Trial Outcomes & Findings for The Role of Emotional Processing in Improving the Quality of Life of Breast Cancer Patients (NCT NCT03377816)
NCT ID: NCT03377816
Last Updated: 2023-10-19
Results Overview
The Center for Epidemiologic Studies-Depression (CES-D) 10-item scale. The possible range of scores is zero to 50, with the higher scores indicating the presence of more symptomatology.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
318 participants
Primary outcome timeframe
Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)
Results posted on
2023-10-19
Participant Flow
Participant milestones
| Measure |
Art Therapy
The AT intervention is an 8-week group intervention comprised of 8 1.5 hour weekly sessions conducted by an experienced Art Therapist who received special training in conducting the treatment protocol as designed.
Art Therapy: In a group setting participants will be encouraged to engage in art making for increased emotional awareness, expression, and acceptance. The role of the art therapist is to encourage a non-judgmental and exploratory approach to artmaking in which the process is emphasized over product. The art therapist obtains these goals by creating an atmosphere that is calm and by remaining tuned in to the verbalizations and body language of participants. If needed she can provide individual attention that is geared toward neutralizing concerns regarding performance during the art making.
|
Mandala Group
The comparison group will color prefabricated shapes. The same art materials as in the intervention group will be on the table as will the same instrumental music.
Sham Art Therapy: In a group setting participants will engage in Mandala coloring
|
|---|---|---|
|
Overall Study
STARTED
|
157
|
161
|
|
Overall Study
COMPLETED
|
107
|
108
|
|
Overall Study
NOT COMPLETED
|
50
|
53
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Role of Emotional Processing in Improving the Quality of Life of Breast Cancer Patients
Baseline characteristics by cohort
| Measure |
Art Therapy
n=146 Participants
The AT intervention is an 8-week group intervention comprised of 8 1.5 hour weekly sessions conducted by an experienced Art Therapist who received special training in conducting the treatment protocol as designed.
Art Therapy: In a group setting participants will be encouraged to engage in art making for increased emotional awareness, expression, and acceptance. The role of the art therapist is to encourage a non-judgmental and exploratory approach to artmaking in which the process is emphasized over product. The art therapist obtains these goals by creating an atmosphere that is calm and by remaining tuned in to the verbalizations and body language of participants. If needed she can provide individual attention that is geared toward neutralizing concerns regarding performance during the art making.
|
Mandala Group
n=143 Participants
The comparison group will color prefabricated shapes. The same art materials as in the intervention group will be on the table as will the same instrumental music.
Sham Art Therapy: In a group setting participants will engage in Mandala coloring
|
Total
n=289 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age · 26-35
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Age, Customized
Age · 36-45
|
31 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Age, Customized
Age · 46-70
|
80 Participants
n=99 Participants
|
85 Participants
n=107 Participants
|
165 Participants
n=206 Participants
|
|
Age, Customized
Age · 70+
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Age, Customized
Age · missing
|
17 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
38 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
146 Participants
n=99 Participants
|
143 Participants
n=107 Participants
|
289 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
146 Participants
n=99 Participants
|
143 Participants
n=107 Participants
|
289 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Israel
|
146 participants
n=99 Participants
|
143 participants
n=107 Participants
|
289 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)Population: The posted data are raw, before multiple imputations.
The Center for Epidemiologic Studies-Depression (CES-D) 10-item scale. The possible range of scores is zero to 50, with the higher scores indicating the presence of more symptomatology.
Outcome measures
| Measure |
Art Therapy
n=122 Participants
The AT intervention is an 8-week group intervention comprised of 8 1.5 hour weekly sessions conducted by an experienced Art Therapist who received special training in conducting the treatment protocol as designed.
