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

Not Applicable

Completed

• Conditions: Schizophrenia Spectrum and Other Psychotic Disorders
• Interventions: Behavioral: Acceptance and Commitment Therapy-based lifestyle counselling programme; Behavioral: Healthy lifestyle talk

• Registration Number: NCT04916496
• Lead Sponsor: Chinese University of Hong Kong

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.

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.

Study Timeline

• Study First Submitted: 2021-06-03
• Study First Submitted QC: 2021-06-03
• Study First Posted: 2021-06-07
• Study Start: 2021-06-14
• Primary Completion: 2023-08-31
• Study Completion: 2024-02-28
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-18
• Last Update Posted: 2024-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ACT-LCP Group	Acceptance and Commitment Therapy-based lifestyle counselling programme	An Acceptance and Commitment Therapy-based healthy lifestyle counselling programme (ACT-LCP) and routine psychiatric outpatient/rehabilitation services of the study hospital.
Control Group	Healthy lifestyle talk	A healthy lifestyle talk and routine psychiatric outpatient/rehabilitation services of the study hospital.

Primary Outcome Measures

Name	Time	Method
Physical activity	Change from baseline assessment to 12 weeks post-intervention	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.

Secondary Outcome Measures

Name	Time	Method
Psychological flexibility	Change from baseline assessment to 12 weeks post-intervention	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).
Healthy dietary intake	Change from baseline assessment to 12 weeks post-intervention	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)
Autonomous motivation	Change from baseline assessment to 12 weeks post-intervention	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).
Mental status	Change from baseline assessment to 12 weeks post-intervention	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.; .
Perceived quality of life	Change from baseline assessment to 12 weeks post-intervention	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).

Trial Locations

Locations (1)

Department of Psychiatry, North District Hospital; 🇭🇰 Sheung Shui, New Territories, Hong Kong