AzTrials
AzTrials

AnxietyNCT01633125

Group Music Therapy for Chinese Prisoners

A study testing Group music therapy in people with Anxiety and Depression, run by Aalborg University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

The prevalence of psychological problems is high in prisons. Many prisoners have unmet needs for appropriate treatments. Although pilot studies have suggested music therapy to be a successful treatment modality for prisoners, more rigorous evidence is needed. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Anxiety, Depression, Self-esteem
What is being tested?
Group music therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
192 participants
Where
1 siteChina
Study dates
Apr 2012to Apr 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Without diagnosis of psychotic problems
  • Show a higher level of anxiety or depression level than the average level of the normal population.
  • Have a remaining sentence of 6 months or more from the date of enrollment into the study.

Who cannot join

  • With severe physical diseases
  • With psychotic disorders
  • Intelligence quotient is ≤69 (mild mental retardation)
  • Unable to understand and complete the questionnaires

Trial locations and contacts

1 site in 1 country.

Yong W Fan, Master contact

+86 010 6021 5129

20716934@qq.com

China1 site, 1 recruiting
  • Xin An Prison

    Beijing, Beijing Municipality, 102627

    Recruiting

Other trials in China

About this study

Official title: Group Music Therapy for Chinese Prisoners: A Randomized Controlled Trial

The prevalence of psychological problems is high in prisons. Many prisoners have unmet needs for appropriate treatments. Although pilot studies have suggested music therapy to be a successful treatment modality for prisoners, more rigorous evidence is needed.

This study aims to investigate the effectiveness of group music therapy to improve anxiety, depression, and self-esteem in prisoners. One hundred and ninety two inmates from a Chinese prison will be allocated to two groups through randomisation. The experimental group will participate in biweekly group music therapy for 10 weeks (20 sessions) while the control group will be placed on a waitlist. Anxiety, depression and self-esteem will be measured by self-report scales three times: before, at the middle, and at the end of the intervention. Logs by prisoners and daily behavior observation by trained prison guards will be used as additional information.

This study will increase the knowledge of the effectiveness of group music therapy. Results will be generalizable to Chinese prisons but also internationally. Generalizability to clinical practice will be high, and findings will be able support the further development of music therapy in prison.

Read the detailed description

Objectives

  • The purpose of this study is to examine the effectiveness of group music therapy in prison. Specifically, the investigators aim to determine whether group music therapy is associated with greater improvements in levels of anxiety, depression, and self-esteem among prisoners than the care that is normally provided. Additionally the investigators aim to explore the unique value of music therapy in prison, its potential advantages to other forms of therapy in this setting, and how it can be effectively implemented in the Chinese prison system.

Methods

  • A randomized controlled study with individual assignment of participants to one of two parallel groups will be conducted to determine the effects of group music therapy compared to no treatment.

Participants

  • Inmates from a prison in Beijing, China will be eligible to participate in this study and will be included if they are willing and meet the inclusion criteria detailed below. Recruitment started in April 2012 and will continue until 192 participants have been enrolled during this period.

Interventions

  • Experimental group
  • Participants in the experimental group will take part in biweekly group music therapy for 10 weeks (20 sessions). Each group will be formed by 6 to 8 people, and each session will last for 90 minutes. The sessions will take place in the activity room in the prison. The academically trained music therapist with previous relevant clinical experience will apply receptive and active music therapy techniques. The active techniques will include musical improvisation as a medium to work with participants according to therapeutic goals and participants' needs. The music therapist has a background in both psychodynamic and humanistic approaches, but will apply existential-humanistic oriented approaches to work with the participants of this study. Taking into account factors such as the limited duration of the intervention, the outcomes of this study, and the group setting of the intervention, the humanistic framework is felt to be more suitable for this study than a psychodynamic framework. Specifically, the outcomes including emotions and self-esteem are closely related to the humanistic approach. The therapist will focus on creating a favorable and respectful environment, building trustful and authentic relationships between the therapist and group members, and increasing their self-awareness, encouraging the participants' expression and sharing of emotions.

The first three sessions will be introductory sessions. The music therapist will introduce the goals of music therapy, three techniques of music therapy (improvisation, song writing, and music imagery), and discuss how these approaches can help the group. Each the following session will start with a discussion on the focus of the group (the thoughts, emotions, or topics which the group wants to share or explore). Then, the therapist and the group will reach an agreement which music therapy technique should be chosen. The therapist will keep the flexibility of music therapy techniques applied in this study to ensure the result of this research to be closely related to clinical work. In usual clinical work, music therapists tend to apply multiple methods in working with clients. At the end of each session, the group members will reflect on the music therapy activity through verbal discussion, drawing, or other musical experiences (such as another improvisation, singing a song together, or movement in music) to bring the session to a closure.

  • Control group
  • Participants assigned to the control group will not receive any specific treatment in this study. The usual care that is normally available at the prison will continue to be available for all participants during the study. This may include medical care and psychological/psychotherapeutic care. The rate of psychotherapy is usually very low, except in case of any extreme events (such as suicidal behavior, severe outbursts of anger, or fights with other prisoners). All prisoners will normally have a psychological class together. Data will be collected of how many participants in each group received other therapies during the study. Due to ethical considerations, the control group will receive group music therapy or psychotherapy by academically qualified therapists for 5 weeks after the study is finished.

