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eMove - Dance/Movement Therapy Study

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dance/movement therapy (eMove)
Sponsored by
Drexel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Dance/movement therapy, Creative arts therapies, Telehealth dance/movement therapy, Non-pharmacological intervention, Online intervention, Psychosocial functioning

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Drexel University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dance/movement therapy

Arm Description

Ten weekly 60-minute individual dance/movement therapy telehealth sessions (eMove).

Outcomes

Primary Outcome Measures

Recruitment rates
Proportion of participants enrolled relative to total trial referrals
Consent rates
Proportion of participants consented relative to total trial referrals
Attrition rates
Proportion of participants who dropped-out/withdrawn relative to total enrolled including reason for drop-out/withdrawal
Treatment compliance
Number of participants who completed 10 eMove sessions
Treatment acceptance
Exit interview based on an interview protocol developed by the researcher
Measurement completion
Proportion of participants who complete questionnaires
Measurement burden
Ease to understand, quantity of questions, and fatigued experienced while completing the outcome assessments will be assessed during exit interview
Treatment Fidelity
Treatment fidelity questionnaire developed by the researcher; (range: 1 to 25 items; A total score of 80% and higher reflects adequate treatment fidelity).
Negative Symptoms (Self-report)
Measured by Self-evaluation of Negative Symptoms (SNS), a self-assessment of 20 items, allowing patients to evaluate themselves on the five dimensions of negative symptoms: social withdrawal, emotional range, alogia, avolition, and anhedonia. Each item is scored as either 2 (strongly agree), 1 (somewhat agree), or 0 (strongly disagree). The total score is the sum of the 20 items, ranging from 0 (no negative symptoms) to 40 (severe negative symptoms).
Negative Symptoms (Clinical assessment)
Measured by Brief Negative Symptom Scale (BNSS) is a 13-item instrument, organized into 6 subscales, that asses negative symptoms (anhedonia, distress, asociality, avolition, blunted affect, and alogia). Items are scored on a 0 to 6 scale, with 0 indicating the symptom is absent and 6 indicating the symptom is severe. Items are summed for a total score that ranges between 0 and 78. The BNSS is administered as a semi-structured interview.
Functional impairment (Self-report)
Measured by Sheehan Disability Scale (SDS), a 3 items self-report questionnaire assessing the extent that symptoms have caused the functional impairment in three inter-related domains; work/school, social and family life. The 3 items are measured on a 10 point visual analog scale. A single score of 5 or greater on any of the three scales are associated with significant functional impairment. The 3 items can also be summed into a single dimensional measure of global functional impairment that rages from 0 (unimpaired) to 30 (highly impaired).
Health and disability (Self-report)
Measured by World Health Organization - Disability Assessment Schedule (WHODAS) 2.0 a 36-item self-report questionnaire assessing health and disability across six domains: cognition, mobility, self-care, getting along, life activities and participation. The 36 items are rated on a five-point Likert scale. The total score ranges from 0 to 100, higher scores representing greater disability.
Movement assessment (Clinical assessment)
Measured by Movement Psychodiagnostic Inventory's (MPI) Action Inventory for Movement Session, an 15-item inventory measuring participation, self-related actions, eye contact, orientation, movement changes, types of interaction, torso/limb configurations while moving. (range: 0-2; higher scores reflect less action (higher severity in movement))

Secondary Outcome Measures

Patient Perception of Change (Self-report)
Measured by Patient's Global Impression of Change (PGIC) scale, a single item self-report scale (range: 1 (No change) to 7 (a great deal better)).
Psychosocial Illness Impact (Self-report)
Measured by PROMIS® Psychosocial Illness Impact - Negative - Scale, a 5-point (from 1= Not at all to 5= Very much) rating scale is used in each of the 8 items; higher results mean more severe illness impact on functioning.
Affect (Self-report)
Measured by PROMIS® Positive Affect Scale, A 5-point (from 1= Not at all to 5= Very much) rating scale is used in each of the 7 items; higher results mean better positive affect.
Clinical Global Impression - Severity of Illness (Clinical assessment)
Measured by Clinical Global Impression (Severity of Illness [CGI-S]) is a single item 7-point scale measure of severity of illness. Range of responses from 1 (normal) through to 7 (amongst the most severely ill patients).
Clinical Global Impression - Global Improvement (Clinical assessment)
Measured by Clinical Global Impression (Measured by Global Improvement [CGI-I]) is a single item 7-point scale measure of global improvement. Range of responses from 1 (very much improved) through to 7 (very much worse).

Full Information

First Posted
March 14, 2022
Last Updated
January 26, 2023
Sponsor
Drexel University
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1. Study Identification

