Trial Outcomes & Findings for The STIC Norway RCT Study: Using Feedback in Psychotherapy. (NCT NCT01873742)
NCT ID: NCT01873742
Last Updated: 2020-05-04
Results Overview
The Beck Depression Inventory (BDI-II - Beck et al., 1995a) is a widely used 21-item self-report questionnaire assessing cognitive, affective, motivational, and physiological symptoms of depression and variation over time. Items are scored on a scale from 0 to 3 and the sum-score expressed the depth of the depression, graded from no clinical depression (0-9), through mild (10-19), moderate (20-29) and severe depression (30-63). The BDI shows adequate psychometric properties (Beck et al., 1995b).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
328 participants
Primary outcome timeframe
The BDI was completed at the start and end of treatment. In this study the treatment length varied from two to 22 sessions.
Results posted on
2020-05-04
Participant Flow
Data were collected from 2013 to 2016 from three couple and family therapy sites in Norway.
Participant milestones
| Measure |
The Use of STIC Feedback System
This condition included the use of the STIC feedback system. This implied that before every therapy session clients completed the STIC questionnaire that was processed into a report that was sent to the client's therapist. He or she used this report to prepare for the session, for instance investigating whether treatment progress and process developed satisfactory, and whether there was a need to address topics mentioned in the report. Sharing the results with the client enabled the client to interpret his or her own results and as such user involvement was strengthened.
|
Treatment as Usual
This condition did not include the use of the STIC feedback system, in other words, treatment as usual (TAU).
|
|---|---|---|
|
Overall Study
STARTED
|
165
|
163
|
|
Overall Study
COMPLETED
|
97
|
87
|
|
Overall Study
NOT COMPLETED
|
68
|
76
|
Reasons for withdrawal
| Measure |
The Use of STIC Feedback System
This condition included the use of the STIC feedback system. This implied that before every therapy session clients completed the STIC questionnaire that was processed into a report that was sent to the client's therapist. He or she used this report to prepare for the session, for instance investigating whether treatment progress and process developed satisfactory, and whether there was a need to address topics mentioned in the report. Sharing the results with the client enabled the client to interpret his or her own results and as such user involvement was strengthened.
|
Treatment as Usual
This condition did not include the use of the STIC feedback system, in other words, treatment as usual (TAU).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
68
|
76
|
Baseline Characteristics
The reason why the row number differs from the overall number is that some participants were still in treatment and/or did not reply at the end of data collection. Those reported here have delivered complete sets of data.
Baseline characteristics by cohort
| Measure |
The Use of STIC Feedback System
n=165 Participants
This condition included the use of the STIC feedback system.
|
Treatment as Usual
n=163 Participants
This condition did not include the use of the STIC feedback system.
|
Total
n=328 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.28 Years
STANDARD_DEVIATION 9.73 • n=165 Participants
|
39.47 Years
STANDARD_DEVIATION 8.63 • n=163 Participants
|
39.86 Years
STANDARD_DEVIATION 9.69 • n=328 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=165 Participants
|
86 Participants
n=163 Participants
|
172 Participants
n=328 Participants
|
|
Sex: Female, Male
Male
|
79 Participants
n=165 Participants
|
77 Participants
n=163 Participants
|
156 Participants
n=328 Participants
|
|
Beck Depression Inventory
|
15.10 Unit on a scale
STANDARD_DEVIATION 11.38 • n=92 Participants • The reason why the row number differs from the overall number is that some participants were still in treatment and/or did not reply at the end of data collection. Those reported here have delivered complete sets of data.
|
16.02 Unit on a scale
STANDARD_DEVIATION 11.56 • n=84 Participants • The reason why the row number differs from the overall number is that some participants were still in treatment and/or did not reply at the end of data collection. Those reported here have delivered complete sets of data.
|
15.36 Unit on a scale
STANDARD_DEVIATION 11.47 • n=176 Participants • The reason why the row number differs from the overall number is that some participants were still in treatment and/or did not reply at the end of data collection. Those reported here have delivered complete sets of data.
|
PRIMARY outcome
Timeframe: The BDI was completed at the start and end of treatment. In this study the treatment length varied from two to 22 sessions.The Beck Depression Inventory (BDI-II - Beck et al., 1995a) is a widely used 21-item self-report questionnaire assessing cognitive, affective, motivational, and physiological symptoms of depression and variation over time. Items are scored on a scale from 0 to 3 and the sum-score expressed the depth of the depression, graded from no clinical depression (0-9), through mild (10-19), moderate (20-29) and severe depression (30-63). The BDI shows adequate psychometric properties (Beck et al., 1995b).
Outcome measures
| Measure |
The Use of STIC Feedback System
n=92 Participants
This condition included the use of the STIC feedback system.
|
Treatment as Usual
n=84 Participants
This condition did not include the use of the STIC feedback system.
|
|---|---|---|
|
Beck Depression Inventory II
Start of treatment
|
15.10 score on a scale
Standard Deviation 11.38
|
16.02 score on a scale
Standard Deviation 11.56
|
|
Beck Depression Inventory II
End of treatment
|
10.78 score on a scale
Standard Deviation 11.28
|
9.35 score on a scale
Standard Deviation 10.58
|
Adverse Events
The Use of STIC Feedback System
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Treatment as Usual
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
The Use of STIC Feedback System
n=165 participants at risk
This condition included the use of the STIC feedback system.
|
Treatment as Usual
n=163 participants at risk
This condition did not include the use of the STIC feedback system.
|
|---|---|---|
|
Social circumstances
Stressor
|
0.00%
0/165 • During treatment that varied from two to 22 sessions, with an average of four months.
This was a non-invasive study where participants responded to standardized questionnaires. For this reason we hypothesize that there was no risk of mortality or serious adverse events caused by this study participation.
|
0.00%
0/163 • During treatment that varied from two to 22 sessions, with an average of four months.
This was a non-invasive study where participants responded to standardized questionnaires. For this reason we hypothesize that there was no risk of mortality or serious adverse events caused by this study participation.
|
Other adverse events
| Measure |
The Use of STIC Feedback System
n=165 participants at risk
This condition included the use of the STIC feedback system.
|
Treatment as Usual
n=163 participants at risk
This condition did not include the use of the STIC feedback system.
|
|---|---|---|
|
Investigations
Clients felt that data collection was a burden
|
3.0%
5/165 • During treatment that varied from two to 22 sessions, with an average of four months.
This was a non-invasive study where participants responded to standardized questionnaires. For this reason we hypothesize that there was no risk of mortality or serious adverse events caused by this study participation.
|
1.8%
3/163 • During treatment that varied from two to 22 sessions, with an average of four months.
This was a non-invasive study where participants responded to standardized questionnaires. For this reason we hypothesize that there was no risk of mortality or serious adverse events caused by this study participation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place