DepressionNCT00903019
Feasibility of Telehealth Problem-Solving Therapy for Depressed Homebound Older Adults
A study testing Tele-Problem-Solving Therapy and In-Person PST in people with Depression, run by University of Texas at Austin at 1 site in United States.
Trial summary
This study will test the feasibility and effectiveness of therapy given via teleconferencing to depressed homebound older adults. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- Tele-Problem-Solving Therapy and In-Person PST
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to May 2013
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non-Hispanic white, African American, or Hispanic
- Homebound, as defined by receiving a home-delivered meals service or personal assistance and in-home support services because of disability
- Moderate-to-severe depressive symptom severity, as defined by a score greater than or equal to 15 on the Hamilton Rating Scale for Depression (HAMD)
- Has a home television set that can be used for problem-solving therapy (PST) sessions
- Has a landline telephone
Who cannot join
- High suicide risk, as defined by an intent or plan to attempt suicide within a month or indication of persistently moderate or severe suicidal ideation or behavior
- Presence of dementia or executive dysfunction
- Presence of bipolar disorder
- Lifetime or current (within 12 months) psychotic symptoms or disorder
- Presence of co-occurring alcohol or other addictive substance abuse, including benzodiazepines and opioids
- Hearing or vision impairment that would interfere with PST participation
Show all 9Show fewer
- Inability to actively participate in PST sessions due to acute or severe medical illness or functional impairment, such as a bed-bound state
- Current involvement in psychotherapy
- Inability to speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas at Austin
Austin, Texas, 78712-0358
About this study
Official title: Telehealth Problem-Solving Therapy for Depressed Homebound Older Adults
This study will test the feasibility and effectiveness of therapy given via teleconferencing to depressed homebound older adults.
Read the detailed description
Older people with disabilities who cannot leave their homes are at increased risk of depression or depressive symptoms. Short-term psychotherapy, without medications, has been found effective for treating this population of people. Problem-solving therapy (PST) is a brief, structured, cognitive-behavioral therapy that teaches people problem-solving and coping skills to deal with negative life events and daily problems. Previous research demonstrated that PST is an effective treatment for depression when delivered to older adults in their homes. The cost of service for these in-home visits, however, can be prohibitive for many older adults and social service providers. One way to extend treatment to more older adults is to deliver PST via teleconferencing (tele-PST). This study will test the feasibility and effectiveness of tele-PST in treating depression in homebound older adults.
This study will have two phases. Phase 1 will examine the feasibility of delivering treatment via teleconference. Participants in this phase will receive six weekly sessions of tele-PST and then complete a 2-week follow-up visit in which their depression, disability, and resourcefulness will be assessed. Logistical and procedural problems and acceptability of the treatment to participants will be used to guide modifications or adaptations made to tele-PST before conducting a larger, randomized trial in Phase 2.
Participation in Phase 2 will last 6 weeks, with follow-up visits lasting until 24 weeks after the conclusion of treatment. Participants will be randomly assigned to one of three groups: tele-PST, in-person PST, and attention control. Participants in the tele-PST group will receive six weekly sessions of PST via teleconference, and participants in the in-person PST group will receive six weekly sessions of PST from a study therapist in person. Both these groups will also receive six monthly maintenance calls from their study therapist after the completion of treatment. Participants in the attention group will receive six weekly phone calls followed by six monthly phone calls to monitor their health. All participants in Phase 2 will complete assessments at 2, 12, and 24 weeks following their treatment. These assessments will measure the adequacy of recruitment, enrollment, and retention strategies; the compliance rates and service delivery costs of tele-PST and in-person PST; and participants' depression, disability, and resourcefulness.
- Conditions
- Depression
- Being tested
- Tele-Problem-Solving Therapy, In-Person PST, Attention control
- Keywords
- Homebound, Older Adults, Disability, Videoconferencing
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-Problem-Solving TherapyBehavioural
Six sessions of tele-PST
In-Person PSTBehavioural
Six sessions of in person PST
Attention controlBehavioural
Six weekly telephone calls
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive problem-solving therapy (PST) delivered via teleconferencing (tele-PST). Receives: Behavioral: Tele-Problem-Solving Therapy |
| 2 | Active comparator | Participants will receive problem-solving therapy (PST) delivered in-person. Receives: Behavioral: In-Person PST |
| 3 | Placebo comparator | Participants will receive monitoring phone calls. Receives: Behavioral: Attention control |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-item Hamilton Rating Scale for Depression (HAMD)
Measured: Measured at 2, 12, and 24 weeks
12-item World Health Organization Disability Assessment Schedule (WHO-DAS-II)
Measured: Measured at 2, 12, and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2009 (estimated)
- Study startJun 2009
- Primary completionMay 2013
- Study completionMay 2013
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 Texas at AustinThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Namkee Choi, University of Texas at Austin
- Investigators
- Namkee G. Choi, PhD, Principal investigator, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903019
- Sponsor's protocol ID
- R34MH083872
- Other IDs
- R34MH083872, DATR A4-GPS
- Status last verified
- Mar 2015
- First submitted
- 13 May 2009
- Last updated
- 23 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Choi NG, Marti CN, Bruce ML, Kunik ME. Relationship between depressive symptom severity and emergency department use among low-income, depressed homebound older adults aged 50 years and older. BMC Psychiatry. 2012 Dec 26;12:233. doi: 10.1186/1471-244X-12-233.
