Mental Health IssueNCT04664270
Developing and Implementing E-psychotherapy Program for Mental Health Challenges in Oncology and Palliative Care
A study testing e-CBT in people with Mental Health Issue and Depression, run by Dr. Nazanin Alavi at 1 site in Canada.
Trial summary
The demand for mental health problems, particularly depression and anxiety, is three times greater in Oncology and Palliative Care Centres than in the general population. There are unique factors in this population that make them more susceptible to mental health challenges. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Mental Health Issue, Depression, Anxiety
- What is being tested?
- e-CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2021to Sep 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed with depressive or anxiety disorder due to another medical condition in the context of cancer or palliative care
- competence to consent and participate
- speak and read English
- consistent and reliable access to the internet
Who cannot join
- acute hypomanic/manic episodes
- acute psychosis
- severe alcohol or substance use disorder
- active suicidal or homicidal ideation
- received CBT in the past year or are currently receiving CBT
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hotel Dieu Hospital
Kingston, Ontario, K7L 5G3
Nazanin Alavi, 6479672079, nazanin.alavitabari@kingstonhsc.ca
Nazanin Alavi, MD FRCPC
About this study
Official title: Developing and Implementing an Online Psychotherapy Program to Address Mental Health Challenges in Oncology and Palliative Care
The demand for mental health problems, particularly depression and anxiety, is three times greater in Oncology and Palliative Care Centres than in the general population. There are unique factors in this population that make them more susceptible to mental health challenges. The disease itself, the adjustment to a chronic/fatal diagnosis, and the treatment options can all perpetuate the development of mental illness. Despite the well-established association, there have been barriers to access suitable treatment for these patients.
Online Psychotherapy is an effective treatment option that may address many of these barriers. This modality has been proven effective in addressing depression and anxiety in other populations. To date, there has been no psychotherapy module developed specifically for oncology and palliative care patients to our knowledge. The aim is to establish the first academic e-psychotherapy treatment option to address mood and anxiety disorders in oncology and palliative care patients. The investigators will use the Online Psychotherapy Tool (OPTT), a secure cloud-based platform for online delivery of e-CBT, developed by the PI.
The proposed study aims to establish the feasibility and effectiveness of delivering online psychotherapy to oncology and palliative care patients who have a comorbid depressive or anxiety disorder. The patients will be enrolled in an 8-week program with a combination of cognitive behavioural therapy (CBT) and Mindfulness techniques delivered via a series of modules. They will receive individualized feedback from a trained therapist weekly. It is hypothesized that delivering this psychotherapeutic intervention in this manner will have great adherence. The aim is to prove that it will improve the quality of life and decrease symptoms of depression and anxiety in this underserved patient population.
Read the detailed description
Sixty patients (n=60) diagnosed with depressive or anxiety disorder due to another medical condition in the context of cancer or palliative care, will be recruited to the study through referrals from health care professionals at Kingston Health Sciences Centre (KHSC) including cancer centre, Providence Care Hospital (PCH), family physicians, and other health care providers or self-referrals. After consenting to take part in the study, a complete assessment will be done by one of the psychiatrists on the team to confirm the diagnosis. Inclusion criteria include 18-55 years of age at the start of the study, diagnosed with depression or anxiety secondary to a general medical condition (in the context of cancer or palliative condition) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) by one of the psychiatrists on the team, competence to consent and participate, ability to speak and read English, and consistent and reliable access to the internet. Exclusion criteria include acute hypomanic/manic episodes, acute psychosis, severe alcohol or substance use disorder, and active suicidal or homicidal ideation or if they have received CBT in the past year or are currently receiving CBT. Participants will then be randomly assigned to two groups: e-psychotherapy group (online CBT+ mindfulness + problem solving) or treatment as usual (TAU, i.e., medication, psychiatric consultation and referrals to in-person activities/groups) arms of the study (n=30 for each group). The TAU arm acts as the control group of the study.
