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Trial registered on ANZCTR
Registration number
ACTRN12625000958482
Ethics application status
Approved
Date submitted
18/07/2025
Date registered
2/09/2025
Date last updated
2/09/2025
Date data sharing statement initially provided
2/09/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
Loneliness, social isolation and chronic illness: A randomised controlled trial of a remote-delivered psychological treatment for older adults with co-occurring loneliness and chronic illness.
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Scientific title
A randomised controlled trial investigating the effect of a remote-delivered psychological treatment on loneliness in older adults with co-occurring loneliness and chronic illness.
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Secondary ID [1]
314908
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Rheumatological conditions
338218
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Diabetes
338219
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Chronic pain
338220
0
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Cardiovascular conditions
338222
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Respiratory Diseases
338223
0
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Osteoporosis
338224
0
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Gastrointestinal conditions
338225
0
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Cancer
338514
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Condition category
Condition code
Mental Health
334495
334495
0
0
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Anxiety
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Mental Health
334496
334496
0
0
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Depression
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Musculoskeletal
334497
334497
0
0
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Other muscular and skeletal disorders
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Musculoskeletal
334498
334498
0
0
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Osteoporosis
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Oral and Gastrointestinal
334499
334499
0
0
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Inflammatory bowel disease
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Metabolic and Endocrine
334500
334500
0
0
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Diabetes
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Cancer
334501
334501
0
0
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Any cancer
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Cardiovascular
334502
334502
0
0
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Hypertension
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
In this randomised controlled trial, participants will receive access to an 8-week internet-delivered, psychological course, the Loneliness-enhanced Chronic Conditions Course, which has been adapted specifically for the current study from an existing resource (https://www.ecentreclinic.org/chronic-conditions-course). The Loneliness-enhanced Chronic Conditions Course provides good information and skills for managing the impacts of chronic conditions on people's emotional wellbeing, including feelings of loneliness and social connection.
The Course runs for 8 weeks and consists of:
(a) 5 online lessons with exercises for learning the information and skills. The duration of each lesson is approximately 20 to 30 minutes. Lessons are completed in weeks 1, 2, 4, 5 and 7. Lessons can be viewed in the online platform, or downloaded as PDF files. Lessons are accompanied by lesson worksheets which can be downloaded and/or printed as PDF files. Participants are encouraged to engage with the home-based exercises at a frequency and duration that is helpful for them, though a suggested time commitment of at least 30 minutes each week is encouraged. The first lesson (in week 1) is a introduction and overview of the course, including psycho-education about chronic health conditions, emotional wellbeing, and relationships/social connection. Participants are encouraged to identify their symptoms (e.g. thinking styles, physical symptoms, unhelpful habits) as a home-based exercise. Lesson 2 (week 2) introduces cognitive challenging skills, and participants are encouraged to practice thought challenging in the following two weeks. Lesson 3 (week 4) covers behavioural activation and relaxation strategies to manage mood and anxiety symptoms, and participants are provided with the resources to undertake activity scheduling as a home-based task. Lesson 4 (week 5) introduces activity pacing to manage symptoms such as pain and fatigue, and graded exposure to manage anxiety and avoidance. Following lesson 4, participants are encouraged to attempt activity pacing and/or graded exposure tasks as a home-based exercise. Finally, Lesson 5 (week 7) includes information and strategies relating to relapse prevention, and participants are given materials to help with goal-setting for the future, and also a relapse prevention plan.
(b) Automatic emails that help guide people through the course with frequency of once or twice per week. Examples of these e-mails include; reminders when new lessons are available, congratulatory messages once a lesson has been completed, brief messages that reinforce the core concepts of the lessons, and e-mails inviting contact and encouraging engagement if a participant has not logged in for a while.
(c) Additional Resources (articles in PDF format) developed specifically for this study. These resources provide information about different problems people often struggle with, including managing sleep, working with health professionals, etc.
(d) Case Stories and examples based on previous participants. These case stories are briefly incorporated into each lesson, commonly in the form of worked examples on worksheets, or participants' experiences learning and practicing the skills within the lesson. Additional case stories are example as optional materials that can be accessed by participants at their own discretion, which provide more in-depth information and experiences.
Adherence with the intervention is monitored via the study's secure web platform, which records information such as the number of participant logins, lesson completions; time spent completing each lesson; and number of downloads of additional resources.
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Intervention code [1]
331510
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Behaviour
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Intervention code [2]
331513
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Treatment: Other
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Comparator / control treatment
A Waitlist Control Group, who receive delayed access to the Loneliness-enhanced Chronic Conditions Course, at 3-months post-treatment.
