Online Peer Networked Collaborative Learning for Managing Depressive Symptoms

Depression Clinical Trial

— MoodTech  

Official title:

Technology Assisted Intervention for the Treatment and Prevention of Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02841787
• Other study ID #: P20MH090318-FT
• Secondary ID: P20MH090318
• Status: Completed
• Phase: N/A
• Start date: December 2015
• Est. completion date: September 2016

Study information

• Verified date: February 2018
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Other known NCT identifiers

• NCT01912664

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: September 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• 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 completion of assessment materials.

• Is diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, 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 8-week treatment phase of the study

• 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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• iCBT for late life depression

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	Patient Health Questionnaire - 9 (PHQ-9) - Depression Severity Module	The PHQ-9 measures degree of depression severity. Possible range of scores for the PHQ-9 is 0-27. Higher values represent a worse outcome. Specifically, scores of 0-4 indicate minimal or no depression; 5-9 is mild; 10-14 is moderate; 15-19 is moderately severe; and 20-27 is severe.; The data table below shows PHQ-9 pre- and post- intervention score differences by group.	Baseline and Week 8 - Difference in PHQ-9 score
Primary	Mean Number of Sessions Across the 8-week Trial		8 weeks
Primary	System Usability Scale (SUS)	The System Usability Scale (SUS) is a usability scale that can be used for global assessments of systems usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Originally created by John Brooke in 1986, it allows you to evaluate a wide variety of products and services, including hardware, software, mobile devices, websites and applications. The participant's scores for each question are converted to a new number, added together and then multiplied by 2.5 to convert the original scores of 0-40 to 0-100. A SUS score above a 68 would be considered above average and anything below 68 is below average.	Week 8
Primary	Average Coaching Time Per Participant by Group	The average time spent on messages and calls and on group moderation.	8 weeks