Mood Management Effects of Brief Unsupported Internet Interventions II

Mood Clinical Trial

Official title:

Mood Management Effects of Brief Unsupported Internet Interventions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02789280
• Other study ID #: 14-009 - H Part II
• Status: Completed
• Phase: N/A
• First received: May 27, 2016
• Last updated: November 21, 2016
• Start date: May 2016
• Est. completion date: November 2016

Study information

• Verified date: April 2016
• Source: i4Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: November 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• most be U.S. citizens

Exclusion Criteria:

• non-U.S. residents

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Mood

Intervention

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

Other:
• Wait list
will receive the behavioral activation condition after one week of completing baseline assessment.

Locations

Country	Name	City	State
United States	Palo Alto University	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
i4Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes