Trial Outcomes & Findings for Self-affirmation Intervention for People Newly Diagnosed With Advanced Cancer (NCT NCT05235750)
NCT ID: NCT05235750
Last Updated: 2025-03-17
Results Overview
Changes include raw score changes and standardized mean differences. Scores on the Rosenberg Self-esteem Scale range from 0 to 30, with higher score indicating higher level of self-esteem.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
57 participants
Primary outcome timeframe
Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)
Results posted on
2025-03-17
Participant Flow
Participant milestones
| Measure |
Writing
This is a single-group study with one arm only.
Self-affirmation writing: Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
COMPLETED
|
45
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Self-affirmation Intervention for People Newly Diagnosed With Advanced Cancer
Baseline characteristics by cohort
| Measure |
Writing
n=54 Participants
This is a single-group study with one arm only.
Self-affirmation writing: Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=5 Participants
|
|
Age, Continuous
|
62.8 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · African American
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · non-Hispanic
|
54 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic
|
0 Participants
n=5 Participants
|
|
Education
Up to 8th grade
|
1 Participants
n=5 Participants
|
|
Education
High school
|
21 Participants
n=5 Participants
|
|
Education
College
|
26 Participants
n=5 Participants
|
|
Education
Graduate school
|
5 Participants
n=5 Participants
|
|
Education
Unknown or not reported
|
1 Participants
n=5 Participants
|
|
Marital status
single
|
7 Participants
n=5 Participants
|
|
Marital status
married
|
31 Participants
n=5 Participants
|
|
Marital status
divorced
|
9 Participants
n=5 Participants
|
|
Marital status
widowed
|
7 Participants
n=5 Participants
|
|
Religious affiliation
None
|
10 Participants
n=5 Participants
|
|
Religious affiliation
Protestant
|
17 Participants
n=5 Participants
|
|
Religious affiliation
Catholic
|
3 Participants
n=5 Participants
|
|
Religious affiliation
Other
|
23 Participants
n=5 Participants
|
|
Religious affiliation
Undisclosed
|
1 Participants
n=5 Participants
|
|
Time since cancer diagnosis
|
46.3 days
STANDARD_DEVIATION 23.5 • n=5 Participants
|
|
Stage of cancer
III
|
17 Participants
n=5 Participants
|
|
Stage of cancer
IV
|
31 Participants
n=5 Participants
|
|
Stage of cancer
recurrent
|
2 Participants
n=5 Participants
|
|
Stage of cancer
unstaged
|
4 Participants
n=5 Participants
|
|
Cancer site
Gastrointestinal (GI)
|
18 Participants
n=5 Participants
|
|
Cancer site
Lung
|
13 Participants
n=5 Participants
|
|
Cancer site
Gynecological (GYN)
|
10 Participants
n=5 Participants
|
|
Cancer site
Head and neck
|
7 Participants
n=5 Participants
|
|
Cancer site
Prostate
|
3 Participants
n=5 Participants
|
|
Cancer site
Breast
|
2 Participants
n=5 Participants
|
|
Cancer site
Hematological
|
1 Participants
n=5 Participants
|
|
Preference to talk
yes
|
33 Participants
n=5 Participants
|
|
Preference to talk
no
|
13 Participants
n=5 Participants
|
|
Preference to talk
not sure
|
8 Participants
n=5 Participants
|
|
Ever wrote a diary in life
no
|
38 Participants
n=5 Participants
|
|
Ever wrote a diary in life
yes
|
16 Participants
n=5 Participants
|
|
Should one have a religious affiliation to be spiritual?
no
|
37 Participants
n=5 Participants
|
|
Should one have a religious affiliation to be spiritual?
yes
|
17 Participants
n=5 Participants
|
|
Perceived threat from cancer diagnosis
a great deal threatening
|
16 Participants
n=5 Participants
|
|
Perceived threat from cancer diagnosis
moderately threatening
|
14 Participants
n=5 Participants
|
|
Perceived threat from cancer diagnosis
a little threatening
|
13 Participants
n=5 Participants
|
|
Perceived threat from cancer diagnosis
not or hardly threatening
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)Changes include raw score changes and standardized mean differences. Scores on the Rosenberg Self-esteem Scale range from 0 to 30, with higher score indicating higher level of self-esteem.
Outcome measures
| Measure |
Writing
n=54 Participants
This is a single-group study with one arm only.
Self-affirmation writing: Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer
|
|---|---|
|
Mean Changes From Baseline in Self-esteem Scores on the Rosenberg Self-esteem Scale (RSES) to Two-, Six-, and Eight Weeks Post Baseline
RSES at T1
|
23.4 score on a scale
Standard Deviation 3.8
|
|
Mean Changes From Baseline in Self-esteem Scores on the Rosenberg Self-esteem Scale (RSES) to Two-, Six-, and Eight Weeks Post Baseline
RSES at T2
|
23.5 score on a scale
Standard Deviation 4.1
|
|
Mean Changes From Baseline in Self-esteem Scores on the Rosenberg Self-esteem Scale (RSES) to Two-, Six-, and Eight Weeks Post Baseline
RSES at T3
|
23.7 score on a scale
Standard Deviation 4.2
|
|
Mean Changes From Baseline in Self-esteem Scores on the Rosenberg Self-esteem Scale (RSES) to Two-, Six-, and Eight Weeks Post Baseline
RSES at T4
|
24.2 score on a scale
Standard Deviation 4.7
|
PRIMARY outcome
Timeframe: Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)Changes include raw score changes and standardized mean differences. Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) range from 0 to 108, with higher score indicating higher level of quality of life. Each subscale ranging from 0 to 28, with higher score indicating higher level of quality of life. The raw scores of overall QoL (total FACT-G), four composite domains (physical well-being, PWB; social/family well-being, SWB; emotional well-being, EWB; functional well-being, FWB), global QoL (item Gf7 "I am content with the quality of my life right now") and one item pertinent to this study (Ge6 "I worry that my condition will get worse") were presented below.
Outcome measures
| Measure |
Writing
n=54 Participants
This is a single-group study with one arm only.
Self-affirmation writing: Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer
|
|---|---|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
Gf7 at T1
|
2.4 score on a scale
Standard Deviation 1.3
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
FACT-G (total score) at T1
|
78.7 score on a scale
Standard Deviation 15.2
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
FACT-G (total score) at T2
|
80.7 score on a scale
Standard Deviation 16.3
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
FACT-G (total score) at T3
|
80.7 score on a scale
Standard Deviation 14.9
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
FACT-G (total score) at T4
|
81.2 score on a scale
Standard Deviation 17.0
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
PWB at T1
|
20.6 score on a scale
Standard Deviation 4.8
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
PWB at T2
|
19.4 score on a scale
Standard Deviation 6.0
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
PWB at T3
|
19.3 score on a scale
Standard Deviation 5.3
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
PWB at T4
|
19.5 score on a scale
Standard Deviation 5.7
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
SWB at T1
|
22.7 score on a scale
Standard Deviation 4.4
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
SWB at T2
|
24.1 score on a scale
Standard Deviation 4.3
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
SWB at T3
|
23.5 score on a scale
Standard Deviation 4.2
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
SWB at T4
|
23.6 score on a scale
Standard Deviation 4.4
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
EWB at T1
|
18.6 score on a scale
Standard Deviation 3.9
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
EWB at T2
|
19.1 score on a scale
Standard Deviation 4.4
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
EWB at T3
|
19.3 score on a scale
Standard Deviation 4.5
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
EWB at T4
|
19.5 score on a scale
Standard Deviation 4.5
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
FWB at T1
|
16.8 score on a scale
Standard Deviation 6.8
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
FWB at T2
|
18.1 score on a scale
Standard Deviation 6.3
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
FWB at T3
|
18.7 score on a scale
Standard Deviation 5.7
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
FWB at T4
|
18.5 score on a scale
Standard Deviation 6.2
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
Gf7 at T2
|
2.6 score on a scale
Standard Deviation 1.2
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
Gf7 at T3
|
2.7 score on a scale
Standard Deviation 1.3
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
Gf7 at T4
|
2.6 score on a scale
Standard Deviation 1.2
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
Ge6 at T1
|
2.8 score on a scale
Standard Deviation 1.1
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
Ge6 at T2
|
2.8 score on a scale
Standard Deviation 1.2
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
Ge6 at T3
|
3.0 score on a scale
Standard Deviation 1.2
|
|
Mean Changes From Baseline in Quality of Life (QoL) Scores on the Functional Assessment of Cancer Therapy-General (FACT-G) to Two-, Six-, and Eight Weeks Post Baseline
Ge6 at T4
|
3.0 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)Changes include raw score changes and standardized mean differences. The FACIT-Sp-12 scale measures an individual's level of spiritual well-being, specifically assessing their sense of meaning, peace, and faith in life, with higher scores indicating a better level of spiritual well-being and lower scores a worse level of spiritual well-being. It consists of 12 items rated on a 5-point Likert scale (0 = Not at all to 4 = Very much). The FACIT-Sp-12 Scale consists of 2 sub-scales Meaning/Peace (M/P) with a range of 0-32, and Faith ranging from 1-16. Possible overall spiritual well-being or FACIT-Sp-12 (total) range from 0 to 48. The revised Faith subscale as well as the revised FACIT-Sp-12 scale have the same scale range of the original measures.
Outcome measures
| Measure |
Writing
n=54 Participants
This is a single-group study with one arm only.
