Cognitive Behavioural Therapy (CBT) for Chronic Loneliness in Children and Young People

NCT05149963 | Unknown

• 1 other identifier: Royal Holloway Ethics ID: 2498
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Loneliness is a significant problem for young people and is associated with a range of physical and mental health difficulties. Meta-analyses have identified that interventions aimed at young people who report loneliness as their primary problem are lacking within the literature. In adults, the most effective interventions for loneliness are those which target the underlying maladaptive social cognitions. Therefore, the investigators have developed a modular Cognitive Behavioural Therapy (CBT) intervention for children and young people aiming to reduce their feelings of loneliness. The aim of this study is to conduct a multiple baseline single-case experimental design (SCED) to assess the efficacy, feasibility and acceptability of this intervention. In total 6-8 11-18-year-olds and their families will be recruited. The design consists of AB+ post-intervention, where A is the baseline phase, B is the intervention phase and then a post-intervention phase. Participants will complete a baseline assessment, before being randomised to one of four different baseline lengths (12 days, 19 days, 26 days or 33 days). Participants will then complete an average of 12 sessions of CBT, with the aim being to reduce their feelings of loneliness over 12 weeks. Participants will then complete a 12-day post-intervention phase. Participant loneliness will be repeatedly assessed throughout the three phases of the intervention using the Three-item Loneliness Scale, which will be the primary outcome. Secondary outcomes will be reliable and clinically meaningful change on the UCLA-LS-3, RCADS and SDQ. Feasibility and participant satisfaction will also be assessed and reported.

Conditions

Loneliness

Keywords

Loneliness; CBT; Cognitive Behavioural Therapy; Single Case Experimental Design; SCED

Outcome Measures

Primary Outcomes (1)

• Change in scores on the Three Item Loneliness Scale (Klein et al., 2021) across the baseline, intervention and post-intervention phases.

  Self-reported child loneliness. The scale is a brief three-item measure with possible scores ranging from 0-12, with higher scores indicating higher levels of loneliness.

  This study is a single-case experimental design. Participants will complete the measure daily during the baseline phase, each session during the intervention phase, and daily during the post-intervention.

Secondary Outcomes (3)

• UCLA-Loneliness Scale-3 (Russell, 1996)

  Completed at baseline and post-intervention assessments at study completion an average of 16 weeks later.

• The Strengths and Difficulties Questionnaires (SDQ) (Goodman, 2001)

  Completed at baseline and post-intervention assessments at study completion an average of 16 weeks later.

• The Revised Child Anxiety and Depression Scale (RCADS) (Chorpita et al., 2000)

  Completed at baseline and post-intervention assessments at study completion an average of 16 weeks later.

Other Outcomes (2)

• Goal based outcomes (Law & Jacob, 2013)

  This will be completed each intervention session over an average of 12 weeks.

• Visual analogue scales (VAS; see Wewers & Lowe, 1990 for review)

  This will be completed each intervention session over an average of 12 weeks.

Study Arms (5)

Cognitive Behavioural Therapy (CBT) for Chronic Loneliness

EXPERIMENTAL

Participants will receive an average of 12 50-minute sessions of CBT aiming to reduce their loneliness. The intervention is modular and has been developed for this study. In total there are 10 treatment modules, 1) Assessment, 2) Formulation and Psychoeducation, 3) Challenging Negative Interpersonal Appraisals and Counterproductive Behaviours, 4) Challenging Negative Thoughts and Cognitive Biases, 5) Challenging Self-focussed Attention, Hypervigilance and Camouflaging, 6) Values-based Social-skills Training, 7) Problem Solving, 8) Findings Friends, 9) Managing Emotions and 10) Relapse Prevention. All participants will complete module 1) Assessment and module 2) Formulation and Psychoeducation. They will then work with the clinician to collaboratively develop a treatment plan based on their formulation. The treatment will be comprised of one or more of the intervention modules. All participants will then complete module 10) Relapse Prevention at the end of their treatment.

Other: Cognitive Behavioural Therapy (CBT) for Chronic Loneliness

Baseline Phase 1 (12 days)

NO INTERVENTION

The design of the study is a randomised multiple-baseline single-case experimental design (SCED). Participants will be randomised to one of 4 baseline lengths (12 days, 19 days, 26 days or 33 days). The baseline phase will act as the control condition within and between participants.

Baseline Phase 2 (19 days)

NO INTERVENTION

The design of the study is a randomised multiple-baseline single-case experimental design (SCED). Participants will be randomised to one of 4 baseline lengths (12 days, 19 days, 26 days or 33 days). The baseline phase will act as the control condition within and between participants.

Baseline Phase 3 (26 days)

NO INTERVENTION

The design of the study is a randomised multiple-baseline single-case experimental design (SCED). Participants will be randomised to one of 4 baseline lengths (12 days, 19 days, 26 days or 33 days). The baseline phase will act as the control condition within and between participants.

Baseline Phase 4 (33 days)

NO INTERVENTION

The design of the study is a randomised multiple-baseline single-case experimental design (SCED). Participants will be randomised to one of 4 baseline lengths (12 days, 19 days, 26 days or 33 days). The baseline phase will act as the control condition within and between participants.

