|- candidate number||26839|
|- NTR Number||NTR6473|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||6-mrt-2017|
|- Secondary IDs||NL59064.028.16 P1630|
|- Public Title||Treatment effects and cost-effectiveness of Autonomy-Enhancing Treatment|
|- Scientific Title||Treatment effects and cost-effectiveness of Autonomy-Enhancing Treatment: A person-centered approach to anxiety disorders|
|- hypothesis||Autonomy Enhancing Treatment (AET) is superior to Cognitive Behaviour Therapy (CBT) with regard to person-centred and comorbid outcomes (general psychopathology, depressive symptoms, autonomy-connectedness, self-esteem, quality of life
), and cost-effectiveness.|
|- Healt Condition(s) or Problem(s) studied||Anxiety disorders|
|- Inclusion criteria||1. An age between 18 and 65 years; |
2. An anxiety disorder according to DSM 5, or DSM-IV-TR with the exception of obsessive-compulsive disorder and post-traumatic stress disorder.
|- Exclusion criteria||1. A current psychotic episode;|
2. Substance abuse disorder;
3. Acute bereavement;
4. Mental retardation;
5. Suicidal thoughts or actions,
6. Severe personality (cluster A/B) problems;
7. Insufficient Dutch language skills.
Possible medication use is allowed but has to be unchanged for the past and coming 3 months.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||17-feb-2017|
|- planned closingdate||31-aug-2019|
|- Target number of participants||118|
|- Interventions||Autonomy Enhancing Treatment and Cognitive Behaviour Therapy|
|- Primary outcome||Person-centered outcomes and comorbid symptoms: autonomy-connectedness, general psychopathology, depressive symptoms, self-esteem, quality of life.|
Anxiety symptoms will also be assessed.
|- Secondary outcome||We will also estimate cost-effectiveness in terms of quality adjusted life years (QALYs) and direct and indirect costs associated with health care use and work absence/productivity loss.|
|- Timepoints||Measurements of disorder-specific (anxiety symptoms) and person-centered outcomes (general psychopathology and comorbid depressive symptoms, autonomy-connectedness, self-esteem and quality of life) will take place at 4 moments: before treatment (T1), mid- treatment (T2), after treatment (T3), and at 3 months follow-up (T4). Additional qualitative questions will be asked at T1, T2, and T3. The first groups of patients will be also asked to complete measurements at 6 months (T5) and 12 months (T6) follow-up. |
Outcomes related to costs (costs per QALY) will be assessed at T1, T3 and T4 (and T5 and T6 for the first groups), so that costs can be evaluated approximately every three months.
|- Trial web site|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Laura Kunst|
|- CONTACT for SCIENTIFIC QUERIES|| Laura Kunst|
|- Sponsor/Initiator ||Tilburg University, University of Amsterdam (UvA), GGZ inGeest, GGZ Drenthe, Wantveld, Mentaal Beter|
(Source(s) of Monetary or Material Support)
|- Brief summary||Rationale: Given the symptom-focused nature of Cognitive Behaviour Therapy (CBT) and its inability to deal effectively with comorbidity, there is a clear need for more person-centered anxiety treatments. Autonomy-Enhancing Treatment (AET) is such a person-centered treatment. Group AET will be compared to group CBT. We expect AET to be superior to CBT with respect to person-centered outcomes and comorbid symptoms, providing a more robust therapeutic change. This makes AET also a likely more cost-effective alternative to CBT. |
Objective: (1) to compare group AET to group CBT in order to assess their effectiveness on symptoms, person-centered outcomes and comorbid symptoms, and (2) to relate the effectiveness of group AET and group CBT to direct and indirect costs, thereby establishing their cost-effectiveness.
Study design: Multicenter randomized controlled study.
|- Main changes (audit trail)|
|- RECORD||6-mrt-2017 - 5-jul-2017|