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 |
|
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 |
|
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) |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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 |
|
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