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

Abstract

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

Effectiveness of Internet-Based Training on Psychotherapists’ Transcultural Competence: A Randomized Controlled Trial

“…The self-report nature of the questionnaires may have contributed to participants’ belief in their training benefits and improved awareness and engagement, potentially explaining the absence of between-group differences in OnTracc scores. Compared to other competence training, guided training tends to be more effective (Seewer et al, 2022). Since participants were already experienced in transcultural treatment (e.g., workshop experience, culturally specific supervision, and some even had CDPs in treatment), the CG may not have needed guidance to enhance their competence and were motivated enough to work through the text-based training on their own.…”

Loneliness is associated with retrospective self-reports of adverse childhood experiences – A replication study in Ethiopia

“…Furthermore, interventions must be adapted to the resource setting. For example, recent studies show promising results for internet-delivered cognitive behavioral therapy against loneliness, presenting a costeffective approach [53][54][55] . A culturally sensitive adaptation of such interventions led by local researchers is crucial to explore effective interventions against loneliness in different cultural settings.…”

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

“…This trial was preregistered with clinicaltrials.gov (NCT04655196, registration date: 07/12/2020), conducted in accordance with the declaration of Helsinki, and has been approved by the Cantonal Ethics Committee Bern (CEC; ID: 202-01298). Moreover, we published a study protocol 47 . Informed consent was obtained from all subjects before participating in the study.…”

“…Before randomization, we administered the Mini-DIPS-Open Access 48 to assess diagnoses of mental disorders. We refer to the online Supplementary Material and the study protocol 47 for a more detailed description of all measures.…”