Trial Outcomes & Findings for Approach-Avoidance Conflict-a Multi-level Predictor for Therapy Response (NCT NCT02807480)

NCT ID: NCT02807480

Last Updated: 2024-03-26

Results Overview

Test the relationship between imaging and behavioral factors and the level of symptoms at baseline assessment. Scores on the Generalized Anxiety Disorder - 7 item scale (GAD-7) range from 0 to 21, higher scores reflect greater symptom severity.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 121 participants
• Primary outcome timeframe: Baseline assessment (one time point)
• Results posted on: 2024-03-26

Participant Flow

After enrollment, participants completed baseline assessments prior to being randomized to a treatment arm. A total of 121 were rolled in the study. Prior to randomization, 27 participants withdrew from the study due to no longer meeting criteria (N=9), indicated being no longer interested in participating (N=8), and other or unknown reasons (N=10), leaving N=94 being randomized and starting treatment.

Participant milestones

Measure	Exposure-based Therapy Participants will complete 10, 90-minute sessions of Exposure-based therapy, conducted using a group format. Each group will include 8-12 participants. Exposure-based therapy seeks to increase abilities to manage anxiety through repeated practice in facing the situations or thoughts that are the focus of worry or fear.	Behavioral Activation Therapy Participants will complete 10, 90-minute sessions of Behavioral Activation therapy, conducted using a group format. Each group will include 8-12 participants. Behavioral Activation therapy seeks to target behaviors that might maintain or worsen negative mood.
Overall Study STARTED	46	48
Overall Study COMPLETED	32	38
Overall Study NOT COMPLETED	14	10

Reasons for withdrawal

Measure	Exposure-based Therapy Participants will complete 10, 90-minute sessions of Exposure-based therapy, conducted using a group format. Each group will include 8-12 participants. Exposure-based therapy seeks to increase abilities to manage anxiety through repeated practice in facing the situations or thoughts that are the focus of worry or fear.	Behavioral Activation Therapy Participants will complete 10, 90-minute sessions of Behavioral Activation therapy, conducted using a group format. Each group will include 8-12 participants. Behavioral Activation therapy seeks to target behaviors that might maintain or worsen negative mood.
Overall Study Withdrawal by Subject	14	10

Baseline Characteristics

Approach-Avoidance Conflict-a Multi-level Predictor for Therapy Response

Baseline characteristics by cohort

Measure	Exposure-based Therapy n=46 Participants Participants will complete 10, 90-minute sessions of Exposure-based therapy, conducted using a group format. Each group will include 8-12 participants. Exposure-based therapy seeks to increase abilities to manage anxiety through repeated practice in facing the situations or thoughts that are the focus of worry or fear.	Behavioral Activation Therapy n=48 Participants Participants will complete 10, 90-minute sessions of Behavioral Activation therapy, conducted using a group format. Each group will include 8-12 participants. Behavioral Activation therapy seeks to target behaviors that might maintain or worsen negative mood.	Total n=94 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=93 Participants	48 Participants n=4 Participants	94 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	34.96 years STANDARD_DEVIATION 10.63 • n=93 Participants	34.27 years STANDARD_DEVIATION 10.54 • n=4 Participants	34.61 years STANDARD_DEVIATION 10.53 • n=27 Participants
Sex: Female, Male Female	44 Participants n=93 Participants	38 Participants n=4 Participants	82 Participants n=27 Participants
Sex: Female, Male Male	2 Participants n=93 Participants	10 Participants n=4 Participants	12 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	44 Participants n=93 Participants	46 Participants n=4 Participants	90 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	9 Participants n=93 Participants	11 Participants n=4 Participants	20 Participants n=27 Participants
Race (NIH/OMB) Asian	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants	6 Participants n=4 Participants	7 Participants n=27 Participants
Race (NIH/OMB) White	30 Participants n=93 Participants	27 Participants n=4 Participants	57 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Region of Enrollment United States	46 participants n=93 Participants	48 participants n=4 Participants	94 participants n=27 Participants
Education Less than high school	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Education High school or GED	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Education Some college, no degree	12 Participants n=93 Participants	14 Participants n=4 Participants	26 Participants n=27 Participants
Education Bachelor's degree	10 Participants n=93 Participants	16 Participants n=4 Participants	26 Participants n=27 Participants
Education Associate's degree	4 Participants n=93 Participants	3 Participants n=4 Participants	7 Participants n=27 Participants
Education Master's degree	13 Participants n=93 Participants	10 Participants n=4 Participants	23 Participants n=27 Participants
Education Professional / doctoral degree	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
GAD7 Baseline Score	12.93 units on a scale STANDARD_DEVIATION 4.62 • n=93 Participants	11.30 units on a scale STANDARD_DEVIATION 3.73 • n=4 Participants	12.12 units on a scale STANDARD_DEVIATION 4.25 • n=27 Participants

