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

This study has been completed.
Sponsor:
Collaborator:
Health Care and Promotion Fund, Government of the Hong Kong SAR
Information provided by:
The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00863031
First received: March 15, 2009
Last updated: March 16, 2009
Last verified: March 2009
  Purpose

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.

Condition Intervention
Undiagnosed Psychological Problems
Behavioral: problem-solving therapy
Behavioral: Video-viewing

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

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • Health-related quality of life scores [ Time Frame: 6, 12, 26 and 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hospital Anxiety & Depression Scale scores [ Time Frame: 6, 12, 26 and 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 299
Study Start Date: November 2002
Study Completion Date: June 2006
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: problem-solving therapy
Three sessions of brief problem-solving counselling at week 1, 3 and 5 by a family doctor.
Behavioral: problem-solving therapy
Three sessions of problem-solving therapy at week 1, 3 and 5.
Placebo Comparator: viewing video
Three sessions of health education viewing video in groups of 3 to 5 people
Behavioral: Video-viewing
Three sessions of viewing health educational videos.

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00863031

Locations
Hong Kong
Two General Outpatient Clinics
Hong Kong, Hong Kong
Sponsors and Collaborators
The University of Hong Kong
Health Care and Promotion Fund, Government of the Hong Kong SAR
Investigators
Principal Investigator: Cindy L.K. Lam, MD Family Medicine Unit, Faculty of Medicine, HKU
  More Information

Additional Information:
Publications:
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.

Responsible Party: Cindy L.K. Lam, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00863031     History of Changes
Other Study ID Numbers: HKCTR-497
Study First Received: March 15, 2009
Last Updated: March 16, 2009
Health Authority: Hong Kong: Department of Health

Keywords provided by The University of Hong Kong:
mental health
problem-solving therapy
elderly
health-related quality of life
primary care
Chinese

ClinicalTrials.gov processed this record on September 18, 2014