Clinical trial NCT05727358: Effectiveness of Group Acceptance and Commitment Therapy in Treating Acute Stroke Patients With Depression
Official title: Effectiveness of Group Acceptance and Commitment Therapy in Treating Acute Stroke Patients With Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Stroke Patients With Depression
Lead sponsor: PLA Rocket Force Characteristic Medical Center
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Science & Technology Commission
First posted: 2023-02-14
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to discover the effectiveness of group-based Acceptance and Commitment Therapy (ACT) in treating depression for acute stroke patients. The main question\[s\] it aims to answer are:

* Group-based ACT (G-ACT) could significantly reduce the depressive symptoms in patients with acute stroke,
* the interventional efficacy could be maintained at 3-month follow-up
* similar benefits would be observed for quality of life (QOL), sleep quality, psychological flexibility, cognitive fusion, and confidence.

The patients included to the control group received usual care support in hospital, and the patients included to the intervention group received G-ACT and usual care support. the G-ACT treatment in this study comprised 7 sessions of 45-60 minutes and was administered throughout the course of the 4-week long trial.


Eligibility criteria: Inclusion Criteria:

1. primary diagnosis of acute stroke, the last onset occurred within 2 weeks
2. being over 18 years old
3. scoring at least 8 on the HAMD scale
4. Be conscious and able to communicate effectively with researchers
5. Primary school education level or above, 6) having signed informed consent.

Exclusion Criteria:

1. having a history of mental illness (such as bipolar disorder) or dementia, using psychiatric drugs or sedatives within 6 months, or currently using antidepressants
2. a diagnosis of cognitive impairment
3. receiving a psychological therapy in the previous three months, or currently experiencing severe psychotic symptoms
4. a history of drug abuse or dependence

Primary outcomes:
measure: The Hamilton Depression Rating Scale (HAMD or HDRS, 24 item)
timeFrame: immediately after the intervention
measure: The Hamilton Depression Rating Scale (HAMD or HDRS, 24 item)
timeFrame: 3 months after the intervention
Secondary outcomes:
measure: Health-related quality of life (HRQoL)
timeFrame: immediately after and 3 months after the intervention
measure: The Acceptance and Action Questionnaire II (AAQ-II)
timeFrame: immediately after and 3 months after the intervention
measure: The Cognitive Fusion Questionnaire (CFQ)
timeFrame: immediately after and 3 months after the intervention
measure: The confidence was assessed using the Confidence after Stroke Measure (CaSM)
timeFrame: immediately after and 3 months after the intervention
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: immediately after and 3 months after the intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: The PLA Rocket Force Characteristic Medical Center
state: Beijing
Study officials:
References: