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Examining the Feasibility and Effectiveness of Case Manager Delivered Problem Solving Therapy on Late Life Depression

Primary Purpose

Depression

Status
Withdrawn
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Problem Solving Therapy
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Depressive Disorder, Depressive Disorder, Major, Mental Disorders, Mood Disorders, Behavioural Symptoms, Problem Solving Therapy

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Are of either gender and greater than 60 years of age.
  • Reside in a community setting (either independent living environment or retirement home).
  • Meet diagnostic criteria for major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) criteria.
  • Have a Hamilton Depression Rating Scale (HAMD) 17-item total score of >= 8 and < 24 at baseline.
  • Have a Mini Mental Status Exam score of >= 20.
  • Have adequate hearing and vision to be able to participate in Problem Solving Therapy.

Exclusion Criteria:

  • Have suicidal ideation requiring inpatient admission to hospital for stabilization.
  • Have an unstable medical condition requiring hospital admission.
  • Have a life expectancy of less than 6 months or are currently receiving palliative care.
  • Have psychotic symptoms.
  • Have a lifetime history of bipolar disorder or schizophrenia.
  • Are currently alcohol dependent or have another substance dependence.
  • Are diagnosed with moderate to severe dementia.
  • Are planning admission to a long-term care facility within next 6 months.

Sites / Locations

  • London Health Sciences Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Problem Solving Therapy

Arm Description

Study participation will involve 9 study visits over a total of 12 weeks. This includes 5 sessions of Case Manager implemented PST over a period of 8 weeks (week 1, 3, 5, 7, and 9) and 4 assessment visits (baseline, week 4, week 8, and week 12).

Outcomes

Primary Outcome Measures

Change in depression symptoms
Depression in study participants will be self rated on the Patient Health Questionnaire (PHQ-9)

Secondary Outcome Measures

Change in Quality of Life
Participants will complete a Short Form-12 to assess the change in their quality of life.
Change in Depression Symptoms- Clinician Rated
Hamilton scale for Depression-17 item (HAM-D 17), as rated by a clinician trained to complete this scale
Change in Depression Symptoms- Overall improvement
Clinical Global Impression- CGI, as rated by a clinician trained to complete this scale

Full Information

First Posted
July 19, 2015
Last Updated
March 7, 2018
Sponsor
Lawson Health Research Institute
Collaborators
University of Western Ontario, Canada, Queen's University
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1. Study Identification

