Depressive DisorderPhase 1/2PsychobabbleNCT00886730
Primary Care Patients With Depression for Internet-Based Social Support
A Phase 1/2 study testing Simple Card, Patient Centered Brochure and Physician's endorsement in people with Depressive Disorder, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to develop and pilot test two interventions that lead to at least 30% of individuals with depression presenting to primary care engaging with an Internet-based depression support group. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Disorder
- What is being tested?
- Simple Card, Patient Centered Brochure and Physician's endorsement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to May 2011
- Phase
- Phase 1/2
- 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
- PHQ score of 8 or above with either depressed mood or anhedonia/and or is considering treatment for depressed mood,
- does not reject all treatment for depression,
- has not viewed or posted messages more than once in the last month on any Internet depression support group website,
- does not self-report diagnoses of bipolar disorder by a health professional,
- age 18 years or older,
- attends a primary care clinic and have visited in last 6 months, AND
- has Internet access for the next four weeks, has been on the Internet at least three times, and has used email by him/herself. We are slightly lowering the PHQ score from the usual 10 (cutoff for major depression) to 8 because we know treatment for depression is frequently initiated for those who do not meet formal criteria for major depression. However we are only including patients with PHQ scores below the usual cutoff for major depression if they are currently receiving or are considering some form of depression treatment. University of Chicago students will need to identify their primary care provider to be enrolled in the study.
Who cannot join
- active bipolar disorder,
- those with no access to the internet,
- those who state they are not under treatment nor would they consider any form of treatment, OR
- those considered to be at high risk of suicide attempts. These include those with past psychiatric hospitalization, past suicide attempts, bipolar disorder or score of greater than 1 on the PHQ-9 suicide assessment or who reports intent for self-harm as per assessment in the suicide prevention protocol.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Physician's Group - PCG Maryland Avenue
Chicago, Illinois, 60637
About this study
Official title: Feasibility Study of Methods of Referral Primary Care Patients With Depression for Internet-Based Social Support
The purpose of this study is to develop and pilot test two interventions that lead to at least 30% of individuals with depression presenting to primary care engaging with an Internet-based depression support group. The investigators will identify primary care patients with depression who state they have access to the Internet and are willing to consider treatment for depression. In the primary care office they will be given one of three interventions introducing them to the Internet depression support group site. The major outcome will be accessing the depression Internet support group at least once in the following four weeks.
The results of this study will provide important information on whether it is possible to recruit a substantial proportion of primary care patients to engage in a potentially useful and inexpensive addition to standard depression care. If this is not possible, the likelihood of successfully completing a RCT of the effectiveness of depression Internet support groups utilizing primary care patients would be low. Researchers trying to assess the effectiveness of depression Internet support groups would have to go to alternative designs such as recruiting patients with depression as they try to join the depression Internet support groups and randomizing some to a delay in joining the group.
Read the detailed description
Our specific aim is to develop and pilot test two interventions that lead to at least 30% of individuals with depression presenting to primary care engaging with an Internet-based depression support group. We will identify primary care patients with depression who state they have access to the Internet and are willing to consider treatment or are currently in treatment for depression. In the primary care office they will be given one of three interventions introducing them to the Internet depression support group site. Patients will be randomized to three experimental groups: 1) simple card with only the name of the web address; 2) 8"x11" paper with screen shots of the Internet site home page, a list of features provided by the site, and two patient stories describing how the Internet site helped them; and 3) the 8"x11" announcement (from intervention 2) plus endorsement of the site by the primary care provider. The last two interventions will also ask patients to provide an email address so one email reminder can be sent to them. The major outcome will be accessing the depression Internet support group at least once in the following four weeks.
