<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04435405</url>
  </required_header>
  <id_info>
    <org_study_id>149/20</org_study_id>
    <nct_id>NCT04435405</nct_id>
  </id_info>
  <brief_title>Micro-Analysis of Processes in a Group Music Therapy for People Living With MHC in the Community</brief_title>
  <official_title>Micro-Analysis of Processes in a Group Music Therapy for People Living With Mental Health Conditions in the Community: a Quantitative Single-Cases Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Haifa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Haifa</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      People with mental health conditions (MHC) often face significant barriers in obtaining&#xD;
      personal valued social roles and feeling a sense of belonging to their community. With the&#xD;
      growing emphasis on community integration, and the fact that the vast majority of people with&#xD;
      MHC live in the community, there is an effort to develop interventions and services which&#xD;
      focus on recovery, wellbeing, and community integration, to reclaim &quot;right to a safe,&#xD;
      dignified, and personal and gratifying life in the community despite his or her psychiatric&#xD;
      condition&quot; (Davidson, Tondora, Lawless, O'Connell, &amp; Rowe, 2009, p.11).Music therapy (MT) has&#xD;
      been practiced for many decades with growing evidence for its effectiveness in different&#xD;
      populations, including people with MHC. Music has pivotal influences on socialization and in&#xD;
      building inter-personal skills and has the potential to be effective as a community-based&#xD;
      therapeutic approach in bringing people together in a shared experience, an important step&#xD;
      towards integration back to the community. MT encourages verbal and non-verbal interactions&#xD;
      and offers opportunity to practice interpersonal skills, build relationships and peruse&#xD;
      common goals.&#xD;
&#xD;
      The proposed study has a potential to shed additional light on the processes of recovery in&#xD;
      people living in the community with MHC who are participating in group CoMT. Although the&#xD;
      study will pinpoint to the domains where MT was mostly studied before (social skills, group&#xD;
      cohesion and emotional expression), it is unique in two main aspects:&#xD;
&#xD;
        1. Majority of previous MT studies on people with MHC were testing short-term MT&#xD;
           interventions in in-patient brief settings. This has limited significance in&#xD;
           understanding the generalization of MT into everyday life and promoting wellbeing. In&#xD;
           the proposed study, on the other hand, I will try to evaluate the significance of&#xD;
           recovery-oriented long-term group CoMT in the community, where most people live,&#xD;
           focusing on behavioral domains where MT is expected to benefit most: The client's social&#xD;
           skills development, group cohesion and emotional expression (affect improvement).&#xD;
&#xD;
        2. This study, to my knowledge, is the first that is based on longitudinal quantitative&#xD;
           micro-analysis of filmed video sessions. This approach bypasses the participants&#xD;
           subjective reaction to a qualitative interview (which by itself is important) allowing&#xD;
           an additional un-biased angle of observation on the interaction process (assuming that&#xD;
           the participants may ignore the presence of the video camera over time).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was an exploratory, retrospective, quantitative, longitudinal single-cases study.&#xD;
&#xD;
      The study was designed to observe the development of different behavioral, emotional, social&#xD;
      and musical domains as well as the development of group cohesion during 9 months of weekly&#xD;
      group CoMT. These behaviors were chosen since they can serve as indicators for satisfying&#xD;
      social recovery and wellbeing (Wilson et al., 2008; Tew et al., 2012; Solli et&#xD;
      al.,2013;Jetten et al., 2014 ; Solli, 2015), can build up gradually through group meetings,&#xD;
      and can simply be observed and quantified.&#xD;
&#xD;
      For this, video recorded sessions were quantitively micro-analyzed by 2 scales: one that&#xD;
      tests individual participants performance, the second tests the group performance as a whole.&#xD;
      The scales score several behavioral domains, focusing on social skills, affect and group&#xD;
      cohesion.&#xD;
&#xD;
      Ethical considerations: The study protocol and informed consent form (ICF) were approved,&#xD;
      prior to data collection, by the ethics committee for the evaluation of research with human&#xD;
      subjects of the faculty of social welfare &amp; health sciences, Haifa University, Israel.&#xD;
      Participants were informed on the study, its purposes, design, and conduct both orally and by&#xD;
      explanation leaflet. Following this, all participants signed an ICF. Participant&#xD;
      confidentiality was maintained at all times. Confidential private data was not exposed in the&#xD;
      video recordings.&#xD;
&#xD;
