Internet Delivered Psychotherapy for Older Adults

NCT ID: NCT05739370

Last Updated: 2024-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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. Examine the preliminary effectiveness of Ger-iPST for symptoms of depression.
2. 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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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:

1. Develop the Ger-iPST intervention.
2. 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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression in Old Age Depression, Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ger-iPST

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.

Group Type EXPERIMENTAL

Problem-Solving Therapy for Older Adults

Intervention Type OTHER

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Problem-Solving Therapy for Older Adults

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.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Ger-iPST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
* Residents of Alberta
* 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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hotchkiss Brain Institute, University of Calgary

OTHER

Sponsor Role collaborator

University of Calgary

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Julia Kirkham, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Calgary, Alberta, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Julia Kirkham, MD

Role: CONTACT

403 955 6155

Lynn Tan, BSc

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lynn Tan, BSc

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

REB21-1012

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.