DepressionNCT01055158
Telephone Based Cognitive Behavioral Therapy for HIV Related Depression
A study testing Telephone-based CBT in people with Depression and HIV Infections, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effectiveness of a telephone-based, cognitive behavioral therapy intervention in the treatment of depression in adults diagnosed with HIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, HIV Infections
- What is being tested?
- Telephone-based CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2010to Jan 2012
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a DSM-IV diagnosis of a Depressive Disorder as measured by the mood battery of the MINI
- Has a diagnosis of HIV and is receiving HIV related outpatient care at the Evelyn Jordan Center in Baltimore, MD
- Is able to speak English
- Is able to read English on approximately the 6th grade reading level or higher as measured by the Wide Range Achievement Test 4 (WRAT-4) or by self-report
- Is at least 18 years old
- Has access to a telephone
Who cannot join
- Meets criteria for dementia by scoring below 10 on the Hopkins HIV Dementia Scale
- Shows signs of serious psychiatric pathology that might either be due to an organic etiology other than HIV, or would generally not be considered treatable solely with psychotherapy, or for whom participation in this protocol might be considered dangerous or unethical
- has a history of serious suicide attempts or is severely suicidal (has ideation, plan, and intent) determined by the MINI
- Patients in psychotherapy are excluded because it is confounded with the study treatments
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center, Evelyn Jordan Center
Baltimore, Maryland, 21201
About this study
Official title: Connect: A Pilot Study of Telephone Based Cognitive Behavioral Therapy for HIV Related Depression
The purpose of this study is to evaluate the effectiveness of a telephone-based, cognitive behavioral therapy intervention in the treatment of depression in adults diagnosed with HIV.
Read the detailed description
Up to 40% of individuals receiving medical care for HIV meet DSM-IV criteria for co-occurring depressive disorder. Individuals with HIV and depressive disorders, compared to those with HIV alone, have been shown to have worse adherence to taking antiretroviral medication, increased HIV related morbidity and among women a higher mortality. Previous research suggests that mental health interventions may lead to improved depressive and HIV related outcomes. However because many HIV infected depressed individuals may have trouble accessing mental health services, there is an urgent need for treatment trials to assess whether treatment of depression targeting patients in urban HIV care settings will result in both improved depressive and HIV related outcomes. The goal of this project is to test the preliminary effectiveness of an adapted telephone-based, cognitive behavioral therapy (CBT) intervention targeting HIV infected depressed individuals receiving care in adult outpatient HIV clinics. A total of 60 HIV infected, depressed individuals receiving care at an urban, outpatient HIV clinic will be randomly assigned to receive either the telephone psychotherapy intervention or enhanced usual care with non-specific telephone contact. The results will provide preliminary data on whether the telephone psychotherapy intervention for HIV infected depressed individuals is effective in reducing depression. The results will also be used to determine feasibility, accessibility, and whether the intervention leads to improved retention and better satisfaction.
- Conditions
- Depression, HIV Infections
- Being tested
- Telephone-based CBT, Enhanced Usual Care
- Keywords
- HIV
- Medical subject headings
- Depression, HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone-based CBTBehavioural
Also called CONNECT
A form of CBT delivered over the telephone by a trained, licensed, master's or doctoral level clinician. The intervention consists of approximately 10 sessions conducted over approximately 14 weeks. Each session is approximately 30 to 50 minutes. All sessions begin with a depression rating and agenda setting and end with task assignments and summaries.
Enhanced Usual CareBehavioural
Participants randomized to this condition will be referred to receive in-person psychotherapy. Research study staff will help participants to set up their first appointment with a psychotherapist.
| Study group | Role | What they receive |
|---|---|---|
| Telephone-based CBT | Experimental | A form of CBT delivered over the telephone by a trained, licensed, master's or doctoral level clinician. The intervention consists of approximately 10 sessions conducted over approximately 14 weeks. Each session is approximately 30 to 50 minutes. Receives: Behavioral: Telephone-based CBT |
| Control | Active comparator | Enhanced Usual Care Receives: Behavioral: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Scale (HAM-D)
Measured: Baseline, Week 8, Week 16
The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) (QIDS-SR16)
Measured: Baseline, Week 8, Week 16
Secondary outcomes (9)
Provision of Social Relationships (PSR)
Measured: Baseline, Week 8, Week 16
Brief COPE
Measured: Baseline, Week 8, Week 16
SF-12 Health Survey
Measured: Baseline, Week 8, Week 16
Therapist Adherence
Measured: Week 1-14
Participant Adherence to Treatment
Measured: Week 1-14
Working Alliance Inventory
Measured: Week 8, Week 16
Satisfaction Index- Mental Health (SIMH-PW)
Measured: Week 8, Week 16
Expectancy Scales
Measured: Week 8, Week 16
Adherence to Highly Active Antiretroviral Therapy (HAART)
Measured: Baseline, Week 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startJan 2010
- Primary completionJan 2012
- Study completionJan 2012
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 University of Maryland, BaltimoreThe 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Maryland, College Park
- Responsible party
- Sponsor
- Investigators
- Seth S Himelhoch, M.D., M.P.H, Principal investigator, University of Maryland, College Park
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055158
- Sponsor's protocol ID
- HP-00043648
- Other IDs
- R34MH080630
- Status last verified
- May 2021
- First submitted
- 22 Jan 2010
- Last updated
- 11 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Himelhoch S, Medoff D, Maxfield J, Dihmes S, Dixon L, Robinson C, Potts W, Mohr DC. Telephone based cognitive behavioral therapy targeting major depression among urban dwelling, low income people living with HIV/AIDS: results of a randomized controlled trial. AIDS Behav. 2013 Oct;17(8):2756-64. doi: 10.1007/s10461-013-0465-5.
