Trial Outcomes & Findings for Clinical Improvement and in Quality of Life-Functional Dyspepsia- (NCT NCT01802710)
NCT ID: NCT01802710
Last Updated: 2019-06-21
Results Overview
The Dyspepsia Related Health Scale (DRHS) is a self-reported dyspepsia-specific questionnaire that consists of four scales: severity of common symptoms, pain intensity, pain disability, and satisfaction with dyspepsia-related health. The score, for each scale, ranges between 0 and 100, with 0 representing the most severe situation and 100 the least severe. It also yields a global score that ranges from 0 to 100, with higher scores indicating less severe dyspepsia. The adapted and validated Spanish version of this questionnaire is known as QoL-PEI (Quality of Life in relation to Stomach and Intestinal Problems Questionnaire). Its reliability was found to be satisfactory (Cronbach's alpha 0.92). Its factorial analysis confirmed the four scales found by the DRHS but added a global score scale. The convergent validity was moderate (0.54).
COMPLETED
NA
158 participants
Participants will be followed at the recruit moment (t0) after treatment (t1) and six months after treatment (t2)
2019-06-21
Participant Flow
Participant milestones
| Measure |
Psychological Support
Ten weekly sessions, which the first 8 were in group and the last 2 were individuals. It consists on a) an informational session; b) Beck's cognitive-behavioural therapy; and c) progressive-muscle relaxation according to Jacobson
Psychological support + conventional medical treatment
|
No Psychological Support
Patients of this group only received the conventional medical treatment, not receiving any psychological support
Only conventional medical treatment
|
|---|---|---|
|
From T0 to T1
STARTED
|
76
|
82
|
|
From T0 to T1
COMPLETED
|
60
|
72
|
|
From T0 to T1
NOT COMPLETED
|
16
|
10
|
|
From T1 to T2
STARTED
|
60
|
72
|
|
From T1 to T2
COMPLETED
|
58
|
70
|
|
From T1 to T2
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Improvement and in Quality of Life-Functional Dyspepsia-
Baseline characteristics by cohort
| Measure |
Psychological Support
n=76 Participants
Ten weekly sessions, which the first 8 were in group and the last 2 were individuals. It consists on a) an informational session; b) Beck's cognitive-behavioural therapy; and c) progressive-muscle relaxation according to Jacobson
Psychological support + conventional medical treatment
|
No Psychological Support
n=82 Participants
Patients of this group only received the conventional medical treatment, not receiving any psychological support
No psychological intervention
|
Total
n=158 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.28 years
STANDARD_DEVIATION 14.06 • n=5 Participants
|
47.09 years
STANDARD_DEVIATION 15.19 • n=7 Participants
|
45.73 years
STANDARD_DEVIATION 14.67 • n=5 Participants
|
|
Sex: Female, Male
Female
|
64 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
76 participants
n=5 Participants
|
82 participants
n=7 Participants
|
158 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Participants will be followed at the recruit moment (t0) after treatment (t1) and six months after treatment (t2)Population: the number analyzed in the rows differs from overall number analyzed because, as it is occur in follow-up studies, patients were lost from T0 to T1.
The Dyspepsia Related Health Scale (DRHS) is a self-reported dyspepsia-specific questionnaire that consists of four scales: severity of common symptoms, pain intensity, pain disability, and satisfaction with dyspepsia-related health. The score, for each scale, ranges between 0 and 100, with 0 representing the most severe situation and 100 the least severe. It also yields a global score that ranges from 0 to 100, with higher scores indicating less severe dyspepsia. The adapted and validated Spanish version of this questionnaire is known as QoL-PEI (Quality of Life in relation to Stomach and Intestinal Problems Questionnaire). Its reliability was found to be satisfactory (Cronbach's alpha 0.92). Its factorial analysis confirmed the four scales found by the DRHS but added a global score scale. The convergent validity was moderate (0.54).
Outcome measures
| Measure |
Psychological Support
n=76 Participants
Ten weekly sessions, which the first 8 were in group and the last 2 were individuals. It consists on a) an informational session; b) Beck's cognitive-behavioural therapy; and c) progressive-muscle relaxation according to Jacobson
Psychological support + conventional medical treatment
|
No Psychological Support
n=82 Participants
Patients of this group only received the conventional medical treatment, not receiving any psychological support
No psychological intervention
|
|---|---|---|
|
Change From Baseline in DYSPEPSIA RELATED HEALTH SCALE (DRHS)
Change from t0 to t1 in DRHS-severity symptoms
|
73.72 units on a scale
Standard Deviation 16.76
|
65.31 units on a scale
Standard Deviation 17.60
|
|
Change From Baseline in DYSPEPSIA RELATED HEALTH SCALE (DRHS)
Change from t0 to t2 in DRHS-severity symptoms
|
71.85 units on a scale
Standard Deviation 20.46
|
64.89 units on a scale
Standard Deviation 19.22
|
SECONDARY outcome
Timeframe: Subjective clinical improvement it is measured after treatment (t1) and six months after treatment (t2)Subjective clinical improvement was measured by a question about how patients feel in regard to the functional dyspepsia ("In relation to functional dyspepsia, how would you rate your health now? a)much better; b) quite a lot better; c) somewhat better; d) about the same; e) somewhat worse; f) quite a lot worse; g) much worse
Outcome measures
| Measure |
Psychological Support
n=60 Participants
Ten weekly sessions, which the first 8 were in group and the last 2 were individuals. It consists on a) an informational session; b) Beck's cognitive-behavioural therapy; and c) progressive-muscle relaxation according to Jacobson
Psychological support + conventional medical treatment
|
No Psychological Support
n=69 Participants
Patients of this group only received the conventional medical treatment, not receiving any psychological support
No psychological intervention
|
|---|---|---|
|
Subjective Clinical Improvement
Better in relation to functional dyspepsia at T1
|
37 Participants
|
17 Participants
|
|
Subjective Clinical Improvement
Better in relation to functional dyspepsia at T2
|
36 Participants
|
26 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Participants will be followed at the recruit moment (t0) after treatment (t1) and six months after treatment (t2)Population: The number analyzed in the rows differs from overall number analyzed because, as it is occur in follow-up studies, patients were lost from T0 to T2.
It is a 14-item measure: 7 items evaluate depression (the HADS-D subscale) and 7 evaluate anxiety (the HADS-A subscale). For each subscale items range from 0 to 21. A subscale score of 0-7 indicates the absence of anxiety or depression; a score of 8-10 indicates a possible case of anxiety or depression; and a score of 11 or higher indicates the presence of anxiety or depression. It has been adapted and validated in a Spanish population
Outcome measures
| Measure |
Psychological Support
n=76 Participants
Ten weekly sessions, which the first 8 were in group and the last 2 were individuals. It consists on a) an informational session; b) Beck's cognitive-behavioural therapy; and c) progressive-muscle relaxation according to Jacobson
Psychological support + conventional medical treatment
|
No Psychological Support
n=82 Participants
Patients of this group only received the conventional medical treatment, not receiving any psychological support
No psychological intervention
|
|---|---|---|
|
Hospital Anxiety and Depression Scale
Change From t0 to t1 in HADS-D
|
8.95 units on a scale
Standard Deviation 1.95
|
9.31 units on a scale
Standard Deviation 2.00
|
|
Hospital Anxiety and Depression Scale
From t0 to t2in HADS-D
|
9.09 units on a scale
Standard Deviation 1.88
|
9.71 units on a scale
Standard Deviation 2.01
|
Adverse Events
Psychological Support
No Psychological Support
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place