A Trial on the Effectiveness of Screening and Brief Problem-Solving Therapy (PST) for Elderly Patients With Psychological Problems

Undiagnosed Psychological Problems Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00863031
• Other study ID #: HKCTR-497
• Status: Completed
• Phase: N/A
• First received: March 15, 2009
• Last updated: March 16, 2009
• Start date: November 2002
• Est. completion date: June 2006

Study information

• Verified date: March 2009
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 299
• Est. completion date: June 2006
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Undiagnosed Psychological Problems

Intervention

Behavioral:
• problem-solving therapy
Three sessions of problem-solving therapy at week 1, 3 and 5.
• Video-viewing
Three sessions of viewing health educational videos.

Locations

Country	Name	City	State
Hong Kong	Two General Outpatient Clinics	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Health Care and Promotion Fund, Government of the Hong Kong SAR

Country where clinical trial is conducted

Hong Kong, 

References & Publications (1)

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 Journa

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality of life scores		6, 12, 26 and 52 weeks	No
Secondary	Hospital Anxiety & Depression Scale scores		6, 12, 26 and 52 weeks	No