DepressionNCT06109610
Cognitive Behavioral Therapy on Adherence and Depression (CBT-AD) Among HIV/AIDS Patients
A study testing Cognitive Behavioral Therapy in people with Depression and Medication Adherence, run by Mattu University at 1 site in Ethiopia.
Trial summary
Depression is highly comorbid with HIV/ AIDS and is associated with worse poor adherence to antiretroviral therapy (ART), and potentially to long-term immune functioning. Cognitive behavioral therapy may solve these problem. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Medication Adherence
- 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
- 128 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 May 2021to 1 Nov 2023
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PLWHA who were 18 years old and above were included in the study
Who cannot join
- PLWHA who were previously took CBT and participants with acute physical or mental disturbances were excluded.
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site, 1 recruiting
- Recruiting
Mattu University
Addis Ababa, 318
Yadeta Alemayehu, MSc, 0984569410, yadoalex45@gmail.com
About this study
Official title: A Randomized Control Trial of Cognitive Behavioral Therapy on Adherence and Depression (CBT-AD) Among HIV/AIDS Patients on Follow up at Mattu Karl and Bedele Hospital, 2019
Depression is highly comorbid with HIV/ AIDS and is associated with worse poor adherence to antiretroviral therapy (ART), and potentially to long-term immune functioning. Cognitive behavioral therapy may solve these problem.
Read the detailed description
Depression is highly comorbid with HIV/ AIDS and is associated with worse poor adherence to antiretroviral therapy (ART), and potentially to long-term immune functioning. Poor adherence decreases the benefits of ART as well as chances of prolonged survival. An intervention that integrates CBT for depression with a cognitive behavioral approach to adherence counseling (cognitive behavioral therapy intervention for adherence and depression (CBT-AD)) has been found to be effective in improving adherence and reducing depression in PLWH.
- Conditions
- Depression, Medication Adherence
- Being tested
- Cognitive Behavioral Therapy
- Medical subject headings
- Depression, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
The treatment will be offered to participants free of charge. Cognitive Behavioral Therapy (CBT) sessions will be delivered in a group therapy format and the sessions will be offered in successive weeks. The protocol will be then administered to the intervention group (in 8 groups over a period of six months, eight sessions, each of 30 minutes' length).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Taking Behavioral Therapy Receives: Behavioral: Cognitive Behavioral Therapy |
| Control group | No intervention | Do not taking Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The mean score of Depression will change after intervention
Depression is measured by Patient Health Questionnaire (PHQ-9) Depression Scale. The minimum value is 0 and the maximum value is 27. The higher score mean worse outcome
Measured: Through study completion, an average of 1 yea
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2023
- Study start1 May 2021
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mattu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zakir Abdu, Mattu University
- Investigators
- Zakir Abdu, MSc, Principal investigator, Mattu UniversitryMohammedamin Hajure, MSc, Study chair, Mattu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06109610
- Sponsor's protocol ID
- CHS/19/2019
- Status last verified
- Oct 2023
- First submitted
- 17 Oct 2023
- Last updated
- 31 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Any qualified researchers could get the data from principal investigator at any time
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial of Cognitive Behavioral Therapy on Adherence and Depression (CBT-AD) Among HIV/AIDS Patients on Follow up at Mattu Karl and Bedele Hospital, 2019
- ClinicalTrials.gov ID
- NCT06109610
- Acronym / sponsor ID
- CHS/19/2019
- Conditions
- Depression, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Mattu UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 31 Oct 2023 (actual)
- 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.
Depression is highly comorbid with HIV/ AIDS and is associated with worse poor adherence to antiretroviral therapy (ART), and potentially to long-term immune functioning. Cognitive behavioral therapy may solve these problem.
Detailed description
Depression is highly comorbid with HIV/ AIDS and is associated with worse poor adherence to antiretroviral therapy (ART), and potentially to long-term immune functioning. Poor adherence decreases the benefits of ART as well as chances of prolonged survival. An intervention that integrates CBT for depression with a cognitive behavioral approach to adherence counseling (cognitive behavioral therapy intervention for adherence and depression (CBT-AD)) has been found to be effective in improving adherence and reducing depression in PLWH.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Cognitive Behavioral TherapyTaking Behavioral Therapy |
| Control group | No intervention | –Do not taking Behavioral Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- PLWHA who were 18 years old and above were included in the study
Key exclusion criteria (1 listed)
- PLWHA who were previously took CBT and participants with acute physical or mental disturbances were excluded.
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 TherapyThe treatment will be offered to participants free of charge. Cognitive Behavioral Therapy (CBT) sessions will be delivered in a group therapy format and the sessions will be offered in successive weeks. The protocol will be then administered to the intervention group (in 8 groups over a period of six months, eight sessions, each of 30 minutes' length). | Behavioural | Intervention group |
Primary outcome
The mean score of Depression will change after intervention
Time frame: Through study completion, an average of 1 yea
Depression is measured by Patient Health Questionnaire (PHQ-9) Depression Scale. The minimum value is 0 and the maximum value is 27. The higher score mean worse outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
- Individual participant dataSharing planned: No. Any qualified researchers could get the data from principal investigator at any time
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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.
Zakir Abdu, MSc principal investigator
Mattu Universitry
Mohammedamin Hajure, MSc study chair
Mattu University
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 Depression and Medication Adherence, run by Mattu University at 1 site in Ethiopia.
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: status not confirmed, as of the sponsor's last update on 31 Oct 2023. 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 Ethiopia. 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?
Contact Zakir Abdu, MSc (0913845371, zakirabdu45@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The mean score of Depression will change after intervention (time frame: Through study completion, an average of 1 yea). 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 31 Oct 2023; AzTrials last refreshed its copy on 2 Nov 2026.