CM Delivered PST in LLD Pilot

NCT03408821 | Completed Phase 1

• 1 other identifier: 4698
• Study Type: interventional
• Target: 29
• 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 8 weekly sessions of Problem Solving Therapy, a form of talk-therapy, over a period of eight weeks. A Case Manager (CM) trained in this therapy will lead the PST sessions. Participants will attend a clinical assessment pre and post study intervention to assess depression severity, quality of life, anxiety, insomnia, functional disability, and participant's acceptability of the intervention. Additionally self-rated depression will be collected weekly over 8 weeks.

Conditions

Late Life Depression

Outcome Measures

Primary Outcomes (1)

• Successful implementation of Problem Solving Therapy (PST).

  The primary outcome measure will be if CM delivered PST can be successfully implemented in the London Health Sciences Centre geriatric outreach program. If the recruitment goal of n=40 is met within 1 year, and 60% of participants complete the PST program, missing no more than 3 of the 8 weekly follow-ups, the primary objective will be considered to be met.

  10 weeks

Secondary Outcomes (6)

• Depression severity as measured by the Hamilton Depression Scale (HAM-D17)

  Week 0, week 9.

• Quality of life as measured by the EuroQol 5 Dimension 5 level (EQ-5D-5L).

  week 0, week 9.

• Anxiety severity as measured by the Generalized Anxiety Disorder 7-item (GAD-7) scale.

  week 0, week 9.

• Insomnia severity as measured by the Athens Insomnia Scale.

  week 0, week 9.

• Functional disability as measured by the World Health Organization Disability Assessment Schedule 2 (WHODAS-2).

  week 0, week 9.

Study Arms (1)

Problem Solving Therapy

EXPERIMENTAL

All participants will attend 8 weekly sessions of Case Manager delivered Problem Solving Therapy.

Other: Problem Solving Therapy (PST)

Interventions

Problem Solving Therapy (PST) OTHER

Participants will attend 8 weekly session of Case Manager (CM) implemented PST, a form of group talk therapy.

Problem Solving Therapy

Eligibility Criteria

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

You may qualify if:

• Participants will be considered eligible for the study if they:
• Are of either gender and 60 years of age or greater.
• 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 \>= 25.
• Have adequate hearing and vision to be able to participate in Problem Solving Therapy, with no significant sensory impairment
• Fluent in English both written and oral.

You may not qualify if:

• Participants will be considered ineligible for participating in the study if they:
• 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
• Bell Let's Talk Community Fund: collaborator

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5W9, Canada

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will attend 8 weekly sessions of Case Manager delivered Problem Solving Therapy.

Study Record Dates

• First Submitted: January 18, 2018
• First Posted: January 24, 2018
• Study Start: February 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: June 11, 2019

Record last verified: 2019-06

Locations

CA (1)