MedPath

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

Completed
Conditions
Psychosis
Interventions
Behavioral: Older participants
Behavioral: TAU
Behavioral: Younger participants
Behavioral: TAU + MIndfulness practice
Registration Number
NCT04711460
Lead Sponsor
University of Minnesota
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
116
Inclusion Criteria
  • All Diagnostic Statistical Manual, Fifth edition, (DSM-5) diagnoses that included a psychosis spectrum disorder
Read More
Exclusion Criteria
  • those lacking symptoms of psychosis
Read More

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Older participantsOlder participantsParticipants were adults ages 30-54 years who received CBT and 10 minutes of Mindfulness Training and practice in group therapy.
Treatment As Usual (TAU)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.
Younger participantsYounger participantsParticipants were adults ages19 to 29 years who recieved CBT and 10 minutes of Mindfulness Training and practice in group therapy.
TAU plus mindfulness practiceTAU + MIndfulness practiceParticipants in the TAU plus Mindfulness Practice had Cognitive Behavioral Therapy (CBT) and 10 minutes of mindfulness practice in group therapy sessions.
Primary Outcome Measures
NameTimeMethod
Change in Patient Health Questionnaire-9 Score From Pre / Post-test at Week 5Five 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.

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

Secondary Outcome Measures
NameTimeMethod
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. 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.

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

© Copyright 2025. All Rights Reserved by MedPath