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Clinical Trials/NCT05727358
NCT05727358
Completed
Not Applicable

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

PLA Rocket Force Characteristic Medical Center1 site in 1 country139 target enrollmentAugust 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute Stroke Patients With Depression
Sponsor
PLA Rocket Force Characteristic Medical Center
Enrollment
139
Locations
1
Primary Endpoint
The Hamilton Depression Rating Scale (HAMD or HDRS, 24 item)
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2018
End Date
August 31, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
PLA Rocket Force Characteristic Medical Center
Responsible Party
Principal Investigator
Principal Investigator

Liu Yun-e

Head nurse

PLA Rocket Force Characteristic Medical Center

Eligibility Criteria

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

Outcomes

Primary Outcomes

The Hamilton Depression Rating Scale (HAMD or HDRS, 24 item)

Time Frame: 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 Outcomes

  • The Pittsburgh Sleep Quality Index (PSQI)(immediately after and 3 months after the intervention)
  • Health-related quality of life (HRQoL)(immediately after and 3 months after the intervention)
  • The Cognitive Fusion Questionnaire (CFQ)(immediately after and 3 months after the intervention)
  • The confidence was assessed using the Confidence after Stroke Measure (CaSM)(immediately after and 3 months after the intervention)
  • The Acceptance and Action Questionnaire II (AAQ-II)(immediately after and 3 months after the intervention)

Study Sites (1)

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