The results of this study will provide important information on whether it is possible to recruit a substantial proportion of primary care patients to engage in a potentially useful and inexpensive addition to standard depression care. If this is not possible, the likelihood of successfully completing a RCT of the effectiveness of depression Internet support groups utilizing primary care patients would be low. Researchers trying to assess the effectiveness of depression Internet support groups would have to go to alternative designs such as recruiting patients with depression as they try to join the depression Internet support groups and randomizing some to a delay in joining the group. We will also use this study to learn more about what patient characteristics are associated with engaging with an internet depression support group. While the focus of this study is Psychobabble, the intent of the study is to explore ease of referral, predictors of use and participant experiences as may relate to the general concept of Internet-based social support.
Specific AIM 1: We believe that participants randomized to the either that 8 x 11" brochure or the recommendation by the primary care physician will be more likely to visit and use the site than those who receive only a recommendation card (50% versus 35% versus 10%). We hypothesize that greater levels of encouragement/recommendation will be associated with higher levels of internet site usage. A sample size of 225 (N-110 at University of Chicago and N=115 at Johns Hopkins) will have power of 0.8 to detect the difference between either the card group or the brochure or physician recommendation group.
Specific Aim 2: We believe that those with higher self-efficacy and greater levels of trust in their primary care physician will be more likely to visit the site one time. We will conduct a logistic regression analysis to determine whether base self-efficacy and greater levels of trust predict use of the internet site after adjusting for group assignment. We hypothesize that higher levels of self-efficacy and physician trust will be associated with greater internet site use. Will believe a total N=225 will be sufficient to evaluate the relationship between 10 independent variables and the outcome of site usage (<15 cells/variable).
Specific Aim 3: We will determine if an internet based social support group is acceptable and feasible for primary care patients. Specifically, we will evaluate whether the internet site increased their knowledge of, or motivation for, depression treatment (Change in level of agreement to with regard to "accepting my doctors diagnosis of depression", strongly disagree 1, strongly agree 5). We hypothesize that levels of agreement will increase pre to post-study. A sample size of 225 (N=110 at University of Chicago and N=115 at Johns Hopkins) will have power of 0.8 to detect the difference of agree (4) pre-study to (5) strongly agree post study.
Specific Aim 4: We believe that social support and knowledge gained on the internet may influence subsequent care seeking or coping behaviors. Specifically, we will evaluate whether they have sought care or adopted coping skills 6 weeks after study entry. We hypothesize that both these behaviors will increase from pre to post study. A sample size of 225 (N=110 at University of Chicago and N=115 at Johns Hopkins) will have power of 0.8 to detect the difference of treatment participation pre-study of 0.4 versus 0.65 post study.
Specific Aim 5: We believe that social support or knowledge gained on the internet site leading to changed behaviors may results in lower levels of depressed mood. Specifically, we will compare levels of depressed mood at baseline and at 6 week follow-up. We hypothesize that their will be modest decline in depressed mood from pre study baseline to post study. A sample size of 225 (N=110 at University of Chicago and N=115 at Johns Hopkins) will have power of 0.8 to detect the difference of treatment participation pre study CES-D score of 24 post study score of 20.
- Conditions
- Depressive Disorder
- Being tested
- Simple Card, Patient Centered Brochure, Physician's endorsement
- Keywords
- Depressive disorder, Primary care, Internet, Social support, Feasibility
- Medical subject headings
- Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simple CardBehavioural
Participants will receive a simple 3"x5" card with the name of the website and the following description. "www.psychobabble.com (or new name). A website to help individuals with depression recover."
Patient Centered BrochureBehavioural
Participants will receive an 8"x11" handout that provides a more complete description of the depression website. The handout will be based on a patient perspective with samples of Internet postings from users. This card will emphasize peer-to-peer support and not mention health care organizations or health care provider endorsements. The information will address potential barriers to use: user will not be identified, posting will not take that much time, information from peers can be checked for accuracy with other peers and providers, and helping patient learn how to tell their usual health care providers about their activities on the Internet site. Participants will be asked to provide their email so a reminder about the Internet depression site can be emailed to them at 1 week and 2 weeks. They will still be part of the study even if they will not provide their email.
