Improving Mental Health and Social Participation Outcomes in Older Adults with Depression and Anxiety

• Register: ANZCTR
• Last refreshed on: 22 January 2024
• Main ID: ACTRN12619000242123
• Date of registration: 19/02/2019
• Prospective Registration: Yes
• Primary sponsor: Centre for Emotional Health, Macquarie University
• Public title: Improving Mental Health and Social Participation Outcomes in Older Adults with Depression and Anxiety
• Scientific title: Improving Mental Health and Social Participation Outcomes in Older Adults with Depression and Anxiety
• Date of first enrolment: 16/07/2019
• Target sample size: 172
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12619000242123.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Jessamine Chen

• Name: Prof Viviana Wuthrich

Key inclusion & exclusion criteria

Inclusion criteria: Older adults aged 65 years of older
Primary anxiety and/or unipolar depressive disorder as assessed by the Anxiety Disorders Interview Schedule (ADIS-V).
Exclusion criteria: English language illiteracy, psychosis or bipolar disorder, active suicidality, significant uncorrected hearing loss and likely moderate to severe dementia based on a standardised cognitive screener test (i.e. the scores on the six-item Cognitive impairment Screener).

Age minimum: 65 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Anxiety;Depression;
Anxiety
Depression

Mental Health - Anxiety

Mental Health - Depression

Intervention(s)

A one-hour one-on-one session per week for 12 weeks using manualised CBT based on the empirically validated CBT program for older age anxiety and depression, Ageing Wisely. The enhanced CBT program teaches the same CBT skills as the standard CBT program, but with a stronger focus on bolstering social participation and connections within those skills. That is, in the enhanced CBT program, standard CBT techniques such as goal setting, activity scheduling, and graded exposure, are specifically focused around social connections, maximising family and community support, and social contribution. Modules of social connection are integrated into the standard CBT program and module length varies from session to session.

Treatment is delivered by Clinical Psychologists and Clinical Psychology registrars, supervised by Chief Investigators to ensure treatment adherence. Adherence of participants to treatment will be monitored with 20% of the sessions coded for fidelity by an independent rater.

Primary Outcome(s)

Mean Clinician’s Severity Rating of anxiety and mood disorders based on the Anxiety and Related Disorders Interview Schedule 5th edition (ADIS-V) posttreatment.[ 14 weeks from baseline assessment.]

Secondary Outcome(s)

Change in The Lubben Social Network Scale total score.[ 14 weeks from baseline assessment and 12 months from start of therapy.]

Change in the iMTA Productivity Cost Questionnaire total score.[ 14 weeks from baseline assessment and 12 months from start of therapy.]

Change in De Jong Gierveld Loneliness Scales total score.[ 14 weeks from baseline assessment and 12 months from start of therapy.]

Change in Geriatric Anxiety Scale total score.[ 14 weeks from baseline assessment and 12 months from start of therapy.]

Change in Clinician’s Severity Rating of anxiety disorders based on the ADIS-V.[ 12 months from start of therapy.]

Change in the Australian Quality of Life total score.[ 14 weeks from baseline assessment and 12 months from start of therapy.]

Change in the Australian Community Participation Questionnaire short form total score.[ 14 weeks from baseline assessment and 12 months from start of therapy.]

Change in Geriatric Anxiety Inventory total score.[ 14 weeks from baseline assessment and 12 months from start of therapy.]

Change in the Bille- Brahe Social Support Scale total score.[ 14 weeks from baseline assessment and 12 months from start of therapy.]

Change in Depressive Symptoms Inventory – Suicide Subscale score.[ 14 weeks from baseline assessment and 12 months from start of therapy.]

Change in Geriatric Depression Scale total score.[ 14 weeks from baseline assessment and 12 months from start of therapy.]

Change in Use of Service Questionnaire total score. This purpose built medical cost questionnaire was designed specifically for this study.[ 14 weeks from baseline assessment and 12 months from start of therapy.]

Secondary ID(s)

NIL

Source(s) of Monetary Support

Beyond Blue

National Health and Medical Research Council

Ethics review

Status: Approved
Approval date: 24/01/2019
Contact:

Macquarie University Human Research Ethics Committee Medical Sciences

Status: Not approved
Approval date:
Contact:

Centre for Health Record Linkage Ethics Committee