|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
13 February 2023 |
|
Main ID: |
NCT02648165 |
|
Date of registration:
|
05/01/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Secondary Prevention of Depression Through Group-based ACT-Therapy Preceded by an Experimental ABM-Procedure
|
|
Scientific title:
|
Secondary Prevention of Depression Through Group-based Acceptance and Commitment Therapy Preceded by an Experimental Attentional Bias Modification Procedure |
|
Date of first enrolment:
|
April 2015 |
|
Target sample size:
|
224 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT02648165 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Norway
| | | | | | | |
|
Contacts
|
|
Name:
|
Vegard Ø Haaland, PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Sørlandet Hospital |
| | |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- Subjects with a history of major depression, currently in remission
Exclusion Criteria:
- Current or past neurological illness, bipolar disorder, psychosis or drug addiction.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Major Depression
|
|
Intervention(s)
|
|
Behavioral: Acceptance and Commitment Therapy
|
|
Behavioral: Attention Bias Modification
|
|
Behavioral: Sham Attention Bias Modification
|
|
Primary Outcome(s)
|
|
Change in residual symptoms of depression - clinician rating
[Time Frame: Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months]
|
|
Change in residual symptoms of depression - self report
[Time Frame: Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months]
|
|
Secondary Outcome(s)
|
|
Changes in Quality of Life - self report
[Time Frame: Will be measured at Baseline, then after 2 months, 6 months, and 12 months]
|
|
Changes in Acceptance - self report
[Time Frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months]
|
|
Changes in Present-moment awareness and acceptance - self report
[Time Frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months (only in ACT-arms)]
|
|
Changes in Values - self report
[Time Frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months]
|
|
Changes in Cognitive fusion - self report
[Time Frame: 1 month, 2 months, 6 months, 12 months (only in ACT-arms)]
|
|
Changes in Cortisol response
[Time Frame: Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months]
|
|
Changes in Emotional, Psychological and Social Well-Being - self report
[Time Frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months]
|
|
Changes in symptoms of anxiety - self report
[Time Frame: Will be measured at Baseline, immediately after ABM-intervention, then after 1 month, 2 months, 6 months, and 12 months]
|
|
Changes in Values and committed action - self report
[Time Frame: Will be measured at Baseline, then after 1 month, 2 months, 6 months, 12 months]
|
|
Recurrence of major depressive episodes
[Time Frame: Will be measured 12 months after baseline]
|
|
Secondary ID(s)
|
|
HSØ-2015056
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|