Mobile App of CBT for Anxiety and Cancer

NCT02286466 | Completed Results

• 1 other identifier: 12-533
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study seeks to implement a randomized controlled trial to evaluate the effectiveness and generalizability of an efficacious cognitive-behavioral therapy (CBT) intervention for use as a self-administered mobile application (mobile app) to treat anxiety in patients with metastatic cancer.

Conditions

Cancer; Anxiety

Outcome Measures

Primary Outcomes (1)

• Change in Anxiety Symptoms From Baseline to Post-assessment

  Hamilton Anxiety Rating Scale (HAM-A): The HAM-A is a clinician-administered interview used widely in psychiatry research to evaluate anxiety symptoms. Consisting of 14 items that are scored on a scale from 0 (not present) to 4 (very severe), the HAM-A total score ranges from 0 to 56, with higher scores indicating worse anxiety symptoms.

  1) Baseline (within 2 weeks after enrollment), 2) Post-Assessment (8-12 weeks after baseline)

Secondary Outcomes (3)

• Change in Quality of Life From Baseline to Post-assessment

  1) Baseline (within 2 weeks after enrollment), 2) Post-Assessment (8-12 weeks after baseline)

• Change in Mood Symptoms From Baseline to Post-assessment

  1) Baseline (within 2 weeks after enrollment), 2) and Post-Assessment (8-12 weeks after baseline)

• Change in Depression Symptoms From Baseline to Post-assessment

  1) Baseline (within 2 weeks after enrollment), 2) Post-Assessment (8-12 weeks after baseline)

Study Arms (2)

Health Education Program

ACTIVE COMPARATOR

The presence and usage of Health Education Program.

Behavioral: Health Education Program

CBT Mobile Application

EXPERIMENTAL

The presence and usage of a CBT Mobile Application.

Behavioral: CBT Mobile Application

Interventions

Health Education Program BEHAVIORAL

Participants in the control group will receive a health education program using a tablet computer identical to the intervention group. The content of this program is adapted from a health education intervention used as the control condition for a cognitive behavioral stress and affect management intervention in a NIH-funded randomized controlled trial of a quality of life intervention for patients with advanced prostate cancer (R21CA102761, PI: Penedo). The program consists of the same number of sessions as the intervention group and includes general information about health and well-being. Specifically, control participants will learn information about topics such as healthy eating, exercise, memory and cognition, and side effects in the context of a cancer diagnosis and treatment.

Health Education Program

CBT Mobile Application BEHAVIORAL

The CBT intervention is brief, consisting of 6 modules lasting approximately 30 minutes each. Sessions focus on skills for relaxation, coping with cancer-related worries, as well as activity planning and pacing. Prior to starting the program, a trained research assistant will meet with participants in a private office setting to orient them to the software and instruct them on the use of the mobile tablet device. Once patients are comfortable with the functions and features of the mobile app, they will be encouraged to self-administer the intervention on their study-issued tablet at home and during their regularly scheduled oncology visits, for example while receiving chemotherapy infusion or waiting for a doctor's appointment or tests.

CBT Mobile Application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of a metastatic solid tumor
• Report clinically significant anxiety symptoms (i.e., Hospital Anxiety and Depression Scale (HADS) -Anxiety Subscale \> or equal to 8)
• Anxiety is principal psychiatric problem
• At least four weeks after cancer diagnosis
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
• Age greater than 18 years
• Ability to read and respond to questions in English

You may not qualify if:

• Co-morbid delirium, dementia, or active and untreated major psychiatric condition such as schizophrenia will be excluded from the study

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Results Point of Contact

• Title: Joseph Greer, PhD
• Organization: Massachusetts General Hospital Cancer Center

jgreer2@mgh.harvard.edu

617-643-2143

Study Officials

• Joseph A Greer, Ph.D.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant in Psychology

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 7, 2014
• Study Start: February 18, 2015
• Primary Completion: October 25, 2016
• Study Completion: October 25, 2016
• Last Updated: August 28, 2018
• Results First Posted: August 28, 2018

Record last verified: 2018-08

Locations

US (1)