Maternal AnxietyNCT02911441
Evaluating CBT Delivered by Community Health Workers on Maternal Mental Health and Infant Cognitive Development in Insecure Environments
A study testing Cognitive Behavioral Therapy in people with Maternal Anxiety and Maternal Depression, run by Heartland Alliance at 1 site in Democratic Republic of the Congo.
Trial summary
This study evaluates a cognitive behavioral therapy intervention for mothers with symptoms of anxiety and depression living in insecure environments using a randomized controlled methodology. Key outcomes of interest include maternal mental health and infant cognitive development. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Maternal Anxiety, Maternal Depression, Infant Cognitive Development
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 262 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- Dec 2015to Oct 2016
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women in their third trimester of pregnancy
- Who exhibited symptoms of anxiety and depression
Who cannot join
- Women who express suicidality
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Heartland Alliance International
Bukavu, South Kivu
About this study
This study evaluates a cognitive behavioral therapy intervention for mothers with symptoms of anxiety and depression living in insecure environments using a randomized controlled methodology. Key outcomes of interest include maternal mental health and infant cognitive development. The intervention will be delivered by community mental health workers who will be trained to administer 8 to 12 cognitive behavioral therapy sessions.
- Being tested
- Cognitive Behavioral Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | Receives 8-12 weeks of one-on-one Cognitive Behavioral Therapy sessions Receives: Behavioral: Cognitive Behavioral Therapy |
| Control Group | No intervention | Receives no intervention during data-collection phase. Participants in this group will receive the intervention post-data collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptoms of anxiety and depression as measured by Hopkins Symptoms Checklist
Measured: 10 months post-birth of their infant
Infant Cognitive Development as measured by Mullen Scales of Early Learning
Measured: 10 months post-birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study startDec 2015
- Primary completionOct 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maternal AnxietyStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 262 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heartland Alliance
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Constantin Kahorha, Principal investigator, Heartland Alliance International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911441
- Sponsor's protocol ID
- 0721-03
- Status last verified
- Sep 2016
- First submitted
- 19 Sep 2016
- Last updated
- 22 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating CBT Delivered by Community Health Workers on Maternal Mental Health and Infant Cognitive Development in Insecure Environments
- ClinicalTrials.gov ID
- NCT02911441
- Acronym / sponsor ID
- 0721-03
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 262 participants (actual)
- Lead sponsor
- Heartland AllianceUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Oct 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 22 Sep 2016 (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.
This study evaluates a cognitive behavioral therapy intervention for mothers with symptoms of anxiety and depression living in insecure environments using a randomized controlled methodology. Key outcomes of interest include maternal mental health and infant cognitive development. The intervention will be delivered by community mental health workers who will be trained to administer 8 to 12 cognitive behavioral therapy sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Cognitive Behavioral TherapyReceives 8-12 weeks of one-on-one Cognitive Behavioral Therapy sessions |
| Control Group | No intervention | –Receives no intervention during data-collection phase. Participants in this group will receive the intervention post-data collection. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Women in their third trimester of pregnancy
- Who exhibited symptoms of anxiety and depression
Key exclusion criteria (1 listed)
- Women who express suicidality
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 |
|---|---|---|
| Cognitive Behavioral Therapy | Behavioural | Treatment Group |
Primary outcome
Symptoms of anxiety and depression as measured by Hopkins Symptoms Checklist
Time frame: 10 months post-birth of their infant
Infant Cognitive Development as measured by Mullen Scales of Early Learning
Time frame: 10 months post-birth
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- 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.
Constantin Kahorha principal investigator
Heartland Alliance International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Maternal Anxiety and Maternal Depression, run by Heartland Alliance at 1 site in Democratic Republic of the Congo.
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 2 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: status not confirmed, as of the sponsor's last update on 22 Sep 2016. 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 Democratic Republic of the Congo. 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?
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?
Symptoms of anxiety and depression as measured by Hopkins Symptoms Checklist (time frame: 10 months post-birth of their infant). 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 22 Sep 2016.