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Completed

NCT Number: NCT03839966

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.

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Key information

Conditions

Loneliness

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida State University, Department of Psychology

Tallahassee, Florida, 32306, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. UCLA Loneliness Scale (ULS)

    Time frame: 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 outcomes

  1. Multidimensional Scale of Perceived Social Support

    Time frame: 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.

  2. Social Phobia inventory

    Time frame: 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.

  3. State-Trait Inventory for Cognitive and Somatic Anxiety-Trait Version (STICSA-T)

    Time frame: 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.

  4. Center for Epidemiological Studies Depression Scale (CES-D)

    Time frame: 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.

  5. Interpersonal Needs Questionnaire (INQ)

    Time frame: 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.

  6. Interpretations Questionnaire- Social Subscale (IQ-S)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Florida State University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 15, 2019
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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