Developing and Implementing E-psychotherapy Program for Mental Health Challenges in Oncology and Palliative Care

NCT04664270 | Recruiting

• 1 other identifier: PSIY-699-20
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

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

  Clinically validated symptom questionnaire. Scale of 0-4, 4 is worse.

  Baseline, week 4, week 8

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

  Clinically validated symptom questionnaire. Scale of 0-3, 3 is worse.

  Baseline, week 4, week 8

• Change in symptoms (Generalized Anxiety Disorder - GAD7 Item)

  Clinically validated symptom questionnaire. Scale of 0-3, 3 is worse.

  Baseline, week 4, week 8

• Change in symptoms (Quality of Life and Satisfaction Questionnaire - Q-LES-Q)

  Clinically validated symptom questionnaire. Scale of 0-5, 5 is better.

  Baseline, week 4, week 8

Secondary Outcomes (2)

• Changes in frequency on online platform

  Week 8

• Changes in duration on online platform

  Week 8

Study Arms (2)

e-Psychotherapy

EXPERIMENTAL

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.

Behavioral: e-CBT

Treatment as Usual

NO 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.)

Interventions

e-CBT BEHAVIORAL

e-CBT + Mindfulness + Problem Solving

e-Psychotherapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Nazanin Alavi: lead
• Online PsychoTherapy Clinic: collaborator

Study Sites (1)

Hotel Dieu Hospital

Kingston, Ontario, K7L 5G3, Canada

RECRUITING

Related Publications (1)

• Alavi N, Stephenson C, Miller S, Khalafi P, Sinan I, Kain D, McDougall M, Davies J, Stark D, Tompkins E, Jagayat J, Omrani M, Shirazi A, Groll D, Soares C. Developing and Implementing a Web-Based Psychotherapy Program to Address Mental Health Challenges Among Patients Receiving Oncologic and Palliative Care: Protocol for an Open-Label Randomized Controlled Trial. JMIR Res Protoc. 2021 Jul 14;10(7):e30735. doi: 10.2196/30735.

  PMID: 34259164 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders; Neoplasms; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Personal Satisfaction

Study Officials

• Nazanin Alavi

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nazanin Alavi

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Assistant Professor

Model Details: Randomly allocated to either treatment or control

Study Record Dates

• First Submitted: December 5, 2020
• First Posted: December 11, 2020
• Study Start: March 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: September 1, 2025
• Last Updated: April 10, 2024

Record last verified: 2024-04

Locations

CA (1)