The Feasibility, Acceptability and Preliminary Efficacy of a Group Intervention to Reduce Loneliness

NCT05831813 | Completed

• 1 other identifier: 2023-CP-15875
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Severe loneliness is a large and growing clinical and societal problem. Although there are interventions for loneliness, elevated levels often remain. This pilot study evaluates the feasibility and acceptability of an intervention to alleviate social and emotional loneliness among students. The second aim is to obtain effect sizes that inform sample size calculations of a subsequent randomized controlled trial (RCT). The goal of this clinical trial is to learn about the feasibility and acceptability of a group intervention aimed at reducing social and emotional loneliness and social isolation in students. In addition, we want to obtain effect sizes that can inform the sample size calculation of a subsequent randomized controlled trial (RCT). The hypotheses are that:

• Participants after completing the intervention have reduced levels of social and emotional loneliness and social isolation compared to baseline (primary outcomes).
• Participants after completing the intervention have reduced levels of social anxiety, depressive symptoms, and better daily functioning compared to baseline (secondary outcomes). Before the group intervention starts, participants will first follow a baseline period, ranging between 1 and 7 weeks. The length of the baseline period is based on the date of enrolment and therefore not random. Following the baseline period, all participants will start in the group intervention. This intervention aims to encourage social behavioural activation tailored to the values of the participant and teach skills that make negative emotions and thoughts less bothersome and reduce feelings of loneliness. This intervention consists of seven weekly group sessions and a booster session. The intervention is offered in a group format to maximize possibilities for interpersonal therapeutic practice and is framed as a psycho-educational course to increase its acceptability. Data are collected at screening, pre-intervention, post-intervention, one-month follow-up and three-month follow-up, as well as during weekly measurements during the baseline period and the course period. Primary outcome measures are social and emotional loneliness and social isolation. Secondary outcome measures are social anxiety, depression, and daily functioning. Other outcome measures are interpersonal problems and assessment of the sessions. Participants will be recruited via posters at the University of Amsterdam.

Conditions

Loneliness; Social Isolation

Keywords

Loneliness; Social Isolation

Outcome Measures

Primary Outcomes (6)

• Changes in social loneliness

  Loneliness Scale (LS; de Jong Gierveld \& van Tilburg, 1999). The 11-item Loneliness Scale was used to measure emotional and social loneliness. Participants score the items on a 5-point Likert scale ("yes!", "yes", "more or less", "no", "no!").

  Assessed at screening (1 to 8 weeks before pretest), pretest, posttest (8 weeks after pretest), one-month follow-up and three-month follow-up.

• Weekly changes in social loneliness

  Loneliness Scale (LS; de Jong Gierveld \& van Tilburg, 2006) The 6-item Loneliness Scale was used to measure emotional and social loneliness. Participants score the items on a 5-point Likert scale ("yes!", "yes", "more or less", "no", "no!").

  Assessed in weekly measurements in the baseline period (up to 7 weeks before pretest) and in weekly measurements in the intervention period (up to 7 weeks after pretest)

• Changes in emotional loneliness

  Measured by the Loneliness Scale (LS; de Jong Gierveld \& van Tilburg, 1999). The 11-item Loneliness Scale was used to measure emotional and social loneliness. Participants score the items on a 5-point Likert scale ("yes!", "yes", "more or less", "no", "no!").

  Assessed at screening (1 to 8 weeks before pretest), pretest, posttest (8 weeks after pretest), one-month follow-up and three-month follow-up.

• Weekly changes in emotional loneliness

  Loneliness Scale (LS; de Jong Gierveld \& van Tilburg, 2006) The 6-item Loneliness Scale was used to measure emotional and social loneliness. Participants score the items on a 5-point Likert scale ("yes!", "yes", "more or less", "no", "no!").

  Assessed in weekly measurements in the baseline period (up to 7 weeks before pretest) and in weekly measurements in the intervention period (up to 7 weeks after pretest)

• Changes in social isolation

  Lubben Social Network Scale (LSNS; Lubben, 1998). The 12-item LSNS-R quantifies social isolation from family and friends. Participants score the items on a 6-point Likert scale.

  Assessed at screening (1 to 8 weeks before pretest), pretest, posttest (8 weeks after pretest), one-month follow-up and three-month follow-up.

• Weekly changes in social isolation

  Lubben Social Network Scale (LSNS; Lubben, 2006). The 6-item LSNS quantifies social isolation from family and friends. Participants score the items on a 6-point Likert scale (0 ≥ 9 relatives/friends to 5 = no relatives/friends).

  Assessed in weekly measurements in the baseline period (up to 7 weeks before pretest) and in weekly measurements in the intervention period (up to 7 weeks after pretest)

Secondary Outcomes (3)

• Changes in depressive symptoms

  Assessed at screening (1 to 8 weeks before pretest), pretest, posttest (8 weeks after pretest), one-month follow-up and three-month follow-up.

• Changes in social anxiety

  Assessed at screening (1 to 8 weeks before pretest), pretest, posttest (8 weeks after pretest), one-month follow-up and three-month follow-up.

