Online Psychotherapy for Anxiety and Depression in Cancer Patients

Overseen By Nazanin Alavi

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Dr. Nazanin Alavi

Disqualifiers: Acute mania, Psychosis, Substance use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an online therapy program designed to help cancer and palliative care patients manage depression or anxiety. The program, called e-CBT (Electronic Cognitive Behavioral Therapy), combines cognitive behavioral therapy (CBT) and mindfulness techniques, delivered through a secure online platform over eight weeks. It aims to improve mental health and quality of life for patients facing these challenges due to their medical conditions. This trial may suit individuals diagnosed with a depressive or anxiety disorder related to cancer or palliative care, who can read and speak English, and have reliable internet access. As an unphased trial, it offers a unique opportunity to access innovative therapy methods that could enhance mental well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on online psychotherapy, so it's best to discuss your medications with the trial coordinators or your doctor.

What prior data suggests that this online psychotherapy is safe for cancer patients?

Research has shown that online cognitive behavioral therapy (e-CBT) is generally easy to use. One study of a 9-week e-CBT program found that participants experienced significant improvements in anxiety and depression symptoms. This suggests the treatment is likely safe, as it improved well-being without major issues.

Another study examined cancer patients using a digital stress management app and found it very helpful. This is significant because it demonstrates that similar digital therapies can be safe and effective for individuals with serious health conditions, such as cancer.

These findings suggest that e-CBT, when used on a secure online platform, can be a safe option for those dealing with anxiety and depression. However, consulting a healthcare professional before starting any new treatment is always important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional face-to-face therapy for anxiety and depression in cancer patients, e-CBT is delivered entirely online, making it accessible to those who might have difficulty attending in-person sessions due to health or mobility issues. This treatment combines cognitive-behavioral therapy with mindfulness and problem-based therapy, offering a comprehensive approach tailored to the unique challenges faced by cancer patients. Additionally, it provides flexibility, allowing patients to engage with therapy modules at their own pace and receive personalized feedback from clinicians through a secure platform. Researchers are particularly excited about its potential to improve mental health care access and provide consistent support throughout the cancer treatment journey.

What evidence suggests that this online psychotherapy is effective for anxiety and depression in cancer patients?

Research has shown that online cognitive behavioral therapy (e-CBT), which participants in this trial may receive, can help reduce anxiety and depression in cancer patients. One study found that e-CBT significantly eases these symptoms, especially with therapist guidance. Another study discovered that e-CBT helps manage stress and improves the quality of life for cancer patients. These findings suggest that online therapy can be a useful tool for those dealing with anxiety and depression related to cancer. This method combines therapy with easy online access, potentially benefiting patients who have difficulty accessing traditional treatments. ^{2 6 7 8 9}

Who Is on the Research Team?

Nazanin Alavi

Principal Investigator

Queen's University

Are You a Good Fit for This Trial?

This trial is for cancer or palliative care patients who can consent, have reliable internet access, and speak English. They must be diagnosed with depression or anxiety linked to their medical condition but haven't had CBT in the last year nor are currently receiving it.

Inclusion Criteria

Competence to consent and participate

You need to have a good and dependable internet connection.

Speak and read English

Exclusion Criteria

You are currently experiencing intense episodes of high energy and excitement.

You are currently experiencing sudden and severe mental illness, such as hallucinations or delusions.

You have a serious problem with drug or alcohol addiction.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week online psychotherapy program including CBT, mindfulness, and problem-solving therapy

8 weeks

Weekly online sessions

Follow-up

Participants are monitored for changes in symptoms and quality of life after treatment

4 weeks

Assessments at baseline, week 4, and week 8

What Are the Treatments Tested in This Trial?

Interventions

• e-CBT

Trial Overview The study tests an online psychotherapy program (e-CBT) using a secure platform called OPTT. It's designed specifically for oncology and palliative care patients to help improve their mental health over an 8-week course with personalized therapist feedback.

How Is the Trial Designed?

Group I: e-Psychotherapy Experimental Treatment 1 Intervention

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.

