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Primary Care Patients With Depression for Internet-Based Social Support (Psychobabble)

This study has been completed.
Sponsor:
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
  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

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:

  1. PHQ score of 8 or above with either depressed mood or anhedonia/and or is considering treatment for depressed mood,
  2. does not reject all treatment for depression,
  3. has not viewed or posted messages more than once in the last month on any Internet depression support group website,
  4. does not self-report diagnoses of bipolar disorder by a health professional,
  5. age 18 years or older,
  6. attends a primary care clinic and have visited in last 6 months, AND
  7. 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:

  1. active bipolar disorder,
  2. those with no access to the internet,
  3. those who state they are not under treatment nor would they consider any form of treatment, OR
  4. 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00886730

Locations
United States, Illinois
University of Chicago Physician's Group - PCG Maryland Avenue
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Johns Hopkins University
  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
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 20, 2014