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

Primary Purpose

Acute Stroke Patients With Depression

Status

Completed

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Group-based Acceptance and Commitment Therapy

About this trial

This is an interventional treatment trial for Acute Stroke Patients With Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The PLA Rocket Force Characteristic Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

control group

Arm Description

G-ACT

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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

The Acceptance and Action Questionnaire II (AAQ-II)

the total score ranges from 7 to 49 with a higher score indicating less psychological flexibility.

The Cognitive Fusion Questionnaire (CFQ)

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)

total scores ranging from 0 to 81 and higher scores representing higher confidence.

The Pittsburgh Sleep Quality Index (PSQI)

total scores ranging from 0 to 21 and higher scores indicating poorer sleep quality.

Full Information

NCT ID

NCT05727358

First Posted

January 25, 2023

Last Updated

February 3, 2023

Sponsor

PLA Rocket Force Characteristic Medical Center

Collaborators

Beijing Municipal Science & Technology Commission

1. Study Identification

Unique Protocol Identification Number

NCT05727358

Brief Title

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

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

August 31, 2021 (Actual)

Study Completion Date

August 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

PLA Rocket Force Characteristic Medical Center

Collaborators

Beijing Municipal Science & Technology Commission

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Stroke Patients With Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

139 (Actual)

8. Arms, Groups, and Interventions

Arm Title

intervention group

Arm Type

Experimental

Arm Description

G-ACT

Arm Title

control group

Arm Type

No Intervention

Intervention Type

Behavioral

Intervention Name(s)

Group-based Acceptance and Commitment Therapy

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

Each item is scored from 0 to 2 or 0 to 4, a higher score indicates much more serious depression

Time Frame

immediately after the intervention

Title

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

Description

Each item is scored from 0 to 2 or 0 to 4, a higher score indicates much more serious depression

Time Frame

3 months after the intervention

Secondary Outcome Measure Information:

Title

Health-related quality of life (HRQoL)

Description

physical component summary (PCS) and mental component summary (MCS) ranging from 0 (worst) to 100 (best).A higher score reflects better HRQoL

Time Frame