Recruiting

E-psychotherapy

Sponsor:

Dr. Nazanin Alavi

Code:

NCT04664270

Conditions

Mental Health Issue

Depression

Anxiety

Palliative Care

Oncology

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

e-CBT

Study Details

Brief 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. 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.

Conditions

Mental Health Issue

Depression

Anxiety

Palliative Care

Oncology

Study ID

NCT04664270

Start date

Mar 1, 2021

Status verified date

Apr, 2024

Completion date

Sep, 2025

Anticipated

Primary completion date

Dec, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: e-Psychotherapy

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.

no intervention: Treatment as Usual

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.)

Interventions

e-CBT

e-CBT + Mindfulness + Problem Solving

Primary outcome measure

  • Change in symptoms (Functional Assessment of Cancer Therapy General - FACT-G) [ Time Frame: Baseline, week 4, week 8 ]
  • Change in symptoms (Patient Health Questionnaire - PHQ-9 Item) [ Time Frame: Baseline, week 4, week 8 ]
  • Change in symptoms (Generalized Anxiety Disorder - GAD7 Item) [ Time Frame: Baseline, week 4, week 8 ]
  • Change in symptoms (Quality of Life and Satisfaction Questionnaire - Q-LES-Q) [ Time Frame: Baseline, week 4, week 8 ]

Central Contacts and Locations

Central contacts

Nazanin Alavi

(613) 544 4900nazanin.alavitabari@kingstonhsc.ca

Locations

Hotel Dieu Hospital

Recruiting

Kingston, Ontario, Canada, K7L 5G3

Contacts

Nazanin Alavi

6479672079nazanin.alavitabari@kingstonhsc.ca

Principal Investigator:

Nazanin Alavi, MD FRCPC

More Information

Sponsor

Dr. Nazanin Alavi

Last update posted

Apr 10, 2024

Last verified

Apr, 2024

Keywords

  • Mental Health
  • Virtual Care
  • Depression
  • Anxiety
  • Palliative Care
  • Psychotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dr. Nazanin Alavi on 2024-04-10.