Treatment of Anxiety and Depression in Head and Neck Cancer Patients
- Conditions
- Anxiety (including Acute Stress Disorder and Posttraumatic Stress Disorder) in Head and Neck Cancer.Depression in Head and Neck Cancer.Cancer - Head and neckMental Health - DepressionMental Health - Anxiety
- Registration Number
- ACTRN12607000219482
- Lead Sponsor
- Dr Maria Kangas, Macquarie University Sydney Australia
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 160
(1) First onset Stage I, II, or III HNC with minimum 12-month prognosis; (2) scheduled to receive primary or adjuvant radiotherapy; (3) meeting criteria for cancer-related PTSD or other anxiety disorders according to DSM-IV AND/OR meeting criteria for Major Depressive Disorder (MDD) within 6-weeks post-cancer diagnosis; (4) able to speak, read and write basic English; (5) medically fit to respond to the assessment and intervention procedure.
(1) Prior history of cancer; (2) brain metastasis at diagnosis; (3) prior history of significant brain impairment; (4) current diagnosis of psychotic, organic mental or substance use disorders; (5) current severe suicidal ideation; (6) undergoing psychiatric treatment for mental illness; and (7) significant concurrent medical problems (e.g., recent heart bypass surgery).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Clinician Administered PTSD Scale (CAPS) to assess cancer-related Posttraumatic Stress Disorder (PTSD)[Pre-treatment; Post-Treatment; 1-month, 6-month and 12-month follow-up.];2. Beck Depression Inventory - second edition (BDI-II) to assess depressive symptoms[Pre-treatment; Post-Treatment; 1-month, 6-month and 12-month follow-up.];3. State Trait Anxiety Inventory (STAI-Y) to assess trait and situational anxiety levels. [Pre-treatment; Post-Treatment; 1-month, 6-month and 12-month follow-up.]
- Secondary Outcome Measures
Name Time Method 1. Functional Assessment of Cancer Therapy (FACIT) to assess multiple dimensions of quality of life including head and neck cancer symptoms[Pre-treatment; Post-Treatment; 1-month, 6-month and 12-month follow-up.];2. Brief COPE (actual full name) to assess cognitive and behavioural coping strategies[Pre-treatment; Post-Treatment; 1-month, 6-month and 12-month follow-up.];3. Treatment Credibility Scale to assess individuals' beliefs about treatment efficacy contingent on the intervention they have been randomized to receive (i.e., CBT or SC).[Pre-treatment; Post-Treatment; 1-month, 6-month and 12-month follow-up.]