NCT04916496

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Schizophrenia Spectrum and Other Psychotic Disorders

Interventions

Type	Name	Description
BEHAVIORAL	Acceptance and Commitment Therapy-based lifestyle counselling programme	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.
BEHAVIORAL	Healthy lifestyle talk	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.

Timeline

• Start date: 2021-06-14
• Primary completion: 2023-08-31
• Completion: 2024-02-28
• First posted: 2021-06-07
• Last updated: 2024-06-20

Locations

1 site across 1 country: Hong Kong