Affective disorders: eliminate WArning signs And REstore functioning: AWARE. Results from a randomized controlled...

Area of Science:

• Psychiatry
• Clinical Psychology
• Rehabilitation Medicine

Background:

• Affective disorders present a growing global health challenge, marked by significant disability and functional impairment.
• Innovative interventions are crucial to address the unmet needs of patients with these conditions.

Purpose of the Study:

• To evaluate the efficacy of the AWARE (Affective disorder Wellness and Rehabilitation Enhancement) intervention in improving functioning in adults with bipolar disorder or major depressive disorder.
• To assess the impact of AWARE on functioning, quality of life, stress, and cognition.

Main Methods:

• A randomized, controlled, rater-blind trial (NCT04701827) involving 103 adult participants with affective disorders and impaired functioning.
• Participants were randomized to a six-month AWARE intervention or treatment as usual (TAU).
• The primary outcome was measured by the Assessment of Motor and Process Skills (AMPS); secondary outcomes included patient-reported functioning, quality of life, stress, and cognition.

Main Results:

• No statistically significant difference was found in the primary outcome (AMPS-based functioning) between the AWARE and TAU groups, although both groups improved significantly over time.
• The AWARE intervention demonstrated statistically significant improvements in secondary outcomes, including patient-reported functioning, stress levels, and cognitive function compared to TAU.
• A total of 96 participants were included in the full analysis set.

Conclusions:

• The AWARE intervention, in its current six-month format, was not effective in improving overall functioning as measured by the primary outcome.
• The study suggests a need for further development of interventions targeting functional recovery in affective disorders, potentially with longer durations or modified components.
• While not meeting the primary endpoint, AWARE showed promise in improving specific aspects of patient well-being and cognition.