Computerized Intervention for Loneliness

Study Overview
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Brief Summary
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This study assesses whether a month long computerized interpretation bias modification intervention will reduce levels of loneliness compared to a control treatment.

Detailed Description
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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.

Official Title
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Computerized Intervention for Loneliness

Conditions
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Loneliness

Intervention / Treatment
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* Behavioral: Interpretation Bias Modification for Loneliness
* Behavioral: Healthy Habits Psychoeducation and Relaxation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Score of >48 on the UCLA Loneliness Scale Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to receive one of two treatments
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Treatment<br>Interpretation Bias Modification for Loneliness | Behavioral: Interpretation Bias Modification for Loneliness<br>* 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.<br>|
| Active Comparator: Control Treatment<br>Healthy Habits Psychoeducation and Relaxation. | Behavioral: Healthy Habits Psychoeducation and Relaxation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change in loneliness from baseline to post treatment (4weeks) and three month follow up (16 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | Change in interpretation style from baseline to post treatment (4 weeks) and three month follow up (16 weeks) |