None listed
Conditions
Brief summary
The overall aim of this research is to test the efficacy of a brief, early cognitive-behavioural therapy (CBT) intervention in reducing anxiety [including cancer-related Posttraumatic Stress Disorder (PTSD)], and/or depression and improving the psychological well-being and quality of life for adult individuals newly diagnosed with head and neck cancer (HNC) who have been scheduled to receive radiation treatment. It is hypothesized that the CBT program (experimental condition) will help reduce anxiety and depressive symptoms both in the short- and longer-term (up to 12-months) following the completion of patients’ radiotherapy regimens, compared with a non-directive Supportive Counselling (SC) program (active control condition).
Interventions
Participants who are recently diagnosed with a first onset head and neck cancer (HNC) and who report experiencing acute stress symptoms and/or depressive symptoms within the initial 4-6 weeks post-cancer diagnosis and prior to commencing their radiotherapy (primary or adjuvant) will be randomly allocated to receive Cognitive Behaviour Therapy (CBT). The CBT intervention is a directive therapy that comprises relaxation, stress management and coping skills training. Therapy will be conducted on an
Participants who are recently diagnosed with a first onset head and neck cancer (HNC) and who report experiencing acute stress symptoms and/or depressive symptoms within the initial 4-6 weeks post-cancer diagnosis and prior to commencing their radiotherapy (primary or adjuvant) will be randomly allocated to receive Cognitive Behaviour Therapy (CBT). The CBT intervention is a directive therapy that comprises relaxation, stress management and coping skills training. Therapy will be conducted on an individual face-to-face basis and will consist of 6 consecutive weekly meetings, 1.5 hours each, commencing on the same week as participants' scheduled radiotherapy program. Participants will also receive a booster (7th) session of CBT at 1-month following the completion of their radiotherapy.
Sponsors
Dr Maria Kangas, Macquarie University Sydney Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
(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.
Exclusion criteria
(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).
Outcome results
None listed