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

Psychosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04711460
• Other study ID #: STUDY00005035
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: August 30, 2019

Study information

• Verified date: May 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• those lacking symptoms of psychosis

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders

Intervention

Behavioral:
• Younger participants
Younger Participants 19-29 years received TAU + Tx over 5 weeks
• Older participants
older participants 30-54 years received TAU + Tx over 5 weeks
• TAU
Participants received TAU or Treatment As Ususal, Cognitive Behavior Therapy only
• TAU + MIndfulness practice
Participants received TAU + mindfulness training

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

References & Publications (23)

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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. — View 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. — View 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. — View 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. — View Citation

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

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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. Erratum In: World Psychiatry. 2016 Jun;15(2):189. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	CAGE-Adapted to Include Drug Use (CAGE-AID)	The Cut-Annoyed-Guilty-Eye (CAGE) adapted to include drug use (CAGE-AID) is a screening tool to assess drug use. Participants are asked to answer yes (score of 1) or no (score of 0) to 4 questions about their drug use. Scores range from 0 to 4 with higher scores indicating greater substance use disorder. A score of 2 or higher indicates a problem with alcohol or drugs and is clinically significant. Outcome is reported as the number of participants who scored 2 or lower.	baseline only
Secondary	The Columbia Suicide Severity Rating Scale (C-SSRS)	The Columbia Suicide Severity Rating Scale, or C-SSRS, measures four constructs: the severity of ideation, the intensity of ideation, behavior, and lethality. Items are rated on a scale from 0-4: Eligible participants scored at 2 or lower.; Only one time; A few times; A lot; All the time; 0) Don't know/Not applicable; The Columbia was done prior to being considered for the Outpatient Mental Health program by another licensed mental health staff in another department. Only those who scored at 1-2 would be considered for Outpatient. Outcome is reported as the number of participants who score a one or two on the scale, which means they are considered safe to participate.	baseline only