Computerized Intervention for Loneliness

NCT03839966 | Completed

• 1 other identifier: 2018.25994
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Loneliness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Multidimensional Scale 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

  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)

  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)

  Change in depression symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks)

• Interpersonal Needs Questionnaire (INQ)

  Change in suicide vulnerability from baseline to post treatment (4 weeks) and three month follow up (16 weeks)

Study Arms (2)

Active Treatment

EXPERIMENTAL

Interpretation Bias Modification for Loneliness

Behavioral: Interpretation Bias Modification for Loneliness

Control Treatment

ACTIVE COMPARATOR

Healthy Habits Psychoeducation and Relaxation.

Behavioral: Healthy Habits Psychoeducation and Relaxation

Interventions

Interpretation Bias Modification for Loneliness BEHAVIORAL

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 Treatment

Healthy Habits Psychoeducation and Relaxation BEHAVIORAL

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.

Control Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Score of \>48 on the UCLA Loneliness Scale

You may not qualify if:

• 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

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University, Department of Psychology

Tallahassee, Florida, 32306, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know if they are receiving the active or control treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized to receive one of two treatments

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 15, 2019
• Study Start: January 25, 2019
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: January 29, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)