Art Therapy: In a group setting participants will be encouraged to engage in art making for increased emotional awareness, expression, and acceptance. The role of the art therapist is to encourage a non-judgmental and exploratory approach to artmaking in which the process is emphasized over product. The art therapist obtains these goals by creating an atmosphere that is calm and by remaining tuned in to the verbalizations and body language of participants. If needed she can provide individual attention that is geared toward neutralizing concerns regarding performance during the art making.
|
Mandala Group
n=118 Participants
The comparison group will color prefabricated shapes. The same art materials as in the intervention group will be on the table as will the same instrumental music.
Sham Art Therapy: In a group setting participants will engage in Mandala coloring
|
|---|---|---|
|
Depression Depression
T1
|
10.82 score on a scale
Standard Deviation 6.01
|
11.57 score on a scale
Standard Deviation 6.46
|
|
Depression Depression
T2
|
9.86 score on a scale
Standard Deviation 6.203
|
11.23 score on a scale
Standard Deviation 5.45
|
|
Depression Depression
T3
|
11.05 score on a scale
Standard Deviation 5.67
|
11.72 score on a scale
Standard Deviation 5.59
|
PRIMARY outcome
Timeframe: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)Population: We utilized full maximum likelihood, and the numbers presented here are raw data in which if an individual missed one item from the scale, it was marked as missing data.
Fatigue will be assessed using the Fatigue Symptom Inventory (FSI), a 14-item self-report measure designed to assess the severity of fatigue on an 11-point scale (0=not at all fatigued; 10=as fatigued as I could be) that assesses most, least, and average fatigue in the past week. A global score can be obtained summing items 1-13, resulting in a scale with a range between 0-130. Higher results represent higher levels of global fatigue.
Outcome measures
| Measure |
Art Therapy
n=117 Participants
The AT intervention is an 8-week group intervention comprised of 8 1.5 hour weekly sessions conducted by an experienced Art Therapist who received special training in conducting the treatment protocol as designed.
Art Therapy: In a group setting participants will be encouraged to engage in art making for increased emotional awareness, expression, and acceptance. The role of the art therapist is to encourage a non-judgmental and exploratory approach to artmaking in which the process is emphasized over product. The art therapist obtains these goals by creating an atmosphere that is calm and by remaining tuned in to the verbalizations and body language of participants. If needed she can provide individual attention that is geared toward neutralizing concerns regarding performance during the art making.
|
Mandala Group
n=120 Participants
The comparison group will color prefabricated shapes. The same art materials as in the intervention group will be on the table as will the same instrumental music.
Sham Art Therapy: In a group setting participants will engage in Mandala coloring
|
|---|---|---|
|
Fatigue
T1
|
61.35 score on a scale
Standard Deviation 28.77
|
63.08 score on a scale
Standard Deviation 29.69
|
|
Fatigue
T2
|
53.28 score on a scale
Standard Deviation 29.4
|
58.99 score on a scale
Standard Deviation 24.79
|
|
Fatigue
T3
|
60.36 score on a scale
Standard Deviation 29.4
|
63.21 score on a scale
Standard Deviation 28.38
|
PRIMARY outcome
Timeframe: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)Population: The overall number of participants analyzed reflects the number of participants at T1. We used the maximum likelihood analyses, thus each row reflects the actual number of participants who had full data and the respective means and standard deviations.
The PROMIS Pain impact Scale measures how much pain impacted different aspects of life in the past 7 days. Scores range from 0-to-60, higher scores indicating higher levels of pain or its impact on functioning and the PROMIS Pain Interference Scale measures how much pain interfered with different aspects of life in the past 7 days. Scores range from 0-to-60, higher scores indicating higher levels of pain or interference with functioning. Our data indicates t-scores calculated so that 50 indicates the population (cancer patient) mean with a standard deviation of 10.
Outcome measures
| Measure |
Art Therapy
n=124 Participants
The AT intervention is an 8-week group intervention comprised of 8 1.5 hour weekly sessions conducted by an experienced Art Therapist who received special training in conducting the treatment protocol as designed.
