DepressionNCT04915040
Management of Depression and Social Isolation in Older Adults With Dementia With Home-based Telehealth Delivered Behavioral Activation + Caregiver Facilitation.
A study testing Behavioral Activation for Depression in people with Depression, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the feasibility of using behavioral activation therapy with caregiver support delivered via telemedicine to older adults with depression and probable mild dementia. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Behavioral Activation for Depression
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2021to 19 Jul 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Participant Eligibility Criteria:
- able to speak and understand English;
- a diagnosis of mild dementia, as determined by a Clinical Dementia Rating interview Sum of Boxes (CDR-SB) score in the mild range as defined by a score of 4.5 - 9.0;
- and able to provide informed consent.
- Caregiver Eligibility Criteria.
- Beck Depression Inventory (BDI) score below clinical cutoff for depression and able to provide informed consent.
Who cannot join
- Participant exclusion criteria:
- presence of suicidal ideation with clear intent,
- concurrent enrollment in another clinical trial for depression,
- substance use disorder.
- Caregiver exclusion criteria:
- Active psychosis or significant dementia at screening;
- presence of suicidal ideation with clear intent.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center at Houston
Houston, Texas, 77030
About this study
The purpose of this study is to evaluate the feasibility of using behavioral activation therapy with caregiver support delivered via telemedicine to older adults with depression and probable mild dementia.
- Conditions
- Depression
- Being tested
- Behavioral Activation for Depression
- Keywords
- social support, dementia, caregivers
- Medical subject headings
- Depression, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Activation for DepressionBehavioural
Behavioral Activation (BA) is an effective treatment for depression, and its components may increase social connection. Generally, caregivers are with the older adult care recipient on a regular basis and may be able, with the correct training, to help enhance certain features of the Behavioral Activation treatment, even under pandemic restrictions on social contact. Therefore, we propose to (a) integrate \& (b) gather feasibility data for home-based Behavioral Activation + Caregiver
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Activation for Depression | Experimental | Not described Receives: Behavioral: Behavioral Activation for Depression |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of recruitment as assessed by number of participants enrolled in the study
Measured: Week 0
Feasibility of retention as assessed by number of participants who complete at least 6 sessions
Measured: Week 8
Feasibility of data collection as assessed by percent of missing data
Measured: Week 8
Change in Depression as measured by the Geriatric Depression Scale
15-item self-report for each construct (yes/no) . Score goes from 1 to 15, a higher number indicates presence of depression.
Measured: Week 0, Week 4, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Jul 2021
- Primary completion19 Jul 2022
- Study completion19 Jul 2022
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.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Bradley Cannell, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04915040
- Sponsor's protocol ID
- HSC-SPH-21-0272
- Status last verified
- Nov 2023
- First submitted
- 31 May 2021
- Last updated
- 30 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Depression and Social Isolation in Older Adults With Dementia With Home-based Telehealth Delivered Behavioral Activation + Caregiver Facilitation.
- ClinicalTrials.gov ID
- NCT04915040
- Acronym / sponsor ID
- HSC-SPH-21-0272
- Conditions
- Depression
- Keywords
- social support, dementia, caregivers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 19 Jul 2022 (actual)
- Study completion
- 19 Jul 2022 (actual)
- First posted
- 7 Jun 2021 (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.
The purpose of this study is to evaluate the feasibility of using behavioral activation therapy with caregiver support delivered via telemedicine to older adults with depression and probable mild dementia.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Behavioral Activation for Depression | Experimental | Behavioral: Behavioral Activation for Depression |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- able to speak and understand English;
- a diagnosis of mild dementia, as determined by a Clinical Dementia Rating interview Sum of Boxes (CDR-SB) score in the mild range as defined by a score of 4.5 - 9.0;
- and able to provide informed consent.
- Caregiver Eligibility Criteria.
- Beck Depression Inventory (BDI) score below clinical cutoff for depression and able to provide informed consent.
Key exclusion criteria (7 listed)
- presence of suicidal ideation with clear intent,
- concurrent enrollment in another clinical trial for depression,
- substance use disorder.
- Active psychosis or significant dementia at screening;
- presence of suicidal ideation with clear intent.
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 |
|---|---|---|
| Behavioral Activation for DepressionBehavioral Activation (BA) is an effective treatment for depression, and its components may increase social connection. Generally, caregivers are with the older adult care recipient on a regular basis and may be able, with the correct training, to help enhance certain features of the Behavioral Activation treatment, even under pandemic restrictions on social contact. Therefore, we propose to (a) integrate \& (b) gather feasibility data for home-based Behavioral Activation + Caregiver | Behavioural | Behavioral Activation for Depression |
Primary outcome
Feasibility of recruitment as assessed by number of participants enrolled in the study
Time frame: Week 0
Feasibility of retention as assessed by number of participants who complete at least 6 sessions
Time frame: Week 8
Feasibility of data collection as assessed by percent of missing data
Time frame: Week 8
Change in Depression as measured by the Geriatric Depression Scale
Time frame: Week 0, Week 4, Week 8
15-item self-report for each construct (yes/no) . Score goes from 1 to 15, a higher number indicates presence of depression.
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 30 Nov 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Activation for Depression in people with Depression, run by The University of Texas Health Science Center, Houston 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 7 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 30 Nov 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 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?
Feasibility of recruitment as assessed by number of participants enrolled in the study (time frame: Week 0). The study lists 4 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 30 Nov 2023.