NCT05739370

Brief Summary

The goal of this mixed-methods, single-arm intervention study is to develop and evaluate a new internet-delivered psychotherapy option called Ger-iPST in older adults with symptoms of depression. The overall aim of this project is to improve access to psychotherapy for older adults by developing, adapting and implementing a new internet-based treatment option, Ger-iPST. Towards this aim, our objectives are to:

  1. 1.Examine the preliminary effectiveness of Ger-iPST for symptoms of depression.
  2. 2.Examine barriers and facilitators to the use of Ger-iPST.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

January 9, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

April 9, 2024

Status Verified

January 1, 2024

Enrollment Period

2 years

First QC Date

January 9, 2023

Last Update Submit

April 5, 2024

Conditions

Keywords

Online Psychotherapy

Outcome Measures

Primary Outcomes (1)

  • Measure the effectiveness for symptoms of depression in older adults.

    The outcome measures the change in depressive symptoms based on the PHQ-9 score,The 9-items on the PHQ-9 reflect DSM-V diagnostic criteria and are rated from 0 (''not at all") to 3 ("nearly every day") based on self-reported symptoms in the preceding 2-weeks. Scores \>5, 10, and 15 indicate mild, moderate, and severe depression symptoms, respectively. The PHQ-9 has been validated for use with older adults in primary care and those with chronic medical illnesses, is relatively brief, and is responsive to change.

    Baseline, mid-point (4-weeks) and after completing the program (8-weeks).

Secondary Outcomes (5)

  • Examine implementation outcomes - Anxiety symptoms.

    8 weeks via OPTT.

  • Examine implementation outcomes - Disability Assessment.

    8 weeks via OPTT.

  • Examine implementation outcomes - Quality of life.

    8 weeks via OPTT.

  • Examine implementation outcomes - Usability.

    8 weeks via OPTT.

  • Explore barriers and facilitators experienced with implementation.

    8 weeks

Study Arms (1)

Ger-iPST

EXPERIMENTAL

Prospective participants will be contacted by telephone to confirm eligibility, explain the study protocol, and obtain informed consent. An in-person or videoconference assessment will be used to administer baseline PHQ-9 to confirm enrolment criteria and will be asked questionnaire to gather demographic information. Participants will then be provided with an email link to access the Online Psycho Therapy Tool (OPTT). PHQ-9 will be collected again at the mid-point (4 weeks) and after completing the program through OPTT. Caregivers will be invited to assist the participant if required in completing Ger-iPST modules, and weekly telephone support calls by a research assistant will be provided to assist with any difficulty navigating technical aspects of the Ger-iPST platform.

Other: Problem-Solving Therapy for Older Adults

Interventions

Problem-Solving Therapy for Older Adults (Ger-iPST) is an 8-week online psychotherapy program with online therapist support delivered through the Online Psycho Therapy Tool (OPTT). Ger-iPST has several evidence-based elements tailored to the specific needs of older adults, including relevant content (e.g. aging-related examples); process adaptations (e.g. more repetition); and digital usability modifications (e.g. high-contrast text). Ger-iPST contains therapy modules assigned weekly and accessible at any time during the week. Modules begin with a brief, guided mindfulness relaxation exercise, followed by approximately 20 slides taking, on an average 1 hour to complete. Each module highlights a different step of Psychotherapy (PST) and includes an overview of a new skill, interactive activities and examples. A homework exercise designed to guide participants in applying a new PST skill exercise is submitted through the platform, and a clinician will provide personalized feedback.

Also known as: Ger-iPST
Ger-iPST

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • Individuals who are 65 years or older
  • Presenting with a primary complaint of depression and a Patient Health Questionnaire (PHQ)-9 score \> 5
  • English Speaking
  • Residents of Alberta
  • Have internet access

You may not qualify if:

  • Individuals with acute safety concerns (e.g.suicidal ideation), psychotic symptoms, moderate cognitive impairment (Montreal Cognitive Assessment(MoCA) \< 21) or currently receiving psychotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry, Cumming School of Medicine, University of Calgary

Calgary, Alberta, T2N 4N1, Canada

RECRUITING

MeSH Terms

Conditions

DepressionAnxiety Disorders

Interventions

Aging

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Intervention Hierarchy (Ancestors)

Growth and DevelopmentPhysiological Phenomena

Study Officials

  • Julia Kirkham, MD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julia Kirkham, MD

CONTACT

Lynn Tan, BSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 9, 2023

First Posted

February 22, 2023

Study Start

January 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 1, 2025

Last Updated

April 9, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations