Trial Outcomes & Findings for Positive Valence System Enhancement Treatment for Anxiety and Depression: Clinical Efficacy and Neural Changes (NCT NCT02330627)

Last Updated: 2021-11-08

Results Overview

The Positive and Negative Affect Schedule (PANAS) measures positive affect. Items are answered on a 5 point scale, 1 (Very slightly or not at all) to 5 (Extremely). The positive affect scale ranges from 10-50 and higher scores indicate greater levels of positive affect. The Modified Differential Emotions Scale (mDES) measures positive emotions. Items are answered on a 5 point scale, 0 (Never/Not at all) to 4 (Most of the time/Extremely). Higher scores on the positive emotions sub-scale indicate higher levels of positive emotion. Participants' scores on the PANAS and mDES were first standardized across assessment sessions by converting to Z scores (M=0, SD=1) across both groups. The composite index of positive affect at each assessment point was the mean of the Z scores for that occasion. Higher z-scores indicate an increase in positive affect from baseline to post-treatment.

Recruitment status

COMPLETED

Study phase

Target enrollment

29 participants

Primary outcome timeframe

Baseline, 10 weeks

Results posted on

2021-11-08

Participant Flow

Participant milestones

Participant milestones
Measure	Positive Valence System Treatment 10 one-hour individual sessions comprised of psychoeducation and positive activity interventions designed to increase positive emotions, cognitions, and behaviors. Positive Valence System Treatment: Clinician-administered one-hour treatment sessions focused on presenting rationale and instructions for completing positive activity exercises (e.g., gratitude, acts of kindness) between sessions.	Delayed Treatment (Waitlist) No treatment received for 10 weeks
Overall Study STARTED	16	13
Overall Study COMPLETED	15	12
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Positive Valence System Enhancement Treatment for Anxiety and Depression: Clinical Efficacy and Neural Changes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Positive Valence System Treatment n=16 Participants 10 one-hour individual sessions comprised of psychoeducation and positive activity interventions designed to increase positive emotions, cognitions, and behaviors. Positive Valence System Treatment: Clinician-administered one-hour treatment sessions focused on presenting rationale and instructions for completing positive activity exercises (e.g., gratitude, acts of kindness) between sessions.	Delayed Treatment (Waitlist) n=12 Participants	Total n=28 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
Age, Categorical Between 18 and 65 years	16 Participants n=5 Participants	12 Participants n=7 Participants	28 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	29.8 Years STANDARD_DEVIATION 12.2 • n=5 Participants	29.0 Years STANDARD_DEVIATION 12.0 • n=7 Participants	29.7 Years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants	8 Participants n=7 Participants	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	12 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 10 weeks

Population: One participant in the delayed treatment (waitlist) arm initiated an alternate treatment following the pre-assessment and was thus excluded from the analysis.

Outcome measures

Outcome measures
Measure	Positive Valence System Treatment n=16 Participants 10 one-hour individual sessions comprised of psychoeducation and positive activity interventions designed to increase positive emotions, cognitions, and behaviors. Positive Valence System Treatment: Clinician-administered one-hour treatment sessions focused on presenting rationale and instructions for completing positive activity exercises (e.g., gratitude, acts of kindness) between sessions.	Delayed Treatment (Waitlist) n=12 Participants
Change From Baseline in Positive Affect (Positive and Negative Affect Schedule; Modified Differential Emotions Scale; Composite) Pre-assessment	-0.41 z-score Standard Deviation .96	-0.40 z-score Standard Deviation .54
Change From Baseline in Positive Affect (Positive and Negative Affect Schedule; Modified Differential Emotions Scale; Composite) Post-assessment	0.73 z-score Standard Deviation .87	-0.02 z-score Standard Deviation .79

PRIMARY outcome

Timeframe: Baseline, 10 weeks

Change from pre- to post-assessment in neural activation during reward trials on the MID task.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 10 weeks

Population: One participant in the delayed treatment (waitlist) arm initiated an alternate treatment following the pre-assessment and was thus excluded from the analysis.

