screening, 4) agreed to participate
Exclusion criteria: 1) history of diagnosed depression or other psychiatric diseases before the index stroke, 2) severe dementia, 3) cognitive dysfunction (stages 5‐7 of the Global Deterioration Scale), 4) aphasia, 5) on antimigraine or antiepileptic medication, 6) suicidal thoughts (a combined MADRS score > 8, 7) pregnant or lactating, 8) participation in another clinical trial
Depression criteria: MADRS
Number included in treatment group: 241
Number included in control group: 237
Treatment: oral escitalopram (SSRI) 10 mg/day
Control: placebo
Duration: 3 months
Follow‐up: 6 months
  • Depression (frequency of moderate or severe depressive symptoms) measured using the (MADRS)

  • Impairment measured using the NIHSS

  • Functional capacity measured using the mRS

  • Activities of daily living measured using the BI

  • Adverse events

Unable to isolate
outcome data for non‐ depressed participants at randomisation
Leathley 2003 Study design:
parallel design
Number of arms: 4
Experimental arm 1: social support
Experimental arm 2: psychological support (cognitive therapy based problem solving)
Experimental arm 3:
social support and psychological support
Control arm: usual care
Geographical location: UK
Setting: outpatient
Number of participants: unclear
Stroke criteria: unclear
Method of stroke diagnosis: unclear
Inclusion criteria: unclear
Exclusion criteria: unclear
Number included in treatment group 1: unclear
Number included in treatment group 2: unclear
Number included in treatment group 3: unclear
Number included in control group: unclear
Treatment 1: social support (information, practical advice, service liaison)
Treatment 2: psychological support (cognitive therapy based problem solving)
Treatment 3: social support and psychological support
Control: usual care, no visits
Duration: unclear
Administered by: unclear
Supervision: unclear
Follow‐up: unclear
  • Depression (difference between groups at end of treatment) measured using the GHQ‐12 total score

Results not available in format suitable
for this review
McCafferty 2000 Study design: parallel design
Number of arms: 2
Experimental arm: psychosocial intervention
Control arm: usual care
Geographical location: USA
Setting: inpatient
Number of participants: 40
Stroke criteria: unclear
Method of stroke diagnosis: unclear
Inclusion criteria: unclear
Exclusion criteria: unclear
Number included in treatment group: 20
Number included in control group: 20
Treatment: psychosocial, addresses cognitive, behavioural and family factors associated with post stroke depression
Control: usual care, no visits
Duration: treatment continued for 6 weeks
Administered by: unclear
Supervision: unclear
Follow‐up: unclear
  • Depression measured using the GDS

Results not available
Ohtomo 1985 Study design: parallel design
Number of arms: 2
Experimental arm: tiapride
Control arm: placebo Geographical location: Japan
Setting: unclear
Number of participants: 188
Stroke criteria: all subtypes
Method of stroke diagnosis: diagnosis via clinical signs and CT
Inclusion criteria: 1) > 40 years of age, high blood pressure (> 160/90 mmHg) and hypertensive changes on fundoscopy changes; 2) stable neuroleptic, minor tranquilliser, antidepressant, brain metabolic activators, cerebro‐vasodilators washed out for 3 to 7 days prior to randomisation
Exclusion criteria: 1) severe aphasia; 2) severe dementia; 3) drug dependence; 4) inadequate conditions for the study
Depression criteria: not reported
Number included in treatment group: 141 (54% men, mean age not reported)
Number included in control group: 147 (61% men, mean age not reported)
Treatment: tiapride, 75 mg daily for 1 week, dose escalation to 150 mg to 225 mg daily for 5 weeks according to clinical response
Control: matched placebo
Duration: 6 weeks
  • Depression‐ unclear what measure was used

Results not available in format suitable for the review
Ostwald 2014 Study design: parallel design
Number of arms: 2
Experimental arm: home‐based psychoeducational programme
Control arm: monthly mailed letter
Geographical location: USA
Setting: outpatient
Number of participants: 159
Stroke criteria: stroke <12 months ago, subtype unclear
Method of stroke diagnosis: unclear
Inclusion criteria: 1) > 50 years of age
Exclusion criteria: 1) global aphasia, 2) patient or carer had comorbidity that took priority, 3) < 6 months life expectancy
Depression criteria: none
Number included in treatment group: 79 (69% men, mean age 67 years)
Number included in control group: 80 (81% men, mean age 66 years)
Treatment: home‐based psychoeducational programme for stroke‐care‐giving dyads post‐discharge. The intervention involved home visits by advance practice nurses, occupational and physical therapists
Administered by: advance practice nurses, occupational and physical therapists
Supervision: not reported
Control: 1 letter a month for 12 months
Duration: 6 months
Follow‐up: 6 months
  • Depression measured using the 15‐item GDS

  • Quality of life measured using the SF‐36

  • Functional capacity measured using the FIM physical and cognitive subscales

Unable to isolate
outcome data for non‐ depressed participants at randomisation
Raffaele 1996 Study design: parallel design
Number of arms: 2
Experimental arm: trazodone
Control arm:
placebo Geographical location: Italy
Setting: outpatient
Number of participants: 22
Stroke criteria: unclear
Method of stroke diagnosis: not reported
Inclusion criteria: not reported
Exclusion criteria: not reported
Depression criteria: ZDS
Number included in treatment group: 11 (45.4% men, mean age 69.5, SD 2.3)
Number included in control group: 11 (72.7% men, mean age 70.4, SD 3.0) Treatment: trazodone 300 mg/day
Control: placebo
Duration: 30‐45 days
Follow‐up: unclear
  • Depression measured using the ZDS

  • Activities of daily living measured using the BI

Unable to isolate
outcome data for non‐ depressed participants at randomisation.

BI: Barthel Index

CES‐D: Center for Epidemiological Studies‐ Depression

CT: computed tomography

FIM: Functional Independence Measure

GDS: 15‐item Geriatric Depression Scale

GHQ‐12: 12 item General Health Questionnaire

GHQ‐28: 28 item General Health Questionnaire

HADS: Hospital Anxiety and Depression Scale

HDRS: Hamilton Depression Rating Scale

MADRS: Montgomery‐Asberg Depression Rating Scale

MRI: magnetic resonance imaging

mRS: modified Rankin Scale

NIHSS: National Institutes of Health Stroke Scale

SD: Standard Deviation

SF‐36: 36‐item Short Form Questionnaire

SSRI: selective serotonin reuptake inhibitors

ZDS: Zund Depression Scale