Drug AbuseNCT06044363
Satir Model for Self-esteem, Mental Health, and Family Function Among Individuals With Substance Use Disorders
A study testing Satir group in people with Drug Abuse and Self Esteem, run by Hong Kong Metropolitan University at 1 site in China.
Trial summary
Self-esteem and family functioning are associated with mental health and success of drug treatment among individuals with substance use disorders (SUD). The Satir model aims to empower individuals to explore their internal resources, address emotional issues, shift coping strategies, enhancing self-esteem, and develop… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Drug Abuse, Self Esteem, Mental Health Wellness 1
- What is being tested?
- Satir group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 30 Sep 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged 18 or above;
- are able to speak, read, and write Chinese;
- are willing to participate in the study and share their experience of the intervention with the research group;
- have informed consent to participate in the study.
Who cannot join
- have been diagnosed with severe mental illnesses, such as schizophrenia, mania, antisocial personality disorder;
- have a diagnosed memory and cognitive impairment;
- are undergoing psychotherapeutic or psychopharmacologic treatment;
- are participating in similar studies.
Trial locations and contacts
1 site in 1 country.
China1 site
Fangqiang compulsory isolation detoxification center
Yancheng, Jiangsu, 224000
About this study
Official title: Assessing the Efficacy and Acceptability of the Satir Model on Self-esteem and Mental Health Among Individuals With Substance Use Disorders in China: A Pilot Study Protocol
Self-esteem and family functioning are associated with mental health and success of drug treatment among individuals with substance use disorders (SUD). The Satir model aims to empower individuals to explore their internal resources, address emotional issues, shift coping strategies, enhancing self-esteem, and develop healthier ways of relating to themselves and others. It offers a range of techniques to enhance self-esteem, challenging negative belief systems, and promote personal growth. The aim of the study is to investigate the acceptability and preliminary efficacy of the Satir model on self-esteem, mental health, and family function among individuals with SUD in China. The study will adopt a mixed-method approach. The quantitative phase will employ a randomized control trial (RCT) utilizing a pre-post study design. The qualitative phase will involve conducting semi-structured individual interviews.The data will be analyzed by using SPSS software package (IBM SPSS statistics version 26.0). The individual-interview will be analyzed by using the six-phase thematic analysis. The study has the potential to advance knowledge in the field of drug rehabilitation interventions, inform evidence-based practice, and improve the wellbeing and outcomes of individual with SUD. It can contribute to the ongoing efforts to address the complex challenges associated with substance use and support individual on their trajectory to recovery.
- Conditions
- Drug Abuse, Self Esteem, Mental Health Wellness 1, Family Dysfunction
- Being tested
- Satir group
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Satir groupOther
Participants in the intervention group will receive a 10-session, 3-hour/session intervention that spans over a period of five days (2 sessions/day). The intervention program will be conducted on specific weekends, with a gap of 1 to 2 weeks. The total duration of the intervention will be 30 hours.
| Study group | Role | What they receive |
|---|---|---|
| Satir group | Experimental | Participants in the intervention group will receive a 10-session Satir model intervention. Receives: Other: Satir group |
| Control group | No intervention | Participants in the control group will receive care as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-esteem
The changes of participants' self-esteem will be assessed by using the Chinese version of Rosenberg self-esteem scale. Total scores range from 10 to 40, with higher scores representing lower self-esteem.
Measured: Through study completion, an average of two months
Secondary outcomes (9)
Adult attachment
Adult attachment will be assessed by using Adult attachment scale (AAS).The scale consists of 18 items scored on a 5 point likert-type scale. It measures adult attachment styles named "Secure", "Anxious" and "Avoidant".
Measured: Through study completion, an average of two months
Coping style
Coping style via Chinese version of simplified coping style questionnaire (SCSQ). It consists of 20 items referring to different ways of coping, with a total score range from 0 to 60. Two subscales are active coping and passive coping.
Measured: Through study completion, an average of two months
Self-efficacy
self-efficacy will be assessed by the general self-efficacy scale (GSES). The total score range from 10 to 40. Higher scores indicate higher perceived general self-efficacy
Measured: Through study completion, an average of two months
Meaning in life
Meaning in life will be assessed by using the Chinese version of meaning in life questionnaire (MLQ). It includes 10 items with a total score range from 10 to 70. It consists two subscales: MLQ Presence (MLQ-P) and Search (MLQ-S), each of them containing five items. The internal consistency of MLQ is 0.819.
Measured: Through study completion, an average of two months
Resilience
Resilience will be assessed via. the 25-item Connor-Davidson Resilience Scale (CD-RISC-25). The items are evaluated on a five-point likert scale ranging from 1 to 4. These ratings result in a number between 0-100, and higher scores indicate higher resilience.
Measured: Through study completion, an average of two months
Positive and negative affect scale
Positive and negative affect scale via Positive and negative affect scale (PANAS). This brief scale is comprised of 20 items, with 10 items measuring positive affect (e.g., excited, inspired) and 10 items measuring negative affect (e.g., upset, afraid). Scores can range from 10 to 50 for both the Positive and Negative Affect, with the lower scores representing lower levels of Positive/Negative Affect and higher scores representing higher levels of Positive/Negative Affect.
