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Utilizing Problem Management Plus (PM+) for older empty-nesters with psychological distress in rural China: a cluster randomized controlled trial

Utilizing Problem Management Plus (PM+) for older empty-nesters with psychological distress in rural China: a cluster randomized controlled trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078367
Enrollment
Unknown
Registered
2023-12-06
Start date
2024-01-01
Completion date
Unknown
Last updated
2023-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psychological distress

Interventions

experimental group:Five weekly in-person group sessions
control group:Non guided supportive therapy (NST)

Sponsors

Xiangya Nursing School of Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: Cluster (village) eligibility criteria are as follows: (1) the village has a minimum of 100 older empty-nesters; (2) the village has a village doctor who is willing to participate in the PM+ intervention, (3) the village does not plan to merge with other villages within one year, and (4) the village is at least two kilometers away from other participating villages to minimize the risk of contamination of the control group with the intervention. Older adults who are eligible for the study should be: (1) aged 60 years and above; (2) living alone or living with spouses for more than six months; (3) experiencing high levels of psychological distress (score >2 on the General Health Questionnaire-12, GHQ-12); and (4) having function impairment (score >16 on the 12-item version of the WHO Disability Assessment Schedule 2.0, WHODAS2.0).

Exclusion criteria

Exclusion criteria: The three villages included in the pilot study will be excluded. Older adults who present with any of the following conditions will be excluded from this study: (1) acute medical conditions; (2) imminent suicide risk (the suicide part of Mini International Neuropsychiatric Interview, MINI-SD); and (3) serious mental illness (e.g., schizophrenia).

Design outcomes

Primary

MeasureTime frame
psychological distress;

Secondary

MeasureTime frame
depression symptoms;anxiety symptoms;daily function;somatic symptoms;self-reported wellbeing;

Countries

China

Contacts

Public ContactXie Zhishan/ Huang Chongmei

Xiangya Nursing School of Central South University

15874162760@163.com+86 158 7416 2760

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026