Efficacy of an Internet-based self-help intervention with human guidance or automated messages to alleviate loneliness: a three-armed randomized controlled trial.

Loneliness is a prevalent and stigmatized phenomenon associated with adverse (mental) health outcomes. However, evidence-based interventions to alleviate loneliness are scarce. This randomized controlled trial (ClinicalTrials.gov-ID: NCT04655196) evaluated the efficacy of an internet-based cognitive behavioral self-help intervention (ICBT) to reduce loneliness by comparing two intervention groups with guidance or automated messages against a waitlist control group. Adults (N = 243) suffering from loneliness were recruited from the general public and then randomly assigned (2:2:1) to a 10-week ICBT with human guidance (GU) or automated messages (AM) or to a waitlist control group (WL). Loneliness, assessed with the UCLA-9, was the primary outcome. Outcomes were assessed at baseline and 10 weeks (post) and analyzed using mixed-effects models. The pooled intervention conditions resulted in lower loneliness scores at post-assessment than the WL (Cohen's d = 0.57, 95% CI [0.25; 0.89]) and reduced depressive symptoms, social anxiety, social avoidance behavior, and rejection sensitivity (d = 0.32-0.52). The GU group had lower loneliness scores at post-assessment than the AM group (d = 0.42, 95% CI [0.13; 0.70]). ICBT effectively alleviated loneliness, and guidance increased the reduction in loneliness compared to automated messages. Alleviating loneliness with ICBT further seems to reduce the overall burden of psychopathological symptoms.

Predictors and moderators of outcome of ICBT for loneliness with guidance or automated messages - A secondary analysis of a randomized controlled trial.

Internet-based cognitive behavioral therapy (ICBT) is promising in alleviating loneliness in adults. Identifying individuals who benefit from ICBT for loneliness is pivotal to offering this intervention in a more targeted way and improving the intervention for those who do not benefit. This secondary analysis of a randomized controlled trial (RCT) aimed to identify predictors and moderators of outcome of an ICBT with guidance or automated messages for loneliness. In the RCT, 243 participants suffering from loneliness were randomly assigned to an ICBT with guidance (n = 98), automated messages (n = 97), or a waitlist-control condition (n = 48). In total, 180 participants completed the post-assessment (i.e., 10 weeks post-randomization). Outcomes were treatment outcome assessed with the UCLA-9 Loneliness Scale at post-assessment and treatment response, i.e., reliable improvement on the UCLA-9 from pre- to post. The relationship between a wide range of patient characteristics (grouped into socio-demographic, clinical, loneliness-specific, and treatment-related variables) and outcome was analyzed using multiple linear and logistic regressions. Feeling less burdened by loneliness resulted in higher odds of reliable improvement in guided ICBT compared to the waitlist-control condition. No treatment outcome or response moderators were identified for ICBT with automated messages compared to the waitlist-control group. Across active intervention groups, loneliness at baseline, age and fit between the tasks and goals of the intervention and participants' need predicted treatment outcome. Predictors of treatment response for ICBT with guidance and automated messages were not identified, and no variables differentially predicted the effects of ICBT with guidance or automated messages on the outcomes. In conclusion, individuals less burdened by their feelings of loneliness benefited more from guided ICBT. Lower baseline loneliness scores, younger age, and a better match between tasks and goals of the intervention and participants' needs also predicted a more favorable treatment outcome for both ICBT with guidance and automated messages.

Evaluating the Efficacy of a Guided and Unguided Internet-Based Self-help Intervention for Chronic Loneliness: Protocol for a 3-Arm Randomized Controlled Trial.

BACKGROUND: Loneliness, or perceived social isolation, is prevalent in both the general population and clinical practice. Although loneliness has repeatedly been associated with mental and physical health, research on interventions that reduce loneliness effectively is still rather scarce. OBJECTIVE: This study aims to evaluate the efficacy of a guided and an unguided version of the same internet-based cognitive behavioral self-help program for loneliness (SOLUS-D) for adults. METHODS: A total of 250 participants will be randomly assigned to 1 of 2 intervention groups (SOLUS-D with guidance or SOLUS-D without guidance) or a wait-list control group (2:2:1 allocation ratio). Adult participants experiencing high levels of loneliness will be recruited from the general population. Individuals currently experiencing at least moderately severe depressive symptoms, an ongoing severe substance use disorder, previous or current bipolar or psychotic disorder, or acute suicidality will be excluded from the trial. Assessments will take place at baseline, 5 weeks (midassessment), and 10 weeks (postassessment). The primary outcome is loneliness assessed using the 9-item University of California, Los Angeles Loneliness Scale at the posttreatment time point. Secondary outcomes include depressive symptoms, symptoms of social anxiety, satisfaction with life, social network size, and variables assessing cognitive bias and social behavior. The maintenance of potentially achieved gains will be assessed and compared at 6 and 12 months after randomization in the 2 active conditions. Potential moderators and mediators will be tested exploratorily. Data will be analyzed on an intention-to-treat basis. RESULTS: Recruitment and data collection started in May 2021 and are expected to be completed by 2022, with the 12-month follow-up to be completed by 2023. As of the time of submission of the manuscript, 134 participants were randomized. CONCLUSIONS: This 3-arm randomized controlled trial will add to the existing research on the efficacy of loneliness interventions. Furthermore, it will shed light on the role of human guidance in internet-based treatments for individuals with increased levels of loneliness and the possible mechanisms of change. If SOLUS-D proves effective, it could provide a low-threshold, cost-efficient method of helping and supporting individuals with increased levels of loneliness. TRIAL REGISTRATION: ClinicalTrials.gov NCT04655196; https://clinicaltrials.gov/ct2/show/NCT04655196. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/36358.