Dance/Movement Therapy for Bone Mineral Density in Schizophrenia

NCT ID: NCT05716802

Last Updated: 2024-03-08

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-07-07

Study Completion Date

2022-07-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Fractures are common accidents for long-term hospitalized patients with schizophrenia (SZ) in psychiatric hospitals, and once they occur, patients usually endure the pain of fractures for a long time. Accumulating evidence has supported implementing dance/movement therapy (DMT) as a promising intervention for patients with SZ. However, no study has been conducted to investigate its role in balance ability and metabolic parameters in SZ. This study was designed to investigate the treatment outcome of a 12-week DMT intervention on bone mineral density, balance ability, and metabolic profile in patients with SZ using a randomized, controlled trial design.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Schizophrenia (SZ) is a chronic, severe psychiatric disorder that affects approximately 1% of the population. The psychiatric symptoms and high rate of relapse of SZ can significantly impair cognitive and social functioning, including problem-solving skills, interpersonal relationships, and work performance. Moreover, individuals with SZ usually have higher disability and premature mortality rates compared to the general population. Falls are a common concern in hospital settings, with studies reporting a fall rate between three and five falls per 1000 bed days. Osteoporosis and its precursors, e.g. osteopenia and low bone mineral density (BMD), have been reported in chronic patients with SZ and were strong predictors for subsequent falls and fractures in psychiatric hospitals.

Dance/movement therapy (DMT), as one of the creative arts therapies, is an emerging therapy for the rehabilitation of patients with SZ in recent years. DMT therapy uses dance activities and body movements to enhance well-being, mood, and quality of life. DMT therapy uses movement, dance, and interpersonal communication to explore a person's emotional, cognitive, social, and physical integration, enabling patients to enhance self-expression, accept and reconnect with their bodies, and strengthen their fitness. The patients share their emotions, concerns, and coping strategies with others through dance/movement. It can be applied to individuals of all ages, races, and genders and can be efficacious in individuals who experience losses in social, physical, and psychological functions. DMT has also been used to improve the cognition and social function of patients with mental diseases in psychiatric hospitals. In particular, a few studies have reported a critical role of DMT intervention in negative symptoms in chronic patients with SZ. However, there is still a lack of evidence that whether DMT is an effective therapy to increase the mean bone mineral density and reduce the risk of fractures due to falls in long-term hospitalized patients with SZ.

In the present study, the investigators hypothesized that DMT intervention was effective to increase BMD and balance ability and decrease the metabolic parameters in long-term hospitalized male veterans with SZ as compared to the control group. They also examined whether DMT intervention can significantly change BMI, the levels of lipid profile, and serum calcium in patients.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Schizophrenia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

dance/movement therapy (DMT), twice a week, 12 weeks,

The multiple-session DMT intervention was applied to participants twice a week as a total of 24 sessions of 60 minutes over three months. The DMT intervention protocol was developed based on the therapist's experience, the theoretical frameworks, and the DMT approach described in a previous study (Bryl and Goodill 2019).

Group Type ACTIVE_COMPARATOR

dance/movement therapy

Intervention Type BEHAVIORAL

dance/movement therapy plus treat as usual

Treatment as usual (TAU), twice a week, 12 weeks,

The TAU group sessions were conducted by the licensed professional employed at the hospital. The patients received regular daily antipsychotic medication and supportive psychotherapy once a week. They also participated in daily activities from Monday to Friday for at least two hours each day, including indoor activities (watching TV, playing games, playing poker) and outside activities (walking and doing radio gymnastics).

Group Type PLACEBO_COMPARATOR

treatment as usual

Intervention Type BEHAVIORAL

The patients received regular daily antipsychotic medication and supportive psychotherapy once a week. They also participated in daily activities from Monday to Friday for at least two hours each day, including indoor activities (watching TV, playing games, playing poker) and outside activities (walking and doing radio gymnastics).

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

dance/movement therapy

dance/movement therapy plus treat as usual

Intervention Type BEHAVIORAL

treatment as usual

The patients received regular daily antipsychotic medication and supportive psychotherapy once a week. They also participated in daily activities from Monday to Friday for at least two hours each day, including indoor activities (watching TV, playing games, playing poker) and outside activities (walking and doing radio gymnastics).

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Clinical diagnosis of schizophrenia using the DSM-V;
* male veterans, aged 40 to 60 years with a disease duration of 5 years or more and a long-term hospitalization of 3 years or more;
* ability to understand Mandarin Chinese;
* legally eligible to sign an informed consent form;
* current antipsychotic medication stability for more than 2 years;
* reduced bone mass, osteoporosis, and severe osteopenia after bone density analysis;
* no comorbid serious physical illness and physical impairments and can cooperate with nurses to complete the general intensity of activity training;
* consent for pre- and post-session interviews.

Exclusion Criteria

1\) substance dependence or abuse; 2) hypercalcemia and hyperuricemia; 3) history of kidney stones or renal calculi; 4) lower limb injury and motor dysfunction, and inability to complete DMT intervention for various reasons.

\-
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hebei Province Veterans Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hengyong Guan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hengyong Guan, Dr.

Role: STUDY_DIRECTOR

Hebei Province Veterans Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

DMT

Baoding, Hebei, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

xmh123

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.