Protocol summary
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Study aim
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Efficacy of Transdiagnostic Group Therapy on Difficulties Emotion Regulation and emotion regulation
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Design
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We designed a diagnostic process based on co-morbidity between anxiety disorder and depression symptoms. Also, we served various materials to identify the appropriate subjects. A combination of Clinical diagnostic and self-report assessments more limited the eligibility of participation. Patients who met The Structured Clinical Interview for DSM-IV SCID-I criteria, for anxiety disorders, were evaluated in terms of the scales of emotion regulation, the scales of depression, and the scales of anxiety disorders. At last, only people who exclusively received at least one self-report score in each of the three domains were selected to randomization.
Also, we investigate a web based intervention condition simoultanously.
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Settings and conduct
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Lorestan University
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Participants/Inclusion and exclusion criteria
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Eligibility criteria included: (a) Diagnosis of MS for three years or more, (b) Fluent in Persian, at least 18 years of age, (c) Received at least one current diagnostic of a valid depression disorder and an anxiety disorder on Structural Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, fourth Edition Axis I Disorders.,provide consent,
exclusion criteria:
suicidal
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Intervention groups
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The sessions were structured based on the Transdiagnostic Therapy basics developed by Barlow et al. Group therapy consisted of 12 weekly sixty-minute sessions.. The subjects who were randomly assigned to two groups of Transdiagnostic
Increasing motivation: Motivational interviewing for participation and involvement of patients during therapy.
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Main outcome variables
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EMOTION REGULATION
General information
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Reason for update
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I have not starting rthe enrollment process.
The mentioned date is an expected day.
We are going to in start recruitement in the next week.
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Acronym
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EUPERMPWMS
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IRCT registration information
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IRCT registration number:
IRCT20190711044173N1
Registration date:
2019-10-31, 1398/08/09
Registration timing:
prospective
Last update:
2019-11-10, 1398/08/19
Update count:
1
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Registration date
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2019-10-31, 1398/08/09
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-11-02, 1398/08/11
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Expected recruitment end date
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2019-12-02, 1398/09/11
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Efficacy of the Unified Protocol on Emotion Regulation and mindfulness in People with Multiple Sclerosis
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Public title
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Effectiveness of a cost effective cognitive behavioural program on improvement mentall health in MS
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
Diagnosis of MS for three years or more
Fluent in Persian
Internet availibility
Exclusion criteria:
Other Chronic physical illnesses (such as insulin-dependent diabetes and chemotherapy for cancer)
Pregnancy or lactation,
Evidence of current or past schizophrenia, psychosis, or organic mental disorder, bipolar disorder, or organic mental disorder
Drug abuse history or drug dependence except for nicotine
Absenteeism for more than three sessions
Presence of comorbid neurological disorders such as Alzheimer, Parkinson's disease, Dementia
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Age
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From 18 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Care provider
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
200
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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All patients, met all inclusion criteria, were assigned to treatment and control groups using computer-generated random numbers.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The blinded researchers did randomization. This study was a clinical elevator-blinded, data-collector Blinded, analyst-blinded, and statistician blinded study.
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Placebo
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Not used
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Assignment
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Other
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Other design features
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Secondary Ids
1
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Registry name
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Who International Clinical Trials
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Secondary trial Id
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U1111-1238-0965
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Registration date
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2019-08-05, 1398/05/14
Ethics committees
1
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Ethics committee
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Approval date
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2019-10-28, 1398/08/06
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Ethics committee reference number
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IR.NIMAD.REC.1398.259
Health conditions studied
1
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Description of health condition studied
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Multiple sclerosis
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ICD-10 code
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G35
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ICD-10 code description
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Multiple sclerosis
Primary outcomes
1
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Description
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depression
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Timepoint
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before allocation
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Method of measurement
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The hospital anxiety and depression scale (HADS): , Structured Clinical Interview for DSM-IV (SCID)
2
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Description
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anxiety
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Timepoint
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before allocation , post intervention, three month follow up
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Method of measurement
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The hospital anxiety and depression scale (HADS): , Structured Clinical Interview for DSM-IV (SCID)
Secondary outcomes
1
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Description
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depression
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Timepoint
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, post intervention, three month follow up
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Method of measurement
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The hospital anxiety and depression scale (HADS): , Structured Clinical Interview for DSM-IV (SCID)
Intervention groups
1
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Description
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The sessions were structured based on the Transdiagnostic Therapy basics developed by Barlow et al. Group(2018 edition) therapy consisted of 12 weekly sixty-minute sessions.. The subjects who were randomly assigned to two groups . Transdiagnostic intervention based on group intervention and consist of 12 session and 8 modules: 1) Increasing motivation: Motivational interviewing for participation and involvement of patients during therapy, providing treatment logic and setting treatment goals. 2)Providing psychological education, recognition of emotions, tracking emotional experiences, and training . 3)Training emotional awareness, learning to see emotional experiences (emotions and response to emotions) especially using mindfulness techniques. 4)IAssessment and cognitive reassessment, awareness of the impact and interaction between thoughts and emotions, identification of maladaptive automated evaluations and common 5)Examining EDBs, knowledge and identification of their effects on emotional experiences, identifying maldaptive EDBs, and creating alternatives for acting through behaviors. 6)Knowledge and tolerance of physical senses, increase awareness of the role of emotional feelings in emotional experiences, practice exercises or visceral confrontation in order to be aware of physical sensations and increase tolerance of these symptoms7)Visceral confrontation and confrontation with situational emotions, awareness of the logic of emotional confrontation, training how to prepare the fear hierarchy, avoidance and design of repeated and effective emotional exposure exercises, visual, objective and avoidance.8)Prevention of recurrence, overview of treatment concepts and discussion about patient's healing and progress
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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ISLAMIC AZAD UNIVERSITY
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Proportion provided by this source
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1
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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Results will send to a peer reviewed international journal without selectivity.
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When the data will become available and for how long
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After trearment without delay
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To whom data/document is available
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All reserchers who confirm an existing study in line with this research must be provided an academic email.
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Under which criteria data/document could be used
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Represnt an Academic Email and IRB code
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From where data/document is obtainable
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Prencipal Invistigator
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What processes are involved for a request to access data/document
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Send an email, Provided by an Academic Email and IRB code
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Comments
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