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Completed

NCT Number: NCT02748954

Mood Management Effects of Brief Unsupported Internet Interventions

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).

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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 765 adults residing in the United States took part in a randomized controlled trial. Participants were randomly assigned to one of five brief plain text interventions lasting five to ten minutes. The interventions designed to address depressive symptoms were: Thoughts (increasing helpful thoughts), Activities (increasing activity level), Sleep Hygiene, Assertiveness (increasing assertiveness awareness), Own Methods (utilizing methods that were previously successful). They were followed-up one week after consenting.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • most be U.S. citizens

Exclusion criteria

  • non-U.S. residents

Treatment and study plan

Thoughts

Behavioral

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.

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

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.

Sleep Hygiene

Behavioral

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".

Own Methods

Behavioral

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

Primary outcomes

  1. Change in Patient Health Questionnaire (PHQ-9; Kroenke & Spitzer, 2002) scores

    Time frame: Baseline - 1 week follow-up

    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.

Secondary outcomes

  1. mood- Likert-type question

    Time frame: Baseline - 10 minutes after the intervention - 1 week follow-up

    How would you describe your mood in the last 2 weeks? and had responses ranging from 0 = Extremely Negative to 9 = Extremely Positive

  2. Motivation - Likert-type question

    Time frame: Baseline - 10 minutes after the intervention - 1 week follow-up

    How motivated are you to do something to improve your mood? and had responses ranging from 0 = Extremely Negative to 9 = Extremely Positive

  3. Confidence - Likert-type question

    Time frame: Baseline - 10 minutes after the intervention - 1 week follow-up

    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

  4. usefulness - Likert-type question

    Time frame: Baseline - 10 minutes after the intervention

    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.

  5. 7-item Generalized Anxiety Disorder questionnaire

    Time frame: Baseline - 1 week follow-up

    self-report questionnaire for measuring the level of generalized anxiety symptoms over a two-week period

Sponsors and collaborators

Lead sponsor

i4Health

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 22, 2016
Registry last updated
Apr 22, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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