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IRCT20181206041868N1 IRCT 2020-03-27 Iran University of Medical Sciences Mindfulness and Acceptance and Cognitive Behavioral Group Therapy on adult stuttering The effectiveness of Mindfulness and Acceptance Group Therapy in comparison with Cognitive Behavioral Group Therapy on severity of social anxiety, quality of life, and verbal fluency in adults with stuttering 2020-04-20 anticipated 54 Complete https://irct.ir/trial/36149 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done using blocked randomization with fixed block sizes. The size of the blocks will be 6 and randomization will be performed using www.sealedenvelope.com. We will have 9 blocks which every one of them has 6 members (n=54) and the members will be replaced by random sequences created by the website. In each block, two participants will be randomly assigned to group A (Mindfulness and Acceptance Group Therapy), two participants to group B (Cognitive Behavioral Group Therapy), and two participants to group C (Control Group). N/A Condition 1: adult stuttering. Condition 2: social phobia. Intervention 1: First Intervention group: Mindfulness and Acceptance Group Therapy plus speech therapy (Smooth Speech); This group, in psychotherapy stage, will be under 10 consecutive weekly 2 hrs sessions group therapy which will have two parts; In first 5 sessions, participants will practice Mindful exercises in addition to learning therapy concepts and in second 5 sessions, Vital Actions. After post test evaluation, participants will be under 4 weekly 4 hrs Smooth Speech Therapy which include teaching principal techniques of the therapy and using these techniques gradually from low to high speed until they can use these techniques in reading and daily speech with normal speed range. Intervention 2: Second Intervention group: Cognitive Behavioral Group Therapy plus speech therapy (Smooth Speech); This group, in psychotherapy stage, will be under 10 consecutive weekly 2 hrs session group therapy which will have two parts. In first 5 sessions, participants will learn cognitive restructuring and in second 5 sessions practice Behavioral experiments and exposures. After post test evaluation, participants will be under 4 weekly 4 hrs Smooth Speech Therapy which include teaching principal techniques of the therapy and using these techniques gradually from low to high speed until participants can use them in reading and daily speech with normal speed range. Intervention 3: Control group: Speech Therapy (Smooth Speech); After being in waiting list and post test evaluation, participants will be under 4 weekly 4 hrs Smooth Speech Therapy which include teaching principal techniques of the therapy and using these techniques gradually from low to high speed until participants can use them in reading and daily speech with normal speed range. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Soroush Khoshnam
School of Behavioral Sciences and Mental Health., No. 1., Mansoori Alley ., Niyaeesh Ave ,. Sattarkhan St,. Tehran
Tehran Iran (Islamic Republic of) ۱۴۴۵۶۱۳۱۱۱ +98 21 6655 1655 soroushkhoshnam@gmail.com Iran University of Medical Sciences scientific Banafshe Gharraee
School of Behavioral Sciences and Mental Health., No. 1., Mansoori Alley ., Niyaeesh Ave ,. Sattarkhan St,. Tehran
Tehran Iran (Islamic Republic of) ۱۴۴۵۶۱۳۱۱۱ +98 21 6655 1655 gharraee.b@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Diagnosis: developmental stuttering language: Persian Age: more than 20 years Education: more than 8 classes Social phobia: moderate and severe 20 years no limit Both Psychotic disorders Drug dependency disorders Any other primary psychiatric disorders which be so severe that the participant could not tolerate group therapies F98.5 F40.1 Stuttering [stammering: ]Speech that is characterized by frequent repetition or prolongation of sounds or syllables or words, or by frequent hesitations or pauses that disrupt the rhythmic flow of speech. It should be classified as a disorder only if its Social phobias: Fear of scrutiny by other people leading to avoidance of social situations. More pervasive social phobias are usually associated with low self-esteem and fear of criticism. They may present as a complaint of blushing, hand tremor, nausea, Treatment - Other Treatment - Other Treatment - Other First Intervention group: Mindfulness and Acceptance Group Therapy plus speech therapy (Smooth Speech); This group, in psychotherapy stage, will be under 10 consecutive weekly 2 hrs sessions group therapy which will have two parts; In first 5 sessions, participants will practice Mindful exercises in addition to learning therapy concepts and in second 5 sessions, Vital Actions. After post test evaluation, participants will be under 4 weekly 4 hrs Smooth Speech Therapy which include teaching principal techniques of the therapy and using these techniques gradually from low to high speed until they can use these techniques in reading and daily speech with normal speed range. Second Intervention group: Cognitive Behavioral Group Therapy plus speech therapy (Smooth Speech); This group, in psychotherapy stage, will be under 10 consecutive weekly 2 hrs session group therapy which will have two parts. In first 5 sessions, participants will learn cognitive restructuring and in second 5 sessions practice Behavioral experiments and exposures. After post test evaluation, participants will be under 4 weekly 4 hrs Smooth Speech Therapy which include teaching principal techniques of the therapy and using these techniques gradually from low to high speed until participants can use them in reading and daily speech with normal speed range. Control group: Speech Therapy (Smooth Speech); After being in waiting list and post test evaluation, participants will be under 4 weekly 4 hrs Smooth Speech Therapy which include teaching principal techniques of the therapy and using these techniques gradually from low to high speed until participants can use them in reading and daily speech with normal speed range. Severity of social anxiety. Timepoint: The evaluation of severity of social anxiety before the start of psychotherapy, after the termination of psychotherapy, after speech therapy, and after 3 month follow up. Method of measurement: Social Phobia and Anxiety Inventory. Quality of life. Timepoint: The evaluation of quality of life before the start of psychotherapy, after the termination of psychotherapy, after speech therapy, and after 3 month follow up. Method of measurement: Overall Assessment of the Speaker's Experience of Stuttering-Adults. Severity of Stuttering. Timepoint: The evaluation of severity of stuttering before the start of psychotherapy, after the termination of psychotherapy, after speech therapy, and after 3 month follow up. Method of measurement: Stuttering Severity Instrument-3. Iran University of Medical Sciences Approved 2019-03-17 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)