Improving mental health and social participation outcomes in older adults with depression and anxiety
| ISRCTN | ISRCTN78951376 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78951376 |
| Secondary identifying numbers | ACTRN12619000242123 |
- Submission date
- 10/07/2019
- Registration date
- 14/07/2019
- Last edited
- 20/06/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Depression and anxiety in older populations are associated with poor physical health, disability, morbidity, increased costs of service use and medications as well as increased risk of cognitive decline. These disorders are also associated with reduced social participation, poor social support, and increased feelings of loneliness and isolation.
Depression and anxiety can be successfully treated in older adults using psychological therapies, particularly cognitive behavioural therapy. However, as in younger adults, while many people benefit from psychological therapy, not everyone does, and some people experience a relapse of symptoms over time. Therefore improvements to psychological treatments are needed to improve effectiveness. One promising innovation is to enhance existing treatments to increase social participation and reduce isolation in older adults.
The aim of this study is to evaluate the efficacy and cost-efficacy of a psychosocial intervention to treat emotional symptoms and increase social participation in anxious and/or depressed older adults, in comparison to current “best practice” standard CBT.
Who can participate?
Older adults, aged 65 years or older who experience clinically significant levels of anxiety and/or low mood. Individuals also need to be able to understand written and spoken English at a sufficient level (such as being able to read the newspaper).
What does the study involve?
1. Informed Consent
The first step is obtaining participants’ informed consent.
2. Assessments
An initial assessment includes both a face-to-face clinical interview at the Centre for Emotional Health Clinic at Macquarie University, Sydney Australia, as well as completion of self-report questionnaires about symptoms, wellbeing, demographics, medical and health service use.
Post-treatment assessments and 12-month post-baseline assessments will take the same format. These follow-up assessments enable us to evaluate changes in symptoms and wellbeing over time and compare the treatment conditions.
3. Random Allocation
Suitable participants will then be randomly allocated to receive one of the two treatment conditions: standard Cognitive Behavioural Therapy (CBT) or enhanced CBT. Both treatment conditions are very likely to be helpful to participants.
4. Therapy conditions
The standard CBT program will comprise our empirically validated CBT program for older age anxiety and depression, Ageing Wisely. This program will be delivered over 12 weekly individual sessions.
The enhanced CBT program comprises 12 weekly individual sessions, teaching the same CBT skills as the standard Ageing Wisely program, but with a stronger focus on bolstering social participation and connections within those skills.
5. Linking to health use data
Linked data will be used to monitor changes in health service use over time. These linked data come from the NSW Centre for Health Record Linkage (CHeReL) on Admitted Patient data, Emergency Department data and Mental Health Ambulatory data. This will be linked to participants’ Medicare number.
What are the possible benefits and risks of participating?
The likely benefits are reductions in symptoms of anxiety and depression. There are few risks with participating. As the psychological assessment and treatment involve talking about participants’ emotional state, some participants may experience discomfort in discussing these symptoms. However, discomfort is anticipated to be mild and temporary.
Where is the study run from?
This study will be conducted at the Centre for Emotional Health Clinic, Macquarie University, Sydney, Australia.
When is the study starting and how long is it expected to run for?
August 2019 to December 2025
Who is funding the study?
The project is co-funded by the National Health and Medical Research Council (NHMRC) and Beyond Blue.
Who is the main contact?
