LonelinessNCT03839966
Computerized Intervention for Loneliness
A study testing Interpretation Bias Modification for Loneliness and Healthy Habits Psychoeducation and Relaxation in people with Loneliness, run by Florida State University at 1 site in United States.
Trial summary
This study assesses whether a month long computerized interpretation bias modification intervention will reduce levels of loneliness compared to a control treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Loneliness
- What is being tested?
- Interpretation Bias Modification for Loneliness and Healthy Habits Psychoeducation and Relaxation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2019to 30 Apr 2020
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Score of >48 on the UCLA Loneliness Scale
Who cannot join
- Concurrent psychotherapy for social anxiety or depression
- Unstable psychotropic medication status (i.e. a change within the last month)
- History of psychotic or (hypo)manic symptoms
- Alcohol or other substance abuse or dependence within the last three months
- Previous participation in a similar IBM study
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida State University, Department of Psychology
Tallahassee, Florida, 32306
About this study
This study assesses whether a month long computerized interpretation bias modification intervention will reduce levels of loneliness compared to a control treatment.
Read the detailed description
This study hopes to assess whether a month long interpretation bias modification intervention will reduce levels of loneliness compared to a control treatment. Participants will be randomized into an active treatment condition or a control treatment that involves a healthy living and relaxation protocol. The investigators hypothesize that participants in the IBM condition will have lower levels of negative interpretation bias and loneliness than those in the healthy habits condition at post treatment and follow up. The investigators further hypothesize that the effects of IBM on loneliness will be accounted for by changes in interpretation bias.
- Conditions
- Loneliness
- Being tested
- Interpretation Bias Modification for Loneliness, Healthy Habits Psychoeducation and Relaxation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpretation Bias Modification for LonelinessBehavioural
Participants will receive eight treatment sessions. They will be presented with ambiguous training scenarios on a computer screen. Scenarios will be presented in two discrete formats: a word-sentence relatedness task (adapted from Beard \& Amir, 2008 and Beard, Weisberg, \& Amir, 2011), and a sentence completion and comprehension task (adapted from paradigms used by Mathews and Mackintosh (2000), Steinman and Teachman (2010), and Beard and Amir (2008)). Both of these formats have been used to reduce maladaptive threat interpretations and increase benign interpretations.
Healthy Habits Psychoeducation and RelaxationBehavioural
Participants will receive eight computerized sessions consisting of psychoeducation on healthy behaviors as well as relaxing video clips with pleasant music (e.g., videos of rainforests, wildlife, and space). These sessions will be matched for time with the active condition, lasting approximately 25-30 minutes each. Psychoeducation will cover the topics of exercise, diet, hygiene, social support, healthy activities, and sleep. The relaxing videos will be presented after the psycho-education in each session. At the conclusion of the study, participants will be provided with the active IBM treatment free of charge if they wish to receive it.
| Study group | Role | What they receive |
|---|---|---|
| Active Treatment | Experimental | Interpretation Bias Modification for Loneliness Receives: Behavioral: Interpretation Bias Modification for Loneliness |
| Control Treatment | Active comparator | Healthy Habits Psychoeducation and Relaxation. Receives: Behavioral: Healthy Habits Psychoeducation and Relaxation |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCLA Loneliness Scale (ULS)
A 20 item Self report scale measuring loneliness. Scales range from 0 to 60 with higher scores indicating a higher level of loneliness.
Measured: Change in loneliness from baseline to post treatment (4weeks) and three month follow up (16 weeks)
Secondary outcomes (6)
Multidimensional Scale of Perceived Social Support
Self-report scale that measures perceived levels of social support. Scores range from 12 to 84 with higher scores indicating higher levels of perceived social support. The three subscales (friends, family and significant other) all have a range of 4 to 28 with higher scores indicating higher levels of perceived social support.
Measured: Change in Perceived Social Support from baseline to post treatment (4weeks) and three month follow up (16 weeks)
Social Phobia inventory
Self-report scale that measures Social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety symptoms.
Measured: Change in social anxiety symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks)
State-Trait Inventory for Cognitive and Somatic Anxiety-Trait Version (STICSA-T)
Self-report measure used to assess overall anxiety symptoms. Scores range from 21 to 84 with higher scores indicating higher levels of overall anxiety.
Measured: Change in overall anxiety symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks)
Center for Epidemiological Studies Depression Scale (CES-D)
Self-report measure used to assess depressive symptoms. Total scores range from 0 to 60 with higher scores indicating a higher level of depressive symptoms.
Measured: Change in depression symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks)
Interpersonal Needs Questionnaire (INQ)
Self report measure of suicide vulnerability. Total scores range from 15 to 105, with higher scores indicating a higher vulnerability for suicide.
Measured: Change in suicide vulnerability from baseline to post treatment (4 weeks) and three month follow up (16 weeks)
Interpretations Questionnaire- Social Subscale (IQ-S)
Self report measure of interpretation bias of ambiguous social situations. Scales range from 0-44 with higher scores indicating a higher level of negative interpretation bias in social situations.