      Data, including the video films, were stored and handled securely, and were destroyed upon&#xD;
      study completion.&#xD;
&#xD;
      The study was registered in ClinicalTrials.gov (XXX). The data collected in this study in&#xD;
      available as a supplementary document to this manuscript.&#xD;
&#xD;
      Participants and setting The study involved eight adult individuals (20-65 years old) of both&#xD;
      genders, who are long term service-users with MHC (schizophrenia and schizoaffective&#xD;
      disorders). The participants took part in a weekly community music therapy group in &quot;Enosh&quot;&#xD;
      community center. The declared goal of this CoMT group was defined as a music therapy project&#xD;
      based on individual and group work, that invites the participants to share and express&#xD;
      emotional and daily life experiences through singing, improvising, playing instruments and&#xD;
      creating original songs.&#xD;
&#xD;
      All group participants were eligible to be included to the study. The participants had a&#xD;
      strong interest in music, although it was not an inclusion criterion. The participants had no&#xD;
      previous music experience. Only participants whose behavior was fully captured in all&#xD;
      video-recordings were included in the individual behavior analysis, thus four out of the&#xD;
      eight individuals fulfilled this criterion and their behaviors were analyzed.&#xD;
&#xD;
      The CoMT sessions were co-facilitated by a certified music therapist, trained for community&#xD;
      music therapy practice, and a psychiatrist. Both the music therapist and the psychiatrist&#xD;
      received ongoing advanced training from a senior music therapist experienced in the field of&#xD;
      CoMT.&#xD;
&#xD;
      The CoMT group followed a pre-defined protocol and the extent to which the delivery of the&#xD;
      intervention adheres to the protocol was monitored. This was done on two levels: individual&#xD;
      and group. The music therapist performed weekly individual sessions, which included original&#xD;
      song-writing based on the preferences of the participant, to explore if the CoMT meets the&#xD;
      participant's goals, needs and expectations. On the group level, a wide variety of musical&#xD;
      engagement were involved, including free improvisations, singing from song-books and the&#xD;
      participant's original songs, and playing instruments. In addition, periodic discussions were&#xD;
      held after the sessions to explore if the group goals were met and changes were applied&#xD;
      accordingly.&#xD;
&#xD;
      Data analysis method Longitudinal video micro-analysis was performed on the video films to&#xD;
      answer the main research question: whether recovery-oriented long-term group CoMT be&#xD;
      beneficial in social skills development, group cohesion and affect improvement. According to&#xD;
      Wigram, and Wosch (2007), video microanalysis is a comprehensive and a powerful tool when&#xD;
      investigating aspects related to interaction and communication. Assessment of video films&#xD;
      have successfully been used before to explore the long-term effects of psychotherapeutic&#xD;
      interventions in people with MHC (Isbell, Thorne and Lawler 1992; Lee and McFerren 2015;&#xD;
      Wang, Yang and Yu 2018).&#xD;
&#xD;
      Five MT sessions, out of 30 filmed during the course of group music therapy were selected for&#xD;
      the study: baseline (at the beginning of the course), after two, four and five months and at&#xD;
      the end of the course (9 months).&#xD;
&#xD;
      Video recording micro-analysis was based on two scales: the first for individual participant&#xD;
      assessment - Individual Behavior Observation Categorization Scale, (Mercadal-Brotons,2014)&#xD;
      the second for group assessment - Group Environmental Scale (Isbell, Thorne and Lawler 1992;&#xD;
      Lee and McFerren 2015; Wang, Yang and Yu 2018).&#xD;
&#xD;
      Assessment was carried out by three blinded raters (blinded to the timepoint of the filmed&#xD;
      session) for the group analysis and by one blinded rater for the individual analysis. In&#xD;
      order to reduce inter-rater variability, the raters were trained on the use of the group&#xD;
      analysis scale in analyzing videos (which were not from those intended for the study&#xD;
      evaluation). The training continued until raters consent was achieved.&#xD;
&#xD;
      The study was planned with a small sample size, underpowered to conclusively confirm or&#xD;
      disconfirm beneficial effects of CoMT in this group of people, but adequate to probe for&#xD;
      signal of potential benefit for future large-scale confirmatory study design.&#xD;
&#xD;
      Statistical analysis was carried out by the F test with N=4 (# of time points), force zero&#xD;
      intercept, 3 degrees of freedom to identify if there was statistically significant difference&#xD;
      over time. This statistical test evaluates the change between each time point to the&#xD;
      baseline.&#xD;
&#xD;
      The Scales&#xD;
&#xD;
      Scale to assess individual performance&#xD;
&#xD;
      The Individual Behavior Observation Categorization Scale (IBOC scale):&#xD;
&#xD;