Dr Jessamine Chen, jessamine.chen@mq.edu.au
Contact information
Scientific
Department of Psychology
Centre for Emotional Health
Faculty of Medicine, Health and Human Sciences
Room 706, 4 First Walk
North Ryde
2109
Australia
 ORCID ID |
0000-0001-8753-8863 |
|---|---|
| Phone | +61 2 9850 9882 |
| jessamine.chen@mq.edu.au |
Study information
| Study design | Interventional, parallel group superiority randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | University/medical school/dental school |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a participant information sheet. |
| Scientific title | Social Participation in Ageing Adults with depression and anxiety |
| Study acronym | SPAA |
| Study objectives | 1. We predict that the enhanced program will lead to significantly greater reductions on our primary outcome, diagnostic severity of all anxiety and unipolar mood disorders, compared to standard CBT program. immediately post-treatment (Primary Hypothesis) 2. We predict that the enhanced program will lead to greater reductions in diagnostic severity of all anxiety and unipolar disorders compared to standard CBT at 12-month follow-up (Secondary Hypothesis). 3. We similarly predict that the enhanced program will show significantly better outcomes than standard CBT on a range of related measures including self-reported depression, anxiety, suicidal ideation, loneliness, and quality of life immediately post-treatment and at 12 month follow up (Secondary Hypotheses), and cognitive outcomes at 12 month follow up. 4. We predict that the enhanced CBT intervention will show greater cost-efficacy at 12-month follow-up compared with standard CBT (Secondary Hypothesis). 5. We predict treatment outcomes will be moderated by the presence of personality disorders, demographics, symptom severity and baseline cognitive ability. |
| Ethics approval(s) | Approved 24/01/2019, the Macquarie University Human Research Ethics Committee Medical Sciences (Human Ethics Research Office Level 3, CSC Building Macquarie University Balaclava Road, NORTH RYDE NSW 2109, Australia), ref: 5201938336887. |
| Health condition(s) or problem(s) studied | Anxiety and depression |
| Intervention | The main study design uses a parallel group superiority randomised controlled trial design to evaluate the clinical and cost-effectiveness of an enhanced CBT program for depressive and/or anxiety disorders in older adults, compared to standard CBT. ). After baseline examination suitable participants will be randomised to either the 1) Standard CBT or 2) Enhanced CBT treatment condition. The standard CBT program will comprise our empirically validated CBT program for older age anxiety and depression, Ageing Wisely. Ageing Wisely consists of 11, weekly sessions to teach practical skills to help manage anxiety and depression including: goal setting, activity scheduling, problem solving, graded exposure, cognitive restructuring, assertiveness skills, and sleep hygiene. For the current trial we will add one treatment session to equate contact hours between treatment conditions. Homework exercises are a critical component that assists skills to be generalised and maintained. The enhanced CBT program comprises 12 weekly sessions, teaching the same CBT skills as the standard Ageing Wisely program, but with a stronger focus on bolstering social participation and connections within those skills. In both treatment conditions, all sessions will be run by clinical psychologists and intern psychologists trained in the delivering of the treatment protocols. To control for therapist differences, all therapists will be trained in and will conduct both treatments (allocated randomly). Supervision will be provided by CIs and postdoctoral fellows managing the trial with treatment adherence and differentiation between conditions as a core focus. All therapy sessions will be recorded, and a random 25% will be rated by an independent expert unaware of the study hypotheses for fidelity to the therapeutic model using a codebook and form based on Waltz et al. (1993). The effectiveness of the programs will be established using mixed model analysis to compare the differences in clinical diagnostic severity (established by clinicians blind to treatment allocation) and scores on self-report measures at pre-treatment, post-treatment, and at a 12-month follow up period. Treatment integrity and adherence checks will be conducted to ensure treatment conditions were accurately delivered. In addition, an economic evaluation will be undertaken to measure the relative benefit in health outcomes and resource use for the enhanced intervention compared to standard CBT. Moderation analyses will examine the impact of moderators on treatment outcomes. |
| Intervention type | Behavioural |
| Primary outcome measure | Disorder Severity indicated by the Mean Clinical Severity Rating of all anxiety and mood disorders assessed in the Anxiety and Related Disorders Interview Schedule 5th edition (ADIS-V) at post-treatment (i.e., 14 weeks from baseline assessment). |
