- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06044363
Satir Model for Self-esteem, Mental Health, and Family Function Among Individuals With Substance Use Disorders
October 18, 2023 updated by: Dr Polly MA Haixia, Hong Kong Metropolitan University
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
45
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 Contact
- Name: Haixia Ma, PhD
- Phone Number: 39702990
- Email: phxma@hkmu.edu.hk
Study Contact Backup
- Name: Yajing Ma, PhD
- Email: 4064@cumt.edu.cn
Study Locations
-
-
Jiangsu
-
Yancheng, Jiangsu, China, 224000
- Fangqiang compulsory isolation detoxification center
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Satir group
Participants in the intervention group will receive a 10-session Satir model intervention.
|
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.
|
No Intervention: Control group
Participants in the control group will receive care as usual.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Through study completion, an average of two months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adult attachment
Time Frame: Through study completion, an average of two months
|
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".
|
Through study completion, an average of two months
|
Coping style
Time Frame: Through study completion, an average of two months
|
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.
|
Through study completion, an average of two months
|
Self-efficacy
Time Frame: Through study completion, an average of two months
|
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
|
Through study completion, an average of two months
|
Meaning in life
Time Frame: Through study completion, an average of two months
|
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.
|
Through study completion, an average of two months
|
Resilience
Time Frame: Through study completion, an average of two months
|
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.
|
Through study completion, an average of two months
|
Positive and negative affect scale
Time Frame: Through study completion, an average of two months
|
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.
|
Through study completion, an average of two months
|
Drug craving
Time Frame: Through study completion, an average of two months
|
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),
|
Through study completion, an average of two months
|
Motivation to abstain from drugs
Time Frame: Through study completion, an average of two months
|
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.
|
Through study completion, an average of two months
|
Family function
Time Frame: Through study completion, an average of two months
|
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.
|
Through study completion, an average of two months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Haixia Ma, PhD, Hong Kong Metropolitan University
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)
September 1, 2023
Primary Completion (Actual)
September 9, 2023
Study Completion (Actual)
September 30, 2023
Study Registration Dates
First Submitted
September 11, 2023
First Submitted That Met QC Criteria
September 16, 2023
First Posted (Actual)
September 21, 2023
Study Record Updates
Last Update Posted (Actual)
October 23, 2023
Last Update Submitted That Met QC Criteria
October 18, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HE-SF2023/26
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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.
IPD Sharing Time Frame
After the project is completed and the results of the project have been published.
IPD Sharing Access Criteria
Request could be sent to Principal Investigator (phxma@hkmu.edu.hk)
IPD Sharing Supporting Information Type
- SAP
- ICF
- CSR
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.
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