PRIMARY outcome

Timeframe: Baseline assessment (one time point)

Population: Participants who 1) had usable pre-treatment fMRI data and 2) completed treatment with at least 7 sessions attended

Test the relationship between imaging and behavioral factors and the level of symptoms at baseline assessment. Scores on the Generalized Anxiety Disorder - 7 item scale (GAD-7) range from 0 to 21, higher scores reflect greater symptom severity.

Outcome measures

Measure	Exposure-based Therapy n=27 Participants Participants will complete 10, 90-minute sessions of Exposure-based therapy, conducted using a group format. Each group will include 8-12 participants. Exposure-based therapy seeks to increase abilities to manage anxiety through repeated practice in facing the situations or thoughts that are the focus of worry or fear.	Behavioral Activation Therapy n=30 Participants Participants will complete 10, 90-minute sessions of Behavioral Activation therapy, conducted using a group format. Each group will include 8-12 participants. Behavioral Activation therapy seeks to target behaviors that might maintain or worsen negative mood.
For Aim1: Baseline Generalized Anxiety Disorder Symptoms as Measured by the Generalized Anxiety Disorder - 7 Item Scale (GAD-7).	12.85 units on a scale Standard Deviation 5.33	11.62 units on a scale Standard Deviation 3.38

PRIMARY outcome

Timeframe: Trajectory of change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment.

Population: Participants who had usable baseline fMRI data and completed treatment. Outcome measure data entered for post-treatment timepoint or last timepoint collected.

Test the predictive effects of imaging and behavioral factors on change in symptoms at baseline compared to within 6 weeks after completing treatment. Scores on the Generalized Anxiety Disorder - 7 item scale (GAD-7) range from 0 to 21, higher scores reflect greater symptom severity.

Outcome measures

Measure	Exposure-based Therapy n=27 Participants Participants will complete 10, 90-minute sessions of Exposure-based therapy, conducted using a group format. Each group will include 8-12 participants. Exposure-based therapy seeks to increase abilities to manage anxiety through repeated practice in facing the situations or thoughts that are the focus of worry or fear.	Behavioral Activation Therapy n=29 Participants Participants will complete 10, 90-minute sessions of Behavioral Activation therapy, conducted using a group format. Each group will include 8-12 participants. Behavioral Activation therapy seeks to target behaviors that might maintain or worsen negative mood.
For Aims 2 and 3: Change in Generalized Anxiety Disorder Symptoms as Measured by the Generalized Anxiety Disorder - 7 Item Scale (GAD-7).	8.48 units on a scale Standard Deviation 4.20	5.90 units on a scale Standard Deviation 3.97

SECONDARY outcome

Timeframe: Trajectory of change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment

Population: Participants who had usable baseline fMRI data and completed treatment. Outcome measure data entered for post-treatment timepoint or last timepoint collected.

Test the predictive effects of imaging and behavioral factors on change in symptoms at baseline compared to within 6 weeks after completing treatment. The PROMIS Anxiety Scale yields t-scores, higher scores indicate greater symptom severity, with 50 indicating the population mean and a standard deviation of 10.

Outcome measures

Measure	Exposure-based Therapy n=27 Participants Participants will complete 10, 90-minute sessions of Exposure-based therapy, conducted using a group format. Each group will include 8-12 participants. Exposure-based therapy seeks to increase abilities to manage anxiety through repeated practice in facing the situations or thoughts that are the focus of worry or fear.	Behavioral Activation Therapy n=29 Participants Participants will complete 10, 90-minute sessions of Behavioral Activation therapy, conducted using a group format. Each group will include 8-12 participants. Behavioral Activation therapy seeks to target behaviors that might maintain or worsen negative mood.
Change in Anxiety Symptoms as Measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety Scale.	60.68 T-score Standard Deviation 5.86	55.98 T-score Standard Deviation 7.23

SECONDARY outcome

Timeframe: Trajectory of change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment

Population: Participants who had usable baseline fMRI data and completed treatment. Outcome measure data entered for post-treatment timepoint or last timepoint collected.

