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DepressionNCT00280319

Study of Treatments for Depression Among Displaced Adolescents in Northern Uganda.

A study testing interpersonal psychotherapy for groups and creative play therapy in people with Depression, run by Boston University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

That interpersonal psychotherapy and creative play therapies can reduce symptoms of depression among adolescents with depressive-type illness in northern Uganda. Read more about this study

Who is it for?
Ages 14 to 17 years
Conditions the study is for
Depression
What is being tested?
interpersonal psychotherapy for groups and creative play therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
338 participants
Where
No sites listed yet
Study dates
May 2005to Dec 2005
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 14 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • aged 14-17 years. living in displaced persons camps in northern Uganda meet study-specific criteria for depression

Who cannot join

  • reported age of less than 14 or older than 17 years does not live in a displaced persons camp

About this study

Official title: Randomized Controlled Study of Non-pharmacologic Treatments for Depression Among Displaced Adolescents in Northern Uganda.

That interpersonal psychotherapy and creative play therapies can reduce symptoms of depression among adolescents with depressive-type illness in northern Uganda.

Read the detailed description

This study represents the third phase of a project aimed at developing, validating, and using locally-relevant assessments of emotional and behavioral problems in Acholi war-affected children to evaluate interventions being delivered by non-governmental organizations in the N. of Uganda. It is positioned to make a unique contribution to the field by both developing culturally appropriate screening and assessment methods and then using them to assess the efficacy of an adapted, manualized treatment both pre-and post-intervention.

The intent of the proposed intervention study is to test the efficacy of group interpersonal psychotherapy (IPT) for treatment of specific psychosocial problems and associated impairment in Acholi IDP adolescents living in the Unyama and Awer camps of Gulu District, Northern Uganda. These interventions represent the existing standard of care provided by NGOs working in this region, but. for tje first time, collaboration of the NGOs in this study will help ensure systematic assessment of participants to investigate the efficacy of interventions being offered.

The proposed research study aims to test the efficacy of a group treatment for emotional and behavioral problems in war-affected adolescents. Emotional and behavioral problems will be assessed using a locally-validated scale of psychosocial problems and functional impairment developed from ethnographic work conducted in the same IDP camps in Gulu District in July 2004. The intervention to be tested will be group interpersonal therapy (IPT) which has shown efficacy for use in treating depression in Ugandan adults In Masaka and Rakai provinces. The decision to use IPT in this IDP population was based on the fact that symptoms similar to depression and comorbid anxiety, for which IPT is indicated, dominated in the ethnographic assessment of emotional and behavioral problems collected in July. Additionally, we have prior direct experience in Uganda that IPT can be easily trained and systematically delivered in a low-resource environment lay practitioners and that it is effective in treating depression. Furthermore, our ethnographic work has resulted in a suitable measure for assessing emotional and behavioral problems in war- affected Acholi youth living in the Northern Uganda for use in screening adolescents into intervention groups. The application of valid instruments to assess psychosocial problems and the degree of impairment both pre and post- intervention will be invaluable to our implementing partners - World Vision/War Child - for developing effective interventions to address the ongoing mental health needs of the young people they serve in Northern Uganda.

Specific Objectives 1. To assess symptoms of locally described depression-like syndromes (Kumu/Par/Two Tam), a local anxiety syndrome (Ma Lwor) and social problems (Gin lugero/tic marac) in Acholi war-affected adolescents using the Acholi Psychosocial Assessment Instrument (APAI), a locally-derived tool for assessment of emotional and behavioral problems in children and youth available in the Luo language.

  1. To randomly assign screened individuals found to have these problems to one of three treatment conditions including: a) group IPT; b) a facilitated arts \& recreation control condition; and c) a wait-list control condition.
  2. To conduct post-intervention testing and comparison of all treatment conditions using the APAI. This will be done immediately after the IPT intervention is completed, and repeated 6 months later.
Conditions
Depression
Being tested
interpersonal psychotherapy for groups, creative play therapy
Keywords
randomized controlled trial, depression, Uganda, adolescents
Medical subject headings
Depression

What participants receive

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

  • interpersonal psychotherapy for groupsBehavioural

    psychotherapy

  • creative play therapyBehavioural

    consisted of play activities

Study groups in NCT00280319
Study groupRoleWhat they receive
IPT armExperimentalinterpersonal psychotherapy for groups (IPT-G). this consists of psychotherapy provided to participants in a group format.
Receives: Behavioral: interpersonal psychotherapy for groups
CP armExperimentalCreative Play therapy consists of play activities provided to participants in groups.
Receives: Behavioral: creative play therapy
controlNo interventionthose who are wait-list controls

What is being measured

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

  1. depression

    adapted depression instrument - HSCL.

    Measured: pre, post and 6 months post treatment

Timeline

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

  1. First posted23 Jan 2006 (estimated)
  2. Study startMay 2005
  3. Primary completionDec 2005
  4. Study completionDec 2005

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
Single blind
Who is masked
Outcomes assessor
Enrolment
338 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00280319
Sponsor's protocol ID
BUWVRCT2
Status last verified
Mar 2017
First submitted
20 Jan 2006
Last updated
14 Mar 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Bolton P, Bass J, Betancourt T, Speelman L, Onyango G, Clougherty KF, Neugebauer R, Murray L, Verdeli H. Interventions for depression symptoms among adolescent survivors of war and displacement in northern Uganda: a randomized controlled trial. JAMA. 2007 Aug 1;298(5):519-27. doi: 10.1001/jama.298.5.519.

    PubMed 17666672

Questions about this trial

What is this clinical trial studying?

A study testing interpersonal psychotherapy for groups and creative play therapy in people with Depression, run by Boston University.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 14 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

depression (time frame: pre, post and 6 months post treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00280319, which also lists 1 linked publication.

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 14 Mar 2017.

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