Study Design

The investigators will allocate participants individually to the interventions using a computer-generated randomization list. Randomization will be balanced within prison departments to ensure equal sizes of intervention groups. This will not compromise allocation concealment because eligible participants from one department will be randomized simultaneously (rather than entering the study successively one by one). A person who has no direct contact with participants will conduct the randomization so that concealment of allocation can be assured before the intervention.

Because of the scarcity of qualified music therapists in Chinese prisons, the first author will also be the music therapist to execute intervention. An advantage of this double role may be that this experience will allow her to be closely involved in the therapy process and to closely observe and experience changes in the participants. This vivid process will facilitate the interpretation of the data because it will help to understand any unexpected results through the therapist's experience and observation from the music therapy sessions. The quality of the therapy will be ensured through weekly supervision with an experienced music therapist. A qualified psychotherapist will be trained to help the participants to complete the self-report scales. This person will ensure that participants understand the questions and complete the questionnaire correctly, but will not be involved in the therapy and will be instructed not to influence the participants in their ratings. The behavioral observations will be collected by the prison guards who will be unaware of the purpose of this study.

Outcomes of this study will be assessed at pre-test (before randomization; these measurements will also be used to screen participants), at the mid-point of the intervention (after 5 weeks) and at post-test (after 10 weeks). A longer follow up investigation is not possible because participants in the control group will be offered therapy after post-test.

Being tested
Group music therapy
Keywords
Group music therapy, prisoners, Anxiety, Depression, Self-esteem
Medical subject headings
Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group music therapyOther

    Also called Music imagery, Song writing, Improvisation

    The academically trained music therapist with previous relevant clinical experience will apply receptive and active music therapy techniques. The receptive methods will include music imagery,The active techniques will include musical improvisation and song writing.

Study groups in NCT01633125
Study groupRoleWhat they receive
Group music therapyExperimentalParticipants in the experimental group will take part in biweekly group music therapy for 10 weeks (20 sessions). Each group will be formed by 6 to 8 people, and each session will last for 90 minutes.The academically trained music therapist with previous relevant clinical experience will apply receptive and active music therapy techniques. The active techniques will include musical improvisation as a medium to work with participants according to therapeutic goals and participants' needs.
Receives: Other: Group music therapy
No music therapyNo interventionParticipants assigned to the control group will not receive any specific treatment in this study. The usual care that is normally available at the prison will continue to be available for all participants during the study.Due to ethical considerations, the control group will receive group music therapy or psychotherapy by academically qualified therapists for 5 weeks after the study is finished.
Receives: Other: Group music therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in State Trait Anxiety Inventory at 10 weeks

    Anxiety will be measured with the State Trait Anxiety Inventory (STAI). The STAI contains two subscales that are relatively similar, and a qualified person will be present to make sure the participants understand the difference between them. The first subscale measures state anxiety (reflecting the current level of anxiety which can change quickly), whereas the second measures trait anxiety (reflecting anxiety as a more general trait that may also change over time but is more lasting than state anxiety).

    Measured: Baseline and 10 weeks

  2. Change from baseline in State Trait Anxiety Inventory at 20 weeks

    Measured: Baseline and 20 weeks

Secondary outcomes (6)
  1. Change from baseline in Beck Depression Inventory at 10 weeks

    Depression will be assessed using the Beck Depression Inventory (BDI). This instrument consists of 21 items; the score of each item ranges from 0 to 3, producing a total range from 0 to 63, with higher scores indicating greater depression. BDI has become one of the most widely used instruments not only for assessing the intensity of depression in psychiatric patients, but also for detecting depression in normal populations.

    Measured: Baseline and 10 weeks

  2. Change from baseline in Beck Depression Inventory at 20 weeks

    Measured: Baseline and 20 weeks

  3. Change from baseline in Rosenberg Self-esteem Inventory at 10 weeks

    Self-esteem will be assessed as a secondary outcome. It will be assessed using two self-report scales, the Rosenberg Self-esteem Inventory (RSI) and the Texas Social Behavior Inventory (TSBI). RSI and TSBI measure global self-esteem and social self-esteem, respectively.

    Measured: Baseline and 10 weeks

  4. Change from baseline in Rosenberg Self-esteem Inventory at 20 weeks

    Measured: Baseline and 20 weeks

  5. Change from baseline in Texas Social Behavior Inventory at 10 weeks

    Self-esteem will also be assessed as a secondary outcome. It will be assessed using two self-report scales, the Rosenberg Self-esteem Inventory (RSI) and the Texas Social Behavior Inventory (TSBI). RSI and TSBI measure global self-esteem and social self-esteem, respectively.

    Measured: Baseline and 10 weeks

  6. Change from baseline in Texas Social Behavior Inventory at 20 weeks

    Measured: Baseline and 20 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Jul 2012 (estimated)
  2. Study startApr 2012
  3. Primary completionApr 2013 (estimated)
  4. Study completionApr 2014 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
192 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01633125
Sponsor's protocol ID
Aau-1
Status last verified
Jun 2012
First submitted
25 Jun 2012
Last updated
4 Jul 2012
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Group music therapy in people with Anxiety and Depression, run by Aalborg University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Yong W Fan, Master (+86 010 6021 5129, 20716934@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in State Trait Anxiety Inventory at 10 weeks (time frame: Baseline and 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2012.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in