Physician's endorsementBehavioural
Participants will include the same card in experimental group 2 with the addition of a personal endorsement by the patient's health care provider in the form of a standardized letter signed by the physician. Participants will be asked to provide their email so a reminder about the Internet depression site can be emailed to them at 1 week and 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Simple Card | Experimental | Participants will receive a simple 3"x5" card with the name of the website and the following description. "www.psychobabble.com (or new name). A website to help individuals with depression recover." Receives: Behavioral: Simple Card |
| Patient Centered Brochure | Experimental | Participants will receive an 8"x11" handout that provides a more complete description of the depression website. The handout will be based on a patient perspective with samples of Internet postings from users. This card will emphasize peer-to-peer support and not mention health care organizations or health care provider endorsements. The information will address potential barriers to use: user will not be identified, posting will not take that much time, information from peers can be checked for accuracy with other peers and providers, and helping patient learn how to tell their usual health care providers about their activities on the Internet site. Participants will be asked to provide their email so a reminder about the Internet depression site can be emailed to them at 1 week and 2 weeks. They will still be part of the study even if they will not provide their email. Receives: Behavioral: Patient Centered Brochure |
| Physicians endorsement | Experimental | Participants will include the same card in experimental group 2 with the addition of a personal endorsement by the patient's health care provider in the form of a standardized letter signed by the physician. Participants will be asked to provide their email so a reminder about the Internet depression site can be emailed to them at 1 week and 2 weeks. Receives: Behavioral: Physician's endorsement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage visiting the Internet site
Measured: 6 weeks
Secondary outcomes (1)
Feasibility, helpfulness and safety of Internet site
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2009 (estimated)
- Study startOct 2008
- Primary completionSep 2009
- Study completionMay 2011
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 Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 1/2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886730
- Sponsor's protocol ID
- 15836A
- Other IDs
- R34MH073742-01
- Acronym
- Psychobabble
- Status last verified
- Dec 2012
- First submitted
- 22 Apr 2009
- Last updated
- 17 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Van Voorhees BW, Hsiung RC, Marko-Holguin M, Houston TK, Fogel J, Lee R, Ford DE. Internal versus external motivation in referral of primary care patients with depression to an internet support group: randomized controlled trial. J Med Internet Res. 2013 Mar 12;15(3):e42. doi: 10.2196/jmir.2197.
PubMed 23482332
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of Methods of Referral Primary Care Patients With Depression for Internet-Based Social Support
- ClinicalTrials.gov ID
- NCT00886730
- Acronym / sponsor ID
- Psychobabble / 15836A
- Conditions
- Depressive Disorder
- Keywords
- Depressive disorder, Primary care, Internet, Social support, Feasibility
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- Oct 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 23 Apr 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.
The purpose of this study is to develop and pilot test two interventions that lead to at least 30% of individuals with depression presenting to primary care engaging with an Internet-based depression support group. The investigators will identify primary care patients with depression who state they have access to the Internet and are willing to consider treatment for depression. In the primary care office they will be given one of three interventions introducing them to the Internet depression support group site. The major outcome will be accessing the depression Internet support group at least once in the following four weeks.
The results of this study will provide important information on whether it is possible to recruit a substantial proportion of primary care patients to engage in a potentially useful and inexpensive addition to standard depression care. If this is not possible, the likelihood of successfully completing a RCT of the effectiveness of depression Internet support groups utilizing primary care patients would be low. Researchers trying to assess the effectiveness of depression Internet support groups would have to go to alternative designs such as recruiting patients with depression as they try to join the depression Internet support groups and randomizing some to a delay in joining the group.
