Treatment of Anxiety and Depression in Adult Brain Tumour Patients

Not Applicable

Recruiting

• Conditions: Depression; Anxiety; Primary brain tumours; Mental Health - Depression; Cancer - Brain; Mental Health - Anxiety

• Registration Number: ACTRN12611000574943
• Lead Sponsor: Macquarie University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-06-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Depression: Beck Depression Inventory [BDI-II], reduction of sample mean scores to non-clinical levels (< 14 points)[Baseline, end of therapy (10 weeks after intervention commencement), 1-month and 3-months follow-up (i.e, 14 weeks and 26 weeks after intervention commencement).];Brain tumour related stress: Impact of Events Scaled- Revised [IES-R], reduction of sample mean scores to scores < 33.[Baseline, end of therapy (10 weeks after intervention commencement), 1-month and 3-months follow-up (i.e, 14 weeks and 26 weeks after intervention commencement).];Acceptance: Acceptance and Action Questionnaire, reduction of mean scales scores in experiential avoidance symptoms and improvements in acceptance.[Baseline, end of therapy (10 weeks after intervention commencement), 1-month and 3-months follow-up (i.e, 14 weeks and 26 weeks after intervention commencement).]

Secondary Outcome Measures

Name	Time	Method
Quality of Life: FACIT - General and Brain tumour scales. Expected improvements of mean scores to non-clinical levels[Baseline, end of therapy (10 weeks after intervention commencement), 1-month and 3-months follow-up (i.e, 14 weeks and 26 weeks after intervention commencement).];Anxiety: State Trait Anxiety Scale (STAI), reduction of mean scales scores to non-clinical levels.[Baseline, end of therapy (10 weeks after intervention commencement), 1-month and 3-months follow-up (i.e, 14 weeks and 26 weeks after intervention commencement).];Coping Strategies: BCOPE[Baseline, end of therapy (10 weeks after intervention commencement), 1-month and 3-months follow-up (i.e, 14 weeks and 26 weeks after intervention commencement).]