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IRCT2016032321385N1 IRCT 2016-05-26 Ministry of Science, Research and Technology of Iran The efficacy of Cognitive Behavioral Group Therapy, Psychodrama and the Combination of Both for the Treatment of Social Anxiety Disorder The efficacy of Cognitive Behavioral Group Therapy, Psychodrama and the Combination of Both for the Treatment of Social Anxiety Disorder in a Randomized Controlled Trial 2016-03-01 anticipated 144 Complete https://irct.ir/trial/18759 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Block randomization with computer randomized allocation to four conditions of equal proportions. The six cohorts will be n=24, with n=6 allocated to each condition. The evaluators are blind the allocation of patients to interventions and waitlist group. State there that randomization will be conducted by an independent researcher at the University of Amsterdam. N/A Social Anxiety Disorder. Intervention 1: Cognitive behavioral group therapy (CBGT) (n=36), psychodrama (n=36), the psychodrama CBGT (n=36) and a wait list group (n=36). The three active groups will undergo 12 sessions of treatment; every session lasts 2.5 hours with 6 patients and one therapist (male for women and female for men), whereas the control group will not receive any active treatment during this period. For the three active arms only, a follow-up measurement will be done 6 months after the intervention. CBGT will be based on Heimberg and Becker’s protocol (2002). It will include 12 weekly sessions; every session lasts 2.5 hours and will be given by two therapists. In the first session, the therapists explain the group’s rules and present the cognitive behavioral therapy model of social anxiety and train cognitive restructuring with focusing on identification of automatic thoughts. Patients share their individual problems and goals. At the end of the first session, the therapists assign homework which is to record automatic thoughts during the following week. During the second session, the homework is reviewed and the therapists use the recorded automatic thoughts to identify thinking errors. The therapists will train the patients how to dispute automatic thoughts with rational responses. At the end of the session, the therapists assign homework to label thinking errors in identified automatic thoughts and prepare for initiation of in-session exposure. From 3rd session to 11th patients will practice in exposure in and between sessions with cognitive restructuring skills that learned. Choices of exposure situations depend on feared and avoided situations, which will be detected during interviews or treatment. Sometimes patients will need help to set the goals and they repeat the exposure with a more rational response to adapt themselves during anxiety provoking situations. The therapists assign to utilize cognitive restructuring before, during and after homework exposure every session for each patient. The last session is divided into two parts. During the first half the therapists do additional exposure and cognitive restructuring. During the second half the therapists review each patient’s development during treatment and work on situations that may still be problematic. Intervention 2: Psychodrama will include 12 weekly sessions. Each session lasts 2.5 hours. In this study we have one therapist as a director.Every psychodrama session is divided into three stages: warming up, action and sharing. The warming up or ice broking stage facilitates a safe, supportive and creative atmosphere to patients at the beginning of every session. Patients introduce themselves and do physical interaction games until ice breaks. After that, the individual who will act as the protagonist needs to be identified. The director can select the protagonist based on the preparation in warming-up stage or ask who is ready to work as a volunteer. In the acting stage, the director creates a scene with the protagonist, in which a problem is played. The protagonist can select the auxiliary ego. The patients can play a childhood experience from the past, or a feared situation in future, or some feared situations in the present. All are played “here and now”; freely, spontaneously and creatively. Catharsis usually takes place in the action stage. Sharing or closure is a time for patients to discuss the effects of acting the scene on them and share their feelings and thoughts with the group.There are several techniques that the director can utilize to solve the protagonist’s problems. ‘Role reversal’ offer protagonists an opportunity to take the role of the other person to see themselves from other’s perspective. In ‘doubling’ a patient of the group plays the protagonist’s inner self and gives a voice to the protagonist’s feelings, thoughts or needs, so that the protagonist can become aware of his or her inner experiences. The auxiliary ego plays the role of the protagonist for a short time in a technique called ‘mirroring’. It can help patients to observe themselves through the auxiliary ego. ‘Soliloquy’ is a monologue in which the patients can express their thoughts and feelings to the audience. In the ‘empty chair’ technique, the protagonist can talk to an imaginary person as represented by an empty chair (Moreno & Fox, 1987; Blatner, 2000). Intervention 3: Psychodrama CBGT.This intervention also has 12 weekly sessions and every session lasts 2.5 hours with one therapists. In the first session, the therapists explain the group’s rules and present the combining CBGT and psychodrama model of social anxiety and train cognitive restructuring with focusing on identification of authomatic thoughts. Patients share their individual problems and goals. At the end of the first session, the therapists assign homework which is to record