Test the predictive effects of imaging and behavioral factors on change in symptoms at baseline compared to within 6 weeks after completing treatment. The PROMIS Depression scale yields t-scores; higher scores indicate greater symptom severity, with population mean being 50 and standard deviation of 10.

Outcome measures

Measure	Exposure-based Therapy n=27 Participants Participants will complete 10, 90-minute sessions of Exposure-based therapy, conducted using a group format. Each group will include 8-12 participants. Exposure-based therapy seeks to increase abilities to manage anxiety through repeated practice in facing the situations or thoughts that are the focus of worry or fear.	Behavioral Activation Therapy n=29 Participants Participants will complete 10, 90-minute sessions of Behavioral Activation therapy, conducted using a group format. Each group will include 8-12 participants. Behavioral Activation therapy seeks to target behaviors that might maintain or worsen negative mood.
Change in Depressive Symptoms as Measured by the Patient Reported Outcomes Measurement Information System (PROMIS) Depression Scale.	53.70 T-score Standard Deviation 6.87	52.12 T-score Standard Deviation 4.73

SECONDARY outcome

Timeframe: Trajectory of change from pre- to post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment

Population: Participants who had usable baseline fMRI data and completed treatment. Outcome measure data entered for post-treatment timepoint or last timepoint collected.

Test the predictive effects of imaging and behavioral factors on change in symptoms at baseline compared to within 6 weeks after completing treatment. The Sheehan Disability Scale assesses functional impairment in the domains of work/school, social life, and family life. Participants are provided with a 0-10 visual analog scale with spatiovisual, numeric, and descriptive anchors and asked to rate the extent to which their symptoms have interfered with their functioning on each item for total score ranges of 0-30. Higher scores indicate greater impairment.

Outcome measures

Measure	Exposure-based Therapy n=27 Participants Participants will complete 10, 90-minute sessions of Exposure-based therapy, conducted using a group format. Each group will include 8-12 participants. Exposure-based therapy seeks to increase abilities to manage anxiety through repeated practice in facing the situations or thoughts that are the focus of worry or fear.	Behavioral Activation Therapy n=29 Participants Participants will complete 10, 90-minute sessions of Behavioral Activation therapy, conducted using a group format. Each group will include 8-12 participants. Behavioral Activation therapy seeks to target behaviors that might maintain or worsen negative mood.
Change in Level of Disability as Measured by the Sheehan Disability Scale	8.93 score on a scale Standard Deviation 6.11	5.36 score on a scale Standard Deviation 5.47

SECONDARY outcome

Timeframe: Post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment

Population: Participants who had usable baseline fMRI data and completed treatment. Outcome measure data entered for post-treatment timepoint or last timepoint collected.

Test the predictive effects of imaging and behavioral factors on post-treatment symptoms (within 6 weeks after completing treatment), covarying for baseline symptom severity. The PSWQ is a 16-item self-report scale designed to measure the trait of worry in adults. Scores range from 16 to 80 with higher scores indicative of higher levels of trait worry. Scores of 66 or greater are thought to indicate clinically significant worry.

Outcome measures

Measure	Exposure-based Therapy n=27 Participants Participants will complete 10, 90-minute sessions of Exposure-based therapy, conducted using a group format. Each group will include 8-12 participants. Exposure-based therapy seeks to increase abilities to manage anxiety through repeated practice in facing the situations or thoughts that are the focus of worry or fear.	Behavioral Activation Therapy n=29 Participants Participants will complete 10, 90-minute sessions of Behavioral Activation therapy, conducted using a group format. Each group will include 8-12 participants. Behavioral Activation therapy seeks to target behaviors that might maintain or worsen negative mood.
Worry Symptoms as Measured by the Penn State Worry Questionnaire	64.26 score on a scale Standard Deviation 10.29	56.29 score on a scale Standard Deviation 10.59

SECONDARY outcome

Timeframe: Post- treatment; last time point assessed within 6 weeks following last treatment session, on average at 16 weeks after baseline assessment

Population: Participants who had usable baseline fMRI data and completed treatment. Outcome measure data entered for post-treatment timepoint or last timepoint collected.