Measured: Through study completion, an average of two months
Drug craving
Drug craving will be assessed via the drug craving scale. It measures five dimensions of substance craving, including (1) prizing substance craving; (2) reflecting substance craving; (3) social substance craving; (4) negative substance craving; and (5) eliminating substance craving. The items are evaluated on a seven-point likert scale ranging from 1(strongly disagree) to 7 (strongly agree),
Measured: Through study completion, an average of two months
Motivation to abstain from drugs
Motivation to abstain from drugs will be assessed via the motivation to abstain from drugs. It includes 31 items, The items are evaluated on a five-point likert scale ranging from 1(strongly disagree) to 5 (strongly agree), with higher score indicates higher level of motivation to abstain from drugs.
Measured: Through study completion, an average of two months
Family function
Family function via the Chinese version of the 60-item McMaster Family Assessment Device (FAD). It includes seven subscale: problem solving, communication, roles, affective responsiveness, affective involvement, behavior control, and general function. The higher the overall score, the worse the level of family function.
Measured: Through study completion, an average of two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start1 Sep 2023
- Primary completion9 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug AbuseStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- a single center, open-label, randomized, controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Polly MA Haixia, Hong Kong Metropolitan University
- Investigators
- Haixia Ma, PhD, Principal investigator, Hong Kong Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044363
- Sponsor's protocol ID
- HE-SF2023/26
- Status last verified
- Oct 2023
- First submitted
- 11 Sep 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The relevant anonymized participant-level data, full dataset, technical appendix, and statistical code are available on reasonable request. The approval from the Principal Investigator for the purpose of data use is required.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy and Acceptability of the Satir Model on Self-esteem and Mental Health Among Individuals With Substance Use Disorders in China: A Pilot Study Protocol
- ClinicalTrials.gov ID
- NCT06044363
- Acronym / sponsor ID
- HE-SF2023/26
- Conditions
- Drug Abuse, Self Esteem, Mental Health Wellness 1, Family Dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 9 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 21 Sep 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.
Self-esteem and family functioning are associated with mental health and success of drug treatment among individuals with substance use disorders (SUD). The Satir model aims to empower individuals to explore their internal resources, address emotional issues, shift coping strategies, enhancing self-esteem, and develop healthier ways of relating to themselves and others. It offers a range of techniques to enhance self-esteem, challenging negative belief systems, and promote personal growth. The aim of the study is to investigate the acceptability and preliminary efficacy of the Satir model on self-esteem, mental health, and family function among individuals with SUD in China. The study will adopt a mixed-method approach. The quantitative phase will employ a randomized control trial (RCT) utilizing a pre-post study design. The qualitative phase will involve conducting semi-structured individual interviews.The data will be analyzed by using SPSS software package (IBM SPSS statistics version 26.0). The individual-interview will be analyzed by using the six-phase thematic analysis. The study has the potential to advance knowledge in the field of drug rehabilitation interventions, inform evidence-based practice, and improve the wellbeing and outcomes of individual with SUD. It can contribute to the ongoing efforts to address the complex challenges associated with substance use and support individual on their trajectory to recovery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- a single center, open-label, randomized, controlled trial
| Arm | Type | Receives |
|---|---|---|
| Satir group | Experimental | Other: Satir groupParticipants in the intervention group will receive a 10-session Satir model intervention. |
| Control group | No intervention | –Participants in the control group will receive care as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- aged 18 or above;
- are able to speak, read, and write Chinese;
- are willing to participate in the study and share their experience of the intervention with the research group;
- have informed consent to participate in the study.
Key exclusion criteria (4 listed)
- have been diagnosed with severe mental illnesses, such as schizophrenia, mania, antisocial personality disorder;
- have a diagnosed memory and cognitive impairment;
- are undergoing psychotherapeutic or psychopharmacologic treatment;
- are participating in similar studies.
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 |
|---|---|---|
| Satir groupParticipants in the intervention group will receive a 10-session, 3-hour/session intervention that spans over a period of five days (2 sessions/day). The intervention program will be conducted on specific weekends, with a gap of 1 to 2 weeks. The total duration of the intervention will be 30 hours. | Other | Satir group |
Primary outcome
Self-esteem
Time frame: Through study completion, an average of two months
The changes of participants' self-esteem will be assessed by using the Chinese version of Rosenberg self-esteem scale. Total scores range from 10 to 40, with higher scores representing lower self-esteem.
9 secondary outcomes
Adult attachment
Time frame: Through study completion, an average of two months
Coping style
Time frame: Through study completion, an average of two months
Self-efficacy
Time frame: Through study completion, an average of two months
Meaning in life
Time frame: Through study completion, an average of two months
Resilience
Time frame: Through study completion, an average of two months
Positive and negative affect scale
Time frame: Through study completion, an average of two months
Drug craving
Time frame: Through study completion, an average of two months
Motivation to abstain from drugs
Time frame: Through study completion, an average of two months
Family function
Time frame: Through study completion, an average of two months
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 23 Oct 2023.
- Individual participant dataSharing planned: Yes. The relevant anonymized participant-level data, full dataset, technical appendix, and statistical code are available on reasonable request. The approval from the Principal Investigator for the purpose of data use is required.
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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.
Haixia Ma, PhD principal investigator
Hong Kong Metropolitan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Satir group in people with Drug Abuse and Self Esteem, run by Hong Kong Metropolitan 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 23 Oct 2023. 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?
Self-esteem (time frame: Through study completion, an average of two months). 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 23 Oct 2023.