Primary Care Patients With Depression for Internet-Based Social Support (Psychobabble)
This study has been completed.
Sponsor:
University of Chicago
Collaborator:
Johns Hopkins University
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00886730
First received: April 22, 2009
Last updated: December 13, 2012
Last verified: December 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Depressive Disorder |
Behavioral: Simple Card Behavioral: Patient Centered Brochure Behavioral: Physician's endorsement |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Feasibility Study of Methods of Referral Primary Care Patients With Depression for Internet-Based Social Support |
Resource links provided by NLM:
Further study details as provided by University of Chicago:
Primary Outcome Measures:
- Percentage visiting the Internet site [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Feasibility, helpfulness and safety of Internet site [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 49 |
| Study Start Date: | October 2008 |
| Study Completion Date: | May 2011 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Simple Card
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."
|
Behavioral: Simple Card
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."
|
|
Experimental: Patient Centered Brochure
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.
|
Behavioral: Patient Centered Brochure
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.
|
|
Experimental: Physicians endorsement
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.
|
Behavioral: Physician's endorsement
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.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations More Information
No publications provided by University of Chicago
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00886730 History of Changes |
| Other Study ID Numbers: | 15836A, R34 MH 073742-01 |
| Study First Received: | April 22, 2009 |
| Last Updated: | December 13, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Chicago:
|
Depressive disorder Primary care Internet Social support Feasibility |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Behavioral Symptoms Mood Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013