Mood Management Effects of Brief Unsupported Internet Interventions II
1 other identifier
interventional
300
1 country
1
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 2016
Shorter than P25 for not_applicable
1 active site
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, 2016
CompletedFirst Submitted
Initial submission to the registry
May 27, 2016
CompletedFirst Posted
Study publicly available on registry
June 2, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedNovember 22, 2016
April 1, 2016
4 months
May 27, 2016
November 21, 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 (2)
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.
Wait List
ACTIVE COMPARATORParticipants will be asked to wait for a week until they receive the behavioral activation condition
Interventions
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
will receive the behavioral activation condition after one week of completing baseline assessment.
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
Study Sites (1)
Palo Alto University
Palo Alto, California, 94304, United States
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
May 27, 2016
First Posted
June 2, 2016
Study Start
May 1, 2016
Primary Completion
September 1, 2016
Study Completion
November 1, 2016
Last Updated
November 22, 2016
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share