Mood Management Effects of Brief Unsupported Internet Interventions II

Mood Management Effects of Brief Unsupported Internet Interventions

The main goal of this study was to compare the effect of a one-session unsupported Internet intervention on participants' clinical symptoms (depressive and anxiety symptoms) and related variables (mood, confidence and motivation).

Study Overview

• Status: Completed
• Conditions: Mood
• Intervention / Treatment: Behavioral: Activities.; Other: Wait list

Detailed Description

The main goal of this study was to compare the effect of a one-session unsupported Internet intervention on participants' clinical symptoms (depressive and anxiety symptoms) and related variables (mood, confidence and motivation).

Method: A total of 275 adults residing in the United States will take part in a randomized controlled trial. Participants were randomly assigned to an experimental condition based on Behavioral activation or a one week wait list condition. They will be follow-up one week after consenting.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Palo Alto University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• most be U.S. citizens

Exclusion Criteria:

• non-U.S. residents

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Activities.; Increasing activity level included a brief description of how activities affect mood. Participants were then asked to choose the activities they could use to improve their mood from an available list of "helpful activities"; users were also able to generate their own helpful activities. Participants were also presented with examples of unhelpful activities such as staying in bed and being isolated.	Behavioral: Activities.; Increasing activity level included a brief description of how activities affect mood. Participants were then asked to choose the activities they could use to improve their mood from an available list of "helpful activities"; users were also able to generate their own helpful activities. Participants were also presented with examples of unhelpful activities such as staying in bed and being isolated
Active Comparator: Wait List; Participants will be asked to wait for a week until they receive the behavioral activation condition	Other: Wait list; will receive the behavioral activation condition after one week of completing baseline assessment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Health Questionnaire (PHQ-9; Kroenke & Spitzer, 2002) scores	Which is a widely used 10-item measure that screens for a presence of a major depressive episode as well as assesses the severity of depressive symptomatology over a 2-week period.	Baseline - 1 week follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motivation - Likert-type question	How motivated are you to do something to improve your mood? and had responses ranging from 0 = Extremely Negative to 9 = Extremely Positive	Baseline - 10 minutes after the intervention - 1 week follow-up
Confidence - Likert-type question	How confident are you that you are able to do something to improve your mood?and had responses ranging from 0 = Extremely Negative to 9 = Extremely Positive	Baseline - 10 minutes after the intervention - 1 week follow-up
7-item Generalized Anxiety Disorder questionnaire	self-report questionnaire for measuring the level of generalized anxiety symptoms over a two-week period	Baseline - 1 week follow-up
Mood- Likert-type question	How would you describe your mood in the last 2 weeks? and had responses ranging from 0 = Extremely Negative to 9 = Extremely Positive	Baseline - 10 minutes after the intervention - 1 week follow-up
Usefulness - Likert-type question	Before you see the ideas we will be sharing with you, how likely do you think they will be useful?" and had responses ranging from 0 = Very Unlikely to 6 = Very Likely.	Baseline - 10 minutes after the intervention

Collaborators and Investigators

• Sponsor: i4Health
• Investigators: Principal Investigator: Ricardo F Muñoz, Ph.D, Palo Alto University

Study record dates

Study Major Dates

• Study Start: May 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: May 27, 2016
• First Submitted That Met QC Criteria: June 1, 2016
• First Posted (Estimate): June 2, 2016

Study Record Updates

• Last Update Posted (Estimate): November 22, 2016
• Last Update Submitted That Met QC Criteria: November 21, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 14-009 - H Part II

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO