A Randomised Controlled Trial (RCT) of iCanADAPT, an internet Cognitive Behavioural Therapy (iCBT) program for the treatment of depression and anxiety in early stagecancer patients and cancer survivors.

Not Applicable

Completed

• Conditions: Depression; Anxiety; Cancer; Mental Health - Depression; Mental Health - Anxiety; Cancer - Any cancer

• Registration Number: ACTRN12616000231448
• Lead Sponsor: St. Vincent's Hospital

Brief Summary

The internet CBT intervention was helpful. People who completed the course had less depression and anxiety. This is great and so we will aim to get the intervention available to the general cancer patient population in 2019.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-19
• Study Completion: 2017-08-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 113

Inclusion Criteria

Adults, aged over 18 years old with no maximum age.
Self-identified as suffering from depression and/or anxiety and have online questionnaire scores indicating a clinical level of anxiety and/or depression on the Hospital Anxiety and Depression Scale (HADS).
Results of telephone diagnostic interview consistent with one, or more, diagnoses of Major Depressive Disorder (MDD), Generalised Anxiety Disorder (GAD), Panic Disorder or Agoraphobia, Illness Anxiety Disorder (IAD), or Adjustment disorder.
Presence of current early stage cancer, or early stage cancer survivorship, will be based on self-report.
Participants must be prepared to provide name/location of primary cancer care centre.
Prepared to provide own name, phone number and address.
Prepared to provide the name and address of a local general practitioner, and to provide written informed consent.
English language skills equivalent to a School Certificate level. Have access to a phone and a computer with internet and a printer.

Exclusion Criteria

Mental health exclusion criteria will include psychosis, bipolar disorder, substance abuse or dependence and current suicidality.

Cancer related exclusion criteria will include:
-Any metastases (cancer spread). The rationale being that the iCanADAPT program is specifically designed for early stage cancer i.e. cancer with curative intention to treat.
-Currently in-patient.
-Being within the first 6 weeks of cancer diagnosis.
-Brain cancer/ malignancy.

Physical health status exclusion will be an ECOG (Eastern Cooperative Oncology Group) performance status of greater than 1 (Oken et al., 1982).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Changes in combined mean anxiety and depression scores according to the Hospital Anxiety and Depression Scale Total Score (HADS-T)[Baseline (just prior to commencing the program i.e. prior to Lesson 1).<br>Midpoint of the program (before Lesson 5, approximately 8 weeks after commencement of the program).<br>One week post-treatment (1 week post end of the program), <br>At 3-months post-treatment (3 months post end of the program, for treatment group only).]