| Secondary outcome measures | 1. Disorder Severity indicated by the Mean Clinician’s Severity Rating of all anxiety and mood disorders based on the ADIS-V 12 months from the start of therapy. 2. Changes in Symptomatology measured at baseline, 14 weeks from baseline assessment, and 12 months from the start of therapy on the following measures: 2.1. Geriatric Anxiety Inventory. 2.2. Geriatric Anxiety Scale. 2.3. The Geriatric Depression Scale. 2.4. The Depressive Symptoms Inventory – Suicide Subscale. 3. Changes in Social Participation measured at baseline, 14 weeks from baseline assessment, and 12 months from the start of therapy on the following measures: 3.1. De Jong Gierveld Loneliness Scales. 3.2. The Lubben Social Network Scale. 3.3. The Bille- Brahe Social Support scale. 4. Cost-Effectiveness measured at baseline, 14 weeks from baseline assessment, and 12 months from the start of therapy on the following measures: 4.1. Australian Quality of Life total score. 4.2. The iMTA Productivity Cost Questionnaire total score. 4.3. The Australian Community Participation Questionnaire short form total score. 4.4. The Use of Service Questionnaire total score. 4.5. Health Resource Use: data will be sourced using a purpose-built medical cost questionnaire, supplemented with linked data from the NSW Centre for Health Record. 4.6. Linkage (CHeReL) on Admitted Patient data, Emergency Department data, and Mental Health Ambulatory data, along with the Medicare Benefit Schedule (MBS) and Pharmaceutical Benefit Schedule (PBS) data. |
| Overall study start date | 15/11/2018 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Sex | Both |
| Target number of participants | 172 |
| Total final enrolment | 173 |
| Key inclusion criteria | 1. Aged 65 years or older. 2. Primary anxiety and/or unipolar depressive disorder as assessed by the Anxiety and Related Disorders Interview Schedule (ADIS-V). |
| Key exclusion criteria | 1. English language illiteracy. 2. Psychosis or bipolar disorder. 3. Active suicidality. 4. 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). |
| Date of first enrolment | 01/08/2019 |
| Date of final enrolment | 30/06/2024 |
Locations
Countries of recruitment
- Australia
Study participating centre
North Ryde
2109
Australia
Sponsor information
Government
16 Marcus Clarke St, Canberra ACT
Canberra
2601
Australia
| Phone | +61 2 6217 9000 |
|---|---|
| nhmrc@nhmrc.gov.au | |
| Website | https://www.nhmrc.gov.au/ |
"ROR" |
https://ror.org/011kf5r70 |
Charity
Level 2, 290 Burwood Road
Hawthorn
3122
Australia
| Phone | +61 3 9810 6111 |
|---|---|
| research@beyondblue.org.au | |
| Website | https://www.beyondblue.org.au/ |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- NHMRC
- Location
- Australia
No information available
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The investigators plan to disseminate the study results by publication in a peer-reviewed journal and by presentation at conferences |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 27/06/2022 | 28/06/2022 | Yes | No |
Editorial Notes
20/06/2024: The following changes were made to the trial record:
1. The overall end date was changed from 30/06/2025 to 31/12/2025.
2. The total final enrolment was added.
3. The intention to publish date was changed from 30/06/2026 to 31/12/2026.
23/01/2024: The publication and dissemination plan has been changed from "Trial results will be published and disseminated in late 2021." to "The investigators plan to disseminate the study results by publication in a peer-reviewed journal and by presentation at conferences".
22/12/2023: The following changes have been made:
1. The recruitment end date has been changed from 31/12/2023 to 30/06/2024.
2. The overall study end date has been changed from 31/12/2024 to 30/06/2025 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 31/12/2025 to 30/06/2026.
06/12/2022: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2022 to 31/12/2023.
2. The overall end date was changed from 31/12/2023 to 31/12/2024.
3. The intention to publish date was changed from 31/12/2024 to 31/12/2025.
4. The plain English summary was updated to reflect these changes.
28/06/2022: Publication reference added.
14/12/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/12/2021 to 31/12/2022.
2. The overall end date was changed from 31/12/2022 to 31/12/2023.
3. The intention to publish date was changed from 31/12/2023 to 31/12/2024.
4. The plain English summary was updated to reflect these changes.
03/08/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/08/2021 to 31/12/2021.
2. The overall end date was changed from 30/12/2021 to 31/12/2022.
3. The intention to publish date was changed from 31/10/2021 to 31/12/2023.
4. The scientific contact was changed.
5. The plain English summary was updated to reflect these changes.
26/02/20221: Recruitment has resumed.
17/04/2020: Due to current public health guidance, recruitment for this study has been paused.
12/07/2019: Trial's existence confirmed by the Macquarie University Human Research Ethics Committee HREC EXEC Medical Sciences.
