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

Trial Summary

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 data supports the effectiveness of the treatment e-CBT for anxiety and depression in cancer patients?

Research shows that internet-based cognitive behavioral therapy (iCBT) can help reduce symptoms of anxiety and depression in cancer patients, making it a promising option for those who may face barriers to traditional face-to-face therapy. ^{1 2 3 4 5}

Is online cognitive behavioral therapy safe for cancer patients with anxiety and depression?

The research does not specifically mention safety concerns, suggesting that online cognitive behavioral therapy is generally considered safe for cancer patients with anxiety and depression. ^{1 3 6 7 8}

How is e-CBT different from other treatments for anxiety and depression in cancer patients?

e-CBT (Electronic Cognitive Behavioral Therapy) is unique because it is delivered online, making it accessible for cancer patients who may have difficulty attending in-person therapy sessions. This treatment is designed to be a low-threshold option, meaning it is easy to access and use, which can be particularly beneficial for those facing barriers like information deficits or fear of stigmatization. ^{2 3 7 8 9}

What is the purpose of this trial?

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.

Research Team

Nazanin Alavi

Principal Investigator

Queen's University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. England 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). [2020]

2. Netherlands 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. [2022]

3. Netherlands 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. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Promise unfulfilled: Implementing web-based psychological therapy in routine cancer care, a qualitative study of oncology health professionals' attitudes. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of internet-based cognitive behavioral therapy on anxiety and depression symptoms in cancer patients: A meta-analysis. [2022]

6. United States 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. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Internet-delivered mindfulness-based cognitive therapy for anxiety and depression in cancer survivors: A randomized controlled trial. [2021]

8. Germany 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. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Guided Imagery: Reducing Anxiety, Depression, and Selected Side Effects Associated With Chemotherapy. [2020]