Art Therapy: In a group setting participants will be encouraged to engage in art making for increased emotional awareness, expression, and acceptance. The role of the art therapist is to encourage a non-judgmental and exploratory approach to artmaking in which the process is emphasized over product. The art therapist obtains these goals by creating an atmosphere that is calm and by remaining tuned in to the verbalizations and body language of participants. If needed she can provide individual attention that is geared toward neutralizing concerns regarding performance during the art making.
|
Mandala Group
n=118 Participants
The comparison group will color prefabricated shapes. The same art materials as in the intervention group will be on the table as will the same instrumental music.
Sham Art Therapy: In a group setting participants will engage in Mandala coloring
|
|---|---|---|
|
Pain (Impact and Interference)
Pain intensity T1
|
58.74 t-score
Standard Deviation 12.5
|
57.4 t-score
Standard Deviation 12.3
|
|
Pain (Impact and Interference)
Pain intensity T2
|
55.9 t-score
Standard Deviation 11.9
|
56.1 t-score
Standard Deviation 11.8
|
|
Pain (Impact and Interference)
Pain intensity T3
|
59.1 t-score
Standard Deviation 11.6
|
58.0 t-score
Standard Deviation 12.5
|
|
Pain (Impact and Interference)
Pain interference T1
|
59.0 t-score
Standard Deviation 9.3
|
59.3 t-score
Standard Deviation 9.4
|
|
Pain (Impact and Interference)
Pain interference T2
|
56.7 t-score
Standard Deviation 9.43
|
57.1 t-score
Standard Deviation 9.0
|
|
Pain (Impact and Interference)
Pain interference T3
|
59.0 t-score
Standard Deviation 9.0
|
57.7 t-score
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)Population: We used maximum likelihood for analyses. The numbers here reflect raw data, where if one question was not answered, the whole questionnaire is marked as missing data.
The Levels of Emotional Awareness Scale is a written performance index of ability to express emotion in a differentiated and complex way. Subjects write about their anticipated feelings and those of another person in response to 10 short vignettes. Responses are scored on a 1 - 4 range and summed up to create a range of 0-50 according to the degree of specificity in the terms used and the range of emotions described, higher scores indicating higher levels of awareness.
Outcome measures
| Measure |
Art Therapy
n=114 Participants
The AT intervention is an 8-week group intervention comprised of 8 1.5 hour weekly sessions conducted by an experienced Art Therapist who received special training in conducting the treatment protocol as designed.
Art Therapy: In a group setting participants will be encouraged to engage in art making for increased emotional awareness, expression, and acceptance. The role of the art therapist is to encourage a non-judgmental and exploratory approach to artmaking in which the process is emphasized over product. The art therapist obtains these goals by creating an atmosphere that is calm and by remaining tuned in to the verbalizations and body language of participants. If needed she can provide individual attention that is geared toward neutralizing concerns regarding performance during the art making.
|
Mandala Group
n=110 Participants
The comparison group will color prefabricated shapes. The same art materials as in the intervention group will be on the table as will the same instrumental music.
Sham Art Therapy: In a group setting participants will engage in Mandala coloring
|
|---|---|---|
|
Emotional Awareness
T1
|
30.11 score on a scale
Standard Deviation 5.28
|
30.59 score on a scale
Standard Deviation 6.24
|
|
Emotional Awareness
T2
|
30.87 score on a scale
Standard Deviation 4.523
|
30.9 score on a scale
Standard Deviation 5.49
|
|
Emotional Awareness
T3
|
30.12 score on a scale
Standard Deviation 5.21
|
28.77 score on a scale
Standard Deviation 4.84
|
SECONDARY outcome
Timeframe: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline (T2), and 8 weeks after the intervention ends (T3)Population: We utilized maximum likelihood, and here are presented raw data, in which if a participant missed one question, the data was marked as missing.
