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

NCT02505178 | Withdrawn

• 1 other identifier: 106856
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

Depression; Depressive Disorder; Depressive Disorder, Major; Mental Disorders; Mood Disorders; Behavioural Symptoms; Problem Solving Therapy

Outcome Measures

Primary Outcomes (1)

• Change in depression symptoms

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

  Baseline, week 4, and week 8

Secondary Outcomes (3)

• Change in Quality of Life

  Baseline and week 12

• Change in Depression Symptoms- Clinician Rated

  Baseline, Week 4 and Week 8

• Change in Depression Symptoms- Overall improvement

  Baseline, Week 4 and Week 8

Study Arms (1)

Problem Solving Therapy

EXPERIMENTAL

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).

Other: Problem Solving Therapy

Interventions

Problem Solving Therapy OTHER

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.

Problem Solving Therapy

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• University of Western Ontario, Canada: collaborator
• Queen's University: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

MeSH Terms

Conditions

Depression; Depressive Disorder; Depressive Disorder, Major; Mental Disorders; Mood Disorders; Behavioral Symptoms

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Akshya Vasudev MD, MRCPsych

Study Record Dates

• First Submitted: July 19, 2015
• First Posted: July 22, 2015
• Study Start: August 1, 2015
• Primary Completion: October 1, 2018
• Study Completion: October 1, 2019
• Last Updated: March 9, 2018

Record last verified: 2018-03

Locations

CA (1)