Depression in Old AgeNCT05739370
Internet Delivered Psychotherapy for Older Adults
A study testing Problem-Solving Therapy for Older Adults in people with Depression in Old Age and Depression, Anxiety, run by University of Calgary at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression in Old Age, Depression, Anxiety
- What is being tested?
- Problem-Solving Therapy for Older Adults
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2023to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- Individuals with acute safety concerns (e.g.suicidal ideation), psychotic symptoms, moderate cognitive impairment (Montreal Cognitive Assessment(MoCA) < 21) or currently receiving psychotherapy
Trial locations and contacts
1 site in 1 country.
Lynn Tan, BSc contact
Canada1 site, 1 recruiting
- Recruiting
Department of Psychiatry, Cumming School of Medicine, University of Calgary
Calgary, Alberta, T2N 4N1
Lynn Tan, BSc, geripst@ucalgary.ca
Julia Kirkham, MD
About this study
Official title: Internet Delivered Psychotherapy for Older Adults: Development and Evaluation of an Online Problem-Solving Therapy Program for Depression.
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:
Read more
- 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.
Read the 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.
- Conditions
- Depression in Old Age, Depression, Anxiety
- Being tested
- Problem-Solving Therapy for Older Adults
- Keywords
- Online Psychotherapy
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem-Solving Therapy for Older AdultsOther
Also called Ger-iPST
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Problem-Solving Therapy for Older Adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, mid-point (4-weeks) and after completing the program (8-weeks).
Secondary outcomes (5)
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
Measured: 8 weeks via OPTT.
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
Measured: 8 weeks via OPTT.
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
Measured: 8 weeks via OPTT.
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
Measured: 8 weeks via OPTT.
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Jan 2023
- Primary completion31 Dec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in Old AgeStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Hotchkiss Brain Institute, University of Calgary
- Responsible party
- Sponsor
- Investigators
- Julia Kirkham, MD, Principal investigator, University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739370
- Sponsor's protocol ID
- REB21-1012
- Status last verified
- Jan 2024
- First submitted
- 9 Jan 2023
- Last updated
- 9 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet Delivered Psychotherapy for Older Adults: Development and Evaluation of an Online Problem-Solving Therapy Program for Depression.
- ClinicalTrials.gov ID
- NCT05739370
- Acronym / sponsor ID
- REB21-1012
- Conditions
- Depression in Old Age, Depression, Anxiety
- Keywords
- Online Psychotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Hotchkiss Brain Institute, University of Calgary
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ger-iPST | Experimental | Other: Problem-Solving Therapy for Older AdultsProspective 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Individuals with acute safety concerns (e.g.suicidal ideation), psychotic symptoms, moderate cognitive impairment (Montreal Cognitive Assessment(MoCA) < 21) or currently receiving psychotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Problem-Solving Therapy for Older AdultsAlso: Ger-iPSTProblem-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. | Other | Ger-iPST |
Primary outcome
Measure the effectiveness for symptoms of depression in older adults.
Time frame: Baseline, mid-point (4-weeks) and after completing the program (8-weeks).
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.
5 secondary outcomes
Examine implementation outcomes - Anxiety symptoms.
Time frame: 8 weeks via OPTT.
Examine implementation outcomes - Disability Assessment.
Time frame: 8 weeks via OPTT.
Examine implementation outcomes - Quality of life.
Time frame: 8 weeks via OPTT.
Examine implementation outcomes - Usability.
Time frame: 8 weeks via OPTT.
Explore barriers and facilitators experienced with implementation.
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynn Tan, BSc contact
Julia Kirkham, MD principal investigator
University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem-Solving Therapy for Older Adults in people with Depression in Old Age and Depression, Anxiety, run by University of Calgary at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Julia Kirkham, MD (403 955 6155, geripst@ucalgary.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the effectiveness for symptoms of depression in older adults. (time frame: Baseline, mid-point (4-weeks) and after completing the program (8-weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2024.