Computerized Intervention for Loneliness

Not Applicable

Completed

• Conditions: Loneliness
• Interventions: Behavioral: Interpretation Bias Modification for Loneliness; Behavioral: Healthy Habits Psychoeducation and Relaxation

• Registration Number: NCT03839966
• Lead Sponsor: Florida State University

Brief Summary

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 Timeline

• Study Start: 2019-01-25
• Study First Submitted: 2019-02-11
• Study First Submitted QC: 2019-02-11
• Study First Posted: 2019-02-15
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Treatment	Interpretation Bias Modification for Loneliness	Interpretation Bias Modification for Loneliness
Control Treatment	Healthy Habits Psychoeducation and Relaxation	Healthy Habits Psychoeducation and Relaxation.

Primary Outcome Measures

Name	Time	Method
UCLA Loneliness Scale (ULS)	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.

Secondary Outcome Measures

Name	Time	Method
Center for Epidemiological Studies Depression Scale (CES-D)	Change in depression symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks)	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.
Interpretations Questionnaire- Social Subscale (IQ-S)	Change in interpretation style from baseline to post treatment (4 weeks) and three month follow up (16 weeks)	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.
Multidimensional Scale of Perceived Social Support	Change in Perceived Social Support from baseline to post treatment (4weeks) and three month follow up (16 weeks)	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.
State-Trait Inventory for Cognitive and Somatic Anxiety-Trait Version (STICSA-T)	Change in overall anxiety symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks)	Self-report measure used to assess overall anxiety symptoms. Scores range from 21 to 84 with higher scores indicating higher levels of overall anxiety.
Social Phobia inventory	Change in social anxiety symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks)	Self-report scale that measures Social anxiety symptoms. Scores range from 0 to 68 with higher scores indicating higher levels of social anxiety symptoms.
Interpersonal Needs Questionnaire (INQ)	Change in suicide vulnerability from baseline to post treatment (4 weeks) and three month follow up (16 weeks)	Self report measure of suicide vulnerability. Total scores range from 15 to 105, with higher scores indicating a higher vulnerability for suicide.

Trial Locations

Locations (1)

Florida State University, Department of Psychology; 🇺🇸 Tallahassee, Florida, United States