NCT02489422 · OUTCOME

Regulation of Psychological Stress Assessed by the Positive and Negative Affect Schedule-Expanded Form (Daily)

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Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: score on a scale
Interval / dispersion: Standard Error
Time frame: At 0-2 weeks and 8-10 weeks after start of intervention

What was measured

Regulation of psychological stress will be assessed daily with the 3-item serenity subscale (calm, relaxed, at ease) from the Positive and Negative Affect Schedule-Expanded Form. Each item is rated on a five-point Likert Scale, ranging from 1 = Very Slightly or Not at all to 5 = Extremely. Positive Affect Score: Scores can range from 10 - 50, with higher scores representing higher levels of positive affect and lower scores representing lower levels of negative affect.

Analysis population: Numbers may vary based on number of participants that actually completed intervention materials

Groups in this outcome

Group I (Yoga Skills Training)

Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studies

Group II (Attention Control)

Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Group I (Yoga Skills Training)	20
Group II (Attention Control)	19

Reported measurements

0-2 weeks, mean

Analysis denominator · Participants

Group	Source count
Group I (Yoga Skills Training)	20
Group II (Attention Control)	19

Values in score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group I (Yoga Skills Training)	10.51	0.55	Not reported	Not reported	Not reported
Group II (Attention Control)	9.59	0.66	Not reported	Not reported	Not reported

8-10 weeks, mean

Analysis denominator · Participants

Group	Source count
Group I (Yoga Skills Training)	16
Group II (Attention Control)	14

Values in score on a scale · Interval/dispersion: Standard Error
Group	Value	Spread	Lower	Upper	Comment
Group I (Yoga Skills Training)	10.53	0.74	Not reported	Not reported	Not reported
Group II (Attention Control)	10.36	0.84	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
0.55
value
10.51
group Id
OG001
spread
0.66
value
9.59
denoms
counts
group Id
OG000
value
20
group Id
OG001
value
19
units
Participants
title
0-2 weeks, mean
categories
measurements
group Id
OG000
spread
0.74
value
10.53
group Id
OG001
spread
0.84
value
10.36
denoms
counts
group Id
OG000
value
16
group Id
OG001
value
14
units
Participants
title
8-10 weeks, mean

denoms

counts
group Id
OG000
value
20
group Id
OG001
value
19
units
Participants

description

dispersion Type

Standard Error

groups

description
Patients participate in YST consisting of four 30 minute in-person yoga sessions at weeks 2, 4, 6, and 8 that instructs skills to enhance mindfulness and promote relaxation, through instruction of awareness, movement, breathing practices, and meditation. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Yoga Skills Training: The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home. Actigraphy Assessment: Ancillary studies
id
OG000
title
Group I (Yoga Skills Training)
description
Patients participate in four 30 minute in-person sessions of supportive conversation at weeks 2, 4, 6, 8. Laboratory Biomarker Analysis: Correlative studies Questionnaire Administration: Ancillary studies Daily Survey Administration: Ancillary studies Attention Control: The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home. Actigraphy Assessment: Ancillary studies
id
OG001
title
Group II (Attention Control)

param Type

MEAN

population Description

Numbers may vary based on number of participants that actually completed intervention materials

reporting Status

POSTED

time Frame

At 0-2 weeks and 8-10 weeks after start of intervention

title

Regulation of Psychological Stress Assessed by the Positive and Negative Affect Schedule-Expanded Form (Daily)

type

SECONDARY

unit Of Measure

score on a scale

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Preserved source evidence · Not medical advice