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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02789280
Other study ID # 14-009 - H Part II
Secondary ID
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


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
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