Evaluation Study of Medical-Social Collaboration Model for Middle-aged and Older Adults With Depressive Symptoms

Overview

The goal of this clinical trial is to learn if a medical-social collaboration model works to reduce depressive symptoms in middle-aged and older adults with depressive symptoms who are waiting for their first psychiatric appointment. Secondary outcomes of the study include reduced anxiety symptoms, reduced loneliness, reduced rumination, reduced self-criticism, improved self-reassurance, improved resilience, improved self-efficacy, improved health-related quality of life, as well as improved quality-adjusted life years, and reduced healthcare service utilisation. Researchers will compare a medical-social collaboration model to a self-management booklet. Participants will: * Receive CBT-based stepped-care interventions through the medical-social collaboration model or a self-management booklet. * Complete a survey about their mental health and service use every three months until their first psychiatric appointment.

Interventions

• Behavioral Cognitive behavioural therapy-based stepped-care intervention
  After initial clinical assessment, participants will be offered interventions based on their depressive symptom severity (Patient Health Questionnaire-9-item \[PHQ-9\]). Mild symptoms (PHQ-9=5-9): 6 weekly low intensity CBT-based group intervention sessions led by trained clinical social workers, with 2 booster sessions as necessary. Moderate symptoms (PHQ-9=10-14): 6 weekly high intensity CBT-based group intervention sessions led by trained clinical social workers, with 2 booster sessions as ne
• Other Self-management booklet
  The booklet incorporates components of behavioural activation, which encourages participants to engage in meaningful activities in daily life to change their mood. Trained research assistants will regularly check in with the participants to monitor their depressive symptoms.

Primary outcome measures

• Changes in Depressive Symptoms [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months]

Secondary outcome measures (4)

• Changes in Anxiety Symptoms [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months]
• Changes in Loneliness [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months]
• Changes in Health Service Use [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months]
• Changes in Health-Related Quality of Life [Time frame: Baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months]

Eligibility criteria

Inclusion criteria

• Currently awaiting psychiatric services provided by the Hospital Authority
• Have depressive symptoms of at least mild severity
• Able to provide informed consent

Exclusion criteria

• A known history of autism spectrum disorder, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia
• Imminent suicidal risk (temporary exclusion)
• Communication difficulties that preclude participation

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

• The University of Hong Kong — Hong Kong

Identifiers

NCT: NCT07064551 · UW 24-649

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