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

Not Applicable

Completed

• Conditions: Acute Stroke Patients With Depression
• Interventions: Behavioral: Group-based Acceptance and Commitment Therapy

• Registration Number: NCT05727358
• Lead Sponsor: PLA Rocket Force Characteristic Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31
• Status Verified: 2022-12
• Study First Submitted: 2023-01-25
• Study First Submitted QC: 2023-02-03
• Last Update Submitted: 2023-02-03
• Study First Posted: 2023-02-14
• Last Update Posted: 2023-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 139

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
intervention group	Group-based Acceptance and Commitment Therapy	G-ACT

Primary Outcome Measures

Name	Time	Method
The Hamilton Depression Rating Scale (HAMD or HDRS, 24 item)	3 months after the intervention	Each item is scored from 0 to 2 or 0 to 4, a higher score indicates much more serious depression

Secondary Outcome Measures

Name	Time	Method
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.
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 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 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.

Trial Locations

Locations (1)

The PLA Rocket Force Characteristic Medical Center; 🇨🇳 Beijing, Beijing, China