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Control group
Active
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Outcomes
Primary outcome [1]
342185
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Loneliness
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Assessment method [1]
342185
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De Jong Gierveld Loneliness Scale 11-item (DLS). This measure assesses subjective loneliness across two constructs: within intimate relationships (emotional loneliness) and a wider social network (social loneliness). A cutoff score of 5 or above indicates ‘moderate loneliness’ in people with health conditions.
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Timepoint [1]
342185
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Initial assessment, pre-treatment (day 1 prior to intervention commencing), mid-treatment (4-weeks post intervention commencement), post-treatment (8-weeks post intervention commencement - primary end point), follow-up (3-months post intervention completion)
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Secondary outcome [1]
449834
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Social isolation
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Assessment method [1]
449834
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Lubben Social Network Scale 6-item (LSNS-6;). This scale assesses perceived social isolation from family, friends and neighbours.
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Timepoint [1]
449834
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Initial assessment, pre-treatment (day 1 prior to intervention commencing), mid-treatment (4-weeks post intervention commencement), post-treatment (8-weeks post intervention commencement), follow-up (3-months post intervention completion)
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Secondary outcome [2]
449835
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Quality of Life
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Assessment method [2]
449835
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World Health Organisation Quality of Life – Older Adults Module 4-item (WHOQOL-OLD). This is a measure of quality of life in elderly people. We are including the 4-items assessing social participation.
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Timepoint [2]
449835
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Pre-treatment (day 1 prior to intervention commencing), post-treatment (8-weeks post intervention commencement), follow-up (3-months post intervention completion)
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Secondary outcome [3]
449836
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Health-related Quality of Life
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Assessment method [3]
449836
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Short-Form Health Survey 1-item (SF-12). This is a measure of health-related quality of life. We are including the 1-item question on ‘general health’.
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Timepoint [3]
449836
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Pre-treatment (day 1 prior to intervention commencing), post-treatment (8-weeks post intervention commencement), follow-up (3-months post intervention completion)
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Secondary outcome [4]
449837
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Depression
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Assessment method [4]
449837
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Patient Health Questionnaire 9-Item (PHQ-9). This measure assesses depression symptoms. An extra item assessing suicidal ideation has also been added to this measure by the researchers for safety monitoring, making it a 9-item scale.
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Timepoint [4]
449837
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Initial assessment, pre-treatment (day 1 prior to intervention commencing), post-treatment (8-weeks post intervention commencement), follow-up (3-months post intervention completion)
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Secondary outcome [5]
449838
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Anxiety
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Assessment method [5]
449838
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Generalized Anxiety Disorder 7-Item (GAD-7). This is a measure of symptoms of anxiety, based on the DSM-IV criteria for GAD, but is sensitive to 5 different anxiety disorders.
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Timepoint [5]
449838
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Initial assessment, pre-treatment (day 1 prior to intervention commencing), post-treatment (8-weeks post intervention commencement), follow-up (3-months post intervention completion)
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Secondary outcome [6]
449839
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Social Anxiety
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Assessment method [6]
449839
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Social Interaction Anxiety Scale 6-item (SIAS 6). This is a measure of distress when meeting and talking with others and is used to assesses social anxiety disorder.
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Timepoint [6]
449839
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Pre-treatment (day 1 prior to intervention commencing), mid-treatment (4-weeks post intervention commencement), post-treatment (8-weeks post intervention commencement), follow-up (3-months post intervention completion)
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Secondary outcome [7]
449840
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Disability
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Assessment method [7]
449840
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World Health Organization Disability Assessment Schedule 2.0 12-Item (WHODAS-12). This is a measure that assesses health and disability, which is applicable to a variety of disability domains, including neurological, mental, and chronic physical conditions.
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Timepoint [7]
449840
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Initial assessment, pre-treatment (day 1 prior to intervention commencing), post-treatment (8-weeks post intervention commencement), follow-up (3-months post intervention completion)
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Secondary outcome [8]
449841
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Daily Functioning
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Assessment method [8]
449841
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Work and Social Adjustment Scale 5-item (WSAS). This is a measure of daily functioning, specifically how current problems affect people’s ability to function in work, home, social and leisure activities.
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Timepoint [8]
449841
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Pre-treatment (day 1 prior to intervention commencing), mid-treatment (4-weeks post intervention commencement), post-treatment (8-weeks post intervention commencement), follow-up (3-months post intervention completion)
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Secondary outcome [9]
449842
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Pain Intensity
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Assessment method [9]
449842
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Wisconsin Brief Pain Questionnaire 1-item (WBPQ). This item measures average pain intensity over the past week.
