NCT02789280

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 22, 2016

Status Verified

April 1, 2016

Enrollment Period

4 months

First QC Date

May 27, 2016

Last Update Submit

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.

EXPERIMENTAL

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.

Wait List

ACTIVE COMPARATOR

Participants will be asked to wait for a week until they receive the behavioral activation condition

Other: Wait list

Interventions

Activities.BEHAVIORAL

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

Activities.

will receive the behavioral activation condition after one week of completing baseline assessment.

Wait List

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

Palo Alto University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Interventions

ExerciseWaiting Lists

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaAppointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Ricardo F Muñoz, Ph.D

    Palo Alto University

    PRINCIPAL INVESTIGATOR

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

Locations