NCT04435405

Brief Summary

People with mental health conditions (MHC) often face significant barriers in obtaining personal valued social roles and feeling a sense of belonging to their community. With the growing emphasis on community integration, and the fact that the vast majority of people with MHC live in the community, there is an effort to develop interventions and services which focus on recovery, wellbeing, and community integration, to reclaim "right to a safe, dignified, and personal and gratifying life in the community despite his or her psychiatric condition" (Davidson, Tondora, Lawless, O'Connell, \& Rowe, 2009, p.11).Music therapy (MT) has been practiced for many decades with growing evidence for its effectiveness in different populations, including people with MHC. Music has pivotal influences on socialization and in building inter-personal skills and has the potential to be effective as a community-based therapeutic approach in bringing people together in a shared experience, an important step towards integration back to the community. MT encourages verbal and non-verbal interactions and offers opportunity to practice interpersonal skills, build relationships and peruse common goals. The proposed study has a potential to shed additional light on the processes of recovery in people living in the community with MHC who are participating in group CoMT. Although the study will pinpoint to the domains where MT was mostly studied before (social skills, group cohesion and emotional expression), it is unique in two main aspects:

  1. 1.Majority of previous MT studies on people with MHC were testing short-term MT interventions in in-patient brief settings. This has limited significance in understanding the generalization of MT into everyday life and promoting wellbeing. In the proposed study, on the other hand, I will try to evaluate the significance of recovery-oriented long-term group CoMT in the community, where most people live, focusing on behavioral domains where MT is expected to benefit most: The client's social skills development, group cohesion and emotional expression (affect improvement).
  2. 2.This study, to my knowledge, is the first that is based on longitudinal quantitative micro-analysis of filmed video sessions. This approach bypasses the participants subjective reaction to a qualitative interview (which by itself is important) allowing an additional un-biased angle of observation on the interaction process (assuming that the participants may ignore the presence of the video camera over time).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 25, 2020

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

June 11, 2020

Last Update Submit

June 14, 2020

Conditions

Keywords

Community music therapyVideo micro-analysis

Outcome Measures

Primary Outcomes (1)

  • Change in the score of the Group Environmental Scale within 9 months

    Social skills, group cohesion and affect improvement change from baseline to nine months is evaluated by the Group Environmental Scale. The minimal score is "0" and the maximal score is "90" while the higher score indicates a better outcome.

    9 months

Secondary Outcomes (2)

  • Change in the score of the active participation in musical activities section of the Individual Behavior Observation Categorization Scale within 9 months.

    9 months

  • Change in the score of the Individual Behavior Observation Categorization Scale within 9 months.

    9 months

Study Arms (1)

Video microanalisys

Video footage analysis of group and individual behavioral processes.

Other: Observational

Interventions

video footage analysis of group and individual behavioral processes.

Video microanalisys

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study involves adult individuals , who are long term service-users with Mental Health Conditions . The participants take part in a weekly community music therapy group in community center.

You may qualify if:

  • All group participants are eligible to be included to the study

You may not qualify if:

  • Only participants whose behavior is fully captured in all video-recordings are to be included in the individual behavior analysis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Haifa

Haifa, Israel

Location

MeSH Terms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2020

First Posted

June 17, 2020

Study Start

March 1, 2020

Primary Completion

May 15, 2020

Study Completion

May 25, 2020

Last Updated

June 17, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
starting 6 months after publication

Locations