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Schizophrenia Spectrum and Other Psychotic DisordersNCT04916496

Acceptance and Commitment Therapy-based Lifestyle Counselling Programme for Early Psychosis on Physical Activity

A study testing Acceptance and Commitment Therapy-based lifestyle counselling programme and Healthy lifestyle talk in people with Schizophrenia Spectrum and Other Psychotic Disorders, run by Chinese University of Hong Kong at 1 site in Hong Kong.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This pilot randomized controlled trial aims to determine the feasibility, acceptability and preliminary effects of an Acceptance and Commitment Therapy-based Lifestyle Counselling Programme (ACT-LCP) on the physical and psychosocial health outcomes of patients with early psychosis over a 12-week follow-up. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Acceptance and Commitment Therapy-based lifestyle counselling programme and Healthy lifestyle talk
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteHong Kong
Study dates
14 Jun 2021to 28 Feb 2024
Phase
Interventional
Are there results?
None posted in the registry

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

Who may be able to join

  • at least 18 years of age or above
  • able to understand the nature of the study and give informed consent,
  • able to communicate in Cantonese,
  • have a diagnosis of psychotic disorders (e.g., delusional/brief psychotic disorder, schizotypal disorder, and psychosis not otherwise specified) according to the DSM IV-TR, DSM-V or ICD-10, within 5 years of onset as documented in their clinical/written records;
  • insufficiently active (i.e., <150 minutes of MVPA per week) based on self-reports in a brief screening form, and
  • having used mobile instant-messaging apps (e.g. WhatsApp/Facebook messenger/WeChat) installed on a smartphone.

Who cannot join

  • have had a record of alcohol abuse and/or substance misuse,
  • poor physical health condition, acute/severe medical diseases seriously reducing their life expectancy or ability to participate,
  • pregnancy or within six months of postpartum,
  • have received (within the past 6 months) or are receiving other physical and psychosocial interventions, and
  • severe psychiatric symptoms appeared in the past month.

Trial locations and contacts

1 site in 1 country.

Hong Kong1 site

  • Department of Psychiatry, North District Hospital

    Sheung Shui, New Territories

Other trials in Hong Kong

About this study

Official title: Effect of Acceptance and Commitment Therapy-based Lifestyle Counselling Programme for People With Early Psychosis on Physical Activity: A Pilot Randomised Controlled Trial

This pilot randomized controlled trial aims to determine the feasibility, acceptability and preliminary effects of an Acceptance and Commitment Therapy-based Lifestyle Counselling Programme (ACT-LCP) on the physical and psychosocial health outcomes of patients with early psychosis over a 12-week follow-up.

Read the detailed description

Background: Three-quarters of deaths in psychotic patients are caused by Cardiometabolic Diseases (CMD), including but not limited to cardiac disease, diabetes, and stroke. Globally, the average life expectancy of a psychotic patient is 10 to 20 years shorter than the average life expectancy of those without a psychotic diagnosis. Research has supported that early intervention on lifestyle and cardiometabolic risks is essential to prevent the occurrence of CMD. This study will integrate the framework of Acceptance and Commitment Therapy and Self-Determination Therapy with a healthy-lifestyle intervention programme cultivating autonomous motivation of psychotic patients to live healthier. In addition, the acceptance and mindfulness-based part of ACT would increase the patient's awareness to psychological struggles. While many studies reviewed the ACT's effectiveness in improving mental health and functioning outcomes as well as enhancing physical activity and maintenance of weight reduction for individuals without mental illness, the use of the ACT-based lifestyle intervention in psychotic patients with the framework of Self-Determination Therapy has not even been examined.

Objectives: To determine the feasibility, acceptability and preliminary effects of an Acceptance and Commitment Therapy-based Lifestyle Counselling Programme (ACT-LCP) on the physical and psychosocial health outcomes of patients with early psychosis over a 12-weeks follow-up period.

