Effectiveness of Group Acceptance and Commitment Therapy in Treating Acute Stroke Patients With Depression

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of Group Acceptance and Commitment Therapy in Treating Acute Stroke Patients With Depression

Conditions
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Acute Stroke Patients With Depression

Intervention / Treatment
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* Behavioral: Group-based Acceptance and Commitment Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: primary diagnosis of acute stroke, the last onset occurred within 2 weeks being over 18 years old scoring at least 8 on the HAMD scale Be conscious and able to communicate effectively with researchers Primary school education level or above, 6) having signed informed consent. Exclusion Criteria: having a history of mental illness (such as bipolar disorder) or dementia, using psychiatric drugs or sedatives within 6 months, or currently using antidepressants a diagnosis of cognitive impairment receiving a psychological therapy in the previous three months, or currently experiencing severe psychotic symptoms a history of drug abuse or dependence

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>G-ACT | Behavioral: Group-based Acceptance and Commitment Therapy<br>* 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.<br>|
| No Intervention: control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Hamilton Depression Rating Scale (HAMD or HDRS, 24 item) | Each item is scored from 0 to 2 or 0 to 4, a higher score indicates much more serious depression | immediately after the intervention | 
| The Hamilton Depression Rating Scale (HAMD or HDRS, 24 item) | Each item is scored from 0 to 2 or 0 to 4, a higher score indicates much more serious depression | 3 months after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life (HRQoL) | physical component summary (PCS) and mental component summary (MCS) ranging from 0 (worst) to 100 (best).A higher score reflects better HRQoL | immediately after and 3 months after the intervention | 
| The Acceptance and Action Questionnaire II (AAQ-II) | the total score ranges from 7 to 49 with a higher score indicating less psychological flexibility. | immediately after and 3 months after the intervention | 
| The Cognitive Fusion Questionnaire (CFQ) | scores range from 0 to 63 with a higher score indicating more fused one is with one's thoughts | immediately after and 3 months after the intervention | 
| The confidence was assessed using the Confidence after Stroke Measure (CaSM) | total scores ranging from 0 to 81 and higher scores representing higher confidence. | immediately after and 3 months after the intervention | 
| The Pittsburgh Sleep Quality Index (PSQI) | total scores ranging from 0 to 21 and higher scores indicating poorer sleep quality. | immediately after and 3 months after the intervention |