Measured: Change in interpretation style from baseline to post treatment (4 weeks) and three month follow up (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start25 Jan 2019
- Primary completion30 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LonelinessStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized to receive one of two treatments
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jesse Cougle, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839966
- Sponsor's protocol ID
- 2018.25994
- Other IDs
- 2018
- Status last verified
- Jan 2021
- First submitted
- 11 Feb 2019
- Last updated
- 29 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Intervention for Loneliness
- ClinicalTrials.gov ID
- NCT03839966
- Acronym / sponsor ID
- 2018.25994
- Conditions
- Loneliness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 25 Jan 2019 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 15 Feb 2019 (actual)
- 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.
This study assesses whether a month long computerized interpretation bias modification intervention will reduce levels of loneliness compared to a control treatment.
Detailed description
This study hopes to assess whether a month long interpretation bias modification intervention will reduce levels of loneliness compared to a control treatment. Participants will be randomized into an active treatment condition or a control treatment that involves a healthy living and relaxation protocol. The investigators hypothesize that participants in the IBM condition will have lower levels of negative interpretation bias and loneliness than those in the healthy habits condition at post treatment and follow up. The investigators further hypothesize that the effects of IBM on loneliness will be accounted for by changes in interpretation bias.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomized to receive one of two treatments
| Arm | Type | Receives |
|---|---|---|
| Active Treatment | Experimental | Behavioral: Interpretation Bias Modification for LonelinessInterpretation Bias Modification for Loneliness |
| Control Treatment | Active comparator | Behavioral: Healthy Habits Psychoeducation and RelaxationHealthy Habits Psychoeducation and Relaxation. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Score of >48 on the UCLA Loneliness Scale
Key exclusion criteria (5 listed)
- Concurrent psychotherapy for social anxiety or depression
- Unstable psychotropic medication status (i.e. a change within the last month)
- History of psychotic or (hypo)manic symptoms
- Alcohol or other substance abuse or dependence within the last three months
- Previous participation in a similar IBM study
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 |
|---|---|---|
| Interpretation Bias Modification for LonelinessParticipants will receive eight treatment sessions. They will be presented with ambiguous training scenarios on a computer screen. Scenarios will be presented in two discrete formats: a word-sentence relatedness task (adapted from Beard \& Amir, 2008 and Beard, Weisberg, \& Amir, 2011), and a sentence completion and comprehension task (adapted from paradigms used by Mathews and Mackintosh (2000), Steinman and Teachman (2010), and Beard and Amir (2008)). Both of these formats have been used to reduce maladaptive threat interpretations and increase benign interpretations. | Behavioural | Active Treatment |
| Healthy Habits Psychoeducation and RelaxationParticipants will receive eight computerized sessions consisting of psychoeducation on healthy behaviors as well as relaxing video clips with pleasant music (e.g., videos of rainforests, wildlife, and space). These sessions will be matched for time with the active condition, lasting approximately 25-30 minutes each. Psychoeducation will cover the topics of exercise, diet, hygiene, social support, healthy activities, and sleep. The relaxing videos will be presented after the psycho-education in each session. At the conclusion of the study, participants will be provided with the active IBM treatment free of charge if they wish to receive it. | Behavioural | Control Treatment |
Primary outcome
UCLA Loneliness Scale (ULS)
Time frame: Change in loneliness from baseline to post treatment (4weeks) and three month follow up (16 weeks)
A 20 item Self report scale measuring loneliness. Scales range from 0 to 60 with higher scores indicating a higher level of loneliness.
6 secondary outcomes
Multidimensional Scale of Perceived Social Support
Time frame: Change in Perceived Social Support from baseline to post treatment (4weeks) and three month follow up (16 weeks)
Social Phobia inventory
Time frame: Change in social anxiety symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks)
State-Trait Inventory for Cognitive and Somatic Anxiety-Trait Version (STICSA-T)
Time frame: Change in overall anxiety symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks)
Center for Epidemiological Studies Depression Scale (CES-D)
Time frame: Change in depression symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks)
Interpersonal Needs Questionnaire (INQ)
Time frame: Change in suicide vulnerability from baseline to post treatment (4 weeks) and three month follow up (16 weeks)
Interpretations Questionnaire- Social Subscale (IQ-S)
Time frame: Change in interpretation style from baseline to post treatment (4 weeks) and three month follow up (16 weeks)
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 29 Jan 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpretation Bias Modification for Loneliness and Healthy Habits Psychoeducation and Relaxation in people with Loneliness, run by Florida State University at 1 site in United States.
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 5 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 29 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
UCLA Loneliness Scale (ULS) (time frame: Change in loneliness from baseline to post treatment (4weeks) and three month follow up (16 weeks)). 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 29 Jan 2021; AzTrials last refreshed its copy on 29 Oct 2026.