NCT04711460

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

Completed Results posted Last updated 2 February 2024

What this trial tests

trial testing Younger participants in Psychosis in 116 participants. Completed in 30 August 2019.

Timeline

1 January 2017

Primary endpoint
30 August 2019

30 August 2019

Quick facts

Lead sponsor	University of Minnesota
Status	Completed
Study type	OBSERVATIONAL
Enrollment	116
Start date	1 January 2017
Primary completion	30 August 2019
Estimated completion	30 August 2019

Drugs / interventions tested

• Younger participants
• Older participants
• TAU — full drug profile →
• TAU + MIndfulness practice

Conditions studied

• Psychosis — all drugs for Psychosis →

Sponsor

University of Minnesota

Who can join

Adults 18 to 60, any sex, with Psychosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
Treatment as Usual	4.68	± 5.4
TAU + Mindfulness Training	6.28	± 5.59
Younger Participants	3.96	± 5.39
Older Participants	7.38	± 5.13

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

Group	Value	95% CI
Treatment as Usual	6.68	± 6.4
TAU + Mindfulness Training	6.96	± 7.19
Younger Participants	3.96	± 5.39
Older Participants	7.38	± 5.13

CAGE-Adapted to Include Drug Use (CAGE-AID) Secondary · 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.

Group	Value	95% CI
The Treatment as Usual (TAU) Group	32
TAU + Mindfulness Group	32
Younger Participants	26
Older Participants	26

The Columbia Suicide Severity Rating Scale (C-SSRS) Secondary · 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

Group	Value	95% CI
1: The TAU Group	32
The TAU + TX Group	32
Younger Participants Scores	26
Older Participants	26

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.