An Investigation into the Effects of mobile based Logotherapy on Mood Symptoms and Suicidal Ideation in Patients with Major Depressive Disorder Undergoing Ketamine Therapy
The Effect of Mobile-Based Meaning-Centered Therapy on Mood Symptoms and Suicidal Ideation in Patients with Major Depressive Disorder Undergoing Ketamine Therapy at ebnesina Hospital in 2026
Design
Clinical trial with a control group, a single-blind, randomized on 50patients
Settings and conduct
Conducted at Ebnesina Hospital, this study examines the impact of mobile-based meaning-centered therapy on suicidal ideation and depression in MDD patients. The intervention is delivered via WhatsApp, and control group participants will receive the materials post-study.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Age 18–60; DSM-5 diagnosis of MDD; prescribed ketamine therapy; absence of comorbid psychiatric or chronic physical illnesses ; no history of epilepsy; and normal intelligence and literacy.
Exclusion Criteria:
Withdrawal of consent; new psychiatric diagnosis during the study; non-compliance with protocols; requirement for hospitalization (including high suicide risk); initiation of other antidepressants; or impairment in orientation.
Intervention groups
Following informed consent, participants will complete online depression and suicidal ideation questionnaires and be assigned to either the intervention or control group via simple randomization. The intervention group will receive twelve meaning-centered therapy packages via WhatsApp over four weeks, delivered three times weekly between 9:00 and 10:00 a.m.
Main outcome variables
The aim of this study is to evaluate the effect of meaning-centered therap on individuals with Major Depressive Disorder (MDD), with assessments conducted through the administration of standardized questionnaires.
General information
Reason for update
Acronym
logotherapy
IRCT registration information
IRCT registration number:IRCT20260505069272N2
Registration date:2026-06-05, 1405/03/15
Registration timing:prospective
Last update:2026-06-05, 1405/03/15
Update count:0
Registration date
2026-06-05, 1405/03/15
Registrant information
Name
Maryam Omidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3837 0822
Email address
maryam.omidi9691@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-06-10, 1405/03/20
Expected recruitment end date
2026-10-22, 1405/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
An Investigation into the Effects of mobile based Logotherapy on Mood Symptoms and Suicidal Ideation in Patients with Major Depressive Disorder Undergoing Ketamine Therapy
Public title
Logotherapy on Suicidal Ideation in Patients with Major Depressive Disorder Undergoing Ketamine Therapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having major depressive disorder based on the psychiatrist’s opinion in accordance with DSM-V criteria
Need to initiate ketamine administration under the psychiatrist’s order
Exclusion criteria:
Lack of insight into psychological illness
Comorbidity of other psychological disorders with major depressive disorder
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random sequence generation was performed by an independent statistician using block randomization with block sizes of 4 and 6, stratified by sex, in SPSS software. To ensure allocation concealment, the generated sequence was placed in opaque, sealed, and sequentially numbered envelopes to prevent any prediction of group assignments in advance. Enrollment and screening of eligible participants were carried out by Researcher 1. After completion of the enrollment process and obtaining informed consent, the next envelope in sequence was opened, and the allocation group was determined by Researcher 2, after which participants were assigned to their respective groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
To ensure blinding, the individual responsible for randomization is not aware of the codes assigned to the participants, and the randomization is carried out using a computer program. At the end of the study, the person entering the data from the completed questionnaires into SPSS, as well as the statistical analyst, are unaware of which participant completed the information and whether they belong to the intervention or control group
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences Ethics Committee
Street address
Karim Khan Zand Boulevard - Central Building of Shiraz University of Medical Sciences - Research and Technology Deputy Unit
City
shiraz
Province
Fars
Postal code
7193613119
Approval date
2026-05-24, 1405/03/03
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1405.016
Health conditions studied
1
Description of health condition studied
Major depressive disorder-Anxiety-Suicide Ideation-Ketamine therapy-Logotherapy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
depression (by completing the Patient Health Questionnaire)
Timepoint
Before the start of the study, one hour after the first ketamine injection, 14 days after the last injection, and three months after the intervention will be performed.
Method of measurement
the Patient Health Questionnaire
Secondary outcomes
1
Description
Assessment of the impact of suicidal thoughts (measured by completing the Cognitive Suicide Scale questionnaire)
Timepoint
Before the start of the study, one hour after the first ketamine injection, 14 days after the last injection, and three months after the intervention will be performed.
