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Behavioral Intervention

e-CBT for Anxiety

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

Study 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.Check my eligibility
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.See study design
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 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Changes in duration on online platform
Changes in frequency on online platform

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
~200

Find a Location

Who is running the clinical trial?

Dr. Nazanin AlaviLead Sponsor
12 Previous Clinical Trials
1,056 Total Patients Enrolled
1 Trials studying Anxiety
100 Patients Enrolled for Anxiety
Online PsychoTherapy ClinicOTHER
8 Previous Clinical Trials
641 Total Patients Enrolled
Queen's UniversityLead Sponsor
366 Previous Clinical Trials
121,677 Total Patients Enrolled
5 Trials studying Anxiety
540 Patients Enrolled for Anxiety

Media Library

e-CBT (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04664270 — N/A
Anxiety Research Study Groups: e-Psychotherapy, Treatment as Usual
Anxiety Clinical Trial 2023: e-CBT Highlights & Side Effects. Trial Name: NCT04664270 — N/A
e-CBT (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04664270 — N/A
Anxiety Patient Testimony for trial: Trial Name: NCT04664270 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the enrollment criteria encompass octogenarians?

"This investigation is only suitable for patients aged 18 to 55. There are 536 trials available specifically for minors, and 3262 studies aimed at individuals over 65 years old."

Answered by AI

Are there any remaining vacancies for participants in this experiment?

"Affirmative. Clinicaltrials.gov lists this trial as recruiting patients, with the initial posting on March 1st 2021 and last update occurring October 14th 2022. At present, 60 individuals need to be recruited from only one medical study centre."

Answered by AI

What is the scope of enrollment for this experiment?

"Affirmative. Data from clinicaltrials.gov indicates that this research program, which was originally made public on March 1st 2021, is currently recruiting participants. Approximately 60 patients need to be recruited from a single site."

Answered by AI

Do I fulfill the criteria for this clinical study?

"The criteria for entry into this clinical trial is that applicants must have a diagnosis of depression and to be aged between 18-55. In total, 60 participants will be accepted in the study."

Answered by AI

Who else is applying?

What state do they live in?
Vermont
Quebec
What site did they apply to?
Hotel Dieu Hospital
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Other treatments were unsuccessful. I signed up with email for clinical trial.
PatientReceived 1 prior treatment

What questions have other patients asked about this trial?

How long is each visit?
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Developing and Implementing E-psychotherapy Program for Mental Health Challenges in Oncology and Palliative Care
Dr. Nazanin Alavi 2021. "Developing and Implementing E-psychotherapy Program for Mental Health Challenges in Oncology and Palliative Care". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04664270.
All > Mental Health
~9 spots leftby Dec 2024
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