Clinical trial NCT00863031: A Trial on the Effectiveness of Screening and Brief Problem-Solving Therapy (PST) for Elderly Patients With Psychological Problems
Official title: A Randomised Controlled Trail on the Effectiveness of Screening and Brief Counselling (Problem-Solving Therapy) for Elderly Patients With Psychological Problems in Primary Care.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Undiagnosed Psychological Problems
Keywords: mental health
problem-solving therapy
elderly
health-related quality of life
primary care
Chinese
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Health Care and Promotion Fund, Government of the Hong Kong SAR
First posted: 2009-03-17
Enrollment: 299
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to determine whether screening followed by brief PSC provided by primary care doctors could improve the quality of life of elderly patients with unrecognized psychological problems in primary care. The following hypotheses were tested:

1. Elderly patients screened positive of psychological problems had poorer health-related quality of life (HRQOL) than those who were screened negative.
2. Primary care doctors could be trained to provide brief PST.
3. Brief PST by a trained primary care doctor could improve the HRQOL of the elderly who were screened positive for psychological problems.

Detailed description: Design \& methods: A prospective single-blind randomised controlled trial (RCT) on 299 patients aged 60 or above without any known psychological diseases but screened positive for psychological problems by the Hospital Anxiety and Depression Scale (HADS). Subjects were randomised to problem-solving (PST) or video-viewing (placebo). All subjects continued with their usual care and were followed up by telephone at 6, 12, 26 and 52 weeks.Changes in SF-36 HRQOL scores, HADS scores and monthly consultation rates at 6, 12, 26 and 52 weeks within groups and between groups.

Eligibility criteria: Inclusion Criteria:

* Aged 60 or above
* not known to have any psychological problem
* HADS Depression score 6 or above, or Anxiety Score 3 or above
* Written consent to study

Exclusion Criteria:

* known psychological disease diagnosed by a registered doctor
* history of taking any psychotropic drug prescribed by a registered doctor within the last year;
* suicidal plan or strong suicidal thought;
* psychotic symptom;
* impairment in cognitive function; or
* communication problem.

Primary outcomes:
measure: Health-related quality of life scores
timeFrame: 6, 12, 26 and 52 weeks
Secondary outcomes:
measure: Hospital Anxiety & Depression Scale scores
timeFrame: 6, 12, 26 and 52 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Two General Outpatient Clinics
Study officials:
affiliation: Family Medicine Unit, Faculty of Medicine, HKU
name: Cindy L.K. Lam, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lam C.L.K., Lee P.W.H., Fong D.Y.T. and Lam T.P., A randomised controlled trial on the effectiveness of screening and brief problem-solving counselling for elderly patients with undiagnosed psychological problems in primary care., Hong Kong Medical Journal. HK Academy of Medicine Press, 2008, 14: 31-35.