Clinical trial NCT03839966: Computerized Intervention for Loneliness
Official title: Computerized Intervention for Loneliness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Loneliness
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2019-02-15
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive one of two treatments
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: UCLA Loneliness Scale (ULS)
timeFrame: Change in loneliness from baseline to post treatment (4weeks) and three month follow up (16 weeks)
Secondary outcomes:
measure: Multidimensional Scale of Perceived Social Support
timeFrame: Change in Perceived Social Support from baseline to post treatment (4weeks) and three month follow up (16 weeks)
measure: Social Phobia inventory
timeFrame: Change in social anxiety symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks)
measure: State-Trait Inventory for Cognitive and Somatic Anxiety-Trait Version (STICSA-T)
timeFrame: Change in overall anxiety symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks)
measure: Center for Epidemiological Studies Depression Scale (CES-D)
timeFrame: Change in depression symptoms from baseline to post treatment (4 weeks) and three month follow up (16 weeks)
measure: Interpersonal Needs Questionnaire (INQ)
timeFrame: Change in suicide vulnerability from baseline to post treatment (4 weeks) and three month follow up (16 weeks)
measure: Interpretations Questionnaire- Social Subscale (IQ-S)
timeFrame: Change in interpretation style from baseline to post treatment (4 weeks) and three month follow up (16 weeks)
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University, Department of Psychology
state: Florida
Study officials:
References: