Skip to main content
OpenTrials
Completed

NCT Number: NCT04711460

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Psychosis Mental Disorders Psychotic Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • those lacking symptoms of psychosis

Treatment and study plan

Younger participants

Behavioral

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

Older participants

Behavioral

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

TAU

Behavioral

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

TAU + MIndfulness practice

Behavioral

Participants received TAU + mindfulness training

Primary outcomes

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

    Time frame: 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.

    Pre / Post-test scores were compared.

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

    Time frame: Five weeks

    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.

Secondary outcomes

  1. CAGE-Adapted to Include Drug Use (CAGE-AID)

    Time frame: 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. 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.

  2. The Columbia Suicide Severity Rating Scale (C-SSRS)

    Time frame: baseline only

    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
    • 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Registry information

Official study title

Mindfulness, Group Therapy and Psychosis; Training Decreases Anxiety and Depression in Outpatients With a Psychotic Disorder in a Non-Randomized Within Group Comparison

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 15, 2021
Registry last updated
Feb 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.