The Positive and Negative Affect Schedule (PANAS) measures negative affect. Items are answered on a 5 point scale, 1 (Very slightly or not at all) to 5 (Extremely). The negative affect scale ranges from 10-50 and lower scores indicate lower levels of negative affect. The Modified Differential Emotions Scale (mDES) measures negative emotions. Items are answered on a 5 point scale, 0 (Never/Not at all) to 4 (Most of the time/Extremely). Lower scores on the negative emotions sub-scale indicate lower levels of negative emotion. Participants' composite scores on the PANAS and mDES were first standardized across assessment sessions by converting to Z scores (M=0, SD=1) across both groups. The composite index of negative affect at each assessment point (i.e., pre assessment - at baseline, post assessment - 10 weeks after baseline) was the mean of the Z scores for that occasion. Lower z-scores indicate a decrease in negative affect from baseline to post-treatment.

Outcome measures

Outcome measures
Measure	Positive Valence System Treatment n=16 Participants 10 one-hour individual sessions comprised of psychoeducation and positive activity interventions designed to increase positive emotions, cognitions, and behaviors. Positive Valence System Treatment: Clinician-administered one-hour treatment sessions focused on presenting rationale and instructions for completing positive activity exercises (e.g., gratitude, acts of kindness) between sessions.	Delayed Treatment (Waitlist) n=12 Participants
Change From Baseline in Negative Affect (Positive and Negative Affect Schedule; Modified Differential Emotions Scale; Composite) Pre Assessment	0.17 z-score Standard Deviation 0.62	0.70 z-score Standard Deviation 0.89
Change From Baseline in Negative Affect (Positive and Negative Affect Schedule; Modified Differential Emotions Scale; Composite) Post Assessment	-0.19 z-score Standard Deviation 0.40	0.29 z-score Standard Deviation 1.11

SECONDARY outcome

Timeframe: Baseline, 10 weeks

Change from pre- to post-assessment in neural activation during loss trials on the MID

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 10 weeks

Population: One participant in the delayed treatment (waitlist) arm initiated an alternate treatment following the pre-assessment and was thus excluded from the analysis.

The Quality of Life, Enjoyment, and Satisfaction Questionnaire (Q-LES-Q) measures the degree of satisfaction experienced by participants in various areas of daily functioning. Items are rated on a 5 point scale, 1 (Very Poor) to 5 (Very Good). The scale ranges from 14-70; higher scores indicate higher levels of life satisfaction. The Satisfaction With Life Scale (SWLS) measures global cognitive judgments of one's life satisfaction. Items are rated on a 7 point scale, 1 (Strongly Disagree) to 7 (Strongly Agree). The scale ranges from 5-35; higher scores indicate higher levels of life satisfaction. Participants' scores on the Q-LES-Q and the SWLS were first standardized across assessment sessions by converting to Z scores (M=0, SD=1) across both groups. The composite index of quality of life and well-being at each assessment point was the mean of the Z scores for that occasion. Higher z-scores indicate an increase in quality of life and well-being from baseline to post-treatment.

Outcome measures

Outcome measures
Measure	Positive Valence System Treatment n=16 Participants 10 one-hour individual sessions comprised of psychoeducation and positive activity interventions designed to increase positive emotions, cognitions, and behaviors. Positive Valence System Treatment: Clinician-administered one-hour treatment sessions focused on presenting rationale and instructions for completing positive activity exercises (e.g., gratitude, acts of kindness) between sessions.	Delayed Treatment (Waitlist) n=12 Participants
Change From Baseline in Quality of Life and Well-being (Composite of Quality of Life, Enjoyment, and Satisfaction Questionnaire; Satisfaction With Life Scale) Pre-assessment	-.25 z-score Standard Deviation .77	-.34 z-score Standard Deviation .81
Change From Baseline in Quality of Life and Well-being (Composite of Quality of Life, Enjoyment, and Satisfaction Questionnaire; Satisfaction With Life Scale) Post-assessment	.76 z-score Standard Deviation .81	-.35 z-score Standard Deviation .87

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 10 weeks

Population: One participant in the delayed treatment (waitlist) arm initiated an alternate treatment following the pre-assessment and was thus excluded from the analysis.