Unique Protocol Identification Number
NCT05712928
Brief Title
eMove - Dance/Movement Therapy Study
Official Title
The Effects of Telehealth Dance/Movement Therapy on People With Chronic Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 29, 2021 (Actual)
Primary Completion Date
December 31, 2022 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Drexel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
Keywords
Dance/movement therapy, Creative arts therapies, Telehealth dance/movement therapy, Non-pharmacological intervention, Online intervention, Psychosocial functioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dance/movement therapy
Arm Type
Experimental
Arm Description
Ten weekly 60-minute individual dance/movement therapy telehealth sessions (eMove).
Intervention Type
Behavioral
Intervention Name(s)
Dance/movement therapy (eMove)
Intervention Description
Ten weekly 60-minute individual dance/movement therapy telehealth sessions (eMove) delivered by a board-certified dance/movement therapist. eMove treatment protocol integrates movement techniques, creative embodiment, the non-verbal aspects of self-awareness and interpersonal communication in treatment. eMove sessions focus on helping the participant to increase physical activity level, increasing participants' energy levels and motivation to stay active and better cope with everyday activities, improving overall functioning; reducing severity of negative symptoms of schizophrenia; and providing participants with a sense of connection and social support by connecting with a therapist. In addition, sessions are individualized to the participant's presenting needs.
Primary Outcome Measure Information:
Title
Recruitment rates
Description
Proportion of participants enrolled relative to total trial referrals
Time Frame
Baseline
Title
Consent rates
Description
Proportion of participants consented relative to total trial referrals
Time Frame
Baseline
Title
Attrition rates
Description
Proportion of participants who dropped-out/withdrawn relative to total enrolled including reason for drop-out/withdrawal
Time Frame
12 weeks following receipt of treatment
Title
Treatment compliance
Description
Number of participants who completed 10 eMove sessions
Time Frame
12 weeks following receipt of treatment
Title
Treatment acceptance
Description
Exit interview based on an interview protocol developed by the researcher
Time Frame
12 weeks
Title
Measurement completion
Description
Proportion of participants who complete questionnaires
Time Frame
12 weeks following receipt of treatment
Title
Measurement burden
Description
Ease to understand, quantity of questions, and fatigued experienced while completing the outcome assessments will be assessed during exit interview
Time Frame
Through study completion, a maximum of 12 weeks
Title
Treatment Fidelity
Description
Treatment fidelity questionnaire developed by the researcher; (range: 1 to 25 items; A total score of 80% and higher reflects adequate treatment fidelity).
Time Frame
Through study completion, a maximum of 12 weeks
Title
Negative Symptoms (Self-report)
Description
Measured by Self-evaluation of Negative Symptoms (SNS), a self-assessment of 20 items, allowing patients to evaluate themselves on the five dimensions of negative symptoms: social withdrawal, emotional range, alogia, avolition, and anhedonia. Each item is scored as either 2 (strongly agree), 1 (somewhat agree), or 0 (strongly disagree). The total score is the sum of the 20 items, ranging from 0 (no negative symptoms) to 40 (severe negative symptoms).
Time Frame
Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Title
Negative Symptoms (Clinical assessment)
Description
Measured by Brief Negative Symptom Scale (BNSS) is a 13-item instrument, organized into 6 subscales, that asses negative symptoms (anhedonia, distress, asociality, avolition, blunted affect, and alogia). Items are scored on a 0 to 6 scale, with 0 indicating the symptom is absent and 6 indicating the symptom is severe. Items are summed for a total score that ranges between 0 and 78. The BNSS is administered as a semi-structured interview.
Time Frame
Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Title
Functional impairment (Self-report)
Description
Measured by Sheehan Disability Scale (SDS), a 3 items self-report questionnaire assessing the extent that symptoms have caused the functional impairment in three inter-related domains; work/school, social and family life. The 3 items are measured on a 10 point visual analog scale. A single score of 5 or greater on any of the three scales are associated with significant functional impairment. The 3 items can also be summed into a single dimensional measure of global functional impairment that rages from 0 (unimpaired) to 30 (highly impaired).
Time Frame
Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Title
Health and disability (Self-report)
Description
Measured by World Health Organization - Disability Assessment Schedule (WHODAS) 2.0 a 36-item self-report questionnaire assessing health and disability across six domains: cognition, mobility, self-care, getting along, life activities and participation. The 36 items are rated on a five-point Likert scale. The total score ranges from 0 to 100, higher scores representing greater disability.
Time Frame
Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Title
Movement assessment (Clinical assessment)
Description
Measured by Movement Psychodiagnostic Inventory's (MPI) Action Inventory for Movement Session, an 15-item inventory measuring participation, self-related actions, eye contact, orientation, movement changes, types of interaction, torso/limb configurations while moving. (range: 0-2; higher scores reflect less action (higher severity in movement))
Time Frame
Through study completion, a maximum of 12 weeks
Secondary Outcome Measure Information:
Title
Patient Perception of Change (Self-report)
Description
Measured by Patient's Global Impression of Change (PGIC) scale, a single item self-report scale (range: 1 (No change) to 7 (a great deal better)).
Time Frame
post-treatment, week 12 time point
Title
Psychosocial Illness Impact (Self-report)
Description
Measured by PROMIS® Psychosocial Illness Impact - Negative - Scale, a 5-point (from 1= Not at all to 5= Very much) rating scale is used in each of the 8 items; higher results mean more severe illness impact on functioning.
Time Frame
Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Title
Affect (Self-report)
Description
Measured by PROMIS® Positive Affect Scale, A 5-point (from 1= Not at all to 5= Very much) rating scale is used in each of the 7 items; higher results mean better positive affect.
Time Frame
Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Title
Clinical Global Impression - Severity of Illness (Clinical assessment)
Description
Measured by Clinical Global Impression (Severity of Illness [CGI-S]) is a single item 7-point scale measure of severity of illness. Range of responses from 1 (normal) through to 7 (amongst the most severely ill patients).
Time Frame
Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point
Title
Clinical Global Impression - Global Improvement (Clinical assessment)
Description
Measured by Clinical Global Impression (Measured by Global Improvement [CGI-I]) is a single item 7-point scale measure of global improvement. Range of responses from 1 (very much improved) through to 7 (very much worse).
Time Frame
Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joke Bradt, PhD
Organizational Affiliation
Drexel University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Karolina Bryl, PhD
Organizational Affiliation
Drexel Unviersity
Official's Role
Principal Investigator
Facility Information:
Facility Name
Drexel University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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eMove - Dance/Movement Therapy Study

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