Self-affirmation writing: Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer
|
|---|---|
|
Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline
FACIT-Sp-12 (total) at T1
|
39.5 score on a scale
Standard Deviation 8.2
|
|
Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline
FACIT-Sp-12 (total) at T2
|
40.5 score on a scale
Standard Deviation 6.8
|
|
Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline
FACIT-Sp-12 (total) at T3
|
41.0 score on a scale
Standard Deviation 7.0
|
|
Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline
FACIT-Sp-12 (total) at T4
|
40.0 score on a scale
Standard Deviation 8.0
|
|
Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline
M/P at T1
|
26.6 score on a scale
Standard Deviation 5.3
|
|
Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline
M/P at T2
|
27.2 score on a scale
Standard Deviation 4.3
|
|
Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline
M/P at T3
|
26.9 score on a scale
Standard Deviation 5.0
|
|
Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline
M/P at T4
|
26.8 score on a scale
Standard Deviation 5.7
|
|
Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline
Faith at T1
|
12.9 score on a scale
Standard Deviation 3.9
|
|
Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline
Faith at T2
|
13.2 score on a scale
Standard Deviation 3.5
|
|
Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline
Faith at T3
|
14.1 score on a scale
Standard Deviation 3.1
|
|
Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline
Faith at T4
|
13.2 score on a scale
Standard Deviation 3.6
|
|
Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline
Faith (revised) at T1
|
13.2 score on a scale
Standard Deviation 3.5
|
|
Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline
Faith (revised) at T2
|
13.7 score on a scale
Standard Deviation 2.9
|
|
Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline
Faith (revised) at T3
|
14.1 score on a scale
Standard Deviation 2.9
|
|
Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline
Faith (revised) at T4
|
13.5 score on a scale
Standard Deviation 3.4
|
|
Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline
FACIT-Sp-12 total (revised) at T1
|
39.8 score on a scale
Standard Deviation 7.7
|
|
Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline
FACIT-Sp-12 total (revised) at T2
|
40.9 score on a scale
Standard Deviation 6.6
|
|
Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline
FACIT-Sp-12 total (revised) at T3
|
40.9 score on a scale
Standard Deviation 6.9
|
|
Mean Changes From Baseline in Spiritual Well-Being Scores on the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (FACIT-Sp-12) to Two-, Six-, and Eight Weeks Post Baseline
FACIT-Sp-12 total (revised) at T4
|
39.8 score on a scale
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: Baseline (T1) as well as 2 weeks (T2), 6 weeks (T3), and 8 weeks post baseline (T4)Changes include raw score changes and standardized mean differences. Scores on the Hospital Anxiety and Depression Scale (HADS) range from 0 to 42, with higher score indicating higher level of anxiety or depression. The two subscales HADS anxiety (HADS-A) and HADS depression (HADS-D) were analyzed separately. Each sub-scale has a range from 0-21, with the higher score indicating higher level of anxiety or depression.
Outcome measures
| Measure |
Writing
n=54 Participants
This is a single-group study with one arm only.
Self-affirmation writing: Writing with a focus on self-affirmation at the time following a diagnosis of an advanced cancer
|
|---|---|
|
Mean Changes From Baseline in Anxiety and Depression Scores on the Hospital Anxiety and Depression Scale (HADS) to Two-, Six-, and Eight Weeks Post Baseline
HADS-A at T1
|
6.6 score on a scale
Standard Deviation 3.9
|
|
Mean Changes From Baseline in Anxiety and Depression Scores on the Hospital Anxiety and Depression Scale (HADS) to Two-, Six-, and Eight Weeks Post Baseline
HADS-A at T2
|
5.4 score on a scale
Standard Deviation 3.3
|
|
Mean Changes From Baseline in Anxiety and Depression Scores on the Hospital Anxiety and Depression Scale (HADS) to Two-, Six-, and Eight Weeks Post Baseline
HADS-A at T3
|
5.7 score on a scale
Standard Deviation 4.0
|
|
Mean Changes From Baseline in Anxiety and Depression Scores on the Hospital Anxiety and Depression Scale (HADS) to Two-, Six-, and Eight Weeks Post Baseline
HADS-A at T4
|
5.3 score on a scale
Standard Deviation 4.1
|
|
Mean Changes From Baseline in Anxiety and Depression Scores on the Hospital Anxiety and Depression Scale (HADS) to Two-, Six-, and Eight Weeks Post Baseline
HADS-D at T1
|
4.7 score on a scale
Standard Deviation 3.2
|
|
Mean Changes From Baseline in Anxiety and Depression Scores on the Hospital Anxiety and Depression Scale (HADS) to Two-, Six-, and Eight Weeks Post Baseline
HADS-D at T2
|
3.9 score on a scale
Standard Deviation 2.8
|
|
Mean Changes From Baseline in Anxiety and Depression Scores on the Hospital Anxiety and Depression Scale (HADS) to Two-, Six-, and Eight Weeks Post Baseline
HADS-D at T3
|
4.2 score on a scale
Standard Deviation 3.5
|
|
Mean Changes From Baseline in Anxiety and Depression Scores on the Hospital Anxiety and Depression Scale (HADS) to Two-, Six-, and Eight Weeks Post Baseline
HADS-D at T4
|
4.5 score on a scale
Standard Deviation 3.7
|
Adverse Events
Writing
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Mei Bai
University of Arkansas for Medical Sciences
Phone: 501-603-1900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place