automatic thoughts during the following week. During the second session, the homework is reviewed and the therapists use the recorded automatic thoughts to identify thinking errors. The therapists will train the patients how to dispute automatic thoughts with rational responses. At the end of the session, the therapists assign homework to label thinking errors in identified automatic thoughts and prepare for initiation of in-session exposure. Session 3 to 11 are divided into three stages: warming up, action and sharing. The warming up or ice broking stage facilitates a safe, supportive and creative atmosphere to patients at the beginning of every session. Patients introduce themselves and do physical interaction games until ice breaks. After that, the individual who will act as the protagonist needs to be identified. The director can select the protagonist based on the preparation in warming up stage or ask who is ready to work as a volunteer. In the acting stage, the director creates a scene with the protagonist, in which a problem is played. The protagonist can select the auxiliary ego. The patients can play a childhood experience from the past, or a feared situation in future, or some feared situations in the present. All are played “here and now”; freely, spontaneously and creatively. Catharsis usually takes place in the action stage. patients will practice in exposure and role playing in and between sessions with cognitive restructuring skills that learned and do exposure with the psychodrama techniques as described above: double, role reversal, soliloquy, mirroring and empty chair. The protagonist can select auxiliary ego to act. Sometimes patients will need help to set the goals and they repeat the exposure with a more rational response to adapt themselves during anxiety provoking situations. Sharing or closure is a time for patients to discuss the effects of acting the scene on them and share their feelings and thoughts with the group. At the end of each sessions, Therapists assign homework exposure similar to those practice in the group and encourage them to utilize cognitive restructuring before, during and after homework exposure every session for each patient. The last session is divided into two parts. During the first half the therapists do additional exposure, role playing and cognitive restructuring. During the second half the therapists review each patient’s development during treatment and work on situations that may still be problematic. Intervention 4: wait-list group.
public Hanieh Abeditehrani
No13, Iranian Building, Iranpars
Tehran Iran (Islamic Republic of) +98 21 4482 7379 haniehtehrani66@gmail.com; H.abeditehrani@uva.nl University of Amsterdam scientific Hanieh Abeditehrani
No 13, Iranian building, Iranpars
Tehran Iran (Islamic Republic of) +98 21 4482 7379 haniehehrani@gmail.com; H.abeditehrani@uva.nl University Of Amsterdam Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: A primary diagnosis of social anxiety disorder according to SCID I, age 18 to 65 years, ability to read and understand the questionnaire and the interview and a written consent for this study. Exclusion Criteria: Comorbid with psychotic or bipolar disorder, or a lifetime history of schizophrenia or bipolar disorder, high suicidality risk, antisocial or borderline personality disorder, comorbid diagnosis of substance abuse or dependence, unwilling to stablize medication for entire duration of the study based on clinical interview. 18 years 65 years Both ّF40.1 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, or urgency of mi Treatment - Other Treatment - Other Treatment - Other N/A Cognitive behavioral group therapy (CBGT) (n=36), psychodrama (n=36), the psychodrama CBGT (n=36) and a wait list group (n=36). The three active groups will undergo 12 sessions of treatment; every session lasts 2.5 hours with 6 patients and one therapist (male for women and female for men), whereas the control group will not receive any active treatment during this period. For the three active arms only, a follow-up measurement will be done 6 months after the intervention. CBGT will be based on Heimberg and Becker’s protocol (2002). It will include 12 weekly sessions; every session lasts 2.5 hours and will be given by two therapists. In the first session, the therapists explain the group’s rules and present the cognitive behavioral therapy model of social anxiety and train cognitive restructuring with focusing on identification of automatic thoughts. Patients share their individual problems and goals. At the end of the first session, the therapists assign homework which is to record automatic thoughts during the following week. During the second session, the homework is reviewed and the therapists use the recorded automatic thoughts to identify thinking errors. The therapists will train the patients how to dispute automatic thoughts with rational responses. At the end of the session, the therapists assign homework to label thinking errors in identified automatic thoughts and prepare for initiation of in-session exposure. From 3rd session to 11th patients will practice in exposure in and between sessions with cognitive restructuring skills that learned. Choices of exposure situations depend on feared and avoided situations, which will be detected during interviews or treatment. Sometimes patients will need help to set the goals and they repeat the exposure with a more rational response to adapt themselves during anxiety provoking situations. The therapists assign to utilize cognitive restructuring before, during and after homework exposure every session for each patient. The last session is divided into two parts. During the first half the therapists do additional exposure and cognitive restructuring. During the second half the therapists