      The IBOC scale is an appraisal method that measures behavior against levels of performance&#xD;
      and also measures the frequency with which the behaviors occur. It is commonly used in the&#xD;
      medical arena, as well as job performance in school and work environments, and other uses. In&#xD;
      brief, the instruments of IBOC is either ordinal scale questionnaire and/or counting the&#xD;
      frequency of the tested behavior. The scale was successfully used before to analyze videos of&#xD;
      MT sessions in dementia patients, and music participation behaviors were adopted into the&#xD;
      scale (Sole et al., 2014).&#xD;
&#xD;
      The scale tests 5 behavioral categories which are simple to quantify in a video film&#xD;
      (Mercadal-brotons,2014). Each of these categories is further divided into sub-categories:&#xD;
      Verbalization, Physical contact, Visual contact (gaze), Active participation in music&#xD;
      activities, and Emotions/facial affect and body expressions.&#xD;
&#xD;
      The rater quantified the number of specific events that the tested individuals exhibited, for&#xD;
      example, how many times in the session the individual had visual contacts with other&#xD;
      participants. A behavior category score is the sum of all the sub-categories of the score.&#xD;
      The whole session lasts 1 hours and the assessment was carried out between minute 23-46&#xD;
      (overall 23 minutes of each session). This time frame was suggested by the music therapist as&#xD;
      it represents the time frame were the musical activity is the most pronounced during the&#xD;
      meeting.&#xD;
&#xD;
      The IBOC scale is highly relevant to the study as it focuses on the domains of social skills&#xD;
      and group cohesion, participation in music activity, and affect (emotional expression):&#xD;
&#xD;
        -  Social skills and group cohesion = Verbalization, Physical contact, Visual contact&#xD;
           (gaze) and Active participation in music activities.&#xD;
&#xD;
        -  Participation in music activity = to assess the degree of engagement in singing, playing&#xD;
           instruments, music listening &amp; improvisation.&#xD;
&#xD;
        -  Affect = Emotional expression.&#xD;
&#xD;
      Repeating the micro-analysis in 5 time points enabled a longitudinal analysis of the CoMT&#xD;
      process on the chosen participants.. A test for regression slope (the F test) was used to&#xD;
      assess whether a trend of improvement is demonstrated per category per participant over time.&#xD;
      The H0 assumed no change in score.&#xD;
&#xD;
      Scale to assess group performance Group Environmental Scale (GES) In brief, the GES offers a&#xD;
      quantitative method for assessing intervention support groups (Moos RH 1994). The GES has (1)&#xD;
      psychometrically established reliability, factor structure, content, and construct validity&#xD;
      (2) has generic applicability to different types of groups from different settings, (3) has&#xD;
      subscales theoretically matching most support group objectives and expands into &quot;leader&quot; and&#xD;
      &quot;systems maintenance&quot; dimensions, and (4) is brief, taking short time to complete 90&#xD;
      true/false items on an answer form, with additive responses easily converted into a 9-point&#xD;
      interval scale for standardized scoring. GES was originally designed to be rated by group&#xD;
      members. To make it suitable for external rating, we slightly altered the wording of the&#xD;
      questions without changing their meanings.&#xD;
&#xD;
      GES was used before to analyze different group interventions and group environments including&#xD;
      in mental health patients (Lavoie 1981; Isbell, Thorne, Ph, Lawler, &amp; Ed, 1992).&#xD;
&#xD;
      GES evaluates 10 &quot;group environment&quot; subscales: Cohesion, Leader (therapist) support,&#xD;
      Expressiveness, Independence, Task orientation, Self-discover, Anger and aggression, Order&#xD;
      and organization, Leader control, and Innovation.&#xD;
&#xD;
      Each subclass has 9 Yes/No questions (total of 90 questions). The rater watches the video and&#xD;
      at the end answers the 90 questions. &quot;Yes&quot;- scores 1, &quot;No&quot; - score 0, and each subclass score&#xD;
      is the total score of its 9 questions.&#xD;
&#xD;
      The GES is highly relevant to the study as it focuses on group cohesion domains as follows:&#xD;
&#xD;
        -  Relationship = Cohesion, leader support, Expressiveness.&#xD;
&#xD;
        -  Personal Growth = Independence, Task orientation, Self-discovery, ( - ) Aggression.&#xD;
&#xD;
        -  System maintenance and change = Order and organization, Leader control, Innovation.&#xD;
&#xD;
      Repeating the micro-analysis in the different time points enabled a longitudinal analysis of&#xD;
      the CoMT process on the group.&#xD;
&#xD;
      The F test for regression slope was used to assess whether a trend of improvement is&#xD;
      demonstrated per domain over time. The H0 assumes no change in score.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 1, 2020</start_date>
  <completion_date type="Actual">May 25, 2020</completion_date>
