Treating Loneliness in Students With a Value-Based Social Approach Cognitive Behavioural Intervention
Study Details
Study Description
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:
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Participants after completing the SA-CBT protocol have reduced levels of social and emotional loneliness and social isolation compared to baseline (primary outcomes).
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Participants after completing the SA-CBT protocol have reduced levels of social anxiety, depressive symptoms, and better daily functioning compared to baseline (secondary outcomes).
Before the SA-CBT 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 SA-CBT 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. SA-CBT is offered in a group format to maximize possibilities for interpersonal therapeutic practise and is framed as a psycho-educational course to increase its acceptability.
Data are collected at screening, pre-test, post-test, one-month follow-up and three-month follow-up, as well as during weekly measurements during the waiting list period and the course. 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Social Approach Cognitive Behavioural Intervention (SA-CBT) Participants start with a 1 to 7 weeks baseline period.The duration is based on the enrolment date and therefore not random. Following the baseline period, all participants start in the SA-CBT 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. The intervention consists of seven weekly sessions and a booster session. SA-CBT is offered in a group to maximize possibilities for interpersonal therapeutic practise and is framed as a course to increase its acceptability. Note: the initial design was as an RCT, with SA-CBT as the experimental arm and a waitlist arm. Participants in the waitlist arm would enter the intervention after a waitlist period. The design was modified due to the small number of enrolments to a single arm. This single arm is similar to the waitlist arm of the initial RCT design. |
Behavioral: Social Approach Cognitive Behavioural Intervention
A value-oriented cognitive behavioural intervention in a group format that addresses negative social cognitions and focuses on social approach processes
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Outcome Measures
Primary Outcome Measures
- Changes in social loneliness [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!").
- Weekly changes in social loneliness [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!").
- Changes in emotional loneliness [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!").
- Weekly changes in emotional loneliness [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!").
- Changes in social isolation [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 11-item LSNS quantifies social isolation from family and friends. Participants score the items on a 6-point Likert scale.
- Weekly changes in social isolation [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 Outcome Measures
- 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.]
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)".
- 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.]
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).
- 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)]
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 Outcome Measures
- Satisfaction of the followed sessions [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.
- 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.]
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").
Eligibility Criteria
Criteria
Inclusion criteria are:
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Participants are students of the UvA and ≥16 years of age
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Being moderately lonely according to the score on the Loneliness Scale (de Jong Gierveld & van Tilburg, 1999) on at least two of the four previous measurements in the longitudinal questionnaire study on predicting loneliness, conducted by the University of Amsterdam (ERB number 2021-CP-13814).
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Sufficient mastery of the English language.
Exclusion criteria are:
- The presence of severe (psychiatric) problems, as indicated, among others by the Mini International Neuropsychiatric Interview (MINI; Sheehan et al., 1998) that hinder participation in the study, or require other forms of immediate care.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Amsterdam | Amsterdam | Noord Holland | Netherlands | 1001 NK |
Sponsors and Collaborators
- University of Amsterdam
Investigators
- Principal Investigator: Carmen van den Bulck, MSc, University of Amsterdam
Study Documents (Full-Text)
More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- FMG-834