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

May 17, 2023 updated by: University of Minnesota

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

116

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

N/A

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • those lacking symptoms of psychosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Younger Participants 19-29 years received TAU + Tx over 5 weeks
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
older participants 30-54 years received TAU + Tx over 5 weeks
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
Participants received TAU or Treatment As Ususal, Cognitive Behavior Therapy only
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
Participants received TAU + mindfulness training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Five weeks
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.
Five weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline only
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.

  1. Only one time
  2. A few times
  3. A lot
  4. 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

August 30, 2019

Study Completion (Actual)

August 30, 2019

Study Registration Dates

First Submitted

December 15, 2020

First Submitted That Met QC Criteria

January 12, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Actual)

February 2, 2024

Last Update Submitted That Met QC Criteria

May 17, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00005035

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data is not available for sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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