Upon completion of the initial assessment, if eligible for the study, participants will randomly be assigned to one of the two arms of the study. Patients in the e-CBT group will receive an 8-week online program including CBT in combination with mindfulness and problem-based therapy in addition to treatment as usual. The content of this program will be customized to reflect challenges cancer and palliative patients face through the course of their treatment and developed into interactive and engaging therapy modules. All online sessions and interactions will occur through a secure online platform (i.e. OPTT). Through the platform, the pre-designed therapy modules are assigned to the patients, accessible to them at any time throughout the week. Each module consists of approximately 30 slides, which take an average of 45-50 minutes to complete. Each weekly module highlights a different topic and includes general information, an overview of skills, and homework that is to be completed within that week. This homework can be directly submitted through the platform to the clinician who will then provide personalized feed-back to the patient. The average time spent per week by a clinician with a particular patient is about 15 minutes. The control group will receive treatment as usual in the first 8 weeks; if still significantly symptomatic (less than 50% response to treatment from baseline), they will then be offered the 8-week e-psychotherapy program.
- Conditions
- Mental Health Issue, Depression, Anxiety, Palliative Care, Oncology
- Being tested
- e-CBT
- Keywords
- Mental Health, Virtual Care, Depression, Anxiety, Palliative Care, Psychotherapy
- Medical subject headings
- Depression, Anxiety Disorders, Neoplasms, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-CBTBehavioural
e-CBT + Mindfulness + Problem Solving
| Study group | Role | What they receive |
|---|---|---|
| e-Psychotherapy | Experimental | Group will receive 8-week online program including CBT in combination with mindfulness and problem-based therapy in addition to treatment as usual. The content will reflect challenges cancer and palliative patients face through the course of treatment and developed into interactive and engaging therapy modules. All online sessions and interactions will occur through a secure online platform. Pre-designed therapy modules are assigned to the patients, accessible to them at any time throughout the week. Each module consists of approximately 30 slides, which take 45-50 minutes to complete. Each module highlights a different topic and includes general information, an overview of skills, and homework that is to be completed within that week. This homework can be directly submitted through the platform to the clinician who will then provide personalized feed-back to the patient. The average time spent per week by a clinician with a particular patient is about 15 minutes. Receives: Behavioral: e-CBT |
| Treatment as Usual | No intervention | The control group will receive treatment as usual in the first 8 weeks; if still significantly symptomatic (less than 50% response to treatment from baseline), they will then be offered the 8-week e-psychotherapy program. They will be instructed to continue with any lifestyle activities (i.e., diet, exercise, medication, etc.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptoms (Functional Assessment of Cancer Therapy General - FACT-G)
Clinically validated symptom questionnaire. Scale of 0-4, 4 is worse.
Measured: Baseline, week 4, week 8
Change in symptoms (Patient Health Questionnaire - PHQ-9 Item)
Clinically validated symptom questionnaire. Scale of 0-3, 3 is worse.
Measured: Baseline, week 4, week 8
Change in symptoms (Generalized Anxiety Disorder - GAD7 Item)
Clinically validated symptom questionnaire. Scale of 0-3, 3 is worse.
Measured: Baseline, week 4, week 8
Change in symptoms (Quality of Life and Satisfaction Questionnaire - Q-LES-Q)
Clinically validated symptom questionnaire. Scale of 0-5, 5 is better.
Measured: Baseline, week 4, week 8
Secondary outcomes (2)
Changes in frequency on online platform
Logins per day
Measured: Week 8
Changes in duration on online platform
Amount of time spent on each session
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Mar 2021
- Primary completionDec 2024 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomly allocated to either treatment or control
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Nazanin Alavi
- Sponsor type
- University, hospital or other
- Collaborators
- Online PsychoTherapy Clinic
- Responsible party
- Sponsor-investigator, Dr. Nazanin Alavi, Queen's University
- Investigators
- Nazanin Alavi, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664270
- Sponsor's protocol ID
- PSIY-699-20
- Status last verified
- Apr 2024
- First submitted
- 5 Dec 2020
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Alavi N, Stephenson C, Miller S, Khalafi P, Sinan I, Kain D, McDougall M, Davies J, Stark D, Tompkins E, Jagayat J, Omrani M, Shirazi A, Groll D, Soares C. Developing and Implementing a Web-Based Psychotherapy Program to Address Mental Health Challenges Among Patients Receiving Oncologic and Palliative Care: Protocol for an Open-Label Randomized Controlled Trial. JMIR Res Protoc. 2021 Jul 14;10(7):e30735. doi: 10.2196/30735.
