The comparison of the effectiveness of unified transdiagnostic treatment and mindfulness based cognitive therapy (MBCT) in cognitive avoidance ,emotional regulation and rumination in depression disorder: a double-blind randomized clinical trial
Comparing the effectiveness of integrated transdiagnostic therapy and mindfulness therapy on cognitive avoidance, emotion regulation and rumination in depressive disorder
Design
A clinical trial with a control group with two parallel treatment groups on 45 patients
Settings and conduct
Background: depression disorder, location: Jahad Counseling Center, Mashhad University. Clinical interviews and depression questionnaires were taken from people who referred to the center with depression complaints, and then, if they were eligible, they were randomly divided into three groups of 15 The subjects were divided into (metadiagnostic therapy group, mindfulness therapy group and control group).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Diagnosis of depressive disorder in structured clinical interview based on SCID-5
Beck depression questionnaire
Exclusion criteria:
Existence of psychiatric disorders (schizophrenic spectrum disorders and other psychotic disorders and bipolar disorder)
Receiving other psychological treatments at the same time
Intervention groups
The first experimental group with integrated metadiagnostic therapeutic intervention, the second experimental group with cognitive therapy intervention based on mindfulness and the control group.
Main outcome variables
Rumination
Cognitive avoidance
Emotion Regulation
General information
Reason for update
Acronym
UM
IRCT registration information
IRCT registration number:IRCT20231107059985N1
Registration date:2023-11-14, 1402/08/23
Registration timing:registered_while_recruiting
Last update:2023-11-14, 1402/08/23
Update count:0
Registration date
2023-11-14, 1402/08/23
Registrant information
Name
Somayeh Afshar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3766 9496
Email address
afshar.so@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-09, 1402/08/18
Expected recruitment end date
2024-03-10, 1402/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of the effectiveness of unified transdiagnostic treatment and mindfulness based cognitive therapy (MBCT) in cognitive avoidance ,emotional regulation and rumination in depression disorder: a double-blind randomized clinical trial
Public title
Investigating the effect of integrated transdiagnostic therapy and cognitive therapy based on mindfulness in depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosing depression disorder in a structured clinical interview based on SCID-5
Beck Depression Questionnaire
not receiving drug treatment (physical and psychological medication)
receiving other psychological treatments
not having severe psychiatric disorders
absence of addiction
Exclusion criteria:
Being less than 18 years old and more than 50 years old
having absence of more than 3 sessions
having an addiction
having a psychiatric disorder
receiving drug treatment (physical and psychological medication)
receiving Other psychological treatments
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method
Randomization unit: individual
Randomization tool: sealed envelope
Explanation about concealment: In order to prevent selection distortion, a number of envelopes are prepared with aluminum foil (in order to make the contents of the envelopes unclear), and each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in order.In order to preserve the random sequence, the outer surface of the envelope is numbered in the same order. Finally, the lid of the letter envelopes is glued and placed in a box in order. At the time of the registration of the participants, according to the order of entry of the eligible participants into the study, one of the letter envelopes will be opened and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Double blinded
Blinding description
After selecting the sample, none of the people in the sample will know about randomization and the process of allocation to groups. The data analyst will be chosen outside the study and all the data will be provided to him in a coded form.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Faculty of Medicine, Islamic Azad University, Mashhad Medical Sciences Unit
Street address
Mashhad ,Faramarz abbasi Blv,faramarz 15 Avenue, resalat 29,45 No
City
Mashhad
Province
Razavi Khorasan
Postal code
9197964916
Approval date
2023-11-07, 1402/08/16
Ethics committee reference number
IR.IAU.MSHD.REC.1402.128
Health conditions studied
1
Description of health condition studied
Major depressive disorder
ICD-10 code
F33.0
ICD-10 code description
Major depressive disorder, recurrent, mild
Primary outcomes
1
Description
depression
Timepoint
A pre-test، post-test and then follow-up after 3 months.