Unique Protocol Identification Number
NCT02505178
Brief Title
Examining the Feasibility and Effectiveness of Case Manager Delivered Problem Solving Therapy on Late Life Depression
Official Title
Examining the Feasibility and Effectiveness of Case Manager Delivered Problem Solving Therapy on Late Life Depression; an Open-label Prospective Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Substantial changes were made to the study protocol and a new ethics application will be submitted.
Study Start Date
August 2015 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute
Collaborators
University of Western Ontario, Canada, Queen's University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study seeks to determine the feasibility and efficacy of a Problem Solving Therapy intervention for the treatment of late life depression (LLD). Participants diagnosed with LLD will participate in six sessions of Problem Solving Therapy, a form of talk-therapy, over a period of eight weeks. A Case Manager (CM) will lead the PST. The primary outcome measure is depression severity and will be measured throughout the study at weeks 0, 4, and 8. the secondary outcome measure is quality of life and will be measured at week 0 (pre-intervention) and week 12.
Detailed Description
In the elderly (i.e. individuals 60 years of age or older) major depressive disorder (MDD) is common occurring in 2-3% of the population and known as late life depression (LLD). LLD is both disabling and associated with a high mortality rate. Response to treatment of LLD using at least one antidepressant trial of adequate dose and duration is around 30-40%. Due to these suboptimal response rates, additional interventions should be tested and implemented to further alleviate the symptoms and severity of LLD. It is common for individuals referred to geriatric psychiatry programs to live alone and have impaired independent mobility, which makes them more susceptible to depression as they are at a higher risk for social isolation. Best practice guidelines recommend using psychosocial therapies, which are effective in reducing symptoms of LLD, as the standard treatment for mild to moderate depression, either alone or in combination with medications. PST can be delivered to patients close to their homes making it ideal for treating seniors with limited mobility. The elderly are more likely to suffer from co-morbid conditions and be treated with multiple medications. Antidepressants are associated with serious adverse events, making psychosocial treatments especially important to the elderly who take more medications and are more likely to suffer comorbid conditions. Problem-solving therapy (PST) is an established psychosocial therapy shown to be effective in treating depression and other mental disorders in adults of all ages. PST involves seven stages of problem resolution including a)identifying and clarifying the problem b)setting clear achievable goals c) brain-storming to generate solutions d) selecting a preferred solution and f) evaluation. Studies of PST in older adults have shown the treatment to be effective in reducing depression. PST has been successfully adapted to meet the needs of seniors with comorbid conditions and those with early dementia or cognitive impairment. Despite the importance of psychotherapy interventions for older adults with MDD there is limited access to these treatments for seniors. At present, nurse case managers and social work case managers (CM) do not receive formal training in problem solving therapy. Since they often provide treatment for geriatric mental health outpatients, this limits access to treatments like PST. However, if CM's have formal training in PST, this treatment option can be made available to seniors that could benefit from such programs. To the best of the investigators' knowledge no study has evaluated the effects of CM trained to deliver PST for individuals with LLD in Canada, as such, this is the aim of the current investigation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Depressive Disorder, Depressive Disorder, Major, Mental Disorders, Mood Disorders, Behavioural Symptoms, Problem Solving Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Problem Solving Therapy
Arm Type
Experimental
Arm Description
Study participation will involve 9 study visits over a total of 12 weeks. This includes 5 sessions of Case Manager implemented PST over a period of 8 weeks (week 1, 3, 5, 7, and 9) and 4 assessment visits (baseline, week 4, week 8, and week 12).
Intervention Type
Other
Intervention Name(s)
Problem Solving Therapy
Intervention Description
PST is a minimally invasive treatment. The five sessions of CM implemented PST will involve psychotherapy also known as talk therapy between the CM's and study participants in a group setting. Psychogeriatric interdisciplinary staff (CM's) i.e. psychiatric nurses, social workers who have been previously trained in PST will function in the roles of facilitator, cofacilitator and scribe. The roles can be shared amongst the professionals to build capacity in each role or maintained over time if so desired. Sessions will be approximately one-and-a-half to two hours in length and conducted at the Cherry Hill Mall library in London.
Primary Outcome Measure Information:
Title
Change in depression symptoms
Description
Depression in study participants will be self rated on the Patient Health Questionnaire (PHQ-9)
Time Frame
Baseline, week 4, and week 8
Secondary Outcome Measure Information:
Title
Change in Quality of Life
Description
Participants will complete a Short Form-12 to assess the change in their quality of life.
Time Frame
Baseline and week 12
Title
Change in Depression Symptoms- Clinician Rated
Description
Hamilton scale for Depression-17 item (HAM-D 17), as rated by a clinician trained to complete this scale
Time Frame
Baseline, Week 4 and Week 8
Title
Change in Depression Symptoms- Overall improvement
Description
Clinical Global Impression- CGI, as rated by a clinician trained to complete this scale
Time Frame
Baseline, Week 4 and Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Are of either gender and greater than 60 years of age. Reside in a community setting (either independent living environment or retirement home). Meet diagnostic criteria for major depressive disorder (MDD) according to the Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) criteria. Have a Hamilton Depression Rating Scale (HAMD) 17-item total score of >= 8 and < 24 at baseline. Have a Mini Mental Status Exam score of >= 20. Have adequate hearing and vision to be able to participate in Problem Solving Therapy. Exclusion Criteria: Have suicidal ideation requiring inpatient admission to hospital for stabilization. Have an unstable medical condition requiring hospital admission. Have a life expectancy of less than 6 months or are currently receiving palliative care. Have psychotic symptoms. Have a lifetime history of bipolar disorder or schizophrenia. Are currently alcohol dependent or have another substance dependence. Are diagnosed with moderate to severe dementia. Are planning admission to a long-term care facility within next 6 months.
Facility Information:
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada

12. IPD Sharing Statement

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Examining the Feasibility and Effectiveness of Case Manager Delivered Problem Solving Therapy on Late Life Depression

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