Group II: Treatment as Usual Active Control 1 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.)

e-CBT is already approved in European Union, United States, Canada for the following indications:

Approved in European Union as e-CBT for:

• Depression
• Anxiety disorders
• Phobias
• PTSD
• Sleep disorders
• Eating disorders

Approved in United States as e-CBT for:

• Depression
• Anxiety disorders
• Phobias
• PTSD
• Sleep disorders
• Eating disorders

Approved in Canada as e-CBT for:

• Depression
• Anxiety disorders
• Phobias
• PTSD
• Sleep disorders
• Eating disorders

Who Is Running the Clinical Trial?

Dr. Nazanin Alavi

Lead Sponsor

Trials

14

Recruited

1,100+

Queen's University

Lead Sponsor

Trials

382

Recruited

122,000+

Dr. Nazanin Alavi

Lead Sponsor

Trials

14

Recruited

1,100+

Online PsychoTherapy Clinic

Collaborator

Trials

9

Recruited

710+

Published Research Related to This Trial

An eight-lesson internet-delivered CBT program for anxiety and depression in early-stage cancer patients received high acceptability from participants, indicating it is user-friendly and engaging.

Participants supported the idea of combining resources for anxiety and depression, but suggested that a separate course should be developed for those with advanced-stage cancer, highlighting the need for tailored interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of an internet cognitive behavioural therapy program for people with early-stage cancer and cancer survivors with depression and/or anxiety: thematic findings from focus groups. Karageorge, A., Murphy, MJ., Newby, JM., et al.[2018]

In a study of 114 cancer survivors, internet-delivered cognitive behavioral therapy (iCBT) significantly reduced symptoms of anxiety and depression compared to treatment-as-usual, with a large effect size (Hedges g = 1.51).

Participants in the iCBT group also experienced lower general distress, reduced fear of cancer recurrence, and improved quality of life, indicating that this therapy is an effective and efficient option for managing mental health in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomised controlled trial of internet-delivered cognitive behaviour therapy for clinical depression and/or anxiety in cancer survivors (iCanADAPT Early). Murphy, MJ., Newby, JM., Butow, P., et al.[2020]

A study involving 27 participants with advanced cancer showed that a six-lesson internet-delivered cognitive behavioral therapy (iCBT) was feasible and acceptable, with high treatment satisfaction reported by most participants.

Participants who completed the iCBT experienced significant reductions in anxiety and depression symptoms, suggesting that this online therapy could be an effective support for individuals facing mental health challenges due to advanced cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mixed methods pilot and feasibility open trial of internet-delivered cognitive behaviour therapy (iCanADAPT Advanced) for people with advanced cancer with depression and/or anxiety. Murphy, MJ., Newby, JM., Butow, P., et al.[2023]

Internet-based cognitive behavioral therapy (ICBT) significantly improves psychological distress, anxiety, and depression in cancer patients, with effects lasting even after the intervention, based on a meta-analysis of 3,249 participants from 20 studies.

Therapist-guided ICBT is more effective than self-guided ICBT for managing psychological distress and enhancing quality of life, making it the preferred option for cancer patients seeking psychological support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of Internet-Based Cognitive Behavioral Therapy for Patients With Cancer: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Yu, S., Liu, Y., Cao, M., et al.[2023]

The study will evaluate the effectiveness of the online self-help program epos in reducing anxiety and depression symptoms among 325 German-speaking cancer patients transitioning from inpatient to outpatient care.

If successful, epos could provide a valuable, accessible adjunct to traditional face-to-face psycho-oncological support, particularly for patients facing barriers to in-person interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An emotion-based online intervention for reducing anxiety and depression in cancer patients: Study protocol for a randomized controlled trial. Tsiouris, A., Mayer, A., Nölke, C., et al.[2022]

The therapist-assisted internet-delivered mindfulness-based cognitive therapy (iMBCT) program significantly reduced anxiety symptoms in cancer survivors, with a moderate effect size (Cohen's d = 0.45) observed immediately after the intervention.

