Trial Outcomes & Findings for Mindfulness, Group Therapy and Psychosis; Training Decreases Anxiety and Depression (NCT NCT04711460)

Last Updated: 2024-02-02

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

116 participants

Primary outcome timeframe

Five weeks

Results posted on

2024-02-02

Participant Flow

There was no recruitment used for this study.

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.

Participant milestones

Participant milestones
Measure	1: TAU 1: The Treatment as usual (TAU) group received only Cognitive Behavioral Therapy (CBT)	The TAU + Treatment Group The TAU plus Mindfulness Training received CBT and Mindfulness Training	Younger Participants scores were compared on pre/post-test scores	Older Participants pre/post-test scores were compared
Overall Study STARTED	32	32	26	26
Overall Study COMPLETED	32	32	26	26
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Gender is defined as male, female, and transgender for each category

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment as Usual CBT n=32 Participants Treatment as usual (TAU group) Participants in the "Treatment as usual" (TAU) group had Cognitive Behavioral Therapy only.	Treatment as Usual + Mindfulness Training n=32 Participants (TAU + TX group) Participants had Cognitive Behavioral Therapy (CBT), mindfulness training	Younger Participants n=26 Participants Younger participants pre/post test scores were compared	Older Participants n=26 Participants Older participants pre/post test scores were compared	Total n=116 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants	32 Participants n=7 Participants	26 Participants n=5 Participants	26 Participants n=4 Participants	116 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex/Gender, Customized Male	19 participants n=5 Participants • Gender is defined as male, female, and transgender for each category	13 participants n=7 Participants • Gender is defined as male, female, and transgender for each category	10 participants n=5 Participants • Gender is defined as male, female, and transgender for each category	11 participants n=4 Participants • Gender is defined as male, female, and transgender for each category	53 participants n=21 Participants • Gender is defined as male, female, and transgender for each category
Sex/Gender, Customized Female	9 participants n=5 Participants • Gender is defined as male, female, and transgender for each category	13 participants n=7 Participants • Gender is defined as male, female, and transgender for each category	6 participants n=5 Participants • Gender is defined as male, female, and transgender for each category	11 participants n=4 Participants • Gender is defined as male, female, and transgender for each category	39 participants n=21 Participants • Gender is defined as male, female, and transgender for each category
Sex/Gender, Customized Transgender	4 participants n=5 Participants • Gender is defined as male, female, and transgender for each category	6 participants n=7 Participants • Gender is defined as male, female, and transgender for each category	10 participants n=5 Participants • Gender is defined as male, female, and transgender for each category	4 participants n=4 Participants • Gender is defined as male, female, and transgender for each category	24 participants n=21 Participants • Gender is defined as male, female, and transgender for each category
Race/Ethnicity, Customized Ethnicity: Caucasian	20 participants n=5 Participants	15 participants n=7 Participants	10 participants n=5 Participants	13 participants n=4 Participants	58 participants n=21 Participants
Race/Ethnicity, Customized Ethnicity: African American	5 participants n=5 Participants	7 participants n=7 Participants	6 participants n=5 Participants	4 participants n=4 Participants	22 participants n=21 Participants
Race/Ethnicity, Customized Ethnicity: Native American	3 participants n=5 Participants	5 participants n=7 Participants	6 participants n=5 Participants	3 participants n=4 Participants	17 participants n=21 Participants
Race/Ethnicity, Customized Ethnicity: Hispanic	1 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	1 participants n=4 Participants	4 participants n=21 Participants
Race/Ethnicity, Customized Ethnicity: Asian	0 participants n=5 Participants	2 participants n=7 Participants	0 participants n=5 Participants	5 participants n=4 Participants	7 participants n=21 Participants
Race/Ethnicity, Customized Ethnicity: Jewish	1 participants n=5 Participants	3 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	5 participants n=21 Participants
Race/Ethnicity, Customized Ethnicity: African continent	2 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	3 participants n=21 Participants
Region of Enrollment United States	32 participants n=5 Participants	32 participants n=7 Participants	26 participants n=5 Participants	26 participants n=4 Participants	116 participants n=21 Participants
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 • n=5 Participants	12.31 units on a scale STANDARD_DEVIATION 7.19 • n=7 Participants	11.84 units on a scale STANDARD_DEVIATION 5.9 • n=5 Participants	12.34 units on a scale STANDARD_DEVIATION 6.9 • n=4 Participants	11.45 units on a scale STANDARD_DEVIATION 6.15 • n=21 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 • n=5 Participants	10.09 units on a scale STANDARD_DEVIATION 5.59 • n=7 Participants	9.15 units on a scale STANDARD_DEVIATION 5.39 • n=5 Participants	11.42 units on a scale STANDARD_DEVIATION 5.13 • n=4 Participants	9.23 units on a scale STANDARD_DEVIATION 5.38 • n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment as Usual n=32 Participants The Treatment as usual (TAU) group received only Cognitive Behavioral Therapy (CBT)	TAU + Mindfulness Training n=32 Participants The TAU plus Mindfulness Training received CBT and Mindfulness Training.	Younger Participants n=26 Participants Pre/post test scores were obtained from younger participants who received TAU + Mindfulness Training	Older Participants n=26 Participants Pre/post test scores were obtained from younger participants who received TAU + mindfulness training.
Change in Generalized Anxiety Disorder-7 Pre/Post Test at Week 5	4.68 units on a scale Standard Deviation 5.4	6.28 units on a scale Standard Deviation 5.59	3.96 units on a scale Standard Deviation 5.39	7.38 units on a scale Standard Deviation 5.13

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Treatment as Usual n=32 Participants The Treatment as usual (TAU) group received only Cognitive Behavioral Therapy (CBT)	TAU + Mindfulness Training n=32 Participants The TAU plus Mindfulness Training received CBT and Mindfulness Training.	Younger Participants n=26 Participants Pre/post test scores were obtained from younger participants who received TAU + Mindfulness Training	Older Participants n=26 Participants Pre/post test scores were obtained from younger participants who received TAU + mindfulness training.
Change in Patient Health Questionnaire-9 Score From Pre / Post-test at Week 5	6.68 units on a scale Standard Deviation 6.4	6.96 units on a scale Standard Deviation 7.19	3.96 units on a scale Standard Deviation 5.39	7.38 units on a scale Standard Deviation 5.13

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Treatment as Usual n=32 Participants The Treatment as usual (TAU) group received only Cognitive Behavioral Therapy (CBT)	TAU + Mindfulness Training n=32 Participants The TAU plus Mindfulness Training received CBT and Mindfulness Training.	Younger Participants n=26 Participants Pre/post test scores were obtained from younger participants who received TAU + Mindfulness Training	Older Participants n=26 Participants Pre/post test scores were obtained from younger participants who received TAU + mindfulness training.
CAGE-Adapted to Include Drug Use (CAGE-AID)	32 Participants	32 Participants	26 Participants	26 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Treatment as Usual n=32 Participants The Treatment as usual (TAU) group received only Cognitive Behavioral Therapy (CBT)	TAU + Mindfulness Training n=32 Participants The TAU plus Mindfulness Training received CBT and Mindfulness Training.	Younger Participants n=26 Participants Pre/post test scores were obtained from younger participants who received TAU + Mindfulness Training	Older Participants n=26 Participants Pre/post test scores were obtained from younger participants who received TAU + mindfulness training.
The Columbia Suicide Severity Rating Scale (C-SSRS)	32 Participants	32 Participants	26 Participants	26 Participants

Adverse Events

1: The TAU Group / TAU vs TAU + TX

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

The TAU + TX Group / TAU vs TAU + TX

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Younger Participants / Younger vs Older Scores

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Older Participants / Younger vs Older Scores

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Joan D. Lund

University of MN

Phone: 612-273-9115

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place