NCT01633125

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
192

participants targeted

Target at P75+ for not_applicable anxiety

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2012

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 4, 2012

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

July 4, 2012

Status Verified

June 1, 2012

Enrollment Period

1 year

First QC Date

June 25, 2012

Last Update Submit

July 3, 2012

Conditions

Keywords

Group music therapyprisonersAnxietyDepressionSelf-esteem

Outcome Measures

Primary Outcomes (2)

  • 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).

    Baseline and 10 weeks

  • Change from baseline in State Trait Anxiety Inventory at 20 weeks

    Baseline and 20 weeks

Secondary Outcomes (6)

  • Change from baseline in Beck Depression Inventory at 10 weeks

    Baseline and 10 weeks

  • Change from baseline in Beck Depression Inventory at 20 weeks

    Baseline and 20 weeks

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

    Baseline and 10 weeks

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

    Baseline and 20 weeks

  • Change from baseline in Texas Social Behavior Inventory at 10 weeks

    Baseline and 10 weeks

  • +1 more secondary outcomes

Study Arms (2)

Group music therapy

EXPERIMENTAL

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 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.

Other: Group music therapy

No music therapy

NO INTERVENTION

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.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.

Other: Group music therapy

Interventions

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.

Also known as: Music imagery, Song writing, Improvisation
Group music therapyNo music therapy

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xin An Prison

Beijing, Beijing Municipality, 102627, China

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Officials

  • Jing X Chen, Master

    Aalborg University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong W Fan, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Cand. PhD

Study Record Dates

First Submitted

June 25, 2012

First Posted

July 4, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2013

Study Completion

April 1, 2014

Last Updated

July 4, 2012

Record last verified: 2012-06

Locations