Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04435405 |
| Other study ID # |
149/20 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 1, 2020 |
| Est. completion date |
May 25, 2020 |
Study information
| Verified date |
June 2020 |
| Source |
University of Haifa |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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. 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. 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).
Description:
This was an exploratory, retrospective, quantitative, longitudinal single-cases study.
The study was designed to observe the development of different behavioral, emotional, social
and musical domains as well as the development of group cohesion during 9 months of weekly
group CoMT. These behaviors were chosen since they can serve as indicators for satisfying
social recovery and wellbeing (Wilson et al., 2008; Tew et al., 2012; Solli et
al.,2013;Jetten et al., 2014 ; Solli, 2015), can build up gradually through group meetings,
and can simply be observed and quantified.
For this, video recorded sessions were quantitively micro-analyzed by 2 scales: one that
tests individual participants performance, the second tests the group performance as a whole.
The scales score several behavioral domains, focusing on social skills, affect and group
cohesion.
Ethical considerations: The study protocol and informed consent form (ICF) were approved,
prior to data collection, by the ethics committee for the evaluation of research with human
subjects of the faculty of social welfare & health sciences, Haifa University, Israel.
Participants were informed on the study, its purposes, design, and conduct both orally and by
explanation leaflet. Following this, all participants signed an ICF. Participant
confidentiality was maintained at all times. Confidential private data was not exposed in the
video recordings.
Data, including the video films, were stored and handled securely, and were destroyed upon
study completion.
The study was registered in ClinicalTrials.gov (XXX). The data collected in this study in
available as a supplementary document to this manuscript.
Participants and setting The study involved eight adult individuals (20-65 years old) of both
genders, who are long term service-users with MHC (schizophrenia and schizoaffective
disorders). The participants took part in a weekly community music therapy group in "Enosh"
community center. The declared goal of this CoMT group was defined as a music therapy project
based on individual and group work, that invites the participants to share and express
emotional and daily life experiences through singing, improvising, playing instruments and
creating original songs.
All group participants were eligible to be included to the study. The participants had a
strong interest in music, although it was not an inclusion criterion. The participants had no
previous music experience. Only participants whose behavior was fully captured in all
video-recordings were included in the individual behavior analysis, thus four out of the
eight individuals fulfilled this criterion and their behaviors were analyzed.
The CoMT sessions were co-facilitated by a certified music therapist, trained for community
music therapy practice, and a psychiatrist. Both the music therapist and the psychiatrist
received ongoing advanced training from a senior music therapist experienced in the field of
CoMT.
The CoMT group followed a pre-defined protocol and the extent to which the delivery of the
intervention adheres to the protocol was monitored. This was done on two levels: individual
and group. The music therapist performed weekly individual sessions, which included original
song-writing based on the preferences of the participant, to explore if the CoMT meets the
participant's goals, needs and expectations. On the group level, a wide variety of musical
engagement were involved, including free improvisations, singing from song-books and the
participant's original songs, and playing instruments. In addition, periodic discussions were
held after the sessions to explore if the group goals were met and changes were applied
accordingly.
Data analysis method Longitudinal video micro-analysis was performed on the video films to
answer the main research question: whether recovery-oriented long-term group CoMT be
beneficial in social skills development, group cohesion and affect improvement. According to
Wigram, and Wosch (2007), video microanalysis is a comprehensive and a powerful tool when
investigating aspects related to interaction and communication. Assessment of video films
have successfully been used before to explore the long-term effects of psychotherapeutic
interventions in people with MHC (Isbell, Thorne and Lawler 1992; Lee and McFerren 2015;
Wang, Yang and Yu 2018).
Five MT sessions, out of 30 filmed during the course of group music therapy were selected for
the study: baseline (at the beginning of the course), after two, four and five months and at
the end of the course (9 months).
Video recording micro-analysis was based on two scales: the first for individual participant
assessment - Individual Behavior Observation Categorization Scale, (Mercadal-Brotons,2014)
the second for group assessment - Group Environmental Scale (Isbell, Thorne and Lawler 1992;
Lee and McFerren 2015; Wang, Yang and Yu 2018).
