Psychosis
Conditions
Keywords
mindfulness, group therapy
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.
Interventions
BEHAVIORALYounger participants
Younger Participants 19-29 years received TAU + Tx over 5 weeks
BEHAVIORALOlder participants
older participants 30-54 years received TAU + Tx over 5 weeks
BEHAVIORALTAU
Participants received TAU or Treatment As Ususal, Cognitive Behavior Therapy only
BEHAVIORALTAU + MIndfulness practice
Participants received TAU + mindfulness training
Sponsors
University of Minnesota
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Inclusion criteria
* All Diagnostic Statistical Manual, Fifth edition, (DSM-5) diagnoses that included a psychosis spectrum disorder
Exclusion criteria
* those lacking symptoms of psychosis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Generalized Anxiety Disorder-7 Pre/Post Test at Week 5 | 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. |
| Change in Patient Health Questionnaire-9 Score From Pre / Post-test at Week 5 | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Recruitment details
There was no recruitment used for this study.
Pre-assignment details
All participants assessed and enrolled had a DSM-V diagnosis that included psychosis. They participated twice a week for 5 weeks. Pre/post-test scores were collected and compared.
Participants by arm
| Arm | Count |
|---|---|
| Treatment as Usual CBT Treatment as usual (TAU group) Participants in the Treatment as usual (TAU) group had Cognitive Behavioral Therapy only. | 32 |
| Treatment as Usual + Mindfulness Training (TAU + TX group) Participants had Cognitive Behavioral Therapy (CBT), mindfulness training | 32 |
| Younger Participants Younger participants pre/post test scores were compared | 26 |
| Older Participants Older participants pre/post test scores were compared | 26 |
| Total | 116 |
Baseline characteristics
| Characteristic | Treatment as Usual CBT | Total | Older Participants | Younger Participants | Treatment as Usual + Mindfulness Training |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants | 116 Participants | 26 Participants | 26 Participants | 32 Participants |
| PHQ-9 and GAD-7 Number of Participants GAD-7 Scores: Mean (Standard Deviation) Unit of measures: scores on a scale | 6.25 units on a scale STANDARD_DEVIATION 5.4 | 9.23 units on a scale STANDARD_DEVIATION 5.38 | 11.42 units on a scale STANDARD_DEVIATION 5.13 | 9.15 units on a scale STANDARD_DEVIATION 5.39 | 10.09 units on a scale STANDARD_DEVIATION 5.59 |
| PHQ-9 and GAD-7 Number of Participants PHQ-9 Scores: Mean (Standard Deviation) Unit of measures: scores on a scale | 9.32 units on a scale STANDARD_DEVIATION 6.4 | 11.45 units on a scale STANDARD_DEVIATION 6.15 | 12.34 units on a scale STANDARD_DEVIATION 6.9 | 11.84 units on a scale STANDARD_DEVIATION 5.9 | 12.31 units on a scale STANDARD_DEVIATION 7.19 |
| Race/Ethnicity, Customized Ethnicity: African American | 5 participants | 22 participants | 4 participants | 6 participants | 7 participants |
| Race/Ethnicity, Customized Ethnicity: African continent | 2 participants | 3 participants | 0 participants | 1 participants | 0 participants |
| Race/Ethnicity, Customized Ethnicity: Asian | 0 participants | 7 participants | 5 participants | 0 participants | 2 participants |
| Race/Ethnicity, Customized Ethnicity: Caucasian | 20 participants | 58 participants | 13 participants | 10 participants | 15 participants |
| Race/Ethnicity, Customized Ethnicity: Hispanic | 1 participants | 4 participants | 1 participants | 2 participants | 0 participants |
| Race/Ethnicity, Customized Ethnicity: Jewish | 1 participants | 5 participants | 0 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized Ethnicity: Native American | 3 participants | 17 participants | 3 participants | 6 participants | 5 participants |
| Region of Enrollment United States | 32 participants | 116 participants | 26 participants | 26 participants | 32 participants |
| Sex/Gender, Customized Female | 9 participants | 39 participants | 11 participants | 6 participants | 13 participants |
| Sex/Gender, Customized Male | 19 participants | 53 participants | 11 participants | 10 participants | 13 participants |
| Sex/Gender, Customized Transgender | 4 participants | 24 participants | 4 participants | 10 participants | 6 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 32 | 0 / 32 | 0 / 26 | 0 / 26 |
| other Total, other adverse events | 0 / 32 | 0 / 32 | 0 / 26 | 0 / 26 |
| serious Total, serious adverse events | 0 / 32 | 0 / 32 | 0 / 26 | 0 / 26 |
Outcome results
Primary
Change in Generalized Anxiety Disorder-7 Pre/Post Test at Week 5
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.