Hypotheses to be tested: When compared with the Control Group receiving standard care and lifestyle education talk, more participants in the ACT-LCP Group will be physically active, defined as participating in at least 150 minutes/week of moderate to vigorous-intensity of physical activity, at 1-week and at 12-weeks post-intervention. The ACT-LCP group will report improvements in healthy dietary intake, autonomous motivation, psychological flexibility, mental status and quality of life.

Design and subjects: An assessor-blind randomized controlled trial with two-arm, repeated-measures design; 72 Cantonese-speaking patients with early psychosis.

Study Instruments: Validated questionnaires, accelerometer-based wristband activity tracker

Intervention: One ACT-LCP, including 5-weekly sessions (2 hours/session) of group therapy, one 'booster' session to be held at 1-month afterwards, followed by 2-weekly telephone follow-ups.

Main outcome measure: Prevalence of being physically active, as measured by the accelerometer-based wristband activity tracker at 12 weeks post-intervention.

Data analysis: The assessment of acceptability and feasibility of the ACT-LCP will be assessed by examining the recruitment rate, the attrition rate, the completion of after-session homework and post programme focus group interviews. Generalized estimating equations with covariate adjustments will be used to examine the preliminary effects of ACT-LCP.

Expected results: Patients with early psychosis will become more autonomously motivated and more psychologically flexible to continue regular healthy lifestyle behaviours, leading to improvements in health outcomes.

Being tested
Acceptance and Commitment Therapy-based lifestyle counselling programme, Healthy lifestyle talk
Keywords
Acceptance and Commitment Therapy, Randomised Controlled Trial, Lifestyle Counselling Programme, Psychosis, Physical Activity
Medical subject headings
Schizophrenia Spectrum and Other Psychotic Disorders, Psychotic Disorders, Motor Activity

What participants receive

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

  • Acceptance and Commitment Therapy-based lifestyle counselling programmeBehavioural

    The ACT-LCP Group will receive an ACT-based lifestyle counselling programme, which composes of 5-weekly group sessions (2 hours per each, 15 hours in total). Acceptance, mindfulness, values clarification skills/exercises will be used to help patients to increase self-perspective taking and willingness to experience distressing sensations, discomfort and urges while engaging in healthy lifestyle behaviours.

    One month after the programme, the participant will receive one 'booster' session (2 hours), followed by 2-weekly telephone follow-up calls (20-30 minutes per call) to evaluate the effort of behavioural change.

  • Healthy lifestyle talkBehavioural

    The Control Group will receive one 2-hour, healthy lifestyle education talk (at least 10 patients in the talk) based on the HEARTS technical package as recommended by the WHO as routine care. This package includes a collection of evidence-based protocols which standardizes a clinical approach to promote a healthy lifestyle among adults. The Control Group will receive routine psychiatric outpatient/rehabilitation services as provided by the clinic in NDH/community centre.

    One month after the talk, three weekly follow-up telephone calls (20-30 minutes) will be arranged for each patient in the Control Group to evaluate the effort of behavioural change.

Study groups in NCT04916496
Study groupRoleWhat they receive
ACT-LCP GroupExperimentalAn Acceptance and Commitment Therapy-based healthy lifestyle counselling programme (ACT-LCP) and routine psychiatric outpatient/rehabilitation services of the study hospital.
Receives: Behavioral: Acceptance and Commitment Therapy-based lifestyle counselling programme
Control GroupPlacebo comparatorA healthy lifestyle talk and routine psychiatric outpatient/rehabilitation services of the study hospital.
Receives: Behavioral: Healthy lifestyle talk

What is being measured

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

  1. Physical activity

    An accelerometer-based wristband activity tracker, the Fitbit Inspire 2, will be used to measure the total number of minutes spent on moderate to vigorous physical activity (MVPA). Examples of MVPA include brisk walking, climbing stairs, dancing or doing household chores (moderate activity), running, fast cycling, fast swimming, or playing sport (vigorous activity).The data are considered valid if the participants wear the Fitbit for ≥10 hours/day on ≥5 consecutive days (4 valid weekdays+1 valid weekend day). Higher minutes indicate more physically active.

