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. 2021 Jan 4;2021(1):CD006440. doi: 10.1002/14651858.CD006440.pub3

Au 2015.

Study characteristics
Methods Design: Multicentre, parallel randomised study.
No. of participating centres: Two centres (United Christian Hospital; Prince of Whales Hospital; Hong Kong, China)
Study dates: Not reported.
Participants Inclusion criteria: Informal caregivers aged 25 or older, caring for a familiar diagnosed of Alzheimer's disease for at least 3 months.
Exclusion criteria: Participants who showed signs of severe intellectual deficits, demonstrated suicidal ideation, exhibited evidence of psychotic disorders, or could not read or speak fluent Chinese/Cantonese.
No. of participants randomised to interventions:
‐ PsyED with BA (n = 51).
‐ PsyED only (n = 45).
Baseline characteristics:
‐ Caregivers: Mean age for participants was 56.2 years (SD = 10.6). Most caregivers were females (76 of 93, 82%), spouses or children of AD patients (85 participants of 93, 91%). The mean time for caring was 10.4 hours/day (SD = 8.9). The mean CES‐D score was 13.5 (SD = 8.0).
‐ Care recipients: Mean age was 80.9 years (SD = 6.6). There were 60 females of 93 (64.5%) and 33 males of 93 (35.5%). Mean MMSE was 15.7 (SD = 5.6).
Interventions Experimental: Psychoeducation with telephone‐assisted behavioral activation (PsyED‐BA). All participants received a psychoeducation program via telephone for 4 weeks. Then, the experimental group received eight biweekly telephone follow‐up calls of BA practice focused on pleasant event scheduling and improving communications.
Control: Psychoeducation only (PsyED). All participants received a psychoeducation program via telephone for 4 weeks. Then, the control group received eight biweekly telephone follow‐up calls of general discussion of psychoeducation and related information.
Length of intervention: 4 months.
Outcomes Primary outcomes:
‐ Center for Epidemiologic Studies‐Depression Scale (CES‐D) (range scores 0 to 30, higher scores denote more depressive symptoms).
Secondary outcomes:
‐ None reported
Outcomes assessment: At 4 months.
Notes Clinical trial registration code: Not reported.
Funding: Food and Health Bureau of the Hong Kong SAR Government (HKPolyU‐2011‐K‐JB3).
Conflicts of interest: None declared.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: Study described as randomised, however the process of randomization is not described.
Allocation concealment (selection bias) Unclear risk Comment: There is no information on allocation concealment.
Blinding of participants and personnel (performance bias)
All outcomes High risk Comment: There is not information on blinding procedures for participants, professionals were not blinded.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "Research staff carrying out the assessments and interventions had no knowledge of the allocation. All assessments at the three time points were carried out by research staff not involved in executing the PsyED program or the subsequent interventions".
Comment: Intervention components and procedures were comparable.
Incomplete outcome data (attrition bias)
All outcomes Low risk Comment: Data recorded from 93 caregivers of 96 randomised, and the study provides reasons for discontinuation on treatment by arm.
Selective reporting (reporting bias) Unclear risk Comment: There is not clinical trial registration and/or available protocol.
Other bias High risk Comment: Break of randomization. Data added to a former pilot study already published.