Time frame: Five weeks
Population: The Generalized Anxiety Disorder 7 number of participants for two studies: Treatment as usual vs TAU + Mindfulness study and the Younger versus older study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Change in Generalized Anxiety Disorder-7 Pre/Post Test at Week 5 | 4.68 units on a scale | Standard Deviation 5.4 |
| TAU + Mindfulness Training | Change in Generalized Anxiety Disorder-7 Pre/Post Test at Week 5 | 6.28 units on a scale | Standard Deviation 5.59 |
| Younger Participants | Change in Generalized Anxiety Disorder-7 Pre/Post Test at Week 5 | 3.96 units on a scale | Standard Deviation 5.39 |
| Older Participants | Change in Generalized Anxiety Disorder-7 Pre/Post Test at Week 5 | 7.38 units on a scale | Standard Deviation 5.13 |
p-value: 0.003t-test, 2 sided
p-value: 0.009ANOVA
p-value: <0.05Tukey Kramer Post-Hoc
Comparison: Threshold of statistically significance was set at p=0.05. No power calculation was conducted.p-value: 0.003t-test, 2 sided
Comparison: Threshold of statistically significance was set at p=0.05. No power calculation was conducted.p-value: 0.454ANOVA
Primary
Change in Patient Health Questionnaire-9 Score From Pre / Post-test at Week 5
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.
Time frame: Five weeks
Population: The Patient Health Questionnaire-9 scale number of participants in each study: The Treatment as usual (TAU) versus TAU + Mindfulness and the Younger versus Older study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment as Usual | Change in Patient Health Questionnaire-9 Score From Pre / Post-test at Week 5 | 6.68 units on a scale | Standard Deviation 6.4 |
| TAU + Mindfulness Training | Change in Patient Health Questionnaire-9 Score From Pre / Post-test at Week 5 | 6.96 units on a scale | Standard Deviation 7.19 |
| Younger Participants | Change in Patient Health Questionnaire-9 Score From Pre / Post-test at Week 5 | 3.96 units on a scale | Standard Deviation 5.39 |
| Older Participants | Change in Patient Health Questionnaire-9 Score From Pre / Post-test at Week 5 | 7.38 units on a scale | Standard Deviation 5.13 |
p-value: 0.002t-test, 2 sided
Comparison: Threshold of statistically significance was set at p=0.05. No power calculation was conducted.p-value: 0.054ANOVA
Comparison: Threshold of statistically significance was set at p=0.05. No power calculation was conducted.p-value: 0.019t-test, 2 sided
Comparison: Threshold of statistically significance was set at p=0.05. No power calculation was conducted.p-value: 0.101ANOVA
Secondary
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. 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.
Time frame: baseline only
Population: The CAGE-AID was used to determine sobriety in all participants, and was done before admission to the program. Scores must be below 2 and indicate no problems with alcohol or drugs.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment as Usual | CAGE-Adapted to Include Drug Use (CAGE-AID) | 32 Participants |
| TAU + Mindfulness Training | CAGE-Adapted to Include Drug Use (CAGE-AID) | 32 Participants |
| Younger Participants | CAGE-Adapted to Include Drug Use (CAGE-AID) | 26 Participants |
| Older Participants | CAGE-Adapted to Include Drug Use (CAGE-AID) | 26 Participants |
Secondary
The Columbia Suicide Severity Rating Scale (C-SSRS)
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.
Time frame: baseline only
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment as Usual | The Columbia Suicide Severity Rating Scale (C-SSRS) | 32 Participants |
| TAU + Mindfulness Training | The Columbia Suicide Severity Rating Scale (C-SSRS) | 32 Participants |
| Younger Participants | The Columbia Suicide Severity Rating Scale (C-SSRS) | 26 Participants |
| Older Participants | The Columbia Suicide Severity Rating Scale (C-SSRS) | 26 Participants |