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Mental DepressionNCT03966833

Using Group Interpersonal Psychotherapy to Improve the Well-Being of Adolescent Girls

A study testing IPT-G and Unconditional Cash Transfer in people with Mental Depression, run by George Washington University at 1 site in Uganda.

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

Adolescent girls in developing countries face high rates of adversity and are at an elevated risk of depression and other forms of psychological distress. Untreated depression can have negative consequences on life outcomes such as early pregnancies, social exclusion and school dropout. Read more about this study

Who is it for?
Ages 13 to 19 years, women onlyHealthy volunteers can take part
Conditions the study is for
Mental Depression
What is being tested?
IPT-G and Unconditional Cash Transfer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,914 participants
Where
1 siteUganda
Study dates
26 May 2019to 30 Sep 2022
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 13 to 19 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • 13-19 year old female who scores 10 or above on PHQ-8

Who cannot join

  • male
  • Score below 10 on PHQ-8

Trial locations and contacts

1 site in 1 country.

Uganda1 site

  • BRAC Uganda

    Kampala

Other trials in Uganda

About this study

Adolescent girls in developing countries face high rates of adversity and are at an elevated risk of depression and other forms of psychological distress. Untreated depression can have negative consequences on life outcomes such as early pregnancies, social exclusion and school dropout. These can result in a cycle of poverty for young women and their families. Despite this being a very pressing problem there is little evidence on what types of interventions can help break the vicious cycle of poor mental health and poverty.

This research program aims to evaluate, through the use of a cluster-Randomized Control Trial (cluster- RCT), the effect of group-based interpersonal psychotherapy (IPT-G) and unconditional cash transfers on adolescent girls' mental health and social functioning. Working with Strong Minds Uganda in collaboration with BRAC Uganda's Empowerment and Livelihood for Adolescents (ELA) clubs, the evidence generated from this research will create a better understanding of whether adolescent mental health improves through this cost-effective approach, and whether improved mental health impacts other outcomes of interest.

Being tested
IPT-G, Unconditional Cash Transfer
Medical subject headings
Depression

What participants receive

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

  • IPT-GBehavioural

    14 weeks of group-based interpersonal therapy (IPT-G)

  • Unconditional Cash TransferBehavioural

    Lump sum cash transfer

Study groups in NCT03966833
Study groupRoleWhat they receive
group-based interpersonal therapy (IPT-G)Experimental14 weeks of group-based interpersonal therapy (IPT-G): StrongMinds is focused on treating depression in Uganda by training community members (in this case ELA club mentors) to act as mentors in IPT-G techniques. This intervention will be offered to 13-19 year old young women who score a 10 or higher on the PHQ-8. These adolescents who take up the offer will then be enrolled in the 14 weeks of therapy. Group therapy sessions build bonds between young women and encourage them to actively engage in the healing process and to support each other in the exploration of their depression triggers. With new healthier patterns and skills, women can learn to manage their current depression and ensure future depressive episodes can be quickly identified and resolved before the onset of any long-term consequences.
Receives: Behavioral: IPT-G
IPT-G + Unconditional Cash Transfer:ExperimentalA one time lump sum of 200,000 UGX (~$54) be provided to all study participants in a random sub-set of intervention (IPT-G) clusters near or at the conclusion of the 14-week therapy. This treatment variation will allow for determination of whether complimentary income support enhances the effects of IPT-G on psychological wellbeing and other outcomes of interest.
Receives: Behavioral: IPT-G; Behavioral: Unconditional Cash Transfer
controlNo interventionELA clubs function as normal

What is being measured

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

  1. Minimal Depression 1a

    Score <=10 Primary Health Questionnaire 8 (0-24, higher is worse)

    Measured: 6 months

  2. Minimal Depression 1b

    Score <=10 Primary Health Questionnaire 8 (0-24, higher is worse)

    Measured: 12 months

  3. Minimal Depression 1c

    Score <=10 Primary Health Questionnaire 8 (0-24, higher is worse)

    Measured: 24 months

  4. Psychological Distress 2a

    Score >=3 on the General Health Questionnaire 12 (0-12, higher is worse)

    Measured: 6 months

  5. Psychological Distress 2b

    Score >=3 on the General Health Questionnaire 12 (0-12, higher is worse)

    Measured: 12 months

  6. Psychological Distress 2c

    Score >=3 on the General Health Questionnaire 12 (0-12, higher is worse)

    Measured: 24 months

  7. Self Esteem a

    score on Rosenberg self esteem (0-30, higher is better)

    Measured: 6 months

  8. Self Esteem b

    score on Rosenberg self esteem (0-30, higher is better)

    Measured: 12 months

  9. Self Esteem c

    score on Rosenberg self esteem (0-30, higher is better)

    Measured: 24 months

  10. Resilience a

    score on Child \& Youth Resilience Measure-Revised (0-34, higher is better)

    Measured: 6 months

  11. Resilience b

    score on Child \& Youth Resilience Measure-Revised (0-34, higher is better)

    Measured: 12 months

  12. Resilience c

    score on Child \& Youth Resilience Measure-Revised (0-34, higher is better)

    Measured: 24 months

Secondary outcomes (10)

  1. Indicator for Self-Reported School Enrollment a

    Indicator for enrolled in school (=1 if Adolescent Self-Reports Enrolled in school at time of survey)

    Measured: 12 months

  2. Indicator for Self-Reported School Enrollment b

    Indicator for enrolled in school (=1 if Adolescent Self-Reports Enrolled in school at time of survey)

    Measured: 24 months

  3. incidence of pregnancy a

    incidence of pregnancy from baseline

    Measured: 12 months

  4. incidence of pregnancy b

    incidence of pregnancy from baseline

    Measured: 24 months

  5. Child Marriage a

    incidence of marriage from baseline

    Measured: 12 months

  6. Child Marriage b

    incidence of marriage from baseline

    Measured: 24 months

  7. Competencies a

    Score on competency test. This is a score that takes on a value of 0-3 across a set of three questions on ability to answer skills based math questions. Higher is better

    Measured: 12 months

  8. Competencies b

    Score on competency test. This is a score that takes on a value of 0-3 across a set of three questions on ability to answer skills based math questions. Higher is better

    Measured: 24 months

  9. Indicator for self -reported condom use at last sex a

    condom use during last sexual encounter (=1 if Adolescent self reports using a condom at last sex)

    Measured: 12 months

  10. indicator for self-reported condom use at last sex b

    condom use during last sexual encounter (=1 if Adolescent self reports using a condom at last sex)

    Measured: 24 months

Timeline

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

  1. First posted29 May 2019
  2. Study start26 May 2019
  3. Primary completion30 Sep 2022
  4. Study completion30 Sep 2022

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
1,914 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03966833
Sponsor's protocol ID
SMU/BRAC 2019
Status last verified
Nov 2022
First submitted
21 May 2019
Last updated
8 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be made available at the conclusion of the study.

Questions about this trial

What is this clinical trial studying?

A study testing IPT-G and Unconditional Cash Transfer in people with Mental Depression, run by George Washington University at 1 site in Uganda.

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 2 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 8 Nov 2022. 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 Uganda. 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?

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?

Minimal Depression 1a (time frame: 6 months). The study lists 12 primary outcomes in all. 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 NCT03966833.

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 8 Nov 2022.

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