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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
- 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.
- 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 group | Role | What they receive |
|---|---|---|
| IPT arm | Experimental | interpersonal psychotherapy for groups (IPT-G). this consists of psychotherapy provided to participants in a group format. Receives: Behavioral: interpersonal psychotherapy for groups |
| CP arm | Experimental | Creative Play therapy consists of play activities provided to participants in groups. Receives: Behavioral: creative play therapy |
| control | No intervention | those who are wait-list controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted23 Jan 2006 (estimated)
- Study startMay 2005
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- World Vision
- Responsible party
- Sponsor
- Investigators
- Paul Bolton, MB BS, Principal investigator, Boston University
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Study of Non-pharmacologic Treatments for Depression Among Displaced Adolescents in Northern Uganda.
- ClinicalTrials.gov ID
- NCT00280319
- Acronym / sponsor ID
- BUWVRCT2
- Conditions
- Depression
- Keywords
- randomized controlled trial, depression, Uganda, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- World Vision
- Study start
- May 2005
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 23 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
That interpersonal psychotherapy and creative play therapies can reduce symptoms of depression among adolescents with depressive-type illness in northern Uganda.
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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IPT arm | Experimental | Behavioral: interpersonal psychotherapy for groupsinterpersonal psychotherapy for groups (IPT-G). this consists of psychotherapy provided to participants in a group format. |
| CP arm | Experimental | Behavioral: creative play therapyCreative Play therapy consists of play activities provided to participants in groups. |
| control | No intervention | –those who are wait-list controls |
Who may qualify
- Ages
- 14 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- aged 14-17 years. living in displaced persons camps in northern Uganda meet study-specific criteria for depression
Key exclusion criteria (1 listed)
- reported age of less than 14 or older than 17 years does not live in a displaced persons camp
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interpersonal psychotherapy for groupspsychotherapy | Behavioural | IPT arm |
| creative play therapyconsisted of play activities | Behavioural | CP arm |
Primary outcome
depression
Time frame: pre, post and 6 months post treatment
adapted depression instrument - HSCL.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2017.
- Derived from this study: PubMed 17666672Bolton 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Bolton, MB BS principal investigator
Boston University
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.