eMove - Dance/Movement Therapy Study

NCT05712928 | Completed

• 1 other identifier: 2104008484
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Keywords

Dance/movement therapy; Creative arts therapies; Telehealth dance/movement therapy; Non-pharmacological intervention; Online intervention; Psychosocial functioning

Outcome Measures

Primary Outcomes (13)

• Recruitment rates

  Proportion of participants enrolled relative to total trial referrals

  Baseline

• Consent rates

  Proportion of participants consented relative to total trial referrals

  Baseline

• Attrition rates

  Proportion of participants who dropped-out/withdrawn relative to total enrolled including reason for drop-out/withdrawal

  12 weeks following receipt of treatment

• Treatment compliance

  Number of participants who completed 10 eMove sessions

  12 weeks following receipt of treatment

• Treatment acceptance

  Exit interview based on an interview protocol developed by the researcher

  12 weeks

• Measurement completion

  Proportion of participants who complete questionnaires

  12 weeks following receipt of treatment

• Measurement burden

  Ease to understand, quantity of questions, and fatigued experienced while completing the outcome assessments will be assessed during exit interview

  Through study completion, a maximum of 12 weeks

• 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).

  Through study completion, a maximum of 12 weeks

• 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).

  Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point

• 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.

  Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point

• 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).

  Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point

• 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.

  Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point

• 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))

  Through study completion, a maximum of 12 weeks

Secondary Outcomes (5)

• Patient Perception of Change (Self-report)

  post-treatment, week 12 time point

• Psychosocial Illness Impact (Self-report)

  Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point

• Affect (Self-report)

  Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point

• Clinical Global Impression - Severity of Illness (Clinical assessment)

  Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point

• Clinical Global Impression - Global Improvement (Clinical assessment)

  Change from Baseline Psychosocial Illness Impact at post-treatment (week 12) time point

Study Arms (1)

Dance/movement therapy

EXPERIMENTAL

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

Behavioral: Dance/movement therapy (eMove)

Interventions

Dance/movement therapy (eMove) BEHAVIORAL

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.

Dance/movement therapy

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Drexel University: lead

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Joke Bradt, PhD

  Drexel University

  PRINCIPAL INVESTIGATOR

• Karolina Bryl, PhD

  Drexel Unviersity

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: February 6, 2023
• Study Start: June 29, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: February 6, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)