Computerized Intervention for Loneliness

Loneliness Clinical Trial

Official title:

Computerized Intervention for Loneliness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03839966
• Other study ID #: 2018.25994
• Status: Completed
• Phase: N/A
• Start date: January 25, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: January 2021
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Loneliness

Intervention

Behavioral:
• Interpretation Bias Modification for Loneliness
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 Relaxation
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.

Locations

Country	Name	City	State
United States	Florida State University, Department of Psychology	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)