Condition category
Mental and Behavioural Disorders
Date applied
10/07/2019
Date assigned
14/07/2019
Last edited
12/07/2019
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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?
Data collection commences from the date of ethics approval 24/01/2019. It is expected that the study participants will be recruited until the end of 2020. The study is anticipated to be completed by the end of 2021.

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?
Professor Viviana Wuthrich (Principal Investigator), viviana.wuthrich@mq.edu.au.

Trial website

Contact information

Type

Scientific

Primary contact

Prof Viviana Wuthrich

ORCID ID

http://orcid.org/0000-0001-7227-229X

Contact details

Department of Psychology
Macquarie University
North Ryde
2109
Australia
+61 2 9850 4866
viviana.wuthrich@mq.edu.au

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

ACTRN12619000242123

Study information

Scientific title

Social Participation in Ageing Adults with depression and anxiety

Acronym

SPAA

Study hypothesis

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

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.

Study design

Interventional, parallel group superiority randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a participant information sheet.

Condition

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

Phase

Drug names

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 trial start date

15/11/2018

Overall trial end date

30/12/2021

Reason abandoned (if study stopped)

Eligibility

Participant 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).

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

172

Participant 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).

Recruitment start date

01/08/2019

Recruitment end date

31/08/2021

Locations

Countries of recruitment

Australia

Trial participating centre

Centre for Emotional Health Clinic at Macquarie University.
Level 1, Australian Hearing Hub, 16 University Avenue, Macquarie University.
North Ryde
2109
Australia

Sponsor information

Organisation

National Health and Medical Research Council

Sponsor details

16 Marcus Clarke St
Canberra ACT
Canberra
2601
Australia
+61 2 6217 9000
nhmrc@nhmrc.gov.au

Sponsor type

Government

Website

https://www.nhmrc.gov.au/

Organisation

Beyond Blue

Sponsor details

Level 2
290 Burwood Road
Hawthorn
3122
Australia
+61 3 9810 6111
research@beyondblue.org.au

Sponsor type

Charity

Website

https://www.beyondblue.org.au/

Funders

Funder type

Government

Funder name

National Health and Medical Research Council

Alternative name(s)

NHMRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Australia

Funder name

Beyond Blue

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Trial results will be published and disseminated in late 2021.

IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/10/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

12/07/2019: Trial's existence confirmed by the Macquarie University Human Research Ethics Committee HREC EXEC Medical Sciences.