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: Thoughts; Behavioral: Activities.; Behavioral: Assertiveness.; Behavioral: Sleep hygiene; Behavioral: Own Methods

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 765 adults residing in the United States took part in a randomized controlled trial. Participants were randomly assigned to one of five brief plain text interventions lasting five to ten minutes. The interventions designed to address depressive symptoms were: Thoughts (increasing helpful thoughts), Activities (increasing activity level), Sleep Hygiene, Assertiveness (increasing assertiveness awareness), Own Methods (utilizing methods that were previously successful). They were followed-up one week after consenting.

• Study Type: Interventional
• Enrollment (Actual): 765
• Phase: Not Applicable

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

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thoughts.; Increasing helpful thoughts consisted of two psychoeducational segments (i.e., thoughts affect emotions, and how to manage harmful thoughts), and a list of "helpful thoughts" that participants could choose to use to increase their mood for the next week	Behavioral: Thoughts; Thoughts. Increasing helpful thoughts consisted of two psychoeducational segments (i.e., thoughts affect emotions, and how to manage harmful thoughts), and a list of "helpful thoughts" that participants could choose to use to increase their mood for the next week.
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
Experimental: Assertiveness; Increasing assertiveness, consisting of tips for communicating assertively, and an example of an assertive statement. Participants were asked to describe a recent conflict and apply the intervention's assertiveness techniques to address the conflict	Behavioral: Assertiveness.; Increasing assertiveness, consisting of tips for communicating assertively, and an example of an assertive statement. Participants were asked to describe a recent conflict and apply the intervention's assertiveness techniques to address the conflict.
Experimental: Sleep hygiene; Increasing sleep hygiene included a description on how sleep can affect mood. Participants were also asked to select from a list of helpful sleep hygiene suggestions to be practiced within the next week such as, "Don't take naps during the day" and "Use the bed/bedroom for sleep or sex only".	Behavioral: Sleep hygiene; Increasing sleep hygiene included a description on how sleep can affect mood. Participants were also asked to select from a list of helpful sleep hygiene suggestions to be practiced within the next week such as, "Don't take naps during the day" and "Use the bed/bedroom for sleep or sex only".
Active Comparator: Own Methods; wherein participants were asked to identify four of their own personal strategies that have helped them improve their mood in the past.	Behavioral: Own Methods; wherein participants were asked to identify four of their own personal strategies that have helped them improve their mood in the past.

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
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
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
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
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

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, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: April 12, 2016
• First Submitted That Met QC Criteria: April 19, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Estimate): April 22, 2016
• Last Update Submitted That Met QC Criteria: April 19, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 14-009- H

Plan for Individual participant data (IPD)

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