Clinical trial NCT04711460: Mindfulness, Group Therapy and Psychosis; Training Decreases Anxiety and Depression
Official title: Mindfulness, Group Therapy and Psychosis; Training Decreases Anxiety and Depression in Outpatients With a Psychotic Disorder in a Non-Randomized Within Group Comparison
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Psychosis
Keywords: mindfulness
group therapy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2021-01-15
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: . Eligible participants had a

DSM-5 diagnosis which included: 295.2 Schizophrenia, Catatonia type, 295.3 Schizophrenia, Paranoid Type, 295.4 Schizophreniform Disorder, 295.70 Schizoaffective Disorder, Depressed Type or Bipolar Type, 295.9 Schizophrenia, Unspecified, 296.34 Major Depressive Disorder, With Psychotic Features, 296.54 Bipolar Disorder, With Psychotic Features, 297.1 Delusional Disorder, 298.8 Brief Psychotic Disorder, 298.9 Unspecified Schizophrenia and Other Psychotic Disorders, 301.22 Schizotypal Personality Disorder.

Brief summary: The objective of this non-randomized, within-group comparison was to evaluate the addition of mindfulness as a new technique in an outpatient group therapy program for participants diagnosed with a psychotic spectrum disorder, alongside of cognitive behavioral therapy.

Detailed description: Participants completed the Patient Health Questionnaire-9 (PHQ-9), and the Generalized Anxiety Disorder 7-item scale (GAD-7), at admission and discharge. The first experiment compared scores of those who received mindfulness training plus standard psychiatric treatment or treatment as usual (TAU) against those who received TAU. The second experiment compared age using matched scores from participants who received mindfulness training plus TAU. Participants attended group therapy for a five-week minimum, and were taught the mindfulness practices of breath, acceptance, observation, remaining non-judgmental, and letting go.

Eligibility criteria: Inclusion Criteria:

* All Diagnostic Statistical Manual, Fifth edition, (DSM-5) diagnoses that included a psychosis spectrum disorder

Exclusion Criteria:

* those lacking symptoms of psychosis

Primary outcomes:
measure: Change in Generalized Anxiety Disorder-7 Pre/Post Test at Week 5
timeFrame: Five weeks
measure: Change in Patient Health Questionnaire-9 Score From Pre / Post-test at Week 5
timeFrame: Five weeks
Secondary outcomes:
measure: CAGE-Adapted to Include Drug Use (CAGE-AID)
timeFrame: baseline only
measure: The Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: baseline only
Other outcomes:
Locations:
Study officials:
affiliation: University of Minnesota
name: Joan D Lund, Psy.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.
citation: Brown RL, Rounds LA. Conjoint screening questionnaires for alcohol and other drug abuse: criterion validity in a primary care practice. Wis Med J. 1995;94(3):135-40.
citation: Chadwick P, Hughes S, Russell D, Russell I, Dagnan D. Mindfulness groups for distressing voices and paranoia: a replication and randomized feasibility trial. Behav Cogn Psychother. 2009 Jul;37(4):403-12. doi: 10.1017/S1352465809990166. Epub 2009 Jun 23.
citation: Chadwick P. Mindfulness for psychosis. Br J Psychiatry. 2014;204:333-4. doi: 10.1192/bjp.bp.113.136044.
citation: Chadwick P, Strauss C, Jones AM, Kingdon D, Ellett L, Dannahy L, Hayward M. Group mindfulness-based intervention for distressing voices: A pragmatic randomised controlled trial. Schizophr Res. 2016 Aug;175(1-3):168-173. doi: 10.1016/j.schres.2016.04.001. Epub 2016 Apr 14.
citation: Chadwick P. Mindfulness for psychosis: a humanising therapeutic process. Curr Opin Psychol. 2019 Aug;28:317-320. doi: 10.1016/j.copsyc.2019.07.022. Epub 2019 Jul 18.
citation: Chien WT, Thompson DR. Effects of a mindfulness-based psychoeducation programme for Chinese patients with schizophrenia: 2-year follow-up. Br J Psychiatry. 2014 Jul;205(1):52-9. doi: 10.1192/bjp.bp.113.134635. Epub 2014 May 8.
citation: Dhalla S, Kopec JA. The CAGE questionnaire for alcohol misuse: a review of reliability and validity studies. Clin Invest Med. 2007;30(1):33-41. doi: 10.25011/cim.v30i1.447.
citation: Dixon LB, Holoshitz Y, Nossel I. Treatment engagement of individuals experiencing mental illness: review and update. World Psychiatry. 2016 Feb;15(1):13-20. doi: 10.1002/wps.20306.
citation: Ellett L. Mindfulness for paranoid beliefs: evidence from two case studies. Behav Cogn Psychother. 2013 Mar;41(2):238-42. doi: 10.1017/S1352465812000586. Epub 2012 Sep 14.
citation: Hayes SC. Acceptance and Commitment Therapy, Relational Frame Theory, and the Third Wave of Behavioral and Cognitive Therapies - Republished Article. Behav Ther. 2016 Nov;47(6):869-885. doi: 10.1016/j.beth.2016.11.006. Epub 2016 Nov 10.
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
citation: Khoury B, Lecomte T, Gaudiano BA, Paquin K. Mindfulness interventions for psychosis: a meta-analysis. Schizophr Res. 2013 Oct;150(1):176-84. doi: 10.1016/j.schres.2013.07.055. Epub 2013 Aug 15.
citation: Langer AI, Cangas AJ, Salcedo E, Fuentes B. Applying mindfulness therapy in a group of psychotic individuals: a controlled study. Behav Cogn Psychother. 2012 Jan;40(1):105-9. doi: 10.1017/S1352465811000464. Epub 2011 Sep 9.
citation: Morrison AP, Wells A. A comparison of metacognitions in patients with hallucinations, delusions, panic disorder, and non-patient controls. Behav Res Ther. 2003 Feb;41(2):251-6. doi: 10.1016/s0005-7967(02)00095-5.
citation: Mundt JC, Greist JH, Jefferson JW, Federico M, Mann JJ, Posner K. Prediction of suicidal behavior in clinical research by lifetime suicidal ideation and behavior ascertained by the electronic Columbia-Suicide Severity Rating Scale. J Clin Psychiatry. 2013 Sep;74(9):887-93. doi: 10.4088/JCP.13m08398.
citation: Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.
citation: Ratcliffe M, Wilkinson S. How anxiety induces verbal hallucinations. Conscious Cogn. 2016 Jan;39:48-58. doi: 10.1016/j.concog.2015.11.009. Epub 2015 Dec 9.
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
citation: Terrill AL, Hartoonian N, Beier M, Salem R, Alschuler K. The 7-item generalized anxiety disorder scale as a tool for measuring generalized anxiety in multiple sclerosis. Int J MS Care. 2015 Mar-Apr;17(2):49-56. doi: 10.7224/1537-2073.2014-008.
citation: Birchwood M, Chadwick P. The omnipotence of voices: testing the validity of a cognitive model. Psychol Med. 1997 Nov;27(6):1345-53. doi: 10.1017/s0033291797005552.
citation: Bach P, Hayes SC. The use of acceptance and commitment therapy to prevent the rehospitalization of psychotic patients: a randomized controlled trial. J Consult Clin Psychol. 2002 Oct;70(5):1129-39. doi: 10.1037//0022-006x.70.5.1129.
citation: Baer RA, Smith GT, Lykins E, Button D, Krietemeyer J, Sauer S, Walsh E, Duggan D, Williams JM. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008 Sep;15(3):329-42. doi: 10.1177/1073191107313003. Epub 2008 Feb 29.