  <primary_completion_date type="Actual">May 15, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the score of the Group Environmental Scale within 9 months</measure>
    <time_frame>9 months</time_frame>
    <description>Social skills, group cohesion and affect improvement change from baseline to nine months is evaluated by the Group Environmental Scale. The minimal score is &quot;0&quot; and the maximal score is &quot;90&quot; while the higher score indicates a better outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the score of the active participation in musical activities section of the Individual Behavior Observation Categorization Scale within 9 months.</measure>
    <time_frame>9 months</time_frame>
    <description>Musical activities improvement change from baseline to nine months is evaluated by the musical activities section of the Individual Behavior Observation Categorization Scale. The score is based on counting the frequency of the activities with a minimal frequency of &quot;0&quot;. The higher the score, the better outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the score of the Individual Behavior Observation Categorization Scale within 9 months.</measure>
    <time_frame>9 months</time_frame>
    <description>The improvement change of social skills and affect from baseline to nine months is evaluated by the total score of the Individual Behavior Observation Categorization Scale. The score is based on counting the frequency of the activities with a minimal frequency of &quot;0&quot;. The higher the score, the better outcome.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">8</enrollment>
  <condition>Mental Health Disorders</condition>
  <arm_group>
    <arm_group_label>Video microanalisys</arm_group_label>
    <description>Video footage analysis of group and individual behavioral processes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational</intervention_name>
    <description>video footage analysis of group and individual behavioral processes.</description>
    <arm_group_label>Video microanalisys</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study involves adult individuals , who are long term service-users with Mental Health&#xD;
        Conditions . The participants take part in a weekly community music therapy group in&#xD;
        community center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All group participants are eligible to be included to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Only participants whose behavior is fully captured in all video-recordings are to be&#xD;
             included in the individual behavior analysis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Haifa</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 11, 2020</study_first_submitted>
  <study_first_submitted_qc>June 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 14, 2020</last_update_submitted>
  <last_update_submitted_qc>June 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Community music therapy</keyword>
  <keyword>Video micro-analysis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>all IPD that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>starting 6 months after publication</ipd_time_frame>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04435405
org study id: 149/20
nct id: NCT04435405
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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).
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.
observational model: Case-Only
time perspective: Retrospective
measure: Change in the score of the Group Environmental Scale within 9 months
time frame: 9 months
description: 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.
measure: Change in the score of the active participation in musical activities section of the Individual Behavior Observation Categorization Scale within 9 months.
time frame: 9 months
description: Musical activities improvement change from baseline to nine months is evaluated by the musical activities section of the Individual Behavior Observation Categorization Scale. The score is based on counting the frequency of the activities with a minimal frequency of "0". The higher the score, the better outcome.
measure: Change in the score of the Individual Behavior Observation Categorization Scale within 9 months.
time frame: 9 months
description: The improvement change of social skills and affect from baseline to nine months is evaluated by the total score of the Individual Behavior Observation Categorization Scale. The score is based on counting the frequency of the activities with a minimal frequency of "0". The higher the score, the better outcome.
arm group label: Video microanalisys
description: Video footage analysis of group and individual behavioral processes.
intervention type: Other
intervention name: Observational
description: video footage analysis of group and individual behavioral processes.
arm group label: Video microanalisys
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Israel
responsible party type: Sponsor
mesh term: Mental Disorders
sharing ipd: Yes
ipd description: all IPD that underlie results in a publication
ipd info type: Study Protocol
ipd info type: Clinical Study Report (CSR)
ipd time frame: starting 6 months after publication