- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05410119
A Community-based Resilience Group Psychotherapy for Only-child Loss Parents in China
June 6, 2022 updated by: Anni Wang, Central South University
An 8-week Resilience-based Community Group Intervention Program for Parents Who Have Lost an Only Child in China
Two communities in Changsha was selected, where principle investigators' institution located, to recruit 80 participants into intervention group and control group.
Resilience therapy group was intervened by a psychotherapy developed by the researchers, which lasts 8 weeks.
The themes of each week are start-up, mutual help, trust in yourself, thanksgiving feedback, care for yourself, emotional management, end-up.
Measurement was conducted before the intervention, immediately after intervention, 3-month after intervention, and 12-month after intervention.
A questionnaire was used during each measurement, including several scales in it, including resilience and depression.The saliva test of Dehydroepiandrosterone was also done in each measurement.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410013
- Central South University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
49 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- had only one child but now passed away;
- failed to have another children;
- volunteered to participate;
- the score of resilience was under 72 points indicating a lower or middle level
Exclusion Criteria:
- in the acute bereavement period (<6 months);
- unable to participate in activities due to severe physical illness;
- receiving drug treatment for mental illness;
- receiving other psychological therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Resilience group
|
Resilience Group Psychotherapy was intervened by a psychotherapy developed by the researchers.
The resilience promotion therapy lasts 8 weeks, and also has a group intervention in each week.
The themes of each week are start-up, mutual help, trust in yourself, thanksgiving feedback, care for yourself, emotional management, end-up.
|
Active Comparator: Controlled group
|
Usual care means treating as usual, such as regular home visit.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of resilience
Time Frame: Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention
|
A kind of ability to bounce back from adversity measured by Connor-Davidson Resilience Scale, with higher score reflecting higher level of resilience, ranging from 0-100.
|
Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention
|
Change of depression
Time Frame: Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
|
Depressive mood in recent two weeks measured by Zung Self-rated Depression Scale, with higher score reflecting higher level of depression, ranging from 0-80.
|
Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of subjective well-being
Time Frame: Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
|
A feeling of happiness measured by Campbell Index of well-being, with higher score reflecting higher subjective well-being, ranging from 1.1 to 14.7.
|
Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
|
Change of social avoidance
Time Frame: Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
|
The phenomenon that a person is absent from normal social interaction with others measured by Social Avoidance and Distress Scale, with higher score reflecting higher social avoidance, ranging from 0 to 7.
|
Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
|
Change of sleeping quality
Time Frame: Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
|
Sleep quality in recent month measured by Pittsburgh sleep quality index, with higher score reflecting bad quality, ranging from 0 to 23.
|
Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
|
Change of post traumatic growth
Time Frame: Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
|
The positive growth after an adversity measured by Post Traumatic Growth Inventory, with higher score reflecting higher growth, ranging from 20 to 120.
|
Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
|
Change of concentration of dehydroepiandrosterone in saliva
Time Frame: Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
|
A kind of hormone that reflects the person's psychological stress collected by saliva collection tube by chewing the sterile cotton strips for 60 seconds, with higher concentration reflecting higher dehydroepiandrosterone level.
The unit is pg/ml.
|
Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2017
Primary Completion (Actual)
January 30, 2018
Study Completion (Actual)
January 30, 2019
Study Registration Dates
First Submitted
May 27, 2022
First Submitted That Met QC Criteria
June 6, 2022
First Posted (Actual)
June 8, 2022
Study Record Updates
Last Update Posted (Actual)
June 8, 2022
Last Update Submitted That Met QC Criteria
June 6, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Resilience Group Psychotherapy
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
Clinical Trials on 8-week Resilience Group Psychotherapy
-
Central South UniversityFudan UniversityCompleted
-
Midlands Psychology CICUnknownAutism Spectrum DisorderUnited Kingdom
-
University of British ColumbiaCanadian Institutes of Health Research (CIHR); The Arthritis Society, Canada; Michael Smith Foundation for Health ResearchCompletedArthritis | Osteoarthritis | Osteo Arthritis Knee | Anterior Cruciate Ligament Tear | Knee Injuries | Meniscus Tear | Arthritis KneeCanada
-
Marianne Lau, MD, DSci.The Ministry of Science, Technology and Innovation, DenmarkUnknownBulimia Nervosa (BN) | Binge Eating Disorder (BED) | Eating Disorder Not Otherwise Specified (EDNOS)Denmark
-
Heartfulness InstituteAngell Animal Medical CenterCompletedStress | Burnout, ProfessionalUnited States
-
National Center for Complementary and Integrative...Completed
-
Memorial Sloan Kettering Cancer CenterFordham UniversityCompletedPalliative CareUnited States
-
The University of Hong KongChinese University of Hong KongCompleted
-
The University of Hong KongCompleted
-
The University of Hong KongChinese University of Hong KongCompleted