This is a 36-item scale in which participants respond on a Likert scale from 1 (I don't do this at all) to 4 (I do this a lot) regarding how they coped with breast cancer experiences in the past four weeks. Two subscales are created from means of items: Approach Coping composite (24 items), and Avoidance composite (12 items) each with a range from 1-4 . Higher scores indicate more approach-oriented or avoidance-oriented coping. Participants rated items on a response scale of 1 (''I don't do this at all'') to 4 (''I do this a lot'').
Outcome measures
| Measure |
Art Therapy
n=106 Participants
The AT intervention is an 8-week group intervention comprised of 8 1.5 hour weekly sessions conducted by an experienced Art Therapist who received special training in conducting the treatment protocol as designed.
Art Therapy: In a group setting participants will be encouraged to engage in art making for increased emotional awareness, expression, and acceptance. The role of the art therapist is to encourage a non-judgmental and exploratory approach to artmaking in which the process is emphasized over product. The art therapist obtains these goals by creating an atmosphere that is calm and by remaining tuned in to the verbalizations and body language of participants. If needed she can provide individual attention that is geared toward neutralizing concerns regarding performance during the art making.
|
Mandala Group
n=98 Participants
The comparison group will color prefabricated shapes. The same art materials as in the intervention group will be on the table as will the same instrumental music.
Sham Art Therapy: In a group setting participants will engage in Mandala coloring
|
|---|---|---|
|
Emotional Expression
Approach T1
|
3.2596 score on a scale
Standard Deviation 0.44
|
3.185 score on a scale
Standard Deviation 0.54
|
|
Emotional Expression
Approach T2
|
3.17 score on a scale
Standard Deviation 0.52
|
3.169312169 score on a scale
Standard Deviation 0.52
|
|
Emotional Expression
Approach T3
|
3.078 score on a scale
Standard Deviation 0.48
|
3.21 score on a scale
Standard Deviation 0.52
|
|
Emotional Expression
Avoidance T1
|
1.99 score on a scale
Standard Deviation 0.56
|
2.08 score on a scale
Standard Deviation 0.59
|
|
Emotional Expression
Avoidance T2
|
2.04 score on a scale
Standard Deviation 0.78
|
2.18 score on a scale
Standard Deviation 0.7
|
|
Emotional Expression
Avoidance T3
|
2.21 score on a scale
Standard Deviation 0.67
|
2.27 score on a scale
Standard Deviation 0.74
|
SECONDARY outcome
Timeframe: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3)Population: We conducted maximum likelihood analyses and the numbers here are raw scores, in which if a participant skipped one item the entire questionnaire was marked missing.
The Acceptance of Emotions Scale assesses the extent to which subjects are accepting and nurturing toward their feelings, ranging 0-100, higher scores indicate higher acceptance of emotion.
Outcome measures
| Measure |
Art Therapy
n=123 Participants
The AT intervention is an 8-week group intervention comprised of 8 1.5 hour weekly sessions conducted by an experienced Art Therapist who received special training in conducting the treatment protocol as designed.
Art Therapy: In a group setting participants will be encouraged to engage in art making for increased emotional awareness, expression, and acceptance. The role of the art therapist is to encourage a non-judgmental and exploratory approach to artmaking in which the process is emphasized over product. The art therapist obtains these goals by creating an atmosphere that is calm and by remaining tuned in to the verbalizations and body language of participants. If needed she can provide individual attention that is geared toward neutralizing concerns regarding performance during the art making.
|
Mandala Group
n=119 Participants
The comparison group will color prefabricated shapes. The same art materials as in the intervention group will be on the table as will the same instrumental music.