Detailed description
Our specific aim is to develop and pilot test two interventions that lead to at least 30% of individuals with depression presenting to primary care engaging with an Internet-based depression support group. We will identify primary care patients with depression who state they have access to the Internet and are willing to consider treatment or are currently in treatment for depression. In the primary care office they will be given one of three interventions introducing them to the Internet depression support group site. Patients will be randomized to three experimental groups: 1) simple card with only the name of the web address; 2) 8"x11" paper with screen shots of the Internet site home page, a list of features provided by the site, and two patient stories describing how the Internet site helped them; and 3) the 8"x11" announcement (from intervention 2) plus endorsement of the site by the primary care provider. The last two interventions will also ask patients to provide an email address so one email reminder can be sent to them. The major outcome will be accessing the depression Internet support group at least once in the following four weeks.
The results of this study will provide important information on whether it is possible to recruit a substantial proportion of primary care patients to engage in a potentially useful and inexpensive addition to standard depression care. If this is not possible, the likelihood of successfully completing a RCT of the effectiveness of depression Internet support groups utilizing primary care patients would be low. Researchers trying to assess the effectiveness of depression Internet support groups would have to go to alternative designs such as recruiting patients with depression as they try to join the depression Internet support groups and randomizing some to a delay in joining the group. We will also use this study to learn more about what patient characteristics are associated with engaging with an internet depression support group. While the focus of this study is Psychobabble, the intent of the study is to explore ease of referral, predictors of use and participant experiences as may relate to the general concept of Internet-based social support.
Specific AIM 1: We believe that participants randomized to the either that 8 x 11" brochure or the recommendation by the primary care physician will be more likely to visit and use the site than those who receive only a recommendation card (50% versus 35% versus 10%). We hypothesize that greater levels of encouragement/recommendation will be associated with higher levels of internet site usage. A sample size of 225 (N-110 at University of Chicago and N=115 at Johns Hopkins) will have power of 0.8 to detect the difference between either the card group or the brochure or physician recommendation group.
Specific Aim 2: We believe that those with higher self-efficacy and greater levels of trust in their primary care physician will be more likely to visit the site one time. We will conduct a logistic regression analysis to determine whether base self-efficacy and greater levels of trust predict use of the internet site after adjusting for group assignment. We hypothesize that higher levels of self-efficacy and physician trust will be associated with greater internet site use. Will believe a total N=225 will be sufficient to evaluate the relationship between 10 independent variables and the outcome of site usage (<15 cells/variable).
Specific Aim 3: We will determine if an internet based social support group is acceptable and feasible for primary care patients. Specifically, we will evaluate whether the internet site increased their knowledge of, or motivation for, depression treatment (Change in level of agreement to with regard to "accepting my doctors diagnosis of depression", strongly disagree 1, strongly agree 5). We hypothesize that levels of agreement will increase pre to post-study. A sample size of 225 (N=110 at University of Chicago and N=115 at Johns Hopkins) will have power of 0.8 to detect the difference of agree (4) pre-study to (5) strongly agree post study.
Specific Aim 4: We believe that social support and knowledge gained on the internet may influence subsequent care seeking or coping behaviors. Specifically, we will evaluate whether they have sought care or adopted coping skills 6 weeks after study entry. We hypothesize that both these behaviors will increase from pre to post study. A sample size of 225 (N=110 at University of Chicago and N=115 at Johns Hopkins) will have power of 0.8 to detect the difference of treatment participation pre-study of 0.4 versus 0.65 post study.
