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

Sponsor
University of Minnesota (Other)
Overall Status
Completed
CT.gov ID
NCT04711460
Collaborator
(none)
190
Enrollment
31.9
Actual Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: observation

Detailed Description

Participants completed the Patient Health Questionnaire-9, and the Generalized Anxiety Disorder 7-item scale, at admission and discharge. The first experiment compared scores of those who received mindfulness training plus standard psychiatric treatment (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.

Study Design

Study Type:
Observational
Actual Enrollment :
190 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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
Actual Study Start Date :
Jan 1, 2017
Actual Primary Completion Date :
Aug 30, 2019
Actual Study Completion Date :
Aug 30, 2019

Arms and Interventions

Arm Intervention/Treatment
treatment plus mindfulness comparing young vs old

Eligible participants had a diagnosis from the DSM-V that included psychotic spectrum disorders, were adults from ages 18 to 55 years, and attended a group therapy-based outpatient mental health program for at least five weeks. Scores were matched for younger vs older participants and compared.

Behavioral: observation
Young participants versus Old participant scores at admission and discharge were compared
treatment plus mindfulness practice and no treatment or Treatment As Usual (TAU)

Participants in the Treatment plus mindfulness practice had Cognitive Behavioral Therapy, mindfulness education and mindfulness technique practice. Participants in the "Treatment As Usual" group had Cognitive Behavioral Therapy and education about the mindfulness process, but no practice of the technique as a group. The scores of each group were compared to determine effect differences.

Behavioral: observation
Young participants versus Old participant scores at admission and discharge were compared

Outcome Measures

Primary Outcome Measures

  1. The Change in PHQ-9 [At least five weeks.]

    : The Patient Health Questionnaire (PHQ-9) is a 9-iteem 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.

  2. The Change in GAD-7 [At least five weeks.]

    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.

Secondary Outcome Measures

  1. The Columbia Suicide Severity Rating Scale (C-SSRS), [Baseline only]

    The Colombia-Suicide Severity Rating Scale (C-SSRS) has 5 items related to suicidal ideation, past attempts, self-injurious behaviors of how often patients are bothered by symptoms of anxiety. Intensity of suicidal ideation is rated from 1 to 5 (most severe). The frequency of thoughts is rated from 0 to 4 (most severe). Suicide behavior includes 11 questions about Actual Attempts, Interrupted Attempts, Aborted Attempts, Preparatory Acts, and Death by Suicide. There are two questions about Acutal Lethality and Potential Lethality that rate answers from no harm to potential death.

  2. CAGE-Adapted to Include Drug Use (CAGE-AID) [Baseline only]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Inclusion Criteria:
  • All DSM-V diagnosis that included a psychosis spectrum disorder
Exclusion Criteria:
  • those lacking symptoms of psychosis

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Minnesota

Investigators

  • Principal Investigator: Joan D Lund, Psy.D., University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT04711460
Other Study ID Numbers:
  • STUDY00005035
First Posted:
Jan 15, 2021
Last Update Posted:
Jan 15, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Minnesota
mindfulness
group therapy
Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders

Study Results

No Results Posted as of Jan 15, 2021