• Changes in daytime functioning

  Assessed at screening (1 to 8 weeks before pretest), pretest, posttest (8 weeks after pretest), one-month and three-month follow-up, in weekly measurements in baseline period and intervention period (up to 7 weeks before and after pretest respectively)

Other Outcomes (2)

• Satisfaction of the followed sessions

  Assessed in the seven weekly measurements in the intervention period (up to 7 weeks after pretest)

• Problematic interpersonal styles

  Assessed at screening (1 to 8 weeks before pretest), pretest, posttest (8 weeks after pretest), one-month follow-up and three-month follow-up.

Study Arms (1)

Goal-Based Cognitive Behavioural Intervention

EXPERIMENTAL

Participants start with a 1 to 7 weeks baseline period. The duration is based on the enrolment date and therefore not random. Afterward, all participants enter the intervention, which promotes social behavioural activation aligned with personal values and teaches skills that make negative emotions and thoughts less bothersome and reduce feelings of loneliness. The intervention comprises seven weekly sessions and a follow-up, conducted in a group format to facilitate interpersonal practice and is presented as a course for enhanced acceptability. Please note: The original design involved an RCT with a Goal-Based Cognitive Behavioral Intervention as the experimental arm and a waitlist arm. Participants in the waitlist arm would enter the intervention after a waitlist period. Due to limited enrollments, the design was modified to a single arm resembling the waitlist arm of the initial RCT design.

Behavioral: Goal-Based Cognitive Behavioural Intervention

Interventions

Goal-Based Cognitive Behavioural Intervention BEHAVIORAL

A goal-based cognitive behavioural intervention in a group format that addresses negative social cognitions and focuses on social approach processes

Goal-Based Cognitive Behavioural Intervention

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Being at least 16 years old
• Exhibiting at least moderate levels of loneliness as assessed by the De Jong Gierveld Loneliness Scale 11-item version (DJGLS; de Jong-Gierveld \& Kamphuls, 1985)
• Possessing sufficient proficiency in the English language.

You may not qualify if:

• \- The presence of severe (psychiatric) problems that hinder participation in the study or require other forms of immediate care, as indicated by the Mini International Neuropsychiatric Interview 7.0.2 (MINI; Sheehan et al., 1998).
• If participants were already receiving psychological or pharmacological treatment for psychiatric problems, this treatment had to be temporarily interrupted for the duration of the study in consultation with the participant's clinician.

Sponsors & Collaborators

• University of Amsterdam: lead

Study Sites (1)

University of Amsterdam

Amsterdam, North Holland, 1001 NK, Netherlands

Location

Related Publications (6)

• Alden LE, Buhr K, Robichaud M, Trew JL, Plasencia ML. Treatment of social approach processes in adults with social anxiety disorder. J Consult Clin Psychol. 2018 Jun;86(6):505-517. doi: 10.1037/ccp0000306.

  PMID: 29781649 BACKGROUND

• Alden LE, Taylor CT. Relational treatment strategies increase social approach behaviors in patients with Generalized Social Anxiety Disorder. J Anxiety Disord. 2011 Apr;25(3):309-18. doi: 10.1016/j.janxdis.2010.10.003. Epub 2010 Oct 20.

  PMID: 21094019 BACKGROUND

• Cacioppo S, Grippo AJ, London S, Goossens L, Cacioppo JT. Loneliness: clinical import and interventions. Perspect Psychol Sci. 2015 Mar;10(2):238-49. doi: 10.1177/1745691615570616.

  PMID: 25866548 BACKGROUND

• Cacioppo JT, Hawkley LC. Perceived social isolation and cognition. Trends Cogn Sci. 2009 Oct;13(10):447-54. doi: 10.1016/j.tics.2009.06.005. Epub 2009 Aug 31.

  PMID: 19726219 BACKGROUND

• Masi CM, Chen HY, Hawkley LC, Cacioppo JT. A meta-analysis of interventions to reduce loneliness. Pers Soc Psychol Rev. 2011 Aug;15(3):219-66. doi: 10.1177/1088868310377394. Epub 2010 Aug 17.

  PMID: 20716644 BACKGROUND

• Qualter P, Vanhalst J, Harris R, Van Roekel E, Lodder G, Bangee M, Maes M, Verhagen M. Loneliness across the life span. Perspect Psychol Sci. 2015 Mar;10(2):250-64. doi: 10.1177/1745691615568999.

  PMID: 25910393 BACKGROUND

MeSH Terms

Conditions

Social Isolation

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Officials

• Carmen van den Bulck, MSc

  University of Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: C.M.M. (Carmen) van den Bulck, MSc

Model Details: Before the intervention starts, participants will first follow a baseline period, ranging between 1 and 7 weeks. The length of the baseline period is based on the date of enrolment and therefore not random. Following the baseline period, all participants will start in the group intervention. Data are collected at screening, pre-intervention, post-intervention, one-month follow-up and three-month follow-up, as well as during weekly measurements during the waiting list period and the course.

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: April 26, 2023
• Study Start: March 11, 2023
• Primary Completion: October 27, 2023
• Study Completion: October 27, 2023
• Last Updated: October 30, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)