LonelinessNCT05149963
Cognitive Behavioural Therapy (CBT) for Chronic Loneliness in Children and Young People
A study testing Cognitive Behavioural Therapy (CBT) for Chronic Loneliness in people with Loneliness, run by Royal Holloway University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Loneliness
- What is being tested?
- Cognitive Behavioural Therapy (CBT) for Chronic Loneliness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 May 2020to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Holloway, University of London
Egham, Surrey, TW20 0EX
Tom Cawthorne, MSc, +44 7553 952174, Thomas.Cawthorne.2019@live.rhul.ac.uk
Roz Shafran, PhD, r.shafran@ucl.ac.uk
About this study
Official title: The Development of Cognitive Behavioural Therapy (CBT) for Chronic Loneliness in Children and Young People: Protocol for a Single-case Experimental Design
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.
Read the detailed description
The efficacy of CBT for loneliness in children and young people will be evaluated through a randomised multiple-baseline single case experimental design. The design consists of AB+ post-intervention, where A is the baseline phase, B is the intervention phase and then a post-intervention phase. In the SCED approach participants are repeatedly assessed on at least one independent variable, in this case self-reported loneliness on the Three-item Loneliness Scale, across each phase of the intervention. This repeated measurement and within subject replication is then used to test the effects of the intervention for individual participants.
The construction of this SCED trial and the reporting of the results will be in accordance with the Single-Case Reporting Guidelines in Behavioural Intervention (SCRIBE).
Participants will be recruited via advertisements emailed to schools, shared via social media and word of mouth. After consenting, participants and their parents/carers will complete a baseline eligibility assessment. Participants will complete a range of online questionnaires via a secure online platform. Participants will then attend a remote research assessment appointment to determine whether the family meet the eligibility criteria. The researcher completing the baseline and post-intervention assessments will not be involved in the clinical intervention and will be blinded to baseline allocation. After all baseline assessments for the participant group are completed, participants will be discussed within supervision to confirm that the participants meet eligibility criteria. Eligible participants will then be randomised using a random number generator to one of four different baseline lengths (12 days, 19 days, 26 days or 33 days). The decision to have a minimum of 12 observations per phase meets the requirements for guidelines and standards and will allow for sufficient power for Tau-U analysis.
Each of the participating families will then be contacted to inform them of their allocation. Randomisation and contacting of the families will be completed by a third researcher, who is not involved in either the clinical intervention or research assessments. A letter will also be sent to the participants General Practitioner (GP) informing them of the family's participation in the research study. The setting for the entire study will be remote, with both assessments and intervention sessions being conducted remotely a secure video platform.
All participants in the group will begin their baseline phase concurrently. During the baseline phase participants will be asked to complete the Three-Item Loneliness Scale each day via a secure online platform. SMS message reminders will also be sent to the participants and their parent/carers each day.
The baselines phase will be immediately followed by the intervention. Each family will receive (on average) 12 sessions of CBT for loneliness in children and young people. The first 4 sessions will take place bi-weekly, the second 4 sessions weekly and the final 4 sessions fortnightly.
For all participants the first two sessions will be focussed on assessment and then formulation. The final session for all participants will focus on relapse prevention. During the assessment session the participant will be asked to define 3 goal-based outcomes for how participants hope the intervention will reduce their loneliness, which will then guide the treatment process. During the intervention phase the participants will complete routine outcome measures (ROMs) for each session. This will include the Three-Item Loneliness Scale, visual analogue scales (VAS) of mood, anxiety and loneliness and ratings of their goal-based outcomes. The ROMs will be completed via a secure online platform before each session. If participants have not completed the ROMs before their appointment, then participants will be completed with the clinician at the start of the session.
Participants will begin the post-intervention phase immediately after the final session of their intervention. During the post-intervention phase participants will be asked to complete the primary outcome measure, Three-Item Loneliness Scale each day for 12 days. Participants will then complete their post-intervention assessment with the second researcher. Before the assessment participants will be asked to re-complete the baseline questionnaires in addition to the parent and child-report versions of the Experience of Service Questionnaire and a questionnaire asking whether COVID-19 or any other events have affected their loneliness during the intervention period. A letter will be sent to the participants General Practitioner (GP) informing them of their participation in the research study has finished.
