Mindfulness, Group Therapy and Psychosis; Training Decreases Anxiety and Depression

NCT04711460 | Completed Results

• 1 other identifier: STUDY00005035
• Study Type: observational
• Target: 116
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Psychosis

Keywords

mindfulness; group therapy

Outcome Measures

Primary Outcomes (2)

• Change in Generalized Anxiety Disorder-7 Pre/Post Test at Week 5

  The Generalized Anxiety Disorder 7-item scale (GAD-7) is a 7-item survey of how often patients are bothered by symptoms of anxiety. Items are rated from 0 (not at all) to 3 (nearly every day). The total score is a sum of item scores and ranges from 0 (minimal depression) to 27 (severe depression). Outcome is reported as the change from baseline to approximately 5 weeks. Pre / Post-test scores were compared.

  Five weeks

• Change in Patient Health Questionnaire-9 Score From Pre / Post-test at Week 5

  The Patient Health Questionnaire (PHQ-9) is a 9-item survey of how often patients are bothered by symptoms of depression. Items are rated from 0 (not at all) to 3 (nearly every day). The total score is a sum of item scores and ranges from 0 (minimal depression) to 27 (severe depression). Outcome is reported as the change from baseline to approximately 5 weeks.

  Five weeks

Secondary Outcomes (2)

• CAGE-Adapted to Include Drug Use (CAGE-AID)

  baseline only

• The Columbia Suicide Severity Rating Scale (C-SSRS)

  baseline only

Study Arms (4)

Younger participants

Participants were adults ages19 to 29 years who recieved CBT and 10 minutes of Mindfulness Training and practice in group therapy.

Behavioral: Younger participants

Older participants

Participants were adults ages 30-54 years who received CBT and 10 minutes of Mindfulness Training and practice in group therapy.

Behavioral: Older participants

Treatment As Usual (TAU)

. Participants in the "Treatment As Usual" (TAU) group had Cognitive Behavioral Therapy and education about the mindfulness process, but no practice of the mindfulness technique as a group.

Behavioral: TAU

TAU plus mindfulness practice

Participants in the TAU plus Mindfulness Practice had Cognitive Behavioral Therapy (CBT) and 10 minutes of mindfulness practice in group therapy sessions.

Behavioral: TAU + MIndfulness practice

Interventions

Younger participants BEHAVIORAL

Younger Participants 19-29 years received TAU + Tx over 5 weeks

Younger participants

Older participants BEHAVIORAL

older participants 30-54 years received TAU + Tx over 5 weeks

Older participants

TAU BEHAVIORAL

Participants received TAU or Treatment As Ususal, Cognitive Behavior Therapy only

Treatment As Usual (TAU)

TAU + MIndfulness practice BEHAVIORAL

Participants received TAU + mindfulness training

TAU plus mindfulness practice

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

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

You may not qualify if:

• those lacking symptoms of psychosis

Sponsors & Collaborators

• University of Minnesota: lead

Related Publications (23)

• 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.

  PMID: 12703651 BACKGROUND

• 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.

  PMID: 7778330 BACKGROUND

• 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.

  PMID: 19545481 BACKGROUND

• Chadwick P. Mindfulness for psychosis. Br J Psychiatry. 2014;204:333-4. doi: 10.1192/bjp.bp.113.136044.

  PMID: 24785766 BACKGROUND

• 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.

  PMID: 27146475 BACKGROUND

• 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.

  PMID: 31382104 BACKGROUND

• 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.

  PMID: 24809397 BACKGROUND

• 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.

  PMID: 17716538 BACKGROUND

• 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.

  PMID: 26833597 BACKGROUND

• 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.

  PMID: 22974494 BACKGROUND

• 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.

  PMID: 27993338 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 23954146 BACKGROUND

• 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.

  PMID: 21902854 BACKGROUND

• 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.

  PMID: 12547384 BACKGROUND

• 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.

  PMID: 24107762 BACKGROUND

• 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.

  PMID: 22193671 BACKGROUND

• 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.

  PMID: 26683229 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 25892974 BACKGROUND

• 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.

  PMID: 9403906 RESULT

• 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.

  PMID: 12362963 RESULT

• 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.

  PMID: 18310597 RESULT

MeSH Terms

Conditions

Psychotic Disorders

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Limitations and Caveats

Limitations and caveats include the sample size. If a larger data base was collected, more significant results may have occurred. Data collection assumes that all participants will answer honestly on both scales. The financial resources and equipment were limited to what the author provided, as there were no grants. The setting was a group room, and some participants may prefer to be outside or be alone.

Results Point of Contact

• Title: Joan D. Lund
• Organization: University of MN

Lund1687@umn.edu

612-273-9115

Study Officials

• Joan D Lund, Psy.D.

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2020
• First Posted: January 15, 2021
• Study Start: January 1, 2017
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: February 2, 2024
• Results First Posted: February 2, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share