PubMed 23644816
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connect: A Pilot Study of Telephone Based Cognitive Behavioral Therapy for HIV Related Depression
- ClinicalTrials.gov ID
- NCT01055158
- Acronym / sponsor ID
- HP-00043648
- Conditions
- Depression, HIV Infections
- Keywords
- HIV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Maryland, College Park
- Study start
- Jan 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 25 Jan 2010 (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.
The purpose of this study is to evaluate the effectiveness of a telephone-based, cognitive behavioral therapy intervention in the treatment of depression in adults diagnosed with HIV.
Detailed description
Up to 40% of individuals receiving medical care for HIV meet DSM-IV criteria for co-occurring depressive disorder. Individuals with HIV and depressive disorders, compared to those with HIV alone, have been shown to have worse adherence to taking antiretroviral medication, increased HIV related morbidity and among women a higher mortality. Previous research suggests that mental health interventions may lead to improved depressive and HIV related outcomes. However because many HIV infected depressed individuals may have trouble accessing mental health services, there is an urgent need for treatment trials to assess whether treatment of depression targeting patients in urban HIV care settings will result in both improved depressive and HIV related outcomes. The goal of this project is to test the preliminary effectiveness of an adapted telephone-based, cognitive behavioral therapy (CBT) intervention targeting HIV infected depressed individuals receiving care in adult outpatient HIV clinics. A total of 60 HIV infected, depressed individuals receiving care at an urban, outpatient HIV clinic will be randomly assigned to receive either the telephone psychotherapy intervention or enhanced usual care with non-specific telephone contact. The results will provide preliminary data on whether the telephone psychotherapy intervention for HIV infected depressed individuals is effective in reducing depression. The results will also be used to determine feasibility, accessibility, and whether the intervention leads to improved retention and better satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telephone-based CBT | Experimental | Behavioral: Telephone-based CBTA form of CBT delivered over the telephone by a trained, licensed, master's or doctoral level clinician. The intervention consists of approximately 10 sessions conducted over approximately 14 weeks. Each session is approximately 30 to 50 minutes. |
| Control | Active comparator | Behavioral: Enhanced Usual CareEnhanced Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Has a DSM-IV diagnosis of a Depressive Disorder as measured by the mood battery of the MINI
- Has a diagnosis of HIV and is receiving HIV related outpatient care at the Evelyn Jordan Center in Baltimore, MD
- Is able to speak English
- Is able to read English on approximately the 6th grade reading level or higher as measured by the Wide Range Achievement Test 4 (WRAT-4) or by self-report
- Is at least 18 years old
Key exclusion criteria (4 listed)
- Meets criteria for dementia by scoring below 10 on the Hopkins HIV Dementia Scale
- Shows signs of serious psychiatric pathology that might either be due to an organic etiology other than HIV, or would generally not be considered treatable solely with psychotherapy, or for whom participation in this protocol might be considered dangerous or unethical
- has a history of serious suicide attempts or is severely suicidal (has ideation, plan, and intent) determined by the MINI
- Patients in psychotherapy are excluded because it is confounded with the study treatments
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 |
|---|---|---|
| Telephone-based CBTAlso: CONNECTA form of CBT delivered over the telephone by a trained, licensed, master's or doctoral level clinician. The intervention consists of approximately 10 sessions conducted over approximately 14 weeks. Each session is approximately 30 to 50 minutes. All sessions begin with a depression rating and agenda setting and end with task assignments and summaries. | Behavioural | Telephone-based CBT |
| Enhanced Usual CareParticipants randomized to this condition will be referred to receive in-person psychotherapy. Research study staff will help participants to set up their first appointment with a psychotherapist. | Behavioural | Control |
Primary outcome
Hamilton Depression Scale (HAM-D)
Time frame: Baseline, Week 8, Week 16
The Quick Inventory of Depressive Symptomatology (16-Item) (Self-Report) (QIDS-SR16)
Time frame: Baseline, Week 8, Week 16
9 secondary outcomes
Provision of Social Relationships (PSR)
Time frame: Baseline, Week 8, Week 16
Brief COPE
Time frame: Baseline, Week 8, Week 16
SF-12 Health Survey
Time frame: Baseline, Week 8, Week 16
Therapist Adherence
Time frame: Week 1-14
Participant Adherence to Treatment
Time frame: Week 1-14
Working Alliance Inventory
Time frame: Week 8, Week 16
Satisfaction Index- Mental Health (SIMH-PW)
Time frame: Week 8, Week 16
Expectancy Scales
Time frame: Week 8, Week 16
Adherence to Highly Active Antiretroviral Therapy (HAART)
Time frame: Baseline, Week 15
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 11 May 2021.
- Derived from this study: PubMed 23644816Himelhoch S, Medoff D, Maxfield J, Dihmes S, Dixon L, Robinson C, Potts W, Mohr DC. Telephone based cognitive behavioral therapy targeting major depression among urban dwelling, low income people living with HIV/AIDS: results of a randomized controlled trial. AIDS Behav. 2013 Oct;17(8):2756-64. doi: 10.1007/s10461-013-0465-5.
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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.
Seth S Himelhoch, M.D., M.P.H principal investigator
University of Maryland, College Park
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone-based CBT in people with Depression and HIV Infections, run by University of Maryland, Baltimore at 1 site in United States.
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 6 inclusion and 4 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 11 May 2021. 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 United States. 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?
Hamilton Depression Scale (HAM-D) (time frame: Baseline, Week 8, Week 16). 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?
On the ClinicalTrials.gov record for NCT01055158, 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 11 May 2021.