- Conditions
- Loneliness
- Being tested
- Cognitive Behavioural Therapy (CBT) for Chronic Loneliness
- Keywords
- Loneliness, CBT, Cognitive Behavioural Therapy, Single Case Experimental Design, SCED
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Therapy (CBT) for Chronic LonelinessOther
Participants will receive an average of 12 50-minute sessions of Cognitive Behavioural Therapy (CBT) aiming to reduce their feelings of loneliness
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Self-reported child loneliness. Scores range from 0-60, with higher scores indicating higher levels of loneliness.
Measured: Completed at baseline and post-intervention assessments at study completion an average of 16 weeks later.
The Strengths and Difficulties Questionnaires (SDQ) (Goodman, 2001)
Parent and self-reported child mental wellbeing. Scores range from 0-40, with higher scores indicating higher levels of difficulty.
Measured: 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)
Parent and self-reported child anxiety and depression. Raw scores are converted into age and gender specific T-scores, with higher scores indicating higher levels of difficulty.
Measured: Completed at baseline and post-intervention assessments at study completion an average of 16 weeks later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start27 May 2020
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for LonelinessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Randomised multiple-baseline Single Case Experimental Design (SCED)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Holloway University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Cawthorne, Royal Holloway University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149963
- Sponsor's protocol ID
- Royal Holloway Ethics ID: 2498
- Status last verified
- Nov 2021
- First submitted
- 13 Nov 2021
- Last updated
- 8 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be made available to other researchers on request and the research ethics committee will be informed.
Publications
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.
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.
PubMed 15680928Goodman 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.
PubMed 11699809Russell 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.
PubMed 8576833Wewers 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.
PubMed 2197679Law, D., & Jacob, J. (2013). Goals and goal based outcomes (GBOs). London: CAMHS Press.
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.
PubMed 30527785Tate 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.
PubMed 27371692Parker 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.
PubMed 21496513Cawthorne 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.
PubMed 36490292
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of Cognitive Behavioural Therapy (CBT) for Chronic Loneliness in Children and Young People: Protocol for a Single-case Experimental Design
- ClinicalTrials.gov ID
- NCT05149963
- Acronym / sponsor ID
- Royal Holloway Ethics ID: 2498
- Conditions
- Loneliness
- Keywords
- Loneliness, CBT, Cognitive Behavioural Therapy, Single Case Experimental Design, SCED
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Royal Holloway UniversityUniversity, hospital or other
- Study start
- 27 May 2020 (actual)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 8 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The efficacy of CBT for loneliness in children and young people will be evaluated through a randomised multiple-baseline single case experimental design. The design consists of AB+ post-intervention, where A is the baseline phase, B is the intervention phase and then a post-intervention phase. In the SCED approach participants are repeatedly assessed on at least one independent variable, in this case self-reported loneliness on the Three-item Loneliness Scale, across each phase of the intervention. This repeated measurement and within subject replication is then used to test the effects of the intervention for individual participants.
The construction of this SCED trial and the reporting of the results will be in accordance with the Single-Case Reporting Guidelines in Behavioural Intervention (SCRIBE).
Participants will be recruited via advertisements emailed to schools, shared via social media and word of mouth. After consenting, participants and their parents/carers will complete a baseline eligibility assessment. Participants will complete a range of online questionnaires via a secure online platform. Participants will then attend a remote research assessment appointment to determine whether the family meet the eligibility criteria. The researcher completing the baseline and post-intervention assessments will not be involved in the clinical intervention and will be blinded to baseline allocation. After all baseline assessments for the participant group are completed, participants will be discussed within supervision to confirm that the participants meet eligibility criteria. Eligible participants will then be randomised using a random number generator to one of four different baseline lengths (12 days, 19 days, 26 days or 33 days). The decision to have a minimum of 12 observations per phase meets the requirements for guidelines and standards and will allow for sufficient power for Tau-U analysis.
