Acute Stroke Patients With Depression
Conditions
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.
Interventions
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.
Sponsors
Beijing Municipal Science & Technology Commission
PLA Rocket Force Characteristic Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Hamilton Depression Rating Scale (HAMD or HDRS, 24 item) | immediately after the intervention | Each item is scored from 0 to 2 or 0 to 4, a higher score indicates much more serious depression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life (HRQoL) | immediately after and 3 months after the intervention | physical component summary (PCS) and mental component summary (MCS) ranging from 0 (worst) to 100 (best).A higher score reflects better HRQoL |
| The Acceptance and Action Questionnaire II (AAQ-II) | immediately after and 3 months after the intervention | the total score ranges from 7 to 49 with a higher score indicating less psychological flexibility. |
| The Cognitive Fusion Questionnaire (CFQ) | immediately after and 3 months after the intervention | scores range from 0 to 63 with a higher score indicating more fused one is with one's thoughts |
| The confidence was assessed using the Confidence after Stroke Measure (CaSM) | immediately after and 3 months after the intervention | total scores ranging from 0 to 81 and higher scores representing higher confidence. |
| The Pittsburgh Sleep Quality Index (PSQI) | immediately after and 3 months after the intervention | total scores ranging from 0 to 21 and higher scores indicating poorer sleep quality. |
Countries
China
Outcome results
None listed