Sham Art Therapy: In a group setting participants will engage in Mandala coloring
|
|---|---|---|
|
Acceptance of Emotions
T1
|
67.7756 score on a scale
Interval 48.14273 to 87.40847
|
63.8561 score on a scale
Interval 39.8156 to 87.8966
|
|
Acceptance of Emotions
T2
|
66.12 score on a scale
Interval 41.852 to 90.753
|
68.42 score on a scale
Interval 45.811 to 90.696
|
|
Acceptance of Emotions
T3
|
69.86 score on a scale
Interval 51.84674999 to 88.72084908
|
71.29713424 score on a scale
Interval 50.35255616 to 92.24171231
|
SECONDARY outcome
Timeframe: Changes will be measured from baseline (T1), after the intervention, 8-10 weeks after baseline T2) and 8 weeks after the intervention ends (T3).Population: Number in each row reflect the number of results obtain for each cytokine at each time point. The overall number analyzed reflects the largest number of individuals that provided blood that was able to produce a quantification of at least one cytokine.
We collected 10 ccs of blood in order to measure immune regulation (pro-inflammatory cytokines IL-6, IL-8, IL-1β, TNF-α), anti-inflammatory (IL-4, IL-10) and regulatory cytokines (TGF-β).
Outcome measures
| Measure |
Art Therapy
n=117 Participants
The AT intervention is an 8-week group intervention comprised of 8 1.5 hour weekly sessions conducted by an experienced Art Therapist who received special training in conducting the treatment protocol as designed.
Art Therapy: In a group setting participants will be encouraged to engage in art making for increased emotional awareness, expression, and acceptance. The role of the art therapist is to encourage a non-judgmental and exploratory approach to artmaking in which the process is emphasized over product. The art therapist obtains these goals by creating an atmosphere that is calm and by remaining tuned in to the verbalizations and body language of participants. If needed she can provide individual attention that is geared toward neutralizing concerns regarding performance during the art making.
|
Mandala Group
n=110 Participants
The comparison group will color prefabricated shapes. The same art materials as in the intervention group will be on the table as will the same instrumental music.
Sham Art Therapy: In a group setting participants will engage in Mandala coloring
|
|---|---|---|
|
Inflammation
tgf_b1_T1
|
51085 pcg/ml
Standard Deviation 32095
|
51016 pcg/ml
Standard Deviation 31641
|
|
Inflammation
IL-8 T1
|
15.78 pcg/ml
Standard Deviation 24.3
|
22.1597 pcg/ml
Standard Deviation 55.01
|
|
Inflammation
IL-8 T2
|
11.02 pcg/ml
Standard Deviation 10.65
|
11.84 pcg/ml
Standard Deviation 11.9
|
|
Inflammation
IL-8 T3
|
9.0135 pcg/ml
Standard Deviation 7.725
|
9.278 pcg/ml
Standard Deviation 9.38
|
|
Inflammation
il_1b_T1
|
0.42 pcg/ml
Standard Deviation 1.15
|
0.55 pcg/ml
Standard Deviation 1.37
|
|
Inflammation
il_1b_T2
|
0.18 pcg/ml
Standard Deviation 0.312
|
0.227 pcg/ml
Standard Deviation 0.5
|
|
Inflammation
il_1b_T3
|
0.2632 pcg/ml
Standard Deviation 0.77
|
0.234 pcg/ml
Standard Deviation 0.68
|
|
Inflammation
il_4_T1
|
16.8 pcg/ml
Standard Deviation 31.6
|
24.33 pcg/ml
Standard Deviation 50.3
|
|
Inflammation
il_4_T2
|
10.1 pcg/ml
Standard Deviation 17.53
|
12.7 pcg/ml
Standard Deviation 23.09
|
|
Inflammation
il_4_T3
|
11.2 pcg/ml
Standard Deviation 35.7
|
14.58 pcg/ml
Standard Deviation 40.49
|
|
Inflammation
il_6_T1
|
1.4 pcg/ml
Standard Deviation 3.1
|
1.52 pcg/ml
Standard Deviation 3.1
|
|
Inflammation
il_6_T2
|
0.75 pcg/ml
Standard Deviation 1.58
|
0.9 pcg/ml
Standard Deviation 1.97
|
|
Inflammation
il_6_T3
|
0.68 pcg/ml
Standard Deviation 1.62
|
1.48 pcg/ml
Standard Deviation 4.11
|
|
Inflammation
tnfa_T1
|
10.85 pcg/ml
Standard Deviation 15.36
|
14.27 pcg/ml
Standard Deviation 23.07
|
|
Inflammation
tnfa_T2
|
8.007 pcg/ml
Standard Deviation 4.8
|
9.64 pcg/ml
Standard Deviation 11.98
|
|
Inflammation
tnfa_T3
|
7.56 pcg/ml
Standard Deviation 10.68
|
10.04 pcg/ml
Standard Deviation 14.49
|
|
Inflammation
il_10_T1
|
0.43 pcg/ml
Standard Deviation 1.3
|
0.65 pcg/ml
Standard Deviation 2.04
|
|
Inflammation
il_10_T2
|
0.19 pcg/ml
Standard Deviation 0.43
|
0.53 pcg/ml
Standard Deviation 1.44
|
|
Inflammation
il_10_T3
|
0.34 pcg/ml
Standard Deviation 0.99
|
0.718 pcg/ml
Standard Deviation 2.36
|
|
Inflammation
tgf_b1_T2
|
48885 pcg/ml
Standard Deviation 22571
|
47819 pcg/ml
Standard Deviation 25255
|
|
Inflammation
tgf_b1_T3
|
51447 pcg/ml
Standard Deviation 34759
|
48178 pcg/ml
Standard Deviation 23994
|
SECONDARY outcome
Timeframe: Changes will be measured from baseline (T1), after the intervention (8-10 weeks after baseline, T2) and 8 weeks after the intervention ends (T3)Population: Each row represents the actual number of participants we were able to collect EKG and obtain a good signal, and data was not discarded because of too much noise, or reporting drinking coffee before the measurement,
20 minutes of resting ECG data will be recorded. The participants will be given instructions not to drink coffee or smoke for 3 hours before the lab visit as well as to sit quietly without talking or moving during the ECG recording. These are physiological data without a specific range, however in our study, for example, at T1 in the art therapy group the measurements ranged from 7.56 to 113.28 miliseconds.
Outcome measures
| Measure |
Art Therapy
n=115 Participants
The AT intervention is an 8-week group intervention comprised of 8 1.5 hour weekly sessions conducted by an experienced Art Therapist who received special training in conducting the treatment protocol as designed.
Art Therapy: In a group setting participants will be encouraged to engage in art making for increased emotional awareness, expression, and acceptance. The role of the art therapist is to encourage a non-judgmental and exploratory approach to artmaking in which the process is emphasized over product. The art therapist obtains these goals by creating an atmosphere that is calm and by remaining tuned in to the verbalizations and body language of participants. If needed she can provide individual attention that is geared toward neutralizing concerns regarding performance during the art making.
|
Mandala Group
n=113 Participants
The comparison group will color prefabricated shapes. The same art materials as in the intervention group will be on the table as will the same instrumental music.
Sham Art Therapy: In a group setting participants will engage in Mandala coloring
|
|---|---|---|
|
Heart Rate Variability
T3
|
35.22226363 miliseconds
Standard Deviation 40.4
|
33.58334362 miliseconds
Standard Deviation 25.6
|
|
Heart Rate Variability
T1
|
32.63 miliseconds
Standard Deviation 21.8
|
37.82 miliseconds
Standard Deviation 38.8
|
|
Heart Rate Variability
T2
|
33.13 miliseconds
Standard Deviation 20.21
|
31.89 miliseconds
Standard Deviation 20.7
|
Adverse Events
Art Therapy
Serious events: 8 serious events
Other events: 16 other events
Deaths: 1 deaths
Mandala Group
Serious events: 6 serious events
Other events: 15 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Art Therapy
n=146 participants at risk
The AT intervention is an 8-week group intervention comprised of 8 1.5 hour weekly sessions conducted by an experienced Art Therapist who received special training in conducting the treatment protocol as designed.