    Measured: Change from baseline assessment to 12 weeks post-intervention

Secondary outcomes (5)

  1. Healthy dietary intake

    The 8-item Starting-The-Conversation is a simplified food frequency instrument for identifying healthy and unhealthy dietary behaviours. Item scores are added to create a summary score (minimum score: 0; maximum score: 6), with higher summary scores reflecting the greatest room for improvement. The STC had acceptable construct validity and was found sensitive to change (Paxton et al., 2011)

    Measured: Change from baseline assessment to 12 weeks post-intervention

  2. Autonomous motivation

    The 19-item Chinese version of the Behavioural Regulation in Exercise Questionnaire-2 will be used to measure why the participants engage in physical activity by providing several possible reasons that represent varying degrees of motivation (19 items, 5-point Likert Scale). Item scores are added to create a summary score (minimum score: 0; maximum score: 76), with higher summary scores reflecting the greatest room for improvement. This instrument had adequate internal consistencies (α=.75), factorial validity and discriminant validity in Hong Kong university students (Chung et al. 2012).

    Measured: Change from baseline assessment to 12 weeks post-intervention

  3. Psychological flexibility

    The 7-item Chinese version of the Acceptance and Action Questionnaire-II. The scale of 1 (never true) to 7 (always true). Item scores are added to create a summary score (minimum score: 7; maximum score: 49), with higher summary scores indicating poor psychological flexibility (i.e., more psychologically inflexible) and a lower total score reflect high psychological flexibility. It demonstrated good internal consistencies (α = .88) and test-retest reliabilities (r = .79-.81) in adult populations in Hong Kong (Chong et al., 2019).

    Measured: Change from baseline assessment to 12 weeks post-intervention

  4. Mental status

    The 18-item Chinese version of the Brief Psychiatric Rating Scale will be used to assess the mental status of the participants. Items are rated on a 7-point Likert scale, from 1 = "not present" to 7 = "extremely severe". Items scores are added to create a summary score (minimum score: 18; maximum score: 126), with higher scores indicate poor mental health. This scale has been used globally in mental health services research, with previous studies indicating good content validity and internal consistency (α = .88) in people with mental illness in Hong Kong (Chien et al., 2015). A higher score suggests a greater level of psychopathology.

    .

    Measured: Change from baseline assessment to 12 weeks post-intervention

  5. Perceived quality of life

    The 26-item Chinese version of the World Health Organization Quality of Life-BREF will be adopted to assess the quality of life as perceived by patients, in terms of physical health, psychological health, social relationship and environmental quality of life. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely". Items scores are added to create a summary score (minimum score: 26; maximum score: 130), with higher scores indicate stronger perceptions along with that question item. This instrument was modified from the World Health Organization Quality of Life-100, it has been shown to have satisfactory internal consistency and test-retest reliability among Chinese psychiatric patients (Leung et al., 1997).

    Measured: Change from baseline assessment to 12 weeks post-intervention

Timeline

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

  1. First posted7 Jun 2021
  2. Study start14 Jun 2021
  3. Primary completion31 Aug 2023
  4. Study completion28 Feb 2024

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
Parallel Assignment; repeated-measures 2-arm randomized controlled trial
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04916496
Sponsor's protocol ID
05190027
Status last verified
Jun 2024
First submitted
3 Jun 2021
Last updated
20 Jun 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chong YY, Chien WT, Mou H, Ip CK, Bressington D. Acceptance and Commitment Therapy-based Lifestyle Counselling Program for people with early psychosis on physical activity: A pilot randomized controlled trial. Schizophr Res. 2025 Jan;275:1-13. doi: 10.1016/j.schres.2024.11.007. Epub 2024 Nov 28.

    PubMed 39612765

Questions about this trial

What is this clinical trial studying?

A study testing Acceptance and Commitment Therapy-based lifestyle counselling programme and Healthy lifestyle talk in people with Schizophrenia Spectrum and Other Psychotic Disorders, run by Chinese University of Hong Kong at 1 site in 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical activity (time frame: Change from baseline assessment to 12 weeks post-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 NCT04916496, which also lists 1 linked publication.

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 20 Jun 2024.

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