Assessment was carried out by three blinded raters (blinded to the timepoint of the filmed
session) for the group analysis and by one blinded rater for the individual analysis. In
order to reduce inter-rater variability, the raters were trained on the use of the group
analysis scale in analyzing videos (which were not from those intended for the study
evaluation). The training continued until raters consent was achieved.
The study was planned with a small sample size, underpowered to conclusively confirm or
disconfirm beneficial effects of CoMT in this group of people, but adequate to probe for
signal of potential benefit for future large-scale confirmatory study design.
Statistical analysis was carried out by the F test with N=4 (# of time points), force zero
intercept, 3 degrees of freedom to identify if there was statistically significant difference
over time. This statistical test evaluates the change between each time point to the
baseline.
The Scales
Scale to assess individual performance
The Individual Behavior Observation Categorization Scale (IBOC scale):
The IBOC scale is an appraisal method that measures behavior against levels of performance
and also measures the frequency with which the behaviors occur. It is commonly used in the
medical arena, as well as job performance in school and work environments, and other uses. In
brief, the instruments of IBOC is either ordinal scale questionnaire and/or counting the
frequency of the tested behavior. The scale was successfully used before to analyze videos of
MT sessions in dementia patients, and music participation behaviors were adopted into the
scale (Sole et al., 2014).
The scale tests 5 behavioral categories which are simple to quantify in a video film
(Mercadal-brotons,2014). Each of these categories is further divided into sub-categories:
Verbalization, Physical contact, Visual contact (gaze), Active participation in music
activities, and Emotions/facial affect and body expressions.
The rater quantified the number of specific events that the tested individuals exhibited, for
example, how many times in the session the individual had visual contacts with other
participants. A behavior category score is the sum of all the sub-categories of the score.
The whole session lasts 1 hours and the assessment was carried out between minute 23-46
(overall 23 minutes of each session). This time frame was suggested by the music therapist as
it represents the time frame were the musical activity is the most pronounced during the
meeting.
The IBOC scale is highly relevant to the study as it focuses on the domains of social skills
and group cohesion, participation in music activity, and affect (emotional expression):
- Social skills and group cohesion = Verbalization, Physical contact, Visual contact
(gaze) and Active participation in music activities.
- Participation in music activity = to assess the degree of engagement in singing, playing
instruments, music listening & improvisation.
- Affect = Emotional expression.
Repeating the micro-analysis in 5 time points enabled a longitudinal analysis of the CoMT
process on the chosen participants.. A test for regression slope (the F test) was used to
assess whether a trend of improvement is demonstrated per category per participant over time.
The H0 assumed no change in score.
Scale to assess group performance Group Environmental Scale (GES) In brief, the GES offers a
quantitative method for assessing intervention support groups (Moos RH 1994). The GES has (1)
psychometrically established reliability, factor structure, content, and construct validity
(2) has generic applicability to different types of groups from different settings, (3) has
subscales theoretically matching most support group objectives and expands into "leader" and
"systems maintenance" dimensions, and (4) is brief, taking short time to complete 90
true/false items on an answer form, with additive responses easily converted into a 9-point
interval scale for standardized scoring. GES was originally designed to be rated by group
members. To make it suitable for external rating, we slightly altered the wording of the
questions without changing their meanings.
GES was used before to analyze different group interventions and group environments including
in mental health patients (Lavoie 1981; Isbell, Thorne, Ph, Lawler, & Ed, 1992).
GES evaluates 10 "group environment" subscales: Cohesion, Leader (therapist) support,
Expressiveness, Independence, Task orientation, Self-discover, Anger and aggression, Order
and organization, Leader control, and Innovation.
Each subclass has 9 Yes/No questions (total of 90 questions). The rater watches the video and
at the end answers the 90 questions. "Yes"- scores 1, "No" - score 0, and each subclass score
is the total score of its 9 questions.
The GES is highly relevant to the study as it focuses on group cohesion domains as follows:
- Relationship = Cohesion, leader support, Expressiveness.
- Personal Growth = Independence, Task orientation, Self-discovery, ( - ) Aggression.
- System maintenance and change = Order and organization, Leader control, Innovation.
Repeating the micro-analysis in the different time points enabled a longitudinal analysis of
the CoMT process on the group.
The F test for regression slope was used to assess whether a trend of improvement is
demonstrated per domain over time. The H0 assumes no change in score.
