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IRCT2015111924265N2 IRCT 2016-07-13 Vice chancellor for research Ferdowsi University of Mashhad Comparison of cognitive therapy and cognitive pain self-management program in depression, anxiety, aggression and pain of women with chronic pain Comparison of cognitive group therapy and its combination with self-management program in reducing of depression, anxiety, aggression and pain of women with chronic pain 2014-06-22 anticipated 30 Complete https://irct.ir/trial/20523 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Participants were selected via judgmental sampling and they were randomly assigned randomly into three groups of 10 as two experimental and one control groups. The way of randomization was done by Simple Random Sampling. A sample is called simple random sample if each unit of the population has an equal chance of being selected for the sample. Lottery method was used for the selection of a simple random sample. N/A chronic pain. Intervention 1: Intervention group 1: Cognitive group therapy treatment sessions comprised of eight 120 min group session.Protocol consisted of cognitive therapy protocol based on Michel Free. Session-by-session outlines are presented: Session 1: Introduction and ground rules, teach ABC model; Session 2: Identifying of automatic thoughts and logical errors ; Session 3: Welcome and reflections from last session, identifying negative schema content using the vertical arrow method; Session 4: Welcome and reflections from last session, making a master list of negative beliefs and cognitive maps; Session 5: Welcome and reflections from last session, beliefs that have changed, utility analysis, investigatory Analysis; Session 6: Welcome and reflections from last session, making counters, hierarchy construction ; Session 7: Welcome and reflections from last session, changing negative beliefs; Session 8: Welcome and reflections from last session, self punishment, using imagery, review of the program, get feedback about the treatment plan. Intervention 2: Intervention group 2: combination of cognitive therapy with self-management program. Treatment session was comprised of eight 120 min group session . Protocol consisted of cognitive therapy protocol based on Michel Free and the chronic disease self-management program (CDSMP) protocol that originally developed by Lorig et al. Session-by-session outlines are presented: Session 1: Introduction and ground rules, teach ABC model; Session 2: Identifying of automatic thoughts and logical errors, boom and bust over\under activity and exercise, breathing, being more active, goal setting and planning for action; Session 3: Welcome and reflections from last session, identifying negative schema content using the vertical arrow method, give an overview of good nutrition and a rationale for eating better, goal setting and planning for action; Session 4: Welcome and reflections from last session, making a master list of negative beliefs and cognitive maps, using Mind to Manage Symptoms and Distraction, goal setting and planning for action; Session 5: Welcome and reflections from last session , beliefs that have changed, utility analysis, investigatory Analysis, muscle Relaxation, goal setting and planning for action; Session 6: Welcome and reflections from last session, making counters, hierarchy construction; problem-Solving skill, communication Skills, goal setting and planning for action; Session 7: Welcome and reflections from last session, changing negative beliefs; depression management, guided Imagery, goal setting and planning for action; Session 8: Welcome and reflections from last session, self punishment, using imagery, review of the program, get feedback about the treatment plan. Intervention 3: control group: Control group did not receive any treatment and after the initial eight-week delay, all those in the control group condition received the intervention.
public Faezeh Salayani
faculty of education and psychology, Ferdowsi University of Mashhad, Azadi Sq, Mashhad, Iran
Mashhad Iran (Islamic Republic of) +98 51 3880 5869 fa.salayani@stu.um.ac.ir Ferdowsi University of Mashhad scientific Mohammad Javad Asghari EbrahimAbad
Faculty of education and psychology, Ferdowsi University of Mashhad, Azadi Sq, Mashhad, Iran
Mashhad Iran (Islamic Republic of) +98 51 3880 5869 mjasghari@um.ac.ir Ferdowsi University of Mashhad Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: ages 18-50 years, suffered from chronic non specific pain, had pain for at least three months, ability to complete self-assessment questionnaires, provision of written, signed informed consent; Exclusion criteria: unwillingness to participants, severe somatic illness requiring specific treatment, manifest psychiatric disorder such as psychosis, failed inclusion criteria, use of stimulants, drugs, alcohol at the time of the study. 18 years 50 years Female R52.9 Generalized pain NOS Behavior Behavior N/A Intervention group 1: Cognitive group therapy treatment sessions comprised of eight 120 min group session.Protocol consisted of cognitive therapy protocol based on Michel Free. Session-by-session outlines are presented: Session 1: Introduction and ground rules, teach ABC model; Session 2: Identifying of automatic thoughts and logical errors ; Session 3: Welcome and reflections from last session, identifying negative schema content using the vertical arrow method; Session 4: Welcome and reflections from last session, making a master list of negative beliefs and cognitive maps; Session 5: Welcome and reflections from last session, beliefs that have changed, utility analysis, investigatory Analysis; Session 6: Welcome and reflections from last session, making counters, hierarchy construction ; Session 7: Welcome and reflections from last session, changing negative beliefs; Session 8: Welcome and reflections from last session, self punishment, using imagery, review of the program, get feedback about the treatment plan Intervention group 2: combination of cognitive therapy with self-management program. Treatment session was comprised of eight 120 min group session . Protocol consisted of cognitive therapy protocol based on Michel Free and the chronic disease self-management program (CDSMP) protocol that originally developed by Lorig et al. Session-by-session outlines are presented: Session 1: Introduction and ground rules, teach ABC model; Session 2: Identifying of automatic thoughts and logical errors, boom and bust over\under activity and exercise, breathing, being more active, goal setting and planning for action; Session 3: Welcome and reflections from last session, identifying negative schema content using the vertical arrow method, give an overview of good nutrition and a rationale for eating better, goal setting and planning for action; Session 4: Welcome and reflections from last session, making a master list of negative beliefs and cognitive maps, using Mind to Manage Symptoms and Distraction, goal setting and planning for action; Session 5: Welcome and reflections from last session , beliefs that have changed, utility analysis, investigatory Analysis, muscle Relaxation, goal setting and planning for action; Session 6: Welcome and reflections from last session, making counters, hierarchy construction; problem-Solving skill, communication Skills, goal setting and planning for action; Session 7: Welcome and reflections from last session, changing negative beliefs; depression management, guided Imagery, goal setting and planning for action; Session 8: Welcome and reflections from last session, self punishment, using imagery, review of the program, get feedback about the treatment plan control group: Control group did not receive any treatment and after the initial eight-week delay, all those in the control group condition received the intervention. Depression. Timepoint: before intervention and two months later. Method of measurement: DASS-21 Questionnaire. Anxiety. Timepoint: before intervention and two months later. Method of measurement: DASS-21 Questionnaire. Aggression. Timepoint: before intervention and two months later. Method of measurement: Aggression Questionnaire (AQ). Pain. Timepoint: before intervention and two months later. Method of measurement: Multidimensional Pain Inventory. Vice chancellor for research Ferdowsi University of Mashhad Approved 2014-06-10 Ethics committee of Ferdowsi University of Mashhad faculty of pschology, Ferdowsi University of Mashhad, Azadi Sq, Mashhad Mashhad Iran (Islamic Republic of)