Interventions

Cognitive Behavioural Therapy (CBT) for Chronic Loneliness OTHER

Participants will receive an average of 12 50-minute sessions of Cognitive Behavioural Therapy (CBT) aiming to reduce their feelings of loneliness

Cognitive Behavioural Therapy (CBT) for Chronic Loneliness

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Be aged 11-18
• Score more than 42 on the UCLA-LS-3 (Russel, 1996), which is more than one standard deviation above the mean in a large community adolescent sample (Shevlin, 2015).
• Have a parent/carer who is willing to take part in the study.
• Report loneliness as their primary difficulty (i.e., they are able to identify relevant goal-based outcomes and their current difficulties are not attributable to a significant mental health problem).

You may not qualify if:

• Currently receiving psychological therapy.
• Started taking antidepressant in the last 8 weeks.
• Eligibility assessment indicates a severe mental health problem not considered suitable for the trial intervention due to the clinical need for immediate intervention, e.g., active suicidality and psychosis.
• Refusal for therapy sessions to be video recorded.
• Having an intellectual disability at a level whereby they cannot access the intervention
• Do not have access to a laptop or smartphone which they can use for video calls.

Sponsors & Collaborators

• Royal Holloway University: lead

Study Sites (1)

Royal Holloway, University of London

Egham, Surrey, TW20 0EX, United Kingdom

RECRUITING

Related Publications (10)

• Klein, E. M., Zenger, M., Tibubos, A. N., Ernst, M., Reiner, I., Schmalbach, B., ... & Beutel, M. E. (2021). Loneliness and its relation to mental health in the general population: Validation and norm values of a brief measure. Journal of Affective Disorders Reports, 4, 100120.

  BACKGROUND

• Chorpita BF, Moffitt CE, Gray J. Psychometric properties of the Revised Child Anxiety and Depression Scale in a clinical sample. Behav Res Ther. 2005 Mar;43(3):309-22. doi: 10.1016/j.brat.2004.02.004.

  PMID: 15680928 BACKGROUND

• Goodman R. Psychometric properties of the strengths and difficulties questionnaire. J Am Acad Child Adolesc Psychiatry. 2001 Nov;40(11):1337-45. doi: 10.1097/00004583-200111000-00015.

  PMID: 11699809 BACKGROUND

• Russell DW. UCLA Loneliness Scale (Version 3): reliability, validity, and factor structure. J Pers Assess. 1996 Feb;66(1):20-40. doi: 10.1207/s15327752jpa6601_2.

  PMID: 8576833 BACKGROUND

• Wewers ME, Lowe NK. A critical review of visual analogue scales in the measurement of clinical phenomena. Res Nurs Health. 1990 Aug;13(4):227-36. doi: 10.1002/nur.4770130405.

  PMID: 2197679 BACKGROUND

• Law, D., & Jacob, J. (2013). Goals and goal based outcomes (GBOs). London: CAMHS Press.

  BACKGROUND

• Kazdin AE. Single-case experimental designs. Evaluating interventions in research and clinical practice. Behav Res Ther. 2019 Jun;117:3-17. doi: 10.1016/j.brat.2018.11.015. Epub 2018 Dec 2.

  PMID: 30527785 BACKGROUND

• Tate RL, Perdices M, Rosenkoetter U, Shadish W, Vohra S, Barlow DH, Horner R, Kazdin A, Kratochwill T, McDonald S, Sampson M, Shamseer L, Togher L, Albin R, Backman C, Douglas J, Evans JJ, Gast D, Manolov R, Mitchell G, Nickels L, Nikles J, Ownsworth T, Rose M, Schmid CH, Wilson B. The Single-Case Reporting Guideline In BEhavioural Interventions (SCRIBE) 2016 Statement. Phys Ther. 2016 Jul;96(7):e1-e10. doi: 10.2522/ptj.2016.96.7.e1.

  PMID: 27371692 BACKGROUND

• Parker RI, Vannest KJ, Davis JL, Sauber SB. Combining nonoverlap and trend for single-case research: Tau-U. Behav Ther. 2011 Jun;42(2):284-99. doi: 10.1016/j.beth.2010.08.006. Epub 2011 Feb 3.

  PMID: 21496513 BACKGROUND

• Cawthorne T, Kall A, Bennett S, Andersson G, Shafran R. The development of Cognitive Behavioural Therapy (CBT) for chronic loneliness in children and young people: Protocol for a single-case experimental design. PLoS One. 2022 Dec 9;17(12):e0278746. doi: 10.1371/journal.pone.0278746. eCollection 2022.

  PMID: 36490292 DERIVED

MeSH Terms

Interventions

Cognitive Behavioral Therapy

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Tom Cawthorne, MSc

CONTACT

+44 7553 952174; Thomas.Cawthorne.2019@live.rhul.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The researcher who completes the assessments will be blinded to baseline allocation length
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Trainee Clinical Psychologist

Model Details: Randomised multiple-baseline Single Case Experimental Design (SCED)

Study Record Dates

• First Submitted: November 13, 2021
• First Posted: December 8, 2021
• Study Start: May 27, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: December 8, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: We are currently in the process of publishing the study protocol. It will be publish Open Access and available for free.

Locations

GB (1)