Abstract
Background. There is a compelling need for innovative intervention strategies for patients
with affective disorders, given their increasing global prevalence and significant associated disability and impaired functioning. This study aimed to investigate whether a comprehensive
multimodule individualized intervention (AWARE), targeting known mediators of functioning, improves functioning in affective disorders.
Methods. AWARE was a randomized, controlled, rater-blind clinical trial conducted at
two centers in the Capital Region of Denmark (Clinicaltrials.gov, NCT 04701827).
Participants were adults with bipolar disorder or major depressive disorder and impaired
functioning. Participants were randomized to the six-month AWARE intervention or treatment as usual (TAU). The AWARE intervention is based on the International
Classification of Functioning, Disability and Health (ICF) Brief Core Set for Bipolar and
Unipolar Disorder.
The primary outcome was observation-based functioning using the Assessment of Motor
and Process Skills (AMPS). Secondary outcomes were functioning, QoL, stress, and cognition.
Results. Between February 2021 and January 2023, 103 patients were enrolled; 50 allocated to
AWARE treatment and 53 to TAU (96 included in the full analysis set). There was no statistically significant differential change over time between groups in the primary outcome
(AMPS), however, both groups showed a statistically significant improvement at endpoint.
The AWARE intervention had a statistically significant effect compared with TAU on secondary outcomes of patient-reported functioning, stress and cognition.
Conclusion. Compared with TAU, the AWARE intervention was ineffective at improving
overall functioning on the primary outcome, presumably due to the short duration of the
intervention. Further development of effective treatments targeting functioning is needed.
with affective disorders, given their increasing global prevalence and significant associated disability and impaired functioning. This study aimed to investigate whether a comprehensive
multimodule individualized intervention (AWARE), targeting known mediators of functioning, improves functioning in affective disorders.
Methods. AWARE was a randomized, controlled, rater-blind clinical trial conducted at
two centers in the Capital Region of Denmark (Clinicaltrials.gov, NCT 04701827).
Participants were adults with bipolar disorder or major depressive disorder and impaired
functioning. Participants were randomized to the six-month AWARE intervention or treatment as usual (TAU). The AWARE intervention is based on the International
Classification of Functioning, Disability and Health (ICF) Brief Core Set for Bipolar and
Unipolar Disorder.
The primary outcome was observation-based functioning using the Assessment of Motor
and Process Skills (AMPS). Secondary outcomes were functioning, QoL, stress, and cognition.
Results. Between February 2021 and January 2023, 103 patients were enrolled; 50 allocated to
AWARE treatment and 53 to TAU (96 included in the full analysis set). There was no statistically significant differential change over time between groups in the primary outcome
(AMPS), however, both groups showed a statistically significant improvement at endpoint.
The AWARE intervention had a statistically significant effect compared with TAU on secondary outcomes of patient-reported functioning, stress and cognition.
Conclusion. Compared with TAU, the AWARE intervention was ineffective at improving
overall functioning on the primary outcome, presumably due to the short duration of the
intervention. Further development of effective treatments targeting functioning is needed.
| Original language | English |
|---|---|
| Journal | Psychological Medicine |
| Volume | 54 |
| Issue number | 14 |
| Pages (from-to) | 3985-3994 |
| Number of pages | 10 |
| ISSN | 0033-2917 |
| DOIs | |
| Publication status | Published - 2024 |