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Timepoint [9]
449842
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Pre-treatment (day 1 prior to intervention commencing), mid-treatment (4-weeks post intervention commencement), post-treatment (8-weeks post intervention commencement), follow-up (3-months post intervention completion)
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Secondary outcome [10]
449843
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Fatigue Severity
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Assessment method [10]
449843
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Fatigue Severity 1-item. This item measures average fatigue severity over the past week on a 0-10 point VAS.
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Timepoint [10]
449843
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Pre-treatment (day 1 prior to intervention commencing), mid-treatment (4-weeks post intervention commencement), post-treatment (8-weeks post intervention commencement), follow-up (3-months post intervention completion)
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Secondary outcome [11]
449844
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Symptom Severity
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Assessment method [11]
449844
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Symptom Severity 1-item. This item measures average severity of chronic health symptoms over the past week on a 0-10 point VAS..
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Timepoint [11]
449844
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Pre-treatment (day 1 prior to intervention commencing), mid-treatment (4-weeks post intervention commencement), post-treatment (8-weeks post intervention commencement), follow-up (3-months post intervention completion)
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Secondary outcome [12]
449845
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Social Support
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Assessment method [12]
449845
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Two Way Social Support Scale 11-item (SSS). This is a measure assessing giving and receiving social support across 2 dimensions: emotional support and instrumental support.
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Timepoint [12]
449845
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Pre-treatment (day 1 prior to intervention commencing), post-treatment (8-weeks post intervention commencement), follow-up (3-months post intervention completion)
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Secondary outcome [13]
449846
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Loneliness Automatic Thoughts
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Assessment method [13]
449846
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Loneliness Automatic Thoughts Questionnaire 17-items (LATQ). This questionnaire was developed by our team and assesses the degree of maladaptive thoughts about loneliness.
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Timepoint [13]
449846
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Pre-treatment (day 1 prior to intervention commencing), mid-treatment (4-weeks post intervention commencement), post-treatment (8-weeks post intervention commencement), follow-up (3-months post intervention completion)
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Secondary outcome [14]
449847
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Social Avoidance
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Assessment method [14]
449847
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Social Avoidance 7-items. This measure was adapted from the Liebowitz Social Anxiety Scale. It assesses the degree of avoidance of social situations due to social fears, or fears related to their chronic health condition.
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Timepoint [14]
449847
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Pre-treatment (day 1 prior to intervention commencing), mid-treatment (4-weeks post intervention commencement), post-treatment (8-weeks post intervention commencement), follow-up (3-months post intervention completion)
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Secondary outcome [15]
449848
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Mental Health Behaviours
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Assessment method [15]
449848
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Big 5 15-items. This is a measure of how much people engage in activities over a week, which are strongly linked to good mental health.
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Timepoint [15]
449848
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Pre-treatment (day 1 prior to intervention commencing), mid-treatment (4-weeks post intervention commencement), post-treatment (8-weeks post intervention commencement), follow-up (3-months post intervention completion)
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Secondary outcome [16]
449850
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Treatment Expectations
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Assessment method [16]
449850
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Credibility and Expectancy Questionnaire (CEQ). This is a widely used 6-item questionnaire designed to get a sense of peoples’ expectations around an intervention.
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Timepoint [16]
449850
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Pre-treatment (day 1 prior to intervention commencing)
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Secondary outcome [17]
449851
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Treatment Satisfaction
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Assessment method [17]
449851
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Treatment Satisfaction Questionnaires (TSQ). This is a purpose-built measure to assess the acceptability of online treatment Courses and to measure participants’ satisfaction with treatment.
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Timepoint [17]
449851
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Post-treatment (8-weeks post intervention commencement)
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Secondary outcome [18]
449853
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Anxiety
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Assessment method [18]
449853
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Generalized Anxiety Disorder 2-Item (GAD-2). This is a brief measure of symptoms of anxiety, based on the DSM-IV criteria for GAD, but is sensitive to 5 different anxiety disorders.
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Timepoint [18]
449853
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Mid-treatment (4-weeks post intervention commencement)
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Secondary outcome [19]
449854
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Depression
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Assessment method [19]
449854
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Patient Health Questionnaire 2-Item (PHQ-2). This brief measure assesses depression symptoms. An extra item assessing suicidal ideation has also been added to this measure by the researchers for safety monitoring, making it a 9-item scale.
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Timepoint [19]
449854
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Mid-treatment (4-weeks post intervention commencement)
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Eligibility
Key inclusion criteria
Inclusion Criteria:
(a) Diagnosed with a self-reproted chronic illness (e.g., arthritis, diabetes, chronic pain, asthma)
(b) Clinically interfering loneliness (>=5 on 11-item De Jong-Gierveld Loneliness Scale)
(c) Aged 60 years or older
(d) English speaking
(e) Living in Australia
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Minimum age
60
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion Criteria:
(a) Significant mental health or physical health issue that requires immediate attention (e.g., active psychosis, suicidality, acute injury or chest pain)
(b) Significant cognitive impairment (e.g., due to dementia or brain injury)
(c) Physical chronic illness not currently managed by a medical professional
(d) Does not have access to a computer/tablet or the internet
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants apply online via the clinic's website (www.ecentreclinic.org.au). Randomisation will occur prior to application and concealment occurs through the use of locked and concealed cells in a spreadsheet, which recruitment staff are required to open serially.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomized using a list generated prior to the study via a software program (www.random.org) using permuted block randomisation.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
With alpha set at 0.05, power set at 0.80, the study sample size of N = 200 (n = 100 per group) will provide adequate power to enable the detection of a moderate effect size (i.e., Cohen’s d = 0.40) between-group difference in the primary outcome loneliness at post-treatment. However, we aim to recruit more participants to enable investigation of sample and clinical predictors of treatment.
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
30/09/2025
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Actual
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Date of last participant enrolment
Anticipated
30/06/2028
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Actual
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Date of last data collection
Anticipated
31/10/2028
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
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Funding & Sponsors
Funding source category [1]
319469
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Government body
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Name [1]
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NHMRC
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Address [1]
319469
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Country [1]
319469
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Australia
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Primary sponsor type
University
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Name
Macquarie University
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Address
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Country
Australia
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Secondary sponsor category [1]
321960
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None
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Name [1]
321960
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Address [1]
321960
0
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Country [1]
321960
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
318043
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Macquarie University Human Research Ethics Committee Medical Sciences
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Ethics committee address [1]
318043
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https://www.mq.edu.au/research/ethics-integrity-and-policies/ethics/human-ethics
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Ethics committee country [1]
318043
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Australia
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Date submitted for ethics approval [1]
318043
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03/06/2025
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Approval date [1]
318043
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17/07/2025
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Ethics approval number [1]
318043
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520251929363156
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Summary
Brief summary
The purpose of this study is to determine whether a Loneliness-enhanced Chronic Conditions Course is effective in improving loneliness in older adults with chronic illness. Who is it for? You may be eligible for this study if you are an adult over the age of 60 who has been diagnosed with a chronic illness (e.g. arthritis, diabetes, cancer, osteoporosis, etc.) and are experiencing loneliness. Study details People in the study are randomly placed into two groups: one starts the Chronic Conditions Course right away, while the other waits three months before beginning. The Course includes five lessons, delivered over 8-weeks. The lessons are all delivered via the internet, and provide information and skills on improving emotional wellbeing, loneliness and quality of life. While working through the Course, people are provided with support from a clinician. Participants will be asked to complete questionnaires across the study. It is hoped that this research will help determine if the Loneliness-enhanced Chronic Conditions Course is helpful in improving loneliness in older adults with chronic conditions.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Blake Dear
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Address
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School of Psychological Sciences, 16 University Avenue, Macquarie University NSW 2109
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Country
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Australia
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Phone
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+61 2 9850 9979
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Fax
142942
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Email
142942
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[email protected]
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Contact person for public queries
Name
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Blake Dear
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Address
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School of Psychological Sciences, 16 University Avenue, Macquarie University NSW 2109
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Country
142943
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Australia
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Phone
142943
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+61 2 9850 9979
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Fax
142943
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Email
142943
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[email protected]
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Contact person for scientific queries
Name
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Blake Dear
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Address
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School of Psychological Sciences, 16 University Avenue, Macquarie University NSW 2109
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Country
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Australia
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Phone
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+61 2 9850 9979
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Fax
142944
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Email
142944
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
•
Researchers working with the approval and under the governance of a Human Research Ethics Committee.
Conditions for requesting access:
•
Yes, conditions apply:
•
Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
•
Requires a scientifically sound proposal or protocol
•
Requires approval by an ethics committee
•
Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
•
Any non-identifiable data necessary to verify the outcomes reported in any published reports by the research team.
What types of analyses could be done with individual participant data?
•
Any analyses required to verify the outcomes reported in published reports.
When can requests for individual participant data be made (start and end dates)?
From:
Data will be made after all original reports have been published.
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
•
Email of trial custodian, sponsor or committee:
Data will be made available following formal request to the chief investigator using a mechanism that is satisfactory for the Macquarie University Human Research Ethics Committee (providing governance for the current research) and any other Human Research Ethics Committee's involved. Data can be obtained by e-mailing the chief investigator (
[email protected]
)
Are there extra considerations when requesting access to individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF