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LonelinessNCT06719843

Acceptance and Commitment Therapy-based Intervention for Loneliness Among Older Adults Living Alone

A study testing ACT-based intervention in people with Loneliness, run by Chinese University of Hong Kong.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The proposed cluster-randomised wait-list-controlled trial will (1) examine the effects of the acceptance and commitment therapy (ACT)-based intervention on loneliness, psychological flexibility, psychological distress, health-related quality of life, and healthcare utilisation among older adults living alone in Hong… Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Loneliness
What is being tested?
ACT-based intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
234 participants
Where
No sites listed yet
Study dates
1 Jan 2025to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • older adults aged 60 years or above
  • residing in the community (living at home without being institutionalised in the past 6 months)
  • capable of speaking and understanding Chinese
  • experiencing loneliness (scoring ≥3 on a three-item loneliness screening scale)
  • living alone for more than 1 year

Who cannot join

  • currently undergoing psychological intervention
  • having a clinical diagnosis of mental illness
  • being cognitively impaired (Abbreviated Mental Test score <6)
  • having visual/language/communication difficulties

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Cho Lee Wong, PhD contact

852-39438166

jojowong@cuhk.edu.hk

About this study

Official title: Effectiveness of an Acceptance and Commitment Therapy-based Intervention in Reducing Loneliness Among Older Adults Living Alone: a Cluster-randomised Wait-list Controlled Trial

The proposed cluster-randomised wait-list-controlled trial will (1) examine the effects of the acceptance and commitment therapy (ACT)-based intervention on loneliness, psychological flexibility, psychological distress, health-related quality of life, and healthcare utilisation among older adults living alone in Hong Kong; (2) investigate whether the effect of the ACT-based intervention on loneliness is mediated through psychological flexibility; and (3) explore the experiences and perceptions of older adults living alone who participate in ACT-based interventions, including their perceptions of the intervention's impact on their loneliness.

Read the detailed description

A convenience sample of 234 older adults living alone will be recruited from six participating community centres (39 participants from each centre). Eligible older adults will be randomly assigned to a waitlist control group (n = 117) or an intervention group (n = 117). Both groups will receive usual community support services. The intervention group will additionally receive four weekly face-to-face ACT-based intervention sessions (approximately 90 minutes each) in group format (each group consisting of six to eight older adults).

The primary outcome (loneliness) and secondary outcomes (psychological flexibility, psychological distress, health-related quality of life, and healthcare utilisation) will be assessed at baseline (T0), immediately post-intervention (T1), 3 months post-intervention (T2) and 6 months post-intervention (T3), using validated questionnaires. A purposive subsample of 36 intervention group participants will be invited for focus group interviews. A generalised estimating equation model with intention-to-treat and path analyses will be used to analyse the quantitative data, whereas thematic analysis will be used for the qualitative data.

Conditions
Loneliness
Being tested
ACT-based intervention
Keywords
Loneliness, Older adults, Acceptance and committment therapy-based intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ACT-based interventionBehavioural

    Participants in the intervention group will receive the face-to-face ACT-based intervention weekly for 4 weeks (each session lasting approximately 90 minutes), with each group consisting of 6-8 older adults. The intervention consists of 4 sessions:

    Session 1 (acceptance and cognitive fusion) Session 2 (contact with the present moment and self-as-context) Session 3 (values) Session 3 (committed action)

Study groups in NCT06719843
Study groupRoleWhat they receive
ACT-based interventionExperimentalIn addition to usual community support services, participants in the intervention group will receive the face-to-face ACT-based intervention weekly for 4 weeks (each session lasting approximately 90 minutes), with each group consisting of 6-8 older adults.
Receives: Behavioral: ACT-based intervention
Wait-list controlNo interventionParticipants in the wait-list control group will receive usual community support services (e.g. meal delivery) provided by the community centres they belong to.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Loneliness

    The Chinese version of the six-item De Jong Gierveld Loneliness Scale (DJGLS) will be used to measure loneliness. This scale comprises six items measuring emotional and social loneliness. The scores range from 0 to 6, a higher score indicates a greater level of loneliness.

    Measured: Assessed at baseline (T0), within 1 day (T1), 3 months (T2), and 6 months (T3) after the completion of the intervention

Secondary outcomes (5)

  1. Psychological flexibility

    The short form of the Comprehensive assessment of Acceptance and Commitment Therapy Processes will be used to measure psychological flexibility. It comprises 10 items measuring openness to experience, behavioural awareness, and valued action. The scores range from 0 to 60. A higher score indicates greater psychological flexibility.

    Measured: Assessed at baseline (T0), within 1 day (T1), 3 months (T2), and 6 months (T3) after the completion of intervention

  2. Psychological distress

    The Chinese version of the Depression Anxiety Stress Scale (DASS-21) will be used to measure psychological distress. It comprises 21 items measuring depressive, anxiety, and stress symptoms in older adults. A higher score indicates a higher level of psychological distress. The cutoff scores that indicate severe and highly severe depression, anxiety, and stress are >20, >14, and >25, respectively.

    Measured: Assessed at baseline (T0), within 1 day (T1), 3 months (T2), and 6 months (T3) after the completion of the intervention

  3. Health-related quality of life

    The Chinese (Hong Kong) Short Form-12 version 2 (SF-12v2) will be used to assess health-related quality of life (HRQOL). It comprises 12 items that measure eight domains of quality of life, which are summed into two subscales. The scores range from 0 to 100. A high score indicates good HRQOL.

    Measured: Assessed at baseline (T0), within 1 day (T1), 3 months (T2), and 6 months (T3) after the completion of intervention

  4. Healthcare utilisation

    It will be assessed based on the number of accident and emergency department visits, outpatient clinic visits (e.g., specialist outpatient clinic, family medicine, general outpatient clinic, and allied health appointments), and inpatient length of stay.

    Measured: Assessed at baseline (T0), within 1 day (T1), 3 months (T2), and 6 months (T3) after the completion of intervention

  5. Experiences and perceptions of older adults in intervention group

    Focus group interviews will be conducted to explore the experiences and perceptions of older adults in intervention group regarding their participation in ACT-based interventions and the impact of the intervention on their loneliness using an interview guide.

    Measured: Assessed within 1 day (T1) after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2024
  2. Study start1 Jan 2025 (estimated)
  3. Primary completion30 Sep 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Wait-list trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
234 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06719843
Sponsor's protocol ID
2024.026-T
Status last verified
Nov 2024
First submitted
27 Nov 2024
Last updated
6 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ACT-based intervention in people with Loneliness, run by Chinese University of Hong Kong.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cho Lee Wong, PhD (852-39438166, jojowong@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Loneliness (time frame: Assessed at baseline (T0), within 1 day (T1), 3 months (T2), and 6 months (T3) after the completion of the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06719843.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.

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