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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01912664
Other study ID # P20MH090318-STU00052134
Secondary ID
Status Completed
Phase N/A
First received July 29, 2013
Last updated September 23, 2016
Start date October 2015
Est. completion date September 2016

Study information

Verified date September 2016
Source Northwestern University
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The mission of this project is to develop novel systems of care that can provide efficacious, scalable, cost-effective, participant friendly technology assisted behavioral interventions (TABIs) for the treatment of depression in adults. The investigators define TABIs as interventions that use information and telecommunications technologies such as the internet, mobile or traditional phones, computers and/or other technologies to support and deliver psychological and behavioral interventions. Through usability testing, focus interviews, and field trials, investigators may modify the technologies and intervention based on immediate usage data.

The goal of this field trial is to tailor, and test, a peer networked intervention in adults 65 years of age or older. Two versions have been created and will be tested, one with and one without an online social network. The purpose of this study is to pilot a novel intervention, examine methods to improve adherence to Internet based interventions (e.g., peer network), and ultimately, to overcome the numerous barriers to treating depression in later life.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date September 2016
Est. primary completion date September 2016
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- Has elevated depressive symptoms

- Has a telephone, e-mail account, computer, and broadband access to the Internet.

- Has basic internet skills and is able to access the internet independently

- Is able to speak and read English.

- Is at least 65 years of age.

- Is able to give informed consent.

Exclusion Criteria:

- Has hearing or voice impairment that would prevent participation in psychotherapy

- Has visual impairment that would prevent use of the workbook and completion of assessment materials.

- Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, current post-traumatic stress disorder (PTSD), current substance abuse, or other diagnosis for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous.

- Is currently receiving individual psychotherapy or planning to receive psychotherapy during the 10-week treatment phase of the study (social networking site only)

- Is planning to be out of town or unavailable for an extended period of time during the study without access to the Internet

- Exhibits severe suicidality, including ideation, plan, and intent.

- Has initiated treatment with an antidepressant in past 14 days. Once patients have been on a stable dose for 14 days and do not have an appointment with a physician or psychiatrist to change this dose, the patient will be eligible based on this criterion.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Website

Behavioral:
Coach support

Network Peer Support


Locations

Country Name City State
United States Northwestern University Chicago Illinois

Sponsors (1)

Lead Sponsor Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depression Change in self-reported depressive symptom severity from baseline to end of treatment Baseline to end of treatment (8 weeks) No
Primary Adherence to the application Number of times accessed from start to last use from baseline to end of treatment (8 weeks) Baseline to end of treatment No
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