Mindfulness RCT for Early Psychosis

Summary

Depressive mood and anxiety are prevalent in patients suffering from early psychosis. Treatments focused on these dimensions are rarely seen. Meanwhile, growing evidence showed Mindfulness-based intervention (MBI) as an effective option in handling depression and anxiety. There is a great possibility that MBI is also useful in depression and anxiety associating with early psychosis. Given that cost-effectiveness is widely concerned in Hong Kong or any other countries, a brief intervention is more favored. Current paper is a study protocol for a randomized controlled trial which assess the feasibility of a 7-week mindfulness-based intervention in patients with early psychosis targeting on their depressive mood and anxiety.

In this RCT, 60 patients aged 18-65 with early psychosis less than 5 years' duration and mild depressive mood or anxiety will be invited to join this single blind randomized controlled trial. After baseline assessments, eligible participants will be, using third party simple randomization, randomly assigned to either the 7-week Mindfulness-based Intervention (MBI), or the psychoeducation group as control.

The primary outcome is depressive mood and anxiety levels at post-intervention and 3 months. The secondary outcomes include life functioning, quality of life, other general clinical symptoms and mindfulness ability. Qualitative interviews will help evaluate and measure the feasibility of the intervention. Data will be analyzed according to the intention-to-treat principle.

This randomized trial offers an insight into mindfulness-based intervention and its effectiveness on psychosis concomitants. It provides the foundation for future evaluation and implementation of an effective and cost-efficient treatment option.

Conditions

• Psychosis

Interventions

OTHER

Mindfulness

Mindfulness is the awareness that emerges from paying attention to the present moment without judgment. In this study, subject in this arm will receive 7 weeks of MBI with a focus on tackling anxiety, depressed mood, and attention deficits among early psychosis participants. The elements of 7-week program included mindful-breathing, indoor and outdoor mindful-walking, mindful-eating, mindul-drawing, tree-of-life exercise and closing celebration.

OTHER

Psychoeducation

Participants in the psychoeducation group will receive seven weeks of psychoeducation sessions which include basic knowledge related to 1) General mental health, 2) Knowledge of psychosis, 3) Treatment and community resources, 4) Recovery and relapse prevention, 5) Healthy lifestyle, 6) Social skills training, and finally a closing celebration at week 7.

Sponsors & Collaborators

• The University of Hong Kong

  lead OTHER

Principal Investigators

• JingXia Lin, PhD · The University of Hong Kong

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-09-30

Primary Completion

2015-09-30

Completion

2015-09-30

Countries

• China

Study Locations