Mood Management Effects of Brief Unsupported Internet Interventions
1 other identifier
interventional
765
0 countries
N/A
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2014
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 12, 2016
CompletedFirst Posted
Study publicly available on registry
April 22, 2016
CompletedApril 22, 2016
April 1, 2016
1.1 years
April 12, 2016
April 19, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (5)
mood- Likert-type question
Baseline - 10 minutes after the intervention - 1 week follow-up
Motivation - Likert-type question
Baseline - 10 minutes after the intervention - 1 week follow-up
Confidence - Likert-type question
Baseline - 10 minutes after the intervention - 1 week follow-up
usefulness - Likert-type question
Baseline - 10 minutes after the intervention
7-item Generalized Anxiety Disorder questionnaire
Baseline - 1 week follow-up
Study Arms (5)
Thoughts.
EXPERIMENTALIncreasing 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
Activities.
EXPERIMENTALIncreasing 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.
Assertiveness
EXPERIMENTALIncreasing 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
Sleep hygiene
EXPERIMENTALIncreasing 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".
Own Methods
ACTIVE COMPARATORwherein participants were asked to identify four of their own personal strategies that have helped them improve their mood in the past.
Interventions
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.
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
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.
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".
wherein participants were asked to identify four of their own personal strategies that have helped them improve their mood in the past.
Eligibility Criteria
You may qualify if:
- \- most be U.S. citizens
You may not qualify if:
- \- non-U.S. residents
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- i4Healthlead
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ricardo F Muñoz, Ph.D
Palo Alto University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2016
First Posted
April 22, 2016
Study Start
May 1, 2014
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
April 22, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share