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

NCT04916496 | Completed DMC

• 1 other identifier: 05190027
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders

Keywords

Acceptance and Commitment Therapy; Randomised Controlled Trial; Lifestyle Counselling Programme; Psychosis; Physical Activity

Outcome Measures

Primary Outcomes (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.

  Change from baseline assessment to 12 weeks post-intervention

Secondary Outcomes (5)

• Healthy dietary intake

  Change from baseline assessment to 12 weeks post-intervention

• Autonomous motivation

  Change from baseline assessment to 12 weeks post-intervention

• Psychological flexibility

  Change from baseline assessment to 12 weeks post-intervention

• Mental status

  Change from baseline assessment to 12 weeks post-intervention

• Perceived quality of life

  Change from baseline assessment to 12 weeks post-intervention

Study Arms (2)

ACT-LCP Group

EXPERIMENTAL

An Acceptance and Commitment Therapy-based healthy lifestyle counselling programme (ACT-LCP) and routine psychiatric outpatient/rehabilitation services of the study hospital.

Behavioral: Acceptance and Commitment Therapy-based lifestyle counselling programme

Control Group

PLACEBO COMPARATOR

A healthy lifestyle talk and routine psychiatric outpatient/rehabilitation services of the study hospital.

Behavioral: Healthy lifestyle talk

Interventions

Acceptance and Commitment Therapy-based lifestyle counselling programme BEHAVIORAL

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.

ACT-LCP Group

Healthy lifestyle talk BEHAVIORAL

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• North District Hospital: collaborator

Study Sites (1)

Department of Psychiatry, North District Hospital

Sheung Shui, New Territories, Hong Kong

Location

Related Publications (1)

• 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.

  PMID: 39612765 DERIVED

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior

Study Officials

• Yuen Yu CHONG, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Outcome assessors and researchers(and health care providers of the study hospital) are blinded to the group assignment and intervention undertaken and concealed to the participant list.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Parallel Assignment; repeated-measures 2-arm randomized controlled trial

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 7, 2021
• Study Start: June 14, 2021
• Primary Completion: August 31, 2023
• Study Completion: February 28, 2024
• Last Updated: June 20, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)