PubMed 34259164
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing and Implementing an Online Psychotherapy Program to Address Mental Health Challenges in Oncology and Palliative Care
- ClinicalTrials.gov ID
- NCT04664270
- Acronym / sponsor ID
- PSIY-699-20
- Conditions
- Mental Health Issue, Depression, Anxiety, Palliative Care, Oncology
- Keywords
- Mental Health, Virtual Care, Depression, Anxiety, Palliative Care, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Dr. Nazanin AlaviUniversity, hospital or other
- Collaborators
- Online PsychoTherapy Clinic
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 11 Dec 2020 (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 demand for mental health problems, particularly depression and anxiety, is three times greater in Oncology and Palliative Care Centres than in the general population. There are unique factors in this population that make them more susceptible to mental health challenges. The disease itself, the adjustment to a chronic/fatal diagnosis, and the treatment options can all perpetuate the development of mental illness. Despite the well-established association, there have been barriers to access suitable treatment for these patients.
Online Psychotherapy is an effective treatment option that may address many of these barriers. This modality has been proven effective in addressing depression and anxiety in other populations. To date, there has been no psychotherapy module developed specifically for oncology and palliative care patients to our knowledge. The aim is to establish the first academic e-psychotherapy treatment option to address mood and anxiety disorders in oncology and palliative care patients. The investigators will use the Online Psychotherapy Tool (OPTT), a secure cloud-based platform for online delivery of e-CBT, developed by the PI.
The proposed study aims to establish the feasibility and effectiveness of delivering online psychotherapy to oncology and palliative care patients who have a comorbid depressive or anxiety disorder. The patients will be enrolled in an 8-week program with a combination of cognitive behavioural therapy (CBT) and Mindfulness techniques delivered via a series of modules. They will receive individualized feedback from a trained therapist weekly. It is hypothesized that delivering this psychotherapeutic intervention in this manner will have great adherence. The aim is to prove that it will improve the quality of life and decrease symptoms of depression and anxiety in this underserved patient population.
Detailed description
Sixty patients (n=60) diagnosed with depressive or anxiety disorder due to another medical condition in the context of cancer or palliative care, will be recruited to the study through referrals from health care professionals at Kingston Health Sciences Centre (KHSC) including cancer centre, Providence Care Hospital (PCH), family physicians, and other health care providers or self-referrals. After consenting to take part in the study, a complete assessment will be done by one of the psychiatrists on the team to confirm the diagnosis. Inclusion criteria include 18-55 years of age at the start of the study, diagnosed with depression or anxiety secondary to a general medical condition (in the context of cancer or palliative condition) according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) by one of the psychiatrists on the team, competence to consent and participate, ability to speak and read English, and consistent and reliable access to the internet. Exclusion criteria include acute hypomanic/manic episodes, acute psychosis, severe alcohol or substance use disorder, and active suicidal or homicidal ideation or if they have received CBT in the past year or are currently receiving CBT. Participants will then be randomly assigned to two groups: e-psychotherapy group (online CBT+ mindfulness + problem solving) or treatment as usual (TAU, i.e., medication, psychiatric consultation and referrals to in-person activities/groups) arms of the study (n=30 for each group). The TAU arm acts as the control group of the study.
