Determining the effect of motivational interviewing intervention on anxiety and life satisfaction in mothers of children with mood disorders
Design
The clinical trial had a control group with parallel groups, no blinding, randomized on 64 references. The Research Randomizer website (www.randomizer.org) was used for randomization.
Settings and conduct
The research population includes mothers with children aged 10 to 19 years with a diagnosis of mood disorder who referred to Ibn Sina Psychiatric Hospital in Mashhad in 1405. The sample size is estimated to be 64 mothers (32 in the intervention group, 32 in the control group). Sampling is done by convenience method followed by simple random assignment. The intervention group receives 4 sessions of 50-60 minutes of motivational interviewing, and the control group receives usual ward care (including child medication and routine nursing sessions). Data are collected using the Beck Anxiety Inventory (BAI) and the Diener Life Satisfaction Questionnaire (SWLS) in two stages: pre-test and post-test. Data analysis is performed with SPSS version 25.
Participants/Inclusion and exclusion criteria
Mother of a child aged 10-19 with mood disorders
Living with a child with mood disorders
Anxiety score greater than 8 on the BAI
Willingness to participate
No history of mental disorder or psychotropic medication
No substance or alcohol abuse
Intervention groups
The intervention group will receive 4 sessions of 50-60 minutes of motivational interviewing, and the control group will receive usual ward care (including the child's medication and routine nursing sessions).
Main outcome variables
Anxiety
Life satisfaction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20260728070403N1
Registration date:2026-08-27, 1405/06/05
Registration timing:prospective
Last update:2026-08-27, 1405/06/05
Update count:0
Registration date
2026-08-27, 1405/06/05
Registrant information
Name
Amirmohammad keivanshokooh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3203 3014
Email address
a.keivanshokooh@gmail.com
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-09-23, 1405/07/01
Expected recruitment end date
2026-12-21, 1405/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Motivational Interviewing on Anxiety and Life Satisfaction of Mothers of Children with Mood Disorders
Public title
The Effect of Motivational Interviewing on Anxiety and Life Satisfaction of Mothers of Children with Mood Disorders
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Mother of a child aged 10-19 with mood disorders
Living with a child with mood disorders
Anxiety score greater than 8 on the BAI
Willingness to participate
No history of mental disorder or psychotropic medication
No substance or alcohol abuse
Exclusion criteria:
Drug and alcohol abuser
Having a history of mental disorder and use of psychotropic
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Simple Randomization
Individual
Using Research Randomizer software (www.randomizer.org)
To conceal allocation, opaque, numbered, and sealed envelopes were used. The envelopes were kept in a separate room in numerical order. After each mother completed the pretest questionnaires, the envelope corresponding to the same number was opened and the individual was assigned to the intervention or control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Vakil Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177943707
Approval date
2026-08-10, 1405/05/19
Ethics committee reference number
IR.MUMS.NURSE.REC.1405.054
Health conditions studied
1
Description of health condition studied
Depressive disorder: F32.9 (unspecified major depression)
ICD-10 code
F32.9
ICD-10 code description
Major depressive disorder, single episode, unspecified
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
anxiety
Timepoint
6 weeks
Method of measurement
Beck Anxiety Inventory
Secondary outcomes
1
Description
Satisfaction with life
Timepoint
6 weeks
Method of measurement
Satisfaction with life scale
Intervention groups
1
Description
Intervention group: Motivational Interviewing (MI) is a participatory, goal-oriented, and empathetic counseling approach designed by Miller and Rollnick (2013) that emphasizes strengthening the individual's intrinsic motivation to change harmful behaviors. This method is implemented in a non-judgmental and supportive environment and in the present study, it is held individually and face-to-face with each mother to help her discover and strengthen her intrinsic motivations to manage anxiety and improve her quality of life. Sessions are held in a private and quiet room in the child psychiatry ward of Ibn Sina Hospital in Mashhad, which is equipped with two comfortable chairs, a small table, and adequate lighting. Required forms, including BAI and Diner questionnaires, and a demographic information form, are provided during the sessions. The intervention consists of 4 40-minute sessions, held once a week for 4 consecutive weeks. The first session, titled Building a Therapeutic Relationship, is dedicated to establishing a trusting relationship, explaining the structure of the sessions, exploring the mother's concerns and challenges, expressing empathy, and identifying strengths and past successes. The second session aims to identify and strengthen internal motivations, explore the mother's values and aspirations, use the importance scale, stimulate a conversation about change with the DARN-C technique (desire, ability, reasons, need, commitment), and strengthen self-efficacy. The third session, focusing on examining barriers to change and resolving oscillations, identifies barriers and ambivalence, uses the two-way review technique, and returns to strong motivations for change. Finally, the fourth session, titled Step-by-Step Planning for Stress Management and Improving Quality of Life, includes brainstorming to find practical solutions, developing a SMART (specific, measurable, attainable, realistic, timed) action plan, and strengthening commitment and final summation. The main techniques used in these sessions include open-ended questions, affirmations and praise, simple and complex reflections of feelings and content, summarization, numerical scales of importance and confidence, and mutual consideration of the pros and cons of change. Between sessions, mothers are asked to do simple home exercises such as a daily record of positive and negative feelings, daily diaphragmatic breathing practice for 5 minutes, and a diary of situations in which they successfully managed their emotions, each taking about 5 to 10 minutes a day.
Category
Behavior
2
Description
Control group: The control group will receive standard hospital care during the study period (4 weeks), including routine nursing sessions to follow up on the child's medication status and general education for the mother, monthly general consultation with the ward's psychiatric nurse, access to the treatment team to answer questions, and continuation of the child's medication treatment as recommended by the treating psychiatrist, and will not receive any structured motivational interviewing intervention. In order to observe fairness and ethics in the study, after completing the follow-up phase and collecting all data, a summary of the motivational interviewing training will be provided to the control group in the form of a 60-minute individual or group session (depending on the mothers' preference) so that this group can also benefit from this method.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان ابن سینا مشهد
Full name of responsible person
سید محمد حسین بحرینی طوسی
Street address
خیابان حرعاملی - جنب نقلیه آستان قدس رضوی
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3712 7017
Email
a.keivanshokooh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
محمود محمدزاده شبستری
Street address
بلوار وکیل آباد
City
Mashhad
Province
Razavi Khorasan
Postal code
9177943707
Phone
+98 51 3841 3007
Email
shabestarim@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Tayebe pourghaznein
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Vakil Abad Blvd
City
mashhad
Province
Razavi Khorasan
Postal code
١٣٩۴۴٩١٣٨٨
Phone
+98 51 3841 2081
Email
PourghazneinT@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
saeed vagheei
Position
Assistant Professor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Vakil Abad Blvd
City
mashhad
Province
Razavi Khorasan
Postal code
١٣٩۴۴ ٩١٣٨٨
Phone
+98 51 3841 2081
Email
vaghees@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
amir mohammad keivanshokooh
Position
student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Vakil Abad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177943707
Phone
+98 51 3841 2081
Email
keivanam4032@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Some data, such as information on the main outcome, can be shared.
When the data will become available and for how long
Access begins 6 months after results are published.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Allowed
From where data/document is obtainable
Amir Mohammad Keyvan Shokooh
Mobile: 09155615792
Zip Code: 9177943707
Email: a.keivanshokooh@gmail.com
Mashhad Medical Sciences Campus
What processes are involved for a request to access data/document