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

• Sponsor: PLA Rocket Force Characteristic Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT05727358
• Collaborator: Beijing Municipal Science & Technology Commission (Other)
• Enrollment: 139
• Location: 1
• Arms: 2
• Actual Duration (Months): 37
• Patients Per Site Per Month: 3.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Acute Stroke Patients With Depression	Behavioral: Group-based Acceptance and Commitment Therapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 139 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Group Acceptance and Commitment Therapy in Treating Acute Stroke Patients With Depression
• Actual Study Start Date: Aug 1, 2018
• Actual Primary Completion Date: Aug 31, 2021
• Actual Study Completion Date: Aug 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: intervention group G-ACT	Behavioral: Group-based Acceptance and Commitment Therapy; 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.
No Intervention: control group

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. 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

2. 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.

3. 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

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The PLA Rocket Force Characteristic Medical Center	Beijing	Beijing	China	1000088

Sponsors and Collaborators

• PLA Rocket Force Characteristic Medical Center
• Beijing Municipal Science & Technology Commission

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Liu Yun-e, Head nurse, PLA Rocket Force Characteristic Medical Center
• ClinicalTrials.gov Identifier: NCT05727358
• Other Study ID Numbers: Z181100001718041
• First Posted: Feb 14, 2023
• Last Update Posted: Feb 14, 2023
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Stroke; Depression; Depressive Disorder

Study Results

No Results Posted as of Feb 14, 2023