Specific Aim 5: We believe that social support or knowledge gained on the internet site leading to changed behaviors may results in lower levels of depressed mood. Specifically, we will compare levels of depressed mood at baseline and at 6 week follow-up. We hypothesize that their will be modest decline in depressed mood from pre study baseline to post study. A sample size of 225 (N=110 at University of Chicago and N=115 at Johns Hopkins) will have power of 0.8 to detect the difference of treatment participation pre study CES-D score of 24 post study score of 20.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Simple Card | Experimental | Behavioral: Simple CardParticipants will receive a simple 3"x5" card with the name of the website and the following description. "www.psychobabble.com (or new name). A website to help individuals with depression recover." |
| Patient Centered Brochure | Experimental | Behavioral: Patient Centered BrochureParticipants will receive an 8"x11" handout that provides a more complete description of the depression website. The handout will be based on a patient perspective with samples of Internet postings from users. This card will emphasize peer-to-peer support and not mention health care organizations or health care provider endorsements. The information will address potential barriers to use: user will not be identified, posting will not take that much time, information from peers can be checked for accuracy with other peers and providers, and helping patient learn how to tell their usual health care providers about their activities on the Internet site. Participants will be asked to provide their email so a reminder about the Internet depression site can be emailed to them at 1 week and 2 weeks. They will still be part of the study even if they will not provide their email. |
| Physicians endorsement | Experimental | Behavioral: Physician's endorsementParticipants will include the same card in experimental group 2 with the addition of a personal endorsement by the patient's health care provider in the form of a standardized letter signed by the physician. Participants will be asked to provide their email so a reminder about the Internet depression site can be emailed to them at 1 week and 2 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- PHQ score of 8 or above with either depressed mood or anhedonia/and or is considering treatment for depressed mood,
- does not reject all treatment for depression,
- has not viewed or posted messages more than once in the last month on any Internet depression support group website,
- does not self-report diagnoses of bipolar disorder by a health professional,
- age 18 years or older,
Key exclusion criteria (4 listed)
- active bipolar disorder,
- those with no access to the internet,
- those who state they are not under treatment nor would they consider any form of treatment, OR
- those considered to be at high risk of suicide attempts. These include those with past psychiatric hospitalization, past suicide attempts, bipolar disorder or score of greater than 1 on the PHQ-9 suicide assessment or who reports intent for self-harm as per assessment in the suicide prevention protocol.
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 |
|---|---|---|
| Simple CardParticipants will receive a simple 3"x5" card with the name of the website and the following description. "www.psychobabble.com (or new name). A website to help individuals with depression recover." | Behavioural | Simple Card |
| Patient Centered BrochureParticipants will receive an 8"x11" handout that provides a more complete description of the depression website. The handout will be based on a patient perspective with samples of Internet postings from users. This card will emphasize peer-to-peer support and not mention health care organizations or health care provider endorsements. The information will address potential barriers to use: user will not be identified, posting will not take that much time, information from peers can be checked for accuracy with other peers and providers, and helping patient learn how to tell their usual health care providers about their activities on the Internet site. Participants will be asked to provide their email so a reminder about the Internet depression site can be emailed to them at 1 week and 2 weeks. They will still be part of the study even if they will not provide their email. | Behavioural | Patient Centered Brochure |
| Physician's endorsementParticipants will include the same card in experimental group 2 with the addition of a personal endorsement by the patient's health care provider in the form of a standardized letter signed by the physician. Participants will be asked to provide their email so a reminder about the Internet depression site can be emailed to them at 1 week and 2 weeks. | Behavioural | Physicians endorsement |
Primary outcome
Percentage visiting the Internet site
Time frame: 6 weeks
1 secondary outcome
Feasibility, helpfulness and safety of Internet site
Time frame: 6 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 17 Dec 2012.
- Derived from this study: PubMed 23482332Van Voorhees BW, Hsiung RC, Marko-Holguin M, Houston TK, Fogel J, Lee R, Ford DE. Internal versus external motivation in referral of primary care patients with depression to an internet support group: randomized controlled trial. J Med Internet Res. 2013 Mar 12;15(3):e42. doi: 10.2196/jmir.2197.
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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 Phase 1/2 study testing Simple Card, Patient Centered Brochure and Physician's endorsement in people with Depressive Disorder, run by University of Chicago 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 7 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 17 Dec 2012. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage visiting the Internet site (time frame: 6 weeks). 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 NCT00886730, 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 17 Dec 2012.