PubMed 23267529
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Problem-Solving Therapy for Depressed Homebound Older Adults
- ClinicalTrials.gov ID
- NCT00903019
- Acronym / sponsor ID
- R34MH083872
- Conditions
- Depression
- Keywords
- Homebound, Older Adults, Disability, Videoconferencing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2009
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 15 May 2009 (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 will test the feasibility and effectiveness of therapy given via teleconferencing to depressed homebound older adults.
Detailed description
Older people with disabilities who cannot leave their homes are at increased risk of depression or depressive symptoms. Short-term psychotherapy, without medications, has been found effective for treating this population of people. Problem-solving therapy (PST) is a brief, structured, cognitive-behavioral therapy that teaches people problem-solving and coping skills to deal with negative life events and daily problems. Previous research demonstrated that PST is an effective treatment for depression when delivered to older adults in their homes. The cost of service for these in-home visits, however, can be prohibitive for many older adults and social service providers. One way to extend treatment to more older adults is to deliver PST via teleconferencing (tele-PST). This study will test the feasibility and effectiveness of tele-PST in treating depression in homebound older adults.
This study will have two phases. Phase 1 will examine the feasibility of delivering treatment via teleconference. Participants in this phase will receive six weekly sessions of tele-PST and then complete a 2-week follow-up visit in which their depression, disability, and resourcefulness will be assessed. Logistical and procedural problems and acceptability of the treatment to participants will be used to guide modifications or adaptations made to tele-PST before conducting a larger, randomized trial in Phase 2.
Participation in Phase 2 will last 6 weeks, with follow-up visits lasting until 24 weeks after the conclusion of treatment. Participants will be randomly assigned to one of three groups: tele-PST, in-person PST, and attention control. Participants in the tele-PST group will receive six weekly sessions of PST via teleconference, and participants in the in-person PST group will receive six weekly sessions of PST from a study therapist in person. Both these groups will also receive six monthly maintenance calls from their study therapist after the completion of treatment. Participants in the attention group will receive six weekly phone calls followed by six monthly phone calls to monitor their health. All participants in Phase 2 will complete assessments at 2, 12, and 24 weeks following their treatment. These assessments will measure the adequacy of recruitment, enrollment, and retention strategies; the compliance rates and service delivery costs of tele-PST and in-person PST; and participants' depression, disability, and resourcefulness.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Tele-Problem-Solving TherapyParticipants will receive problem-solving therapy (PST) delivered via teleconferencing (tele-PST). |
| 2 | Active comparator | Behavioral: In-Person PSTParticipants will receive problem-solving therapy (PST) delivered in-person. |
| 3 | Placebo comparator | Behavioral: Attention controlParticipants will receive monitoring phone calls. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-Hispanic white, African American, or Hispanic
- Homebound, as defined by receiving a home-delivered meals service or personal assistance and in-home support services because of disability
- Moderate-to-severe depressive symptom severity, as defined by a score greater than or equal to 15 on the Hamilton Rating Scale for Depression (HAMD)
- Has a home television set that can be used for problem-solving therapy (PST) sessions
- Has a landline telephone
Key exclusion criteria (9 listed)
- High suicide risk, as defined by an intent or plan to attempt suicide within a month or indication of persistently moderate or severe suicidal ideation or behavior
- Presence of dementia or executive dysfunction
- Presence of bipolar disorder
- Lifetime or current (within 12 months) psychotic symptoms or disorder
- Presence of co-occurring alcohol or other addictive substance abuse, including benzodiazepines and opioids
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 |
|---|---|---|
| Tele-Problem-Solving TherapySix sessions of tele-PST | Behavioural | 1 |
| In-Person PSTSix sessions of in person PST | Behavioural | 2 |
| Attention controlSix weekly telephone calls | Behavioural | 3 |
Primary outcome
24-item Hamilton Rating Scale for Depression (HAMD)
Time frame: Measured at 2, 12, and 24 weeks
12-item World Health Organization Disability Assessment Schedule (WHO-DAS-II)
Time frame: Measured at 2, 12, and 24 weeks
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 23 Mar 2015.
- Derived from this study: PubMed 23267529Choi NG, Marti CN, Bruce ML, Kunik ME. Relationship between depressive symptom severity and emergency department use among low-income, depressed homebound older adults aged 50 years and older. BMC Psychiatry. 2012 Dec 26;12:233. doi: 10.1186/1471-244X-12-233.
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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.
Namkee G. Choi, PhD principal investigator
University of Texas at Austin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-Problem-Solving Therapy and In-Person PST in people with Depression, run by University of Texas at Austin 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 5 inclusion and 9 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 23 Mar 2015. 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. Some participants in this study may receive a placebo. 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?
24-item Hamilton Rating Scale for Depression (HAMD) (time frame: Measured at 2, 12, and 24 weeks). 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 NCT00903019, 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 23 Mar 2015.