Test the predictive effects of imaging and behavioral factors on symptoms at post-treatment (within 6 weeks after completing treatment), covarying for baseline symptom severity. The BDI-II is a 21-item questionnaire, with each individual item being rated from 0-3 in a list of four statements arranged in increasing severity about a particular symptom of depression. The outcome measure is the total score on the BDI-II, which is the sum of all 21 items. Higher scores equate to greater severity of depression symptoms. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.

Outcome measures

Measure	Exposure-based Therapy n=27 Participants Participants will complete 10, 90-minute sessions of Exposure-based therapy, conducted using a group format. Each group will include 8-12 participants. Exposure-based therapy seeks to increase abilities to manage anxiety through repeated practice in facing the situations or thoughts that are the focus of worry or fear.	Behavioral Activation Therapy n=29 Participants Participants will complete 10, 90-minute sessions of Behavioral Activation therapy, conducted using a group format. Each group will include 8-12 participants. Behavioral Activation therapy seeks to target behaviors that might maintain or worsen negative mood.
Depressive Symptoms as Measured by the Beck Depression Inventory - II.	13.56 score on a scale Standard Deviation 6.95	9.68 score on a scale Standard Deviation 8.64

Adverse Events

Exposure-based Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Behavioral Activation Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Exposure-based Therapy n=46 participants at risk Participants will complete 10, 90-minute sessions of Exposure-based therapy, conducted using a group format. Each group will include 8-12 participants. Exposure-based therapy seeks to increase abilities to manage anxiety through repeated practice in facing the situations or thoughts that are the focus of worry or fear. All participants will complete computer-based behavioral assessments, surveys and interviews, functional magnetic resonance imaging (fMRI), and electroencephalography (EEG). Exposure-based therapy: Exposure-based therapy Computer-based behavioral assessment: Computer-based tasks during which participants respond to images on the screen, including abstract images, emotional faces, and pleasant and unpleasant images. Surveys and Interviews: Surveys and interviews in which participants will be asked to answer questions related to their mental and physical health history and current symptoms. Magnetic resonance imaging (MRI): Magnetic resonance imaging (MRI) will be used to obtain information concerning the structure of the brain, as well as to assess changes associated with blood flow in the brain while participants are completing behavioral tasks (see description of computer-based behavioral assessment intervention). Electroencephalography (EEG): Electroencephalography (EEG) will be used to assess changes in electrical activity of the brain while participants complete behavioral tasks (see description of computer-based behavioral assessment).	Behavioral Activation Therapy n=48 participants at risk Participants will complete 10, 90-minute sessions of Behavioral Activation therapy, conducted using a group format. Each group will include 8-12 participants. Behavioral Activation therapy seeks to target behaviors that might maintain or worsen negative mood. All participants will complete computer-based behavioral assessments, surveys and interviews, functional magnetic resonance imaging (fMRI), and electroencephalography (EEG). Behavioral Activation therapy: Behavioral Activation therapy Computer-based behavioral assessment: Computer-based tasks during which participants respond to images on the screen, including abstract images, emotional faces, and pleasant and unpleasant images. Surveys and Interviews: Surveys and interviews in which participants will be asked to answer questions related to their mental and physical health history and current symptoms. Magnetic resonance imaging (MRI): Magnetic resonance imaging (MRI) will be used to obtain information concerning the structure of the brain, as well as to assess changes associated with blood flow in the brain while participants are completing behavioral tasks (see description of computer-based behavioral assessment intervention). Electroencephalography (EEG): Electroencephalography (EEG) will be used to assess changes in the electrical activity of the brain while participants are completing behavioral tasks (see description of computer-based behavioral assessment intervention).
Psychiatric disorders Active suicidal ideation	0.00% 0/46 • From pre- to post-treatment: post-treatment timepoint assessed within 6 weeks following last treatment session, on average 16 weeks after baseline assessment	2.1% 1/48 • Number of events 1 • From pre- to post-treatment: post-treatment timepoint assessed within 6 weeks following last treatment session, on average 16 weeks after baseline assessment

Additional Information

Robin Aupperle

Laureate Institute for Brain Research

Phone: 918-502-5744

Email: raupperle@laureateinstitute.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place