While iMBCT also showed a reduction in depressive symptoms (Cohen's d = 0.42), these effects were not maintained at the 6-month follow-up, indicating that further research is needed to assess its long-term efficacy for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-delivered mindfulness-based cognitive therapy for anxiety and depression in cancer survivors: A randomized controlled trial. Nissen, ER., O'Connor, M., Kaldo, V., et al.[2021]

Internet-based cognitive behavioral therapy (ICBT) significantly reduces anxiety and depression symptoms in cancer patients, with a meta-analysis of 13 studies involving over 4,200 participants showing effective results, particularly for those undergoing anti-cancer treatment.

Therapist-guided ICBT is more effective than self-directed ICBT, and programs lasting 12 weeks or less are beneficial, while those with fewer than 5 modules may not be effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of internet-based cognitive behavioral therapy on anxiety and depression symptoms in cancer patients: A meta-analysis. Liu, T., Xu, J., Cheng, H., et al.[2022]

Health professionals believe that integrating web-based mental health interventions (e-MhIs) into standard cancer care can improve patient outcomes, but they emphasize the need for trust in the intervention's content and process.

Most participants preferred a fully integrated model of care that includes local health professional involvement in designing tailored therapies with e-MhI components, although they acknowledged that resource limitations may hinder this ideal approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promise unfulfilled: Implementing web-based psychological therapy in routine cancer care, a qualitative study of oncology health professionals' attitudes. Davies, F., Harris, M., Shepherd, HL., et al.[2022]

Guided imagery, used for 20 minutes daily over one week, significantly reduced anxiety and depression in cancer patients undergoing chemotherapy compared to a control group.

Patients who practiced guided imagery also reported improvements in side effects related to chemotherapy, particularly in pain, insomnia, appetite, and nausea.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided Imagery: Reducing Anxiety, Depression, and Selected Side Effects Associated With Chemotherapy. Mahdizadeh, MJ., Tirgari, B., Abadi, OSRR., et al.[2020]

Citations

1. ascopubs.org ascopubs.org/doi/10.1200/OP.23.00210

Effects of a Cognitive Behavioral Digital Therapeutic on ... Results from a clinical trial of a new cognitive behavioral stress management (CBSM) app show a significant benefit for patients with cancer ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37552227/

Effectiveness of Internet-Based Cognitive Behavioral ... Internet-based cognitive behavioral therapy effectively improves psychological distress, anxiety, and depression in patients with cancer after intervention and ...

3. mental.jmir.org mental.jmir.org/2023/1/e51102

Efficacy of an Electronic Cognitive Behavioral Therapy ... The objective of the study was to investigate the efficacy of online psychotherapy tailored to depression and anxiety symptoms during the pandemic.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36375342/

Effects of internet-based cognitive behavioral therapy on ... ICBT lasting for ≤12 weeks, especially therapist-directed, helps relieve the anxiety and depressive symptoms of cancer patients.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0272735824001399

Do the effects of internet-delivered cognitive-behavioral ... The i-CBTs had small to large effects in reducing anxiety, depression, and PTSD. Long-term efficacy was weaker for insomnia, stronger for ER and QOL and ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12157961/

Internet-Based Cognitive Behavioral Therapy Interventions ... This study aimed to provide a scoping review of ICBT interventions for caregivers of patients with cancer, examining intervention content, outcome measures, ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10760511/

Efficacy of an Electronic Cognitive Behavioral Therapy ... The study demonstrated significant improvements in clinical symptoms of anxiety and depression after the use of a 9-week COVID-19–specific e-CBT program.

8. sciencedirect.com sciencedirect.com/science/article/pii/S0005789419300978

Cognitive-Behavioral Therapy in the Digital Age This paper discusses a number of technology-enabled solutions to our field's challenges, including Internet-based and smartphone-based cognitive-behavioral ...

9. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-025-06628-3

Effects of cognitive behavioral therapy on resilience among ... This study provided moderately strong evidence that CBT is a valuable tool for enhancing resilience among cancer patients.