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Behavioral Intervention

Online Psychotherapy for Anxiety and Depression in Cancer Patients

N/A

Recruiting

Led By Nazanin Alavi

Research Sponsored by Dr. Nazanin Alavi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 4, week 8

Awards & highlights

No Placebo-Only Group

Summary

This trialaims to evaluate the use of online psychotherapy to help oncology and palliative care patients with depression and anxiety, who often lack access to traditional treatments. It will test the feasibility and effectiveness of online CBT & Mindfulness techniques.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While e-CBT isn't a drug, participants may experience emotional discomfort, increased awareness of negative feelings, or distress as they confront difficult issues during therapy sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 4, week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 4, week 8

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 4, week 8 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in symptoms (Functional Assessment of Cancer Therapy General - FACT-G)

Anxiety Disorders

Change in symptoms (Patient Health Questionnaire - PHQ-9 Item)

+1 more

Secondary study objectives

Changes in duration on online platform

Changes in frequency on online platform

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: e-PsychotherapyExperimental Treatment1 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 UsualActive Control1 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.)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

e-CBT

2021

N/A

~300

Do I qualify?Apply below to find out