Mindfulness RCT for Early Psychosis

NCT02244970 | Unknown

• 1 other identifier: MIND2014
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Mindfulness; Depressive mood; anxiety; early psychosis

Outcome Measures

Primary Outcomes (2)

• Depressive mood

  Depressive mood is measured by the Positive and Negative Symptom Scale Item G2 (PANSS-G2); Calgary Depression Scale for Schizophrenics (CDSS); Depression Anxiety Stress Scale - Depression subscale (DASS-21-D) and Beck Depression Inventory - II (BDI-II).

  19weeks

• Anxiety

  Anxiety is measured by DASS-21 - Anxiety subscale and PANSS item G6.

  19weeks

Secondary Outcomes (3)

• Quality of Life

  19weeks

• Life Functioning

  19weeks

• Mindfulness

  19weeks

Other Outcomes (1)

• Program evaluation

  19weeks

Study Arms (2)

Mindfulness

EXPERIMENTAL

Subjects are scheduled to receive a 7-week group mindfulness-based intervention (MBI) program.

Other: Mindfulness

Psychoeducation

ACTIVE COMPARATOR

Subjects will receive 7 weeks of group-based psychoeducation as an active comparison group parallel to the mindfulness group.

Other: Psychoeducation

Interventions

Mindfulness OTHER

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.

Mindfulness

Psychoeducation OTHER

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.

Psychoeducation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cantonese-speaking patients aged 18-65, who are service users of the aforementioned community mental health services in Hong Kong.
• diagnosis of Schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, brief psychotic disorder, psychotic disorder not otherwise specified, or manic episodes with psychotic features according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) and less than 5 years' duration since onset of psychosis.
• present with mild depressive or anxiety symptoms (PANSS items G2 or G6 scores higher than or equal to 3; any item on CDSS scores more than or equal to 1).
• They must have an ability to consent, stable positive symptoms (PANSS symptomatic items: P1-P7 scores less than or equal to 3) and good medication compliance (assessed by clinical interview, informant interview, and pill-counting).

You may not qualify if:

• Known organic brain disorder
• Known history of intellectual disability,
• Diagnosed with drug-induced psychosis,
• Practice of mindfulness (in forms of yoga, Tai Chi, etc.) more than twice a week during the previous three months,
• Previous or current substance abuse,
• High risk features associated with acute psychotic episodes, and
• Questionable adherence to medication treatment and follow-up.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Conditions

Psychotic Disorders; Anxiety Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• JingXia Lin, PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JingXia Lin, PhD

CONTACT

jingxia.lin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: September 19, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 19, 2014

Record last verified: 2014-09

Locations

CN (1)