MoodNCT02748954
Mood Management Effects of Brief Unsupported Internet Interventions
A study testing Thoughts, Activities. and Assertiveness. in people with Mood, run by i4Health.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mood
- What is being tested?
- Thoughts, Activities. and Assertiveness.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 765 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- most be U.S. citizens
Who cannot join
- non-U.S. residents
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).
Read the detailed 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 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.
- Conditions
- Mood
- Being tested
- Thoughts, Activities., Assertiveness., Sleep hygiene, Own Methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThoughtsBehavioural
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.Behavioural
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.Behavioural
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 hygieneBehavioural
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 MethodsBehavioural
wherein participants were asked to identify four of their own personal strategies that have helped them improve their mood in the past.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: 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". Receives: 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. Receives: Behavioral: Own Methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline - 1 week follow-up
Secondary outcomes (5)
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
Measured: Baseline - 10 minutes after the intervention - 1 week follow-up
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
Measured: Baseline - 10 minutes after the intervention - 1 week follow-up
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
Measured: Baseline - 10 minutes after the intervention - 1 week follow-up
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.
Measured: Baseline - 10 minutes after the intervention
7-item Generalized Anxiety Disorder questionnaire
self-report questionnaire for measuring the level of generalized anxiety symptoms over a two-week period
Measured: Baseline - 1 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startMay 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MoodStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 765 participants (actual)
Sponsor and investigators
- Lead sponsor
- i4Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo F Muñoz, Ph.D, Principal investigator, Palo Alto University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748954
- Sponsor's protocol ID
- 14-009- H
- Status last verified
- Apr 2016
- First submitted
- 12 Apr 2016
- Last updated
- 22 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mood Management Effects of Brief Unsupported Internet Interventions
- ClinicalTrials.gov ID
- NCT02748954
- Acronym / sponsor ID
- 14-009- H
- Conditions
- Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 765 participants (actual)
- Lead sponsor
- i4HealthUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed 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 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Thoughts. | Experimental | Behavioral: ThoughtsIncreasing 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. | Experimental | 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. |
| Assertiveness | Experimental | Behavioral: Assertiveness.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 | Experimental | Behavioral: Sleep hygieneIncreasing 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 | Active comparator | Behavioral: Own Methodswherein participants were asked to identify four of their own personal strategies that have helped them improve their mood in the past. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- most be U.S. citizens
Key exclusion criteria (1 listed)
- non-U.S. residents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThoughtsThoughts. 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. | Behavioural | Thoughts. |
| 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 | Behavioural | Activities. |
| Assertiveness.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. | Behavioural | Assertiveness |
| Sleep hygieneIncreasing 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". | Behavioural | Sleep hygiene |
| Own Methodswherein participants were asked to identify four of their own personal strategies that have helped them improve their mood in the past. | Behavioural | Own Methods |
Primary outcome
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.
5 secondary outcomes
mood- Likert-type question
Time frame: Baseline - 10 minutes after the intervention - 1 week follow-up
Motivation - Likert-type question
Time frame: Baseline - 10 minutes after the intervention - 1 week follow-up
Confidence - Likert-type question
Time frame: Baseline - 10 minutes after the intervention - 1 week follow-up
usefulness - Likert-type question
Time frame: Baseline - 10 minutes after the intervention
7-item Generalized Anxiety Disorder questionnaire
Time frame: Baseline - 1 week follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo F Muñoz, Ph.D principal investigator
Palo Alto University
Questions about this trial
What is this clinical trial studying?
A study testing Thoughts, Activities. and Assertiveness. in people with Mood, run by i4Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Health Questionnaire (PHQ-9; Kroenke & Spitzer, 2002) scores (time frame: Baseline - 1 week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2016; AzTrials last refreshed its copy on 6 Nov 2026.