Computerized Intervention for Loneliness

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

Study Overview

• Status: Completed
• Conditions: Loneliness
• Intervention / Treatment: Behavioral: Interpretation Bias Modification for Loneliness; Behavioral: Healthy Habits Psychoeducation and Relaxation

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 Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tallahassee, Florida, United States, 32306
      • Florida State University, Department of Psychology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Active Treatment; Interpretation Bias Modification for Loneliness	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.
ACTIVE_COMPARATOR: Control Treatment; Healthy Habits Psychoeducation and Relaxation.	Behavioral: 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Florida State University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 25, 2019
• Primary Completion (ACTUAL): April 30, 2020
• Study Completion (ACTUAL): April 30, 2020

Study Registration Dates

• First Submitted: February 11, 2019
• First Submitted That Met QC Criteria: February 11, 2019
• First Posted (ACTUAL): February 15, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 29, 2021
• Last Update Submitted That Met QC Criteria: January 26, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 2018.25994

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No