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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-14

Study Completion Date

2024-02-28

Brief Summary

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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.

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Detailed Description

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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

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Schizophrenia Spectrum and Other Psychotic Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment; repeated-measures 2-arm randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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ACT-LCP Group

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

Group Type EXPERIMENTAL

Acceptance and Commitment Therapy-based lifestyle counselling programme

Intervention Type 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.

Control Group

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

Group Type PLACEBO_COMPARATOR

Healthy lifestyle talk

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

1. at least 18 years of age or above
2. able to understand the nature of the study and give informed consent,
3. able to communicate in Cantonese,
4. 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;
5. insufficiently active (i.e., \<150 minutes of MVPA per week) based on self-reports in a brief screening form, and
6. having used mobile instant-messaging apps (e.g. WhatsApp/Facebook messenger/WeChat) installed on a smartphone.

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No