search
Back to results

Internet Delivered Psychotherapy for Older Adults

Primary Purpose

Depression in Old Age, Depression, Anxiety

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Problem-Solving Therapy for Older Adults
Sponsored by
University of Calgary
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression in Old Age focused on measuring Online Psychotherapy

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Have internet access Exclusion Criteria: Individuals with acute safety concerns (e.g.suicidal ideation), psychotic symptoms, moderate cognitive impairment (Montreal Cognitive Assessment(MoCA) < 21) or currently receiving psychotherapy

Sites / Locations

  • Department of Psychiatry, Cumming School of Medicine, University of CalgaryRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ger-iPST

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Examine implementation outcomes - Anxiety symptoms.
• Anxiety symptoms based on the Geriatric Anxiety Inventory (GAI), a 20-item scale developed specifically for measuring anxiety in older adults
Examine implementation outcomes - Disability Assessment.
• Disability using the 12-item World Health Organization Disability Assessment Schedule (WHODAS 2.0). The WHODAS measures disability (irrespective of underlying disease) within 6 functional domains: cognition, mobility, self-care, getting along, life activities and participation. Each item is rated on a scale of 0-4; higher scores indicate greater disability
Examine implementation outcomes - Quality of life.
• Quality of life using the 34-item Quality of Life in Depression Scale (QLDS). The scale has both positive and negative items; lower scores indicate higher quality of life
Examine implementation outcomes - Usability.
• Usability of Ger-iPST will be measured using the 10-item System Usability Scale (SUS) used often and validated in the assessment of the usability of technological interfaces. Items are rated from 0-6 based on the extent to an agreement with statements about ease of use of the software, such as "I felt very confident using the system." Scores are converted to a percentile ranking; higher scores indicate above average usability
Explore barriers and facilitators experienced with implementation.
The investigator will use a semi structured interview conducted by telephone or videoconferencing with participants in their own homes. The investigator is doing interviews not focus groups, to maintain the anonymity of participants in the Ger-iPST intervention. We will explore the user experience of Ger-iPST implementation, focusing on the acceptability and usability of the intervention and any barriers or facilitators of implementation. The analysis will be facilitated with NVIVO software.

Full Information

First Posted
January 9, 2023
Last Updated
February 21, 2023
Sponsor
University of Calgary
Collaborators
Hotchkiss Brain Institute, University of Calgary
search

1. Study Identification

Unique Protocol Identification Number
NCT05739370
Brief Title
Internet Delivered Psychotherapy for Older Adults
Official Title
Internet Delivered Psychotherapy for Older Adults: Development and Evaluation of an Online Problem-Solving Therapy Program for Depression.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Calgary
Collaborators
Hotchkiss Brain Institute, University of Calgary

