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Completed

NCT Number: NCT05831813

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

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.

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Key information

Conditions

Loneliness Behavior Social Behavior Social Isolation

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Amsterdam

Amsterdam, North Holland, 1001 NK, Netherlands

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

Primary outcomes

  1. Changes in social loneliness

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

    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!").

  2. Weekly changes in social loneliness

    Time frame: 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)

    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!").

  3. Changes in emotional loneliness

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

    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!").

  4. Weekly changes in emotional loneliness

    Time frame: 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)

    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!").

  5. Changes in social isolation

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

    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.

  6. Weekly changes in social isolation

    Time frame: 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)

    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).

Secondary outcomes

  1. Changes in depressive symptoms

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

    Center for Epidemiological Studies Depression Scale (CES-D; Radloff, 1977). The 20-item CES-D was used to measure feelings of depression. Participants score the items on a 4-point scale, from "Rarely or none of the time (Less than 1 Day)" to "Most or all of the time (5-7 days)".

  2. Changes in social anxiety

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

    Social Interaction Anxiety Scale (SIAS; Mattick & Clarke, 1998). The SIAS is a 20-item questionnaire to assess social anxiety symptoms, specifically from the perspective of the individual when engaging in social interactions. Items are rated on a 5-point Likert scale (0 = not at all, 4 = very much).

  3. Changes in daytime functioning

    Time frame: 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)

    Daytime functioning (Hawkley et al.,2010) To measure daily functioning, the questionnaire 5-item questionnaire from Hawkley et al. (2010) rates the extent of sleepiness, exhaustion, liveliness, energy, and fatigue over the last seven days on a 5-point scale ("Not at all" to "Very much").

Other outcomes

  1. Satisfaction of the followed sessions

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

    Session Rating Scale 3.0 (SRS 3.0; Duncan et al., 2003) The SRS 3.0 is a 4-item visual analogue scale to assess the working alliance with the trainer and includes gathering information about how the client feels about the relationship with the trainer, the goals and topics of the session, the approach or method used, and an overall rating of the session.

  2. Problematic interpersonal styles

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

    Inventory of Interpersonal Problems-32 (IIP-32; Barkham et al.,1996). The 32-item IIP-32 was used to measure problematic interpersonal styles and consists of eight subscales (Domineering/ Controlling, Self-Serving/ Vindictive, Cold/ Distant, Avoidant/ Socially Inhibited, Non-assertive/ Obsequious, Exploitable/ Overly Accommodating, Overly Nurturant/ Self-Sacrificing, Intrusive/ Needy). The items are rated on a 5-point scale ("Not at all" to "Extremely").

Sponsors and collaborators

Lead sponsor

University of Amsterdam

Other

Registry information

Official study title

The Feasibility, Acceptability and Preliminary Efficacy of a Group Intervention Aimed at Reducing Social and Emotional Loneliness: a Pilot Study

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Apr 26, 2023
Registry last updated
Oct 30, 2023

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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