Clinical trial NCT05712928: eMove - Dance/Movement Therapy Study
Official title: The Effects of Telehealth Dance/Movement Therapy on People With Chronic Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Keywords: Dance/movement therapy
Creative arts therapies
Telehealth dance/movement therapy
Non-pharmacological intervention
Online intervention
Psychosocial functioning
Lead sponsor: Drexel University
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Schizophrenia is a chronic and severe mental disorder affecting 20 million people throughout the world and is the fourth leading cause of disability in the developed world. Currently, restrictions due to the COVID-19 pandemic, cause greater social withdrawal, reduced access to social support, lack of motivation, under-activity and loneliness for patients with schizophrenia. Given the prevalence of under-activity, interventions such as dance/movement therapy that use movement and dance to support intellectual, emotional, and motor functions of the body, can optimize the functioning of individuals with schizophrenia. There have been urgent calls for research on telehealth interventions to address the mental health needs caused by COVID-19 pandemic. To address this call, this study will test the feasibility and acceptability of a novel, 10-week dance/movement therapy protocol to promote activation in chronic schizophrenia designed for telehealth delivery. This study will be the first to examine the feasibility and preliminary effects of telehealth dance/movement therapy to promote activation in chronic schizophrenia. This study can contribute towards the development of telehealth interventions for treatment and rehabilitation of individuals with chronic schizophrenia.

Detailed description: Schizophrenia is a chronic and severe mental disorder affecting 20 million people throughout the world and is the fourth leading cause of disability in the developed world. Anhedonia, apathy, social withdrawal, and under-activity are common negative symptoms that have a detrimental impact on patients' overall quality of life. Activation, defined as physical, psychological and social engagement in everyday activities, is one of the most important psychosocial predictors of functional outcomes in people with schizophrenia. Psychosocial interventions designed to decrease negative symptoms and improve activation are considered crucial in the treatment of schizophrenia. Movement/body based interventions are one type of psychosocial interventions that are recommended. Given the prevalence of under-activity, interventions such as dance/movement therapy that focuses on movement behavior, emotional expression and social support, can optimize the functioning of individuals with schizophrenia. In addition, as many people with schizophrenia are treated on an outpatient basis and rarely require hospitalization, COVID-19 restrictions cause greater social withdrawal, reduced access to social support, lack of motivation, under-activity, and loneliness. Dance/movement therapy as a therapeutic holistic approach has unique potential to promote activity engagement in individuals with schizophrenia. Preliminary evidence suggests that dance/movement therapy enhances psychosocial functioning and reduces severity of negative symptoms of schizophrenia however to date no study has examined a telehealth delivery of dance/movement therapy to promote activation in this population. Therefore, the overarching goals of this feasibility study are (1) to evaluate the feasibility, acceptability and credibility of a telehealth dance/movement therapy treatment procedures and research protocol; (2) to assess and improve methodological procedures for conducting a randomized controlled trial (RCT) test of telehealth dance/movement therapy protocol; and (3) to determine preliminary effects of telehealth dance/movement therapy to promote activation in chronic schizophrenia. This feasibility study uses a single-group convergent mixed methods design in which quantitative (survey data) and qualitative (semi-structured exit interviews) data are collected concurrently and analyzed independently; the results are then compared and contrasted. The quantitative strand of the study will be a one-group pre/post-test design. For the qualitative strand, we will conduct semi-structured exit interviews post-intervention. The qualitative data will help to (1) obtain participant feedback on the intervention and its telehealth delivery, and (2) enhance our understanding of the impact of the intervention on activation in chronic schizophrenia.

This is the first study to examine the feasibility and preliminary effects of telehealth dance/movement therapy to promote activation in chronic schizophrenia. The findings from this study will provide (1) important methodological and protocol data and substantive pilot data necessary for the next phase of this line of research (a fully powered RCT to evaluate efficacy of treatment); and (2) will contribute towards the development of telehealth interventions for treatment and rehabilitation of individuals with chronic schizophrenia.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older,
* Schizophrenia or schizoaffective disorder diagnosis,
* Able to speak and write English,
* Able to attend sessions via Zoom (including internet connection and a device with camera).

Exclusion Criteria:

* An organic brain disease or substance abuse as the primary diagnosis,
* A diagnosis of dementia or cognitive impairment that would interfere with competence to consent to participation.

Primary outcomes:
measure: Recruitment rates
timeFrame: Baseline
measure: Consent rates
timeFrame: Baseline
measure: Attrition rates
timeFrame: 12 weeks following receipt of treatment
measure: Treatment compliance
timeFrame: 12 weeks following receipt of treatment
measure: Treatment acceptance
timeFrame: 12 weeks
measure: Measurement completion
timeFrame: 12 weeks following receipt of treatment
measure: Measurement burden
timeFrame: Through study completion, a maximum of 12 weeks
measure: Treatment Fidelity
timeFrame: Through study completion, a maximum of 12 weeks
measure: Negative Symptoms (Self-report)
timeFrame: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
measure: Negative Symptoms (Clinical assessment)
timeFrame: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
measure: Functional impairment (Self-report)
timeFrame: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
measure: Health and disability (Self-report)
timeFrame: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
measure: Movement assessment (Clinical assessment)
timeFrame: Through study completion, a maximum of 12 weeks
Secondary outcomes:
measure: Patient Perception of Change (Self-report)
timeFrame: post-treatment, week 12 time point
measure: Psychosocial Illness Impact (Self-report)
timeFrame: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
measure: Affect (Self-report)
timeFrame: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
measure: Clinical Global Impression - Severity of Illness (Clinical assessment)
timeFrame: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
measure: Clinical Global Impression - Global Improvement (Clinical assessment)
timeFrame: Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Drexel University
state: Pennsylvania
Study officials:
affiliation: Drexel University
name: Joke Bradt, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Drexel Unviersity
name: Karolina Bryl, PhD
role: PRINCIPAL_INVESTIGATOR
References: