None listed
Conditions
Brief summary
This study aims to evaluate the effect of a psychological treatment program on anxiety and depression in adult brain tumour patients. Who is it for? You can join this study if you are aged 18 to 80 years and have been diagnosed with a primary low to medium grade brain tumour, for which you have completed all acute medical treatments. You must also be experiencing at least moderate levels of anxiety and depressive symptoms for which you may or may not be taking medication. Trial details: Participants in this trial will be randomly (by chance) assigned to one of two groups. Participants in one group will undertake a psychological therapy program, titled the ‘Behavioural and Acceptance Based Therapy (BABT)’ program. This involves attending six consecutive weekly meetings of 1.5 hours each with a psychologist, followed by two follow-up sessions at fortnightly intervals. Participants in the other group will receive no psychological treatment for 12 weeks, after which time they will be offered the BABT program. Participants in both groups will be asked to complete questionnaires at 4 timepoints throughout the study to assess whether the program is effective in helping them to reduce their distress and improve their overall quality of life.
Interventions
The purpose of this study is to investigate whether the psychological therapy program, titled the ‘Behavioural and Acceptance Based Therapy (BABT)’ program is useful in helping individuals reduce their distress (including anxiety and depressive symptoms) resulting from their brain tumour experience, as well as improve their overall quality of life.
The BABT intervention will be conducted in an individual face-to-face format and will consist of six consecutive
weekly meetings, 1.5 hours each, pl
The purpose of this study is to investigate whether the psychological therapy program, titled the ‘Behavioural and Acceptance Based Therapy (BABT)’ program is useful in helping individuals reduce their distress (including anxiety and depressive symptoms) resulting from their brain tumour experience, as well as improve their overall quality of life. The BABT intervention will be conducted in an individual face-to-face format and will consist of six consecutive weekly meetings, 1.5 hours each, plus two follow-up/ booster sessions conducted at fortnightly intervals. The program will be administered by qualified psychologists.
Sponsors
Macquarie University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1) diagnosed with a primary low - medium grade BT (i.e., at least 12 month prognosis); 2) completion of all acute medical treatments at time of referral; 3) reporting at least moderate (sub-clinical or clinical) levels of anxiety or depressive symptoms (which will be screened at initial assessment); 4) aged 18 to 80 years; 5) able to speak, read and write basic English; and 5) medically fit to respond to the assessment and intervention procedures (i.e., able to sit for 1 hour at a time). 6) In the event a participant has been prescribed and currently using medication for psychological problems (notably anti-depressants or anxiolytics), they will be required to be on a stable dosage for at least 4 weeks prior to the initial/baseline assessment. If they are deemed suitable for the therapy program after the screening assessment, patients taking antidepressants or anxiolytics will be required to remain on a stable dose throughout the course of the BABT program.
Exclusion criteria
1) Presence of severe cognitive and language deficits (defined as score < 1.96 SD below mean) that will be assessed via a neuropsychological assessment battery; 2) current history of significant alcohol/ drug abuse or psychosis; 3) current suicidal ideation (will be referred to acute crisis team); and 4) currently undergoing psychiatric treatment for mental illness.
Outcome results
None listed