DepressionNCT05410119
A Community-based Resilience Group Psychotherapy for Only-child Loss Parents in China
A study testing 8-week Resilience Group Psychotherapy in people with Depression, run by Central South University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 49 years and older
- Conditions the study is for
- Depression
- What is being tested?
- 8-week Resilience Group Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2017to 30 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 49 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Depression
- Being tested
- 8-week Resilience Group Psychotherapy, Usual care
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-week Resilience Group PsychotherapyBehavioural
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.
Usual careOther
Usual care means treating as usual, such as regular home visit.
| Study group | Role | What they receive |
|---|---|---|
| Resilience group | Experimental | Not described Receives: Behavioral: 8-week Resilience Group Psychotherapy |
| Controlled group | Active comparator | Not described Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of resilience
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.
Measured: Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention
Change of depression
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.
Measured: Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
Secondary outcomes (5)
Change of subjective well-being
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.
Measured: Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
Change of social avoidance
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.
Measured: Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
Change of sleeping quality
Sleep quality in recent month measured by Pittsburgh sleep quality index, with higher score reflecting bad quality, ranging from 0 to 23.
Measured: Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
Change of post traumatic growth
The positive growth after an adversity measured by Post Traumatic Growth Inventory, with higher score reflecting higher growth, ranging from 20 to 120.
Measured: Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
Change of concentration of dehydroepiandrosterone in saliva
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.
Measured: Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start1 Nov 2017
- Primary completion30 Jan 2018
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anni Wang, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410119
- Sponsor's protocol ID
- Resilience Group Psychotherapy
- Status last verified
- Jun 2022
- First submitted
- 27 May 2022
- Last updated
- 8 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-week Resilience-based Community Group Intervention Program for Parents Who Have Lost an Only Child in China
- ClinicalTrials.gov ID
- NCT05410119
- Acronym / sponsor ID
- Resilience Group Psychotherapy
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 30 Jan 2018 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Resilience group | Experimental | Behavioral: 8-week Resilience Group Psychotherapy |
| Controlled group | Active comparator | Other: Usual care |
Who may qualify
- Ages
- 49 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 8-week Resilience Group PsychotherapyResilience 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. | Behavioural | Resilience group |
| Usual careUsual care means treating as usual, such as regular home visit. | Other | Controlled group |
Primary outcome
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 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.
5 secondary outcomes
Change of subjective well-being
Time frame: 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.
Change of sleeping quality
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8-week Resilience Group Psychotherapy in people with Depression, run by Central South University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of resilience (time frame: Change from before intervention, immediately after intervention,3-month after intervention, to 12-month after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2022.