Method of measurement
Suicide Cognition Scale questionnaire
Intervention groups
1
Description
Intervention group: For the sampling in this study, patients with major depressive disorder who meet the inclusion criteria and are using injectable ketamine will be referred to the research team by a specialist in neurology and psychiatry. After completing the informed consent form, the depression and suicidal ideation questionnaires will be provided to the participants online. Then, the participants will be allocated into either the intervention or control group by simple randomization using randomization software.Then, the individuals in the intervention group, by joining the virtual group through mobile phone and in the WhatsApp application, will receive eight meaning-centered therapy educational packages over a period of four weeks. The content of these educational packages will include a set of targeted educational texts, audio files, images, and videos, which will be provided to the participants three days per week between 9 and 10 a.m. The protocol of the virtual meaning-centered therapy training sessions will be developed by the researchers, and the content of these sessions will be based on Victor Frankl’s meaning-centered therapy theory and similar studies.The weekly educational packages will include the following, in order:In the first week, educational packages 1, 2, and 3 will be presented. In this package, multimedia content regarding the goals and plans of the group, familiarization with Frankl’s life, the causes of depression and hopelessness based on the meaning-centered therapy approach, and familiarization with self-awareness skills will be provided to the participants. With the aim of finding meaning in life, the participants will be asked to describe their experiences of suffering and loss in past life and how they overcame previous hardships in their lives, and in a group exercise in order to increase self-awareness, they will record their strengths and weaknesses, fulfilled and unfulfilled desires and tendencies, hopes and expectations, and answer these questions: Who am I? Who do I want to be? What things do I like and what things do I dislike?In the second week, educational packages 4, 5, and 6 will be presented. In this package, with the aim of searching for meaning in life, content regarding the ways of attaining meaning, finding meaning through experiential values, the three values from Dr. Frankl’s viewpoint, and the stages of determining life values will be provided to the participants. With the aim of making individuals aware of their life values, the participants will be asked to organize their life goals and values. In the group exercise, the participants will be asked to imagine themselves in the place of a person whom they would like to be like. Content regarding nature and the meaning of life, love and the meaning of life, self-love, and gratitude will be provided to the participants. The participants will be asked to perform the exercises of love and gratitude and also to prepare a list of the things they have that are worthy of gratitude.In the third week, educational packages 7, 8, and 9 will be presented. In this package, with the aim of finding meaning through doing work, content regarding creativity and enjoying life as well as hope, moral virtues, the concept of suffering, and the limitations of life will be provided to the participants. The participants will be asked to perform a useful task or a valuable activity for themselves or others during this week and share it with others. Also, in order to overcome limiting thoughts, the participants will be asked to answer this question: “If God answered your wish, what wishes would you have?”In the fourth week, educational packages 10, 11, and 12 will be presented. In this package, with the aim of finding meaning through attitudinal values and understanding meaning through conscience, content on existential limitations, content related to the concepts of death and loneliness, and finding the meaning of life in various dimensions will be presented. The concepts of freedom and choice, responsibility and effort, aggressive and discouraging behaviors will be explained, and also, with the aim of controlling negative thoughts and feelings, positive thinking techniques will be taught. The participants will be asked to use these techniques in necessary situations and share the results with others.The control group will remain on the waiting list until the end of the study and will only receive educational content, including video and educational texts about ketamine pharmacotherapy, three days per week between 9 and 10 a.m.At the end of the study, the provided trainings will also be made available to the control group, and their احتمالی questions will be answered.It should be noted that the patients will be visited by the specialist in neurology and psychiatry according to routine practice, and in case exclusion criteria are observed, such as the need for hospitalization due to a high risk of suicide or the need to use other antidepressant drugs, the patient will be excluded from the study.At baseline and after the completion of the interventions, the questionnaires will be completed online by the participants.
Category
Rehabilitation
2
Description
Control group: The control group will undergo their treatment stages. Before the start of the study, one hour after the initial ketamine therapy, 14 days after the end of ketamine therapy, and 3 months after the end of ketamine therapy after the completion of meaning-centered training and relevant questionnaires are completed. During the total study time, all participants will be in contact with the researcher in WhatsApp and through direct calls and their questions will be answered. In order to observe ethical points in research, educational contents are provided to the control group after the completion of the study. In case of observing clear suicidal thought problems at any time of performing the research or at the end at the time of determining results, participants will be removed from the research and referred to a psychologist.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebnesina Psychiatric Hospital, Shiraz
Full name of responsible person
Fahimeh Sadat Hosseini
Street address
Hafez Street, next to 13 Aban Park
City
Shiraz
Province
Fars
Postal code
7144676541
Phone
+98 71 3228 0960
Fax
+98 71 3228 0236
Email
sinahosp@sums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Research and Technology Deputy
Street address
Karim Khan Zand Boulevard - Central Building of Shiraz University of Medical Sciences - Research and Technology Deputy Unit
City
shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Fax
+98 71 3230 5410
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Fahimeh Sadat Hosseini
Position
coach
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazi Square - Hazrat Fatemeh (PBUH) School of Nursing
City
shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
fhosseini۲۲۱@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Shaygan
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Namazi Square - Hazrat Fatemeh (PBUH) School of Nursing
City
shiraz
Province
Fars
Postal code
7193613119
Phone
009836474254
Email
m۲۶۲۰.shaygan@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Omidi
Position
Master’s degree student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Namazi Square - Hazrat Fatemeh (PBUH) School of Nursing
City
shiraz
Province
Fars
Postal code
7193613119
Phone
+98 71 3647 4254
Email
maryam.omidi9691@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The educational content for the intervention group consists of twelve separate modules from Frankl’s logotherapy program, which are provided to the patient. At the end of the study, the written content of these training materials will be published in the related article. In accordance with ethical research principles, and after de‑identifying all personal information, the completed questionnaire documents, obtained results, and statistical analyses will be made available to the participants. The data will be published without names. All potentially shareable data will be accessible once participant information has been fully de‑identified
When the data will become available and for how long
The access period begins after the completion of the research and the publication of the relevant article
To whom data/document is available
Access is permitted for all applicants
Under which criteria data/document could be used
With citation of the source, data can be used without making modifications.
From where data/document is obtainable
After publication of the results, volunteers may request access to further documents via the email of the responsible person, Ms. Dr. Maryam Shaygan (m2620.shaygan@gmail.com), and through Hazrat Fatemeh School of Nursing.
What processes are involved for a request to access data/document
In case of demand for access to the documents of this research, send your request to the responsible person’s email. The documents will be provided to the volunteers at the earliest opportunity, in compliance with research ethics principles.