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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Psychosis

Intervention / Treatment
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* Behavioral: observation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All DSM-V diagnosis that included a psychosis spectrum disorder Exclusion Criteria: those lacking symptoms of psychosis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| treatment plus mindfulness comparing young vs old<br>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<br>* Young participants versus Old participant scores at admission and discharge were compared<br>|
| treatment plus mindfulness practice and no treatment or Treatment As Usual (TAU)<br>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<br>* Young participants versus Old participant scores at admission and discharge were compared<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Change in PHQ-9 | : 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. | At least five weeks. | 
| The Change in GAD-7 | 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. | At least five weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Columbia Suicide Severity Rating Scale (C-SSRS), | 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. | Baseline only | 
| CAGE-Adapted to Include Drug Use (CAGE-AID) | 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. | Baseline only | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mindfulness, group therapy