Upon completion of the initial assessment, if eligible for the study, participants will randomly be assigned to one of the two arms of the study. Patients in the e-CBT group will receive an 8-week online program including CBT in combination with mindfulness and problem-based therapy in addition to treatment as usual. The content of this program will be customized to reflect challenges cancer and palliative patients face through the course of their treatment and developed into interactive and engaging therapy modules. All online sessions and interactions will occur through a secure online platform (i.e. OPTT). Through the platform, the pre-designed therapy modules are assigned to the patients, accessible to them at any time throughout the week. Each module consists of approximately 30 slides, which take an average of 45-50 minutes to complete. Each weekly module highlights a different topic and includes general information, an overview of skills, and homework that is to be completed within that week. This homework can be directly submitted through the platform to the clinician who will then provide personalized feed-back to the patient. The average time spent per week by a clinician with a particular patient is about 15 minutes. The control group will receive treatment as usual in the first 8 weeks; if still significantly symptomatic (less than 50% response to treatment from baseline), they will then be offered the 8-week e-psychotherapy program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomly allocated to either treatment or control
| Arm | Type | Receives |
|---|---|---|
| e-Psychotherapy | Experimental | Behavioral: e-CBTGroup will receive 8-week online program including CBT in combination with mindfulness and problem-based therapy in addition to treatment as usual. The content will reflect challenges cancer and palliative patients face through the course of treatment and developed into interactive and engaging therapy modules. All online sessions and interactions will occur through a secure online platform. Pre-designed therapy modules are assigned to the patients, accessible to them at any time throughout the week. Each module consists of approximately 30 slides, which take 45-50 minutes to complete. Each module highlights a different topic and includes general information, an overview of skills, and homework that is to be completed within that week. This homework can be directly submitted through the platform to the clinician who will then provide personalized feed-back to the patient. The average time spent per week by a clinician with a particular patient is about 15 minutes. |
| Treatment as Usual | No intervention | –The control group will receive treatment as usual in the first 8 weeks; if still significantly symptomatic (less than 50% response to treatment from baseline), they will then be offered the 8-week e-psychotherapy program. They will be instructed to continue with any lifestyle activities (i.e., diet, exercise, medication, etc.) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed with depressive or anxiety disorder due to another medical condition in the context of cancer or palliative care
- competence to consent and participate
- speak and read English
- consistent and reliable access to the internet
Key exclusion criteria (5 listed)
- acute hypomanic/manic episodes
- acute psychosis
- severe alcohol or substance use disorder
- active suicidal or homicidal ideation
- received CBT in the past year or are currently receiving CBT
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 |
|---|---|---|
| e-CBTe-CBT + Mindfulness + Problem Solving | Behavioural | e-Psychotherapy |
Primary outcome
Change in symptoms (Functional Assessment of Cancer Therapy General - FACT-G)
Time frame: Baseline, week 4, week 8
Clinically validated symptom questionnaire. Scale of 0-4, 4 is worse.
Change in symptoms (Patient Health Questionnaire - PHQ-9 Item)
Time frame: Baseline, week 4, week 8
Clinically validated symptom questionnaire. Scale of 0-3, 3 is worse.
Change in symptoms (Generalized Anxiety Disorder - GAD7 Item)
Time frame: Baseline, week 4, week 8
Clinically validated symptom questionnaire. Scale of 0-3, 3 is worse.
Change in symptoms (Quality of Life and Satisfaction Questionnaire - Q-LES-Q)
Time frame: Baseline, week 4, week 8
Clinically validated symptom questionnaire. Scale of 0-5, 5 is better.
2 secondary outcomes
Changes in frequency on online platform
Time frame: Week 8
Changes in duration on online platform
Time frame: Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Derived from this study: PubMed 34259164Alavi N, Stephenson C, Miller S, Khalafi P, Sinan I, Kain D, McDougall M, Davies J, Stark D, Tompkins E, Jagayat J, Omrani M, Shirazi A, Groll D, Soares C. Developing and Implementing a Web-Based Psychotherapy Program to Address Mental Health Challenges Among Patients Receiving Oncologic and Palliative Care: Protocol for an Open-Label Randomized Controlled Trial. JMIR Res Protoc. 2021 Jul 14;10(7):e30735. doi: 10.2196/30735.
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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.
Nazanin Alavi principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-CBT in people with Mental Health Issue and Depression, run by Dr. Nazanin Alavi 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 4 inclusion and 5 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 10 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 Nazanin Alavi ((613) 544 4900 ext. 73002, nazanin.alavitabari@kingstonhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptoms (Functional Assessment of Cancer Therapy General - FACT-G) (time frame: Baseline, week 4, week 8). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04664270, which also lists 1 linked publication.
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 10 Apr 2024.