Resilience, PsychologicalNCT05703529
Group-based Positive Psychotherapy in Psychological Resilience of Only-Child-Lost People
A study testing Positive Psychotherapy in people with Resilience, Psychological and Bereavement, run by Central South University.
Trial summary
A randomized controlled trial was conducted to evaluate the effectiveness of group-based positive psychotherapy on psychological resilience, depression, well-being, sleep quality, dehydroepiandrosterone in only-child-lost people. Read more about this study
- Who is it for?
- Ages 49 years and olderHealthy volunteers can take part
- Conditions the study is for
- Resilience, Psychological, Bereavement, Mental Health
- What is being tested?
- Positive Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2016to 31 Oct 2016
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- having only one child or legally adopting;
- No surviving children;
- basic language expression and comprehension skills;
- the score of Connor-Davidson Resilience Scale is lower than 82
Who cannot join
- in the acute bereavement period (<6 months);
- unable to participate in activities due to severe physical illness;
- having diagnosis of sever mental illness;
- receiving other psychological therapy.
About this study
Official title: The Impact of Group-based Positive Psychotherapy in Psychological Resilience of Only-child-lost People: A Randomized Controlled Trial
A randomized controlled trial was conducted to evaluate the effectiveness of group-based positive psychotherapy on psychological resilience, depression, well-being, sleep quality, dehydroepiandrosterone in only-child-lost people. A total of 80 only-child-lost people who met the inclusion and exclusion criteria were expected to recruit. There were six weeks in the intervention, including positive introduction, positive reaction, gratitude, meaningful, three good things, and using personal strength. The measurements were conducted at the baseline, immediately after the intervention, 3-month after the intervention.
- Conditions
- Resilience, Psychological, Bereavement, Mental Health
- Being tested
- Positive Psychotherapy, Usual Care
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive PsychotherapyBehavioural
A 6-week group-based positive psychotherapy was conducted in this group. The themes of each week include positive introduction, three good things and positive reactions, gratitude, positive memory, identifying personal strengths and utilizing strengths.
Usual CareOther
Usual Care means treating as usual, including a regular home visit.
| Study group | Role | What they receive |
|---|---|---|
| Positive Psychotherapy group | Experimental | Not described Receives: Behavioral: Positive Psychotherapy |
| Control group | Other | Usual Care means treating as usual, including a regular home visit. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of psychological resilience
It is assessed by Connor-Davidson Resilience Scale. A higher score suggests a higher level of psychological resilience. The range is 0-100.
Measured: Baseline, immediately after the intervention, 3-month after the intervention
Secondary outcomes (5)
Change of depressive symptoms
It is measured by Zung Self-rating Depression Scale with a higher score suggesting a more severe of depressive symptoms
Measured: Baseline, immediately after the intervention, 3-month after the intervention
Change of index of well-being
It is measured by Campbell's Index of Well-being. A high score indicates a high level of well-being.
Measured: Baseline, immediately after the intervention, 3-month after the intervention
Change of Dehydroepiandrosterone (DHEA) in saliva
Saliva is collected using a saliva collector and assayed using the Elisa assay. After the specimens were collected, they were tested with the Elisa kit of Salimetrics® according to its instructions.
Measured: Baseline, immediately after the intervention, 3-month after the intervention
Change of Sleep Quality
It is measured by Pittsburgh Sleep Quality Index. If the total score is over 7, the sleep quality is normal, and if the score is over 7, it suggests a low sleep quality
Measured: Baseline, immediately after the intervention, 3-month after the intervention
Change of Social Avoidance and Social Distress
It is measured by Social Avoidance and Distress Scale. A high score indicates a high level of social avoidance and social distress.
Measured: Baseline, immediately after the intervention, 3-month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2023
- Study start1 Mar 2016
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Resilience, PsychologicalStudies 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central South University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Wen, Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05703529
- Sponsor's protocol ID
- 2015058
- Status last verified
- Jan 2023
- First submitted
- 20 Dec 2022
- Last updated
- 30 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Group-based Positive Psychotherapy in Psychological Resilience of Only-child-lost People: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05703529
- Acronym / sponsor ID
- 2015058
- Conditions
- Resilience, Psychological, Bereavement, Mental Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Central South UniversityUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 30 Jan 2023 (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.
A randomized controlled trial was conducted to evaluate the effectiveness of group-based positive psychotherapy on psychological resilience, depression, well-being, sleep quality, dehydroepiandrosterone in only-child-lost people. A total of 80 only-child-lost people who met the inclusion and exclusion criteria were expected to recruit. There were six weeks in the intervention, including positive introduction, positive reaction, gratitude, meaningful, three good things, and using personal strength. The measurements were conducted at the baseline, immediately after the intervention, 3-month after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Psychotherapy group | Experimental | Behavioral: Positive Psychotherapy |
| Control group | Other | Other: Usual CareUsual Care means treating as usual, including a regular home visit. |
Who may qualify
- Ages
- 49 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- having only one child or legally adopting;
- No surviving children;
- basic language expression and comprehension skills;
- the score of Connor-Davidson Resilience Scale is lower than 82
Key exclusion criteria (4 listed)
- in the acute bereavement period (<6 months);
- unable to participate in activities due to severe physical illness;
- having diagnosis of sever 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 |
|---|---|---|
| Positive PsychotherapyA 6-week group-based positive psychotherapy was conducted in this group. The themes of each week include positive introduction, three good things and positive reactions, gratitude, positive memory, identifying personal strengths and utilizing strengths. | Behavioural | Positive Psychotherapy group |
| Usual CareUsual Care means treating as usual, including a regular home visit. | Other | Control group |
Primary outcome
Change of psychological resilience
Time frame: Baseline, immediately after the intervention, 3-month after the intervention
It is assessed by Connor-Davidson Resilience Scale. A higher score suggests a higher level of psychological resilience. The range is 0-100.
5 secondary outcomes
Change of depressive symptoms
Time frame: Baseline, immediately after the intervention, 3-month after the intervention
Change of index of well-being
Time frame: Baseline, immediately after the intervention, 3-month after the intervention
Change of Dehydroepiandrosterone (DHEA) in saliva
Time frame: Baseline, immediately after the intervention, 3-month after the intervention
Change of Sleep Quality
Time frame: Baseline, immediately after the intervention, 3-month after the intervention
Change of Social Avoidance and Social Distress
Time frame: Baseline, immediately after the intervention, 3-month after the 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 30 Jan 2023.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Positive Psychotherapy in people with Resilience, Psychological and Bereavement, run by Central South University.
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 30 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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 psychological resilience (time frame: Baseline, immediately after the intervention, 3-month after the intervention). 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 30 Jan 2023.