Clinical trial NCT04916496: Acceptance and Commitment Therapy-based Lifestyle Counselling Programme for Early Psychosis on Physical Activity
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia Spectrum and Other Psychotic Disorders
Keywords: Acceptance and Commitment Therapy
Randomised Controlled Trial
Lifestyle Counselling Programme
Psychosis
Physical Activity
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: North District Hospital
First posted: 2021-06-07
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment; repeated-measures 2-arm randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical activity
timeFrame: Change from baseline assessment to 12 weeks post-intervention
Secondary outcomes:
measure: Healthy dietary intake
timeFrame: Change from baseline assessment to 12 weeks post-intervention
measure: Autonomous motivation
timeFrame: Change from baseline assessment to 12 weeks post-intervention
measure: Psychological flexibility
timeFrame: Change from baseline assessment to 12 weeks post-intervention
measure: Mental status
timeFrame: Change from baseline assessment to 12 weeks post-intervention
measure: Perceived quality of life
timeFrame: Change from baseline assessment to 12 weeks post-intervention
Other outcomes:
Locations:
city: Sheung Shui
country: Hong Kong
facility: Department of Psychiatry, North District Hospital
state: New Territories
Study officials:
affiliation: Chinese University of Hong Kong
name: Yuen Yu CHONG, PhD
role: PRINCIPAL_INVESTIGATOR
References: