NCT03730155

Brief Summary

This study will begin a novel line of research on CCT in Denmark as a preventive intervention for caregivers of people suffering from a mental illness. The primary aim of the study is to investigate the effectiveness of a Compassion Cultivation Training (CCT) course on psychological distress of informal caregivers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 15, 2018

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 5, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2020

Completed
Last Updated

March 26, 2020

Status Verified

October 1, 2018

Enrollment Period

1.6 years

First QC Date

October 24, 2018

Last Update Submit

March 25, 2020

Conditions

Psychological Distress

Outcome Measures

Primary Outcomes (1)

  • Change is being assessed: Depression Anxiety Stress Scales (DASS: Lovibond, S.H. & Lovibond, P.F., 1995)

    The DASS is a 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress.

    Baseline, 8 weeks, and 3-months and 6-months follow up.

Secondary Outcomes (8)

  • Change is being assessed: Perceived Stress Scale, (PSS: Cohen et al., 1983)

    Baseline, 8 weeks, and 3-months and 6-months follow up.

  • Change is being assessed: The Emotion Regulation Questionnaire (ERQ: Gross & John, 2003).

    Baseline, 8 weeks, and 3-months and 6-months follow up.

  • Change is being assessed: Self-compassion Scale -12 (SCS-12: Raes et al., 2011).

    Baseline, 8 weeks, and 3-months and 6-months follow up.

  • Change is being assessed: Multidimensional Compassion Scale (MCS: Jazaieri et al., 2018)

    Baseline, 8 weeks, and 3-months and 6-months follow up.

  • Change is being assessed: Five Facet Mindfulness Scale (FFMQ-15: Baer et al., 2006).

    Baseline, 8 weeks, and 3-months and 6-months follow up.

  • +3 more secondary outcomes

Other Outcomes (1)

  • Demographical questions

    Baseline

Study Arms (2)

CCT intervention

EXPERIMENTAL

CCT intervention. 8 weeks with 2 hours session every week. Homework approx. 25 min. of meditation daily.

Other: CCT intervention.

Control waitlist

NO INTERVENTION

No treatment given. Participants only answer questionnaire packages.

Interventions

CCT intervention.OTHER

8-week course with 2 hours sessions weekly. Participants should meditate 25 min. pr. day during the 8 weeks.

CCT intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • caregiver male and female (fx. parent /spouse/other family member) of a person with a mental illness,
  • years of age
  • Danish speaking
  • not pregnant.

You may not qualify if:

  • having an untreated mental illness,
  • addictions, or substance abuse
  • meditation practice (studies have shown that people who are long-term meditation practitioners are more resilient and have greater psychological well-being (Lykins \& Baer, 2009). Therefore, people with 1 year or more of prior formal meditation practice, will not be eligible for the study as we cannot rule out whether their scores are due to their long-term practice or to the CCT intervention),
  • or current psychotherapeutic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aarhus Universitet

Copenhagen, 2400, Denmark

Location

Aarhus University

Kolding, 6000, Denmark

Location

Related Publications (25)

  • Jinpa, T. (2010). Compassion cultivation training program (CCT program): An eight-week course on cultivation a compassionate heart and mindset. Instructor's Manual. The Center for Compassion and Altruism Research and Education (CCARE). Stanford Institute for Neuro-Innovation and Translational Neuroscience, Stanford University (Unpublished).

    BACKGROUND

  • Jazaieri, H., Lee, I.A., McGonigal, K., Jinpa, T., Doty, J.R., Gross, J.J., & Goldin, P.R.,(2015). A wandering mind is a less caring mind: Daily experience sampling during compassion meditation training. The Journal of Positive Psychology, Routledge

    BACKGROUND

  • Duggan C, Parry G, McMurran M, Davidson K, Dennis J. The recording of adverse events from psychological treatments in clinical trials: evidence from a review of NIHR-funded trials. Trials. 2014 Aug 27;15:335. doi: 10.1186/1745-6215-15-335.

    PMID: 25158932BACKGROUND

  • Kazdin AE. Mediators and mechanisms of change in psychotherapy research. Annu Rev Clin Psychol. 2007;3:1-27. doi: 10.1146/annurev.clinpsy.3.022806.091432.

    PMID: 17716046BACKGROUND

  • Chen, H-T., (1994). Theory-driven evaluations: Need, difficulties, and option. American Journal of Evaluations, 15, pp. 79-82.

    BACKGROUND

  • Goldsmith KA, MacKinnon DP, Chalder T, White PD, Sharpe M, Pickles A. Tutorial: The practical application of longitudinal structural equation mediation models in clinical trials. Psychol Methods. 2018 Jun;23(2):191-207. doi: 10.1037/met0000154. Epub 2017 Dec 28.

    PMID: 29283590BACKGROUND

  • Jazaieri, H., Jinpa, T., McGonigal, K., Rosenberg, E., Finkelstein, J., Simon-Thomas, E., & Goldin, P.R. (2013). Enhancing compassion: randomized controlled trial of a compassion cultivation training program. Journal of Happiness Studies, 14, pp. 1113-1126.

    BACKGROUND

  • Kuhlmann SM, Burger A, Esser G, Hammerle F. A mindfulness-based stress prevention training for medical students (MediMind): study protocol for a randomized controlled trial. Trials. 2015 Feb 8;16:40. doi: 10.1186/s13063-014-0533-9.

    PMID: 25887430BACKGROUND

  • Galante J, Galante I, Bekkers MJ, Gallacher J. Effect of kindness-based meditation on health and well-being: a systematic review and meta-analysis. J Consult Clin Psychol. 2014 Dec;82(6):1101-14. doi: 10.1037/a0037249. Epub 2014 Jun 30.

    PMID: 24979314BACKGROUND

  • Brito, G.P. (2014). Cultivating healthy minds and open hearts. A mixed method controlled study on the psychological effects of compassion cultivation training in Chile. A dissertation submitted in partial fulfillment of the requirements for the degree of Doctor of Philosophy in transpersonal psychology, Sofia University, Palo Alto, California, USA.

    BACKGROUND

  • Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

    PMID: 6668417BACKGROUND

  • Gross JJ, John OP. Individual differences in two emotion regulation processes: implications for affect, relationships, and well-being. J Pers Soc Psychol. 2003 Aug;85(2):348-62. doi: 10.1037/0022-3514.85.2.348.

    PMID: 12916575BACKGROUND

  • Raes F, Pommier E, Neff KD, Van Gucht D. Construction and factorial validation of a short form of the Self-Compassion Scale. Clin Psychol Psychother. 2011 May-Jun;18(3):250-5. doi: 10.1002/cpp.702. Epub 2010 Jun 8.

    PMID: 21584907BACKGROUND

  • Jazaieri, H., McGonigal, K., Jinpa, T., Doty, J.R., Gross, J.J., & Goldin, P.R. (2014). A randomized controlled trial of compassion cultivation training: Effects on mindfulness, affect, and emotion regulation. Motivation and Emotion, 38, pp. 23-35

    BACKGROUND

  • Jazaieri, H., Lee, I.A., McGonigal, K., Jinpa, T., Doty, J.R., Gross, J.J., & Goldin, P.R.,(2015). A wandering mind is a less caring mind: Daily experience sampling during compassion meditation training. The Journal of Positive Psychology, Routledge.

    BACKGROUND

  • Jazaieri, H., Goldin, P. R., Simon-Thomas, E., Keltner, D., & Mendoza-Denton, R. (in prep). Predicting Compassionate Behavior: Application, development, and psychometric properties of the Multidimensional Compassion Scale.

    BACKGROUND

  • Lovibond, S.H. & Lovibond, P.F. (1995). Manual for the Depression Anxiety Stress Scales. (2nd. Ed.) Sydney: Psychology Foundation. ISBN 7334-1423-0.

    BACKGROUND

  • Smith BW, Dalen J, Wiggins K, Tooley E, Christopher P, Bernard J. The brief resilience scale: assessing the ability to bounce back. Int J Behav Med. 2008;15(3):194-200. doi: 10.1080/10705500802222972.

    PMID: 18696313BACKGROUND

  • Horvath, Adam O.,Greenberg, Leslie S. (1989). Development and validation of the Working Alliance Inventory.Journal of Counseling Psychology, Vol 36(2), Apr 1989, 223-233

    BACKGROUND

  • Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.

    PMID: 16443717BACKGROUND

  • Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.

    PMID: 25831962BACKGROUND

  • Lykins, E.R.B., & Baer, R.A. (2009). Psychological functioning in a sample of longtern practioners of mindfulness meditation. Journal of Cognitive Psychotherapy, 23, (3), pp. 226-241.

    BACKGROUND

  • Bech P. (2012). Clinical Psychometrics , Wiley-Blackwell, Oxford.

    BACKGROUND

  • Tracey, T. J., & Kokotovic, A. M. (1989). Factor structure of the Working Alliance Inventory. Psychological Assessment: A Journal of Consulting and Clinical Psychology, 1(3), 207-210.

    BACKGROUND

  • Hansen NH, Juul L, Pallesen KJ, Fjorback LO. Effect of a Compassion Cultivation Training Program for Caregivers of People With Mental Illness in Denmark: A Randomized Clinical Trial. JAMA Netw Open. 2021 Mar 1;4(3):e211020. doi: 10.1001/jamanetworkopen.2021.1020.

    PMID: 33683334DERIVED

Study Officials

  • Lone Fjorback, MD

    Aarhus University, Danish Center for mindfulness

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2018

First Posted

November 5, 2018

Study Start

May 15, 2018

Primary Completion

December 20, 2019

Study Completion

January 29, 2020

Last Updated

March 26, 2020

Record last verified: 2018-10

Locations

DK(2)