The Overall Anxiety Severity and Impairment Scale (OASIS) measures frequency, severity, and functional impairment of anxiety symptoms. Items are rated on a 4 point scale, 0 (None) to 4 (Extreme). The scale ranges from 0-20 and higher scores indicate higher levels of anxiety. The State Trait Anxiety Inventory - Trait (STAI-T) measures general anxiety. Items are rated on a 4 point scale, 1 (Almost Never) to 4 (Almost Always). The scale ranges from 20-80 and higher scores indicate higher levels of anxiety. Participants' composite scores on the OASIS and the STAI were first standardized across assessment sessions by converting to Z scores (M=0, SD=1) across both groups. The composite index of anxiety at each assessment point (i.e., pre assessment - at baseline, post assessment - 10 weeks after baseline) was the mean of the Z scores for that occasion. Lower z-scores indicate a decrease in anxiety from baseline to post-treatment.

Outcome measures

Outcome measures
Measure	Positive Valence System Treatment n=16 Participants 10 one-hour individual sessions comprised of psychoeducation and positive activity interventions designed to increase positive emotions, cognitions, and behaviors. Positive Valence System Treatment: Clinician-administered one-hour treatment sessions focused on presenting rationale and instructions for completing positive activity exercises (e.g., gratitude, acts of kindness) between sessions.	Delayed Treatment (Waitlist) n=12 Participants
Change From Baseline in Anxiety (Overall Anxiety Severity and Impairment Scale; State Trait Anxiety Inventory - Trait Composite) Pre Assessment	.14 z-score Standard Deviation .54	.40 z-score Standard Deviation .62
Change From Baseline in Anxiety (Overall Anxiety Severity and Impairment Scale; State Trait Anxiety Inventory - Trait Composite) Post Assessment	-.61 z-score Standard Deviation .68	.23 z-score Standard Deviation .91

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, 10 weeks

Population: One participant in the delayed treatment (waitlist) arm initiated an alternate treatment following the pre-assessment and was thus excluded from the analysis.

The Patient Health Questionnaire-9 (PHQ-9) measures depression symptoms. Items are rated on a 4 point scale, 0 (Not at all) to 3 (Nearly every day). The scale ranges from 0-27 and higher scores indicate higher levels of depression. The Beck Depression Inventory-II (BDI-II) measures the severity of depression. Participants choose 1 of 4 response options; a value of 0 to 3 is assigned to each response option. The scale ranges from 0-63 and higher scores indicate higher severity of depression. Participants' composite scores on the PHQ-9 and the BDI-II were first standardized across assessment sessions by converting to Z scores (M=0, SD=1) across both groups. The composite index of depression at each assessment point (i.e., pre assessment - at baseline, post assessment - 10 weeks after baseline) was the mean of the Z scores for that occasion. Lower z-scores indicate a decrease in depression from baseline to post-treatment.

Outcome measures

Outcome measures
Measure	Positive Valence System Treatment n=16 Participants 10 one-hour individual sessions comprised of psychoeducation and positive activity interventions designed to increase positive emotions, cognitions, and behaviors. Positive Valence System Treatment: Clinician-administered one-hour treatment sessions focused on presenting rationale and instructions for completing positive activity exercises (e.g., gratitude, acts of kindness) between sessions.	Delayed Treatment (Waitlist) n=12 Participants
Change From Baseline in Depression (Patient Health Questionnaire-9; Beck Depression Inventory-II Composite) Pre Assessment	.29 z-score Standard Deviation .90	.47 z-score Standard Deviation .77
Change From Baseline in Depression (Patient Health Questionnaire-9; Beck Depression Inventory-II Composite) Post Assessment	-.87 z-score Standard Deviation .55	.29 z-score Standard Deviation .97

Adverse Events

Positive Valence System Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Delayed Treatment (Waitlist)

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

Dr. Charles Taylor

University of California, San Diego

Phone: 8585349446

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place