NCT02748954

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

100
On Track

Trial Health Score

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

Enrollment
765

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

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, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
Last Updated

April 22, 2016

Status Verified

April 1, 2016

Enrollment Period

1.1 years

First QC Date

April 12, 2016

Last Update Submit

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.

EXPERIMENTAL

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

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.

Assertiveness

EXPERIMENTAL

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.

Sleep hygiene

EXPERIMENTAL

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

Own Methods

ACTIVE COMPARATOR

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

Interventions

ThoughtsBEHAVIORAL

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.

Thoughts.
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.
Assertiveness.BEHAVIORAL

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.

Assertiveness
Sleep hygieneBEHAVIORAL

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".

Sleep hygiene
Own MethodsBEHAVIORAL

wherein participants were asked to identify four of their own personal strategies that have helped them improve their mood in the past.

Own Methods

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

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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

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