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. 2021 Aug 5;2021(8):CD009149. doi: 10.1002/14651858.CD009149.pub3

Xie 2019.

Study characteristics
Methods Study design: RCT 
Duration of study: March 2014 to March 2015 
Participants Country: China  
Income classification: upper‐middle income  
Geographical scope: Yankou Town is a representative town of Lengshuijiang City of Hunan Province, where many young couples have moved to the cities to work; their parents are typically left behind without care 
Healthcare setting: local community health centre 
Mental health condition: depression
Population: ‘left behind’ elders with GDS score 11 to 25 in Hunan Province 
1. Age: ≥ 65 years 
2. Gender: both 
3. Socioeconomic background: economic support < 500 RMB/month  
3. Inclusion criteria   
a. GDS score 11 to 25 AND 
b. Over 65 years of age  
c. Only 1 participant from each family  
d. Left behind for longer than 6 months  
5. Exclusion criteria  
a. Psychiatric and medical comorbidities that are potentially life threatening or expected to severely limit client participation or adherence 
b. Currently seeing a cognitive‐behavioural therapist, psychotherapist, or counsellor 
c. People unable to understand and fill out the questionnaires 
Interventions Stated purpose: to evaluate the effectiveness of a modified behavioural activation treatment (MBAT) intervention on reducing depressive symptoms in rural left‐behind elderly 
INTERVENTION (n = 37)
Name: Modified Behavioral Activation Treatment (MBAT) and regular care
Delivered by: LHW and PHP
Title/name of PW and number: facilitators ‐ 4, volunteers ‐ 10  
1. Selection: 4 postgraduate nursing students served as facilitators. In addition, 10 local nurses familiar with the dialect were recruited as volunteers and were trained over a period of 2 days on test procedures and questionnaire items. These 10 volunteers were primarily responsible for the survey and for regional dialect co‐ordination
2. Educational background: postgraduate nursing students, local nurses 
3. Training: no details of training provided. Facilitators were trained by the investigator to administer treatments. Volunteers were trained over a period of 2 days on test procedures and questionnaire items
4. Supervision: each facilitator worked with 1 of the 4 groups of participants in the intervention period in close collaboration with the investigator. To ensure competent provision of intervention, all facilitators met for weekly individual supervision sessions with the investigator 
5. Incentives/remuneration: not mentioned 
Intervention details 
1. Duration/frequency: 8 weekly sessions, each lasting 2 hours 
2. Content of intervention: before the first session, participants in the intervention group were divided into 4 groups. Then, a treatment rationale and outline for BA for depression were provided to participants by the Co‐PI. The daily monitoring form (a blank calendar of the hours of each day of a week) was typically assigned as homework but was started in session to ensure that participants understood the concepts and expectations. Strategies such as enlisting a supportive family member to help with written assignments were encouraged. After submitting the assignment, local volunteers translated the log and confirmed it with participants 
CONTROL: usual care ("regular care") (n = 36)
Included regular physical examinations, such as checking temperature, blood pressure, heart, and breathing rate, and reviewing current health symptoms depending on health needs, and receiving education (knowledge on prevention of and treatments for chronic diseases, infectious diseases, etc.), delivered by village doctors weekly during the 8‐week intervention period 
CO‐INTERVENTIONS: both groups received regular care 
Outcomes (Participants were given 30 to 45 minutes to finish the questionnaires; reading assistance was provided when necessary by nurse volunteers)
Patients  
1. Beck Anxiety Inventory (BAI) (score ≥ 45 was defined as positive for anxiety) 
2. Oxford Happiness Questionnaire (OHQ) 
3. Geriatric depression scale (long form) (remission of depression symptoms was defined as score < 11 on the GDS) 
Carers
Nil 
Process/health workers
Nil
Economic outcomes
Nil 
Time points: baseline, 3 months post‐intervention 
Notes Source of funding: China Family Foundation Health Fellowship Program of Yale‐China Association and the National Natural Science Foundation of China (NO.81502701) 
Notes on validation of instruments (screening and outcomes): all locally validated 
Additional information: declarations of interest ‐ none
Handling the data: as per footnotes in data and analysis 
Prospective trial registration numbers: ChiCTR‐IOR‐17011289 and NCT02785211 
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk A random number table was used to allocate the 80 participants randomly to 2 groups of 40 each
Allocation concealment (selection bias) Unclear risk Judgement comment: both reviewers rated unclear; no mention of any effort made to conceal allocation of participants. Participants were allocated to their groups at the start of the study
Blinding of participants and personnel (performance bias)
All outcomes High risk Outcomes were self‐assessed. Facilitators read out questions to participants while participants filled out their responses. Participants are aware of their treatment assignment and may choose to answer favourably if they are in the intervention group because of pressure from attending the intervention or from facilitators who are translating and reading out questions on the questionnaires 
Blinding of outcome assessment (detection bias)
all outcomes High risk Outcomes were self‐assessed. Facilitators read out questions to participants while participants filled out their responses. Participants are aware of their treatment assignment and may choose to answer favourably if they are in the intervention group because of pressure from attending the intervention or from facilitators who are translating and reading out questions on the questionnaires 
Baseline outcome measurements similar Low risk Baseline GDS, BAI, and OHQ score were similar in both groups
Baseline characteristics similar? Low risk Partipants in the 2 groups were similar in age, gender, education, economic means, visit frequency by children, previous exposure to psychoeducation or counselling, and need for psychoeducation or counselling
Incomplete outcome data (attrition bias)
Efficacy data Low risk Yen ‐ unclear: dropout numbers were small (3/80 immediately post intervention and 7/80 3 months post intervention), but because effect sizes are small, it is possible for participants who had dropped out to have an influence on study results if they had stayed on
Rakesh ‐ low
Protection against contamination Unclear risk Participants in both groups lived in the same area and may have shared information with each other
Selective reporting (reporting bias) Unclear risk No clinical trial registry data available. Outcomes planned in methods section were reported in results section
Other bias Low risk No comment