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Effectiveness of Spiritual Therapy Intervention on Meaning in Life, Quality of Life, and Hope for Life in Women with Multiple Sclerosis

Protocol summary

Study aim
To determine the effectiveness of spirituality therapy on meaning in life, quality of life, and hope for life among women with multiple sclerosis in Isfahan.
Design
A quasi-experimental, parallel-group study with a pretest-posttest design and a control group will be conducted on 30 participants. Participants will be selected using purposive sampling and non-randomly allocated to an intervention group and a control group, with 15 participants in each group.
Settings and conduct
The study will be conducted among women with multiple sclerosis attending medical centers and the MS Society in Isfahan Province. Thirty eligible participants will be recruited through purposive sampling and non-randomly allocated to intervention and control groups. The intervention group will receive eight weekly 90-minute group-based spirituality therapy sessions, while the control group will receive no intervention. Outcomes will be assessed using paper-based or online questionnaires. No blinding will be performed.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Participants aged 20–50 years, with at least a high school diploma, who provide informed consent and have no severe concurrent physical or mental illness.
Intervention groups
Intervention Group: Participants will receive eight weekly 90-minute group-based spirituality therapy sessions focusing on spirituality, self-awareness, prayer, hope, spiritual beliefs, relationships, meaning in suffering, and self-transcendence. Control Group: Participants will receive no intervention and continue their usual care. Both groups will complete the same outcome assessments.
Main outcome variables
Meaning in Life, Quality of Life, Hope for Life.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20251129068145N5
Registration date: 2026-10-01, 1405/07/09
Registration timing: prospective

Last update: 2026-10-01, 1405/07/09
Update count: 0
Registration date
2026-10-01, 1405/07/09
Registrant information
Name
Mohammadreza Gorji Azghandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3872 0567
Email address
gorji@article-lab.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-10-07, 1405/07/15
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
Effectiveness of Spiritual Therapy Intervention on Meaning in Life, Quality of Life, and Hope for Life in Women with Multiple Sclerosis
Public title
Effectiveness of Spiritual Therapy Intervention on Meaning in Life, Quality of Life, and Hope for Life in Women with Multiple Sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20–50 years. Minimum educational level of a high school diploma. Willingness to participate and provision of written informed consent. Absence of severe concurrent physical or mental illness.
Exclusion criteria:
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Research Ethics Committee of the University of Isfahan
Street address
Office of the Vice-Chancellor for Research and Technology, Research Misconduct Review Committee, University of Isfahan, Azadi Square, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
81746–73441
Approval date
2026-02-21, 1404/12/02
Ethics committee reference number
IR.UI.REC.1404.294

Health conditions studied

1

Description of health condition studied
Women with multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
Meaning in Life
Timepoint
Meaning in life will be assessed at baseline (pre-tst), immediately after completion of the 8-week spirituality therapy intervention (post-test), and one month after the intervention (follow-up).
Method of measurement
Meaning in life will be assessed using the 10-item Meaning in Life Questionnaire developed by Steger and Frazier. Each item is rated on a 7-point Likert scale ranging from 1 (absolutely untrue) to 7 (absolutely true). Item 9 is reverse-scored. The total score will be calculated by summing the relevant item scores, with higher scores indicating a greater perceived meaning in life.

2

Description
Quality of Life
Timepoint
Quality of Life will be assessed at baseline (pre-test), immediately after completion of the 8-week spirituality therapy intervention (post-test), and one month after the intervention (follow-up).
Method of measurement
Quality of life will be assessed using the 29-item multiple sclerosis impact scale (MSIS-29) questionnaire. The first 20 items assess the physical impact of multiple sclerosis, while the remaining 9 items assess its psychological impact. Each item is rated on a 5-point response scale scored from 1 to 5. Total scores range from 29 to 145, with higher scores indicating a greater impact of MS and, consequently, poorer quality of life.

3

Description
Hope for Life
Timepoint
Hope for life will be assessed at baseline (pre-test), immediately after completion of the 8-week spirituality therapy intervention (post-test), and one month after the intervention (follow-up).
Method of measurement
Hope will be assessed using the 12-item Hope Scale. Each item is rated on a 5-point Likert scale from 1 (very low) to 5 (very high). The scale assesses two dimensions of hope: agency thinking and pathway thinking. Four items are distractors and are excluded from scoring. The total score will be calculated based on the eight scored items, with higher scores indicating greater levels of hope.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Participants in the intervention group will receive a structured, group-based spirituality therapy program consisting of eight weekly 90-minute sessions. The sessions will be conducted by a trained therapist and will include psychoeducation, guided discussion, experiential exercises, feedback, and homework assignments. The intervention will address spirituality, self-awareness, awareness of God’s presence, prayer and spiritual practices, hope and reliance on God, spiritual beliefs, interpersonal relationships, generosity, meaning in suffering, patience, self-transcendence, and personal responsibility. The first session will focus on establishing therapeutic conditions, introducing the rationale and objectives of the intervention, building group interaction, identifying participants’ concerns, and developing a therapeutic contract. Subsequent sessions will address spirituality education and practice, self-knowledge and personal responsibility, prayer and communication with God, hope and reliance on God, remembrance and spiritual practices, spiritual beliefs and their relationship with well-being and social relationships, generosity and giving and receiving love and respect, and finally the meaning of suffering, patience, self-transcendence, and responsibility toward oneself and others. Participants will be encouraged to practice the discussed concepts between sessions through assigned homework and reflective exercises. At the end of the program, participants will be evaluated and scheduled for follow-up assessment.
Category
Treatment - Other

2

Description
Control group: Participants in the control group will not receive the spirituality therapy intervention during the study period and will continue their usual care and routine activities. They will receive the same outcome assessments as the intervention group at the scheduled measurement points, including baseline and post-intervention assessments and follow-up. No additional therapeutic sessions or spirituality-based training will be provided to this group during the study period.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Kerman Multiple Sclerosis Treatment Center
Full name of responsible person
Dr. Hossein-Ali Ebrahimi Meymand
Street address
22 Shafa Alley, Corner of Shafa Alley, Kosar Square, Neurological Diseases Research Center, Kerman, Iran.
City
Kerman
Province
Kerman
Postal code
۷۶۱۸۷۵۹۶۳۹
Phone
+98 34 3212 4727
Fax
Email
kerman.neuroscience@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Isfahan
Full name of responsible person
Dr. Babak Safari
Street address
Office of the Vice-Chancellor for Research and Technology, 3rd Floor, Central Library Building, University of Isfahan, Hezar-Jarib Street, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 2170
Email
b_saffari@ase.ui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Isfahan
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
University of Isfahan
Full name of responsible person
Dr. Mohammad Bagher Kajbaf
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Educational Sciences and Psychology, University of Isfahan, Azadi Square, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 5458
Email
m.b.kaj@edu.ui.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Dr. Mohammad Bagher Kajbaf
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Educational Sciences and Psychology, University of Isfahan, Azadi Square, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 31 3793 5458
Email
m.b.kaj@edu.ui.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Najmeh Shahaboddini Parizi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Faculty of Educational Sciences and Psychology, University of Isfahan, Azadi Square, Isfahan, Iran.
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۴۱
Phone
+98 913 193 8688
Email
najmehshahabadiniparizi@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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