review each patient’s development during treatment and work on situations that may still be problematic. Psychodrama will include 12 weekly sessions. Each session lasts 2.5 hours. In this study we have one therapist as a director.Every psychodrama session is divided into three stages: warming up, action and sharing. The warming up or ice broking stage facilitates a safe, supportive and creative atmosphere to patients at the beginning of every session. Patients introduce themselves and do physical interaction games until ice breaks. After that, the individual who will act as the protagonist needs to be identified. The director can select the protagonist based on the preparation in warming-up stage or ask who is ready to work as a volunteer. In the acting stage, the director creates a scene with the protagonist, in which a problem is played. The protagonist can select the auxiliary ego. The patients can play a childhood experience from the past, or a feared situation in future, or some feared situations in the present. All are played “here and now”; freely, spontaneously and creatively. Catharsis usually takes place in the action stage. Sharing or closure is a time for patients to discuss the effects of acting the scene on them and share their feelings and thoughts with the group.There are several techniques that the director can utilize to solve the protagonist’s problems. ‘Role reversal’ offer protagonists an opportunity to take the role of the other person to see themselves from other’s perspective. In ‘doubling’ a patient of the group plays the protagonist’s inner self and gives a voice to the protagonist’s feelings, thoughts or needs, so that the protagonist can become aware of his or her inner experiences. The auxiliary ego plays the role of the protagonist for a short time in a technique called ‘mirroring’. It can help patients to observe themselves through the auxiliary ego. ‘Soliloquy’ is a monologue in which the patients can express their thoughts and feelings to the audience. In the ‘empty chair’ technique, the protagonist can talk to an imaginary person as represented by an empty chair (Moreno & Fox, 1987; Blatner, 2000). Psychodrama CBGT.This intervention also has 12 weekly sessions and every session lasts 2.5 hours with one therapists. In the first session, the therapists explain the group’s rules and present the combining CBGT and psychodrama model of social anxiety and train cognitive restructuring with focusing on identification of authomatic thoughts. Patients share their individual problems and goals. At the end of the first session, the therapists assign homework which is to record automatic thoughts during the following week. During the second session, the homework is reviewed and the therapists use the recorded automatic thoughts to identify thinking errors. The therapists will train the patients how to dispute automatic thoughts with rational responses. At the end of the session, the therapists assign homework to label thinking errors in identified automatic thoughts and prepare for initiation of in-session exposure. Session 3 to 11 are divided into three stages: warming up, action and sharing. The warming up or ice broking stage facilitates a safe, supportive and creative atmosphere to patients at the beginning of every session. Patients introduce themselves and do physical interaction games until ice breaks. After that, the individual who will act as the protagonist needs to be identified. The director can select the protagonist based on the preparation in warming up stage or ask who is ready to work as a volunteer. In the acting stage, the director creates a scene with the protagonist, in which a problem is played. The protagonist can select the auxiliary ego. The patients can play a childhood experience from the past, or a feared situation in future, or some feared situations in the present. All are played “here and now”; freely, spontaneously and creatively. Catharsis usually takes place in the action stage. patients will practice in exposure and role playing in and between sessions with cognitive restructuring skills that learned and do exposure with the psychodrama techniques as described above: double, role reversal, soliloquy, mirroring and empty chair. The protagonist can select auxiliary ego to act. Sometimes patients will need help to set the goals and they repeat the exposure with a more rational response to adapt themselves during anxiety provoking situations. Sharing or closure is a time for patients to discuss the effects of acting the scene on them and share their feelings and thoughts with the group. At the end of each sessions, Therapists assign homework exposure similar to those practice in the group and encourage them to utilize cognitive restructuring before, during and after homework exposure every session for each patient. The last session is divided into two parts. During the first half the therapists do additional exposure, role playing and cognitive restructuring. During the second half the therapists review each patient’s development during treatment and work on situations that may still be problematic. wait-list group Social anxiety. Timepoint: before intervention,in the middle (after 6th session). Method of measurement: The Liebowitz Social Anxiety interview (LSAS; Liebowitz, 1987) . Brief Fear of Negative Evaluation Scale (BFNE; Rodebaugh et al., 2004; Weeks et al., 2005). Quality of life. Timepoint: before intervention, after intervention, 6-month follow-up. Method of measurement: The Quality of Life Inventory (QOLI; Frisch, Cornell, Villanueva, Retzlaff, 1992). Ministry of Science, Research and Technology of Iran Approved 2016-02-27 ٍEthics committee of Hamedan University of Medical Science Khajerashid four way, AyatollaKashani Bolivar Hamedan Iran (Islamic Republic of)