Each of the participating families will then be contacted to inform them of their allocation. Randomisation and contacting of the families will be completed by a third researcher, who is not involved in either the clinical intervention or research assessments. A letter will also be sent to the participants General Practitioner (GP) informing them of the family's participation in the research study. The setting for the entire study will be remote, with both assessments and intervention sessions being conducted remotely a secure video platform.
All participants in the group will begin their baseline phase concurrently. During the baseline phase participants will be asked to complete the Three-Item Loneliness Scale each day via a secure online platform. SMS message reminders will also be sent to the participants and their parent/carers each day.
The baselines phase will be immediately followed by the intervention. Each family will receive (on average) 12 sessions of CBT for loneliness in children and young people. The first 4 sessions will take place bi-weekly, the second 4 sessions weekly and the final 4 sessions fortnightly.
For all participants the first two sessions will be focussed on assessment and then formulation. The final session for all participants will focus on relapse prevention. During the assessment session the participant will be asked to define 3 goal-based outcomes for how participants hope the intervention will reduce their loneliness, which will then guide the treatment process. During the intervention phase the participants will complete routine outcome measures (ROMs) for each session. This will include the Three-Item Loneliness Scale, visual analogue scales (VAS) of mood, anxiety and loneliness and ratings of their goal-based outcomes. The ROMs will be completed via a secure online platform before each session. If participants have not completed the ROMs before their appointment, then participants will be completed with the clinician at the start of the session.
Participants will begin the post-intervention phase immediately after the final session of their intervention. During the post-intervention phase participants will be asked to complete the primary outcome measure, Three-Item Loneliness Scale each day for 12 days. Participants will then complete their post-intervention assessment with the second researcher. Before the assessment participants will be asked to re-complete the baseline questionnaires in addition to the parent and child-report versions of the Experience of Service Questionnaire and a questionnaire asking whether COVID-19 or any other events have affected their loneliness during the intervention period. A letter will be sent to the participants General Practitioner (GP) informing them of their participation in the research study has finished.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (investigator)
- Number of arms
- 5
- Model description
- Randomised multiple-baseline Single Case Experimental Design (SCED)
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioural Therapy (CBT) for Chronic Loneliness | Experimental | Other: Cognitive Behavioural Therapy (CBT) for Chronic LonelinessParticipants 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. |
| 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. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural Therapy (CBT) for Chronic LonelinessParticipants will receive an average of 12 50-minute sessions of Cognitive Behavioural Therapy (CBT) aiming to reduce their feelings of loneliness | Other | Cognitive Behavioural Therapy (CBT) for Chronic Loneliness |
Primary outcome
Change in scores on the Three Item Loneliness Scale (Klein et al., 2021) across the baseline, intervention and post-intervention phases.
Time frame: 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.
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.
3 secondary outcomes
UCLA-Loneliness Scale-3 (Russell, 1996)
Time frame: Completed at baseline and post-intervention assessments at study completion an average of 16 weeks later.
The Strengths and Difficulties Questionnaires (SDQ) (Goodman, 2001)
Time frame: 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)
Time frame: Completed at baseline and post-intervention assessments at study completion an average of 16 weeks later.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2021.
- BackgroundKlein, 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: PubMed 15680928Chorpita 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.
- Background: PubMed 11699809Goodman 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.
- Background: PubMed 8576833Russell 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.
- Background: PubMed 2197679Wewers 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.
- BackgroundLaw, D., & Jacob, J. (2013). Goals and goal based outcomes (GBOs). London: CAMHS Press.
- Background: PubMed 30527785Kazdin 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.
- Background: PubMed 27371692Tate 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.
- Background: PubMed 21496513Parker 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.
- Derived from this study: PubMed 36490292Cawthorne 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.
- Individual participant dataSharing planned: Yes. Anonymised data will be made available to other researchers on request and the research ethics committee will be informed.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy (CBT) for Chronic Loneliness in people with Loneliness, run by Royal Holloway University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tom Cawthorne, MSc (+44 7553 952174, Thomas.Cawthorne.2019@live.rhul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in scores on the Three Item Loneliness Scale (Klein et al., 2021) across the baseline, intervention and post-intervention phases. (time frame: 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05149963, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2021.