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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: Examine the preliminary effectiveness of Ger-iPST for symptoms of depression. Examine barriers and facilitators to the use of Ger-iPST. Participants will be asked to complete 8 weekly online therapy modules (Ger-iPST) through the Online Psycho Therapy Tool (OPTT); each module takes 45-60 minutes, and an extra 20-30 on weekly homework. Caregivers will be invited to assist participants if required. Homework exercises are submitted through the platform, and a clinician trained in PST l will provide personalized, asynchronous online feedback. Participants will receive a weekly phone call from a research assistant to support any technical issues with completing the online modules. Following completion of the Ger-iPST modules, participants will be interviewed to provide feedback on acceptability and barriers and facilitators to the use of Ger-iPST.
Detailed Description
Background & Rationale: Many older adults in the community experience symptoms of depression, but few receive adequate treatment, which can include medications or psychotherapy (talk therapy). Problem-Solving Therapy (PST) is a very effective psychotherapy for depression, but psychotherapy such as PST is usually not available to older adults due to high cost, limited resources, and other barriers such as lack of transportation. Internet-delivered psychotherapy is a more accessible option that can be as effective as traditional face-to-face therapy. Research Question and Objectives: The overall aim of this project is to improve access to psychotherapy for older adults by developing, adapting and implementing a new evidence-based treatment option, Ger-iPST. Towards this aim, our objectives are to: Develop the Ger-iPST intervention. Examine the effectiveness and implementation of Ger-iPST: 2a. Measure the preliminary effectiveness of symptoms of depression in older adults; 2b. Explore barriers and facilitators to the use of Ger-iPST among participants and experiences with implementation. Methods: The investigator will implement and evaluate the effectiveness of Ger-iPST in Calgary, Alberta. Ger-iPST is an 8-week online psychotherapy program with online therapist support based on Problem Solving Therapy (PST), a proven and safe psychotherapy for depression in older adults. Ger-iPST will be tailored to the specific needs of older adults with relevant content (e.g. modules using aging-related examples); process adaptations (e.g. more repetition); and digital usability modifications. Participants will complete weekly online Ger-iPST modules, and the investigator will measure symptoms of depression before, during, and after completing the program. The investigator will also collect information on symptoms of anxiety, quality of life, and disability. The Ger-iPST intervention will be hosted on an existing, secure, cloud-based psychotherapy platform, Online PsychoTherapy Tool (OPTT). All quantitative data collection will occur using questionnaires on the platform. Following completion of the Ger-iPST modules, participants will be interviewed to provide feedback on acceptability and barriers and facilitators to the use of Ger-iPST. These results will be used to improve and adapt the resource to best suit the needs of older adults. Treating depression improves functioning, emotional well-being, and overall health among older adults. Many older adults prefer psychotherapy over (or in addition to) medication for the treatment of depression, and given that a growing number of older adults use the internet, internet-delivered therapy has the potential to greatly improve access to treatment for older adults with depression.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression in Old Age, Depression, Anxiety
Keywords
Online Psychotherapy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Ger-iPST
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Problem-Solving Therapy for Older Adults
Other Intervention Name(s)
Ger-iPST
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measure the effectiveness for symptoms of depression in older adults.
Description
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.
Time Frame
Baseline, mid-point (4-weeks) and after completing the program (8-weeks).
Secondary Outcome Measure Information:
Title
Examine implementation outcomes - Anxiety symptoms.
Description
• Anxiety symptoms based on the Geriatric Anxiety Inventory (GAI), a 20-item scale developed specifically for measuring anxiety in older adults
Time Frame
8 weeks via OPTT.
Title
Examine implementation outcomes - Disability Assessment.
Description
• Disability using the 12-item World Health Organization Disability Assessment Schedule (WHODAS 2.0). The WHODAS measures disability (irrespective of underlying disease) within 6 functional domains: cognition, mobility, self-care, getting along, life activities and participation. Each item is rated on a scale of 0-4; higher scores indicate greater disability
Time Frame
8 weeks via OPTT.
Title
Examine implementation outcomes - Quality of life.
Description
• Quality of life using the 34-item Quality of Life in Depression Scale (QLDS). The scale has both positive and negative items; lower scores indicate higher quality of life
Time Frame
8 weeks via OPTT.
Title
Examine implementation outcomes - Usability.
Description
• Usability of Ger-iPST will be measured using the 10-item System Usability Scale (SUS) used often and validated in the assessment of the usability of technological interfaces. Items are rated from 0-6 based on the extent to an agreement with statements about ease of use of the software, such as "I felt very confident using the system." Scores are converted to a percentile ranking; higher scores indicate above average usability
Time Frame
8 weeks via OPTT.
Title
Explore barriers and facilitators experienced with implementation.
Description
The investigator will use a semi structured interview conducted by telephone or videoconferencing with participants in their own homes. The investigator is doing interviews not focus groups, to maintain the anonymity of participants in the Ger-iPST intervention. We will explore the user experience of Ger-iPST implementation, focusing on the acceptability and usability of the intervention and any barriers or facilitators of implementation. The analysis will be facilitated with NVIVO software.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Have internet access Exclusion Criteria: Individuals with acute safety concerns (e.g.suicidal ideation), psychotic symptoms, moderate cognitive impairment (Montreal Cognitive Assessment(MoCA) < 21) or currently receiving psychotherapy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julia Kirkham, MD
Phone
403 955 6155
Email
geripst@ucalgary.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Pattara (Belle) Tavilsup, MSc
Email
geripst@ucalgary.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Kirkham, MD
Organizational Affiliation
University of Calgary
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry, Cumming School of Medicine, University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pattara (Belle) Tavilsup, MSc
Email
geripst@ucalgary.ca
First Name & Middle Initial & Last Name & Degree
Julia Kirkham, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Internet Delivered Psychotherapy for Older Adults

We'll reach out to this number within 24 hrs