Art Therapy: In a group setting participants will be encouraged to engage in art making for increased emotional awareness, expression, and acceptance. The role of the art therapist is to encourage a non-judgmental and exploratory approach to artmaking in which the process is emphasized over product. The art therapist obtains these goals by creating an atmosphere that is calm and by remaining tuned in to the verbalizations and body language of participants. If needed she can provide individual attention that is geared toward neutralizing concerns regarding performance during the art making.
|
Mandala Group
n=143 participants at risk
The comparison group will color prefabricated shapes. The same art materials as in the intervention group will be on the table as will the same instrumental music.
Sham Art Therapy: In a group setting participants will engage in Mandala coloring
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
disease progression AE
|
0.68%
1/146 • Number of events 1 • Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
|
0.70%
1/143 • Number of events 1 • Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
|
|
General disorders
prolonged hospitalization AE
|
1.4%
2/146 • Number of events 2 • Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
|
0.70%
1/143 • Number of events 1 • Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
|
|
Surgical and medical procedures
surgery adverse event reporting
|
2.7%
4/146 • Number of events 4 • Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
|
2.8%
4/143 • Number of events 4 • Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
|
|
General disorders
Car accident
|
0.68%
1/146 • Number of events 1 • Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
|
0.00%
0/143 • Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
|
Other adverse events
| Measure |
Art Therapy
n=146 participants at risk
The AT intervention is an 8-week group intervention comprised of 8 1.5 hour weekly sessions conducted by an experienced Art Therapist who received special training in conducting the treatment protocol as designed.
Art Therapy: In a group setting participants will be encouraged to engage in art making for increased emotional awareness, expression, and acceptance. The role of the art therapist is to encourage a non-judgmental and exploratory approach to artmaking in which the process is emphasized over product. The art therapist obtains these goals by creating an atmosphere that is calm and by remaining tuned in to the verbalizations and body language of participants. If needed she can provide individual attention that is geared toward neutralizing concerns regarding performance during the art making.
|
Mandala Group
n=143 participants at risk
The comparison group will color prefabricated shapes. The same art materials as in the intervention group will be on the table as will the same instrumental music.
Sham Art Therapy: In a group setting participants will engage in Mandala coloring
|
|---|---|---|
|
General disorders
COVID-19
|
2.1%
3/146 • Number of events 3 • Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
|
2.1%
3/143 • Number of events 3 • Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
|
|
General disorders
Side effect from medication or vaccine- not study related
|
1.4%
2/146 • Number of events 2 • Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
|
0.00%
0/143 • Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
|
|
Social circumstances
In mourning
|
0.68%
1/146 • Number of events 1 • Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
|
0.70%
1/143 • Number of events 1 • Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
|
|
Social circumstances
Stress from family illness
|
1.4%
2/146 • Number of events 2 • Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
|
0.00%
0/143 • Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
|
|
Social circumstances
War
|
4.1%
6/146 • Number of events 6 • Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
|
7.7%
11/143 • Number of events 11 • Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
|
|
General disorders
Injury
|
0.68%
1/146 • Number of events 1 • Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
|
0.00%
0/143 • Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
|
|
General disorders
Medication
|
0.68%
1/146 • Number of events 1 • Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
|
0.00%
0/143 • Participants were followed for an average of 20 weeks. Baseline data was collected following signing informed consent, and two weeks before the intervention began (which was 8 weeks long), and until T3, which occurred 8 weeks after the 8-week intervention ended. Having said that, because of the COVID-10 pandemic, and a war, there were several cases in which the intervention started several weeks late due to lockdowns. Thus, some participants were followed for up to 30 weeks.
Team members received categorization of adverse event descriptions and were requested to document them in Redcap.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place