The aim of this study is a clinical trial to investigate the Processes of change in psychological flexibility in an interdisciplinary group-based treatment for chronic backache based on Acceptance and Commitment Therapy (ACT) by using per and post-test. Participants are 28th of patients who attended treatment at pain clinic of Razi hospital in Rasht. Participants are clinically have chronic backache under the assessment of a specialist and the observation inclusion and exclusion criteria for the study will be checked. Participants completed an assessment instrument before treatment which was included MPQ( McGill Pain questionnaire) for collecting the data. The inclusion criteria of this study were informed consent for participating in group treatment, no drug consumer, no psychiatric disorders ,no absence more than one session will make the participants leave the study.. This study will be set up during 8 sessions of 90 minutes and the intervention will be according to manual of kevin.Evowles john T sorell included training of skills like mind fullness exercises and chronic pain acceptance. Effectiveness of treatment will be assessing by McGill Pain questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201206039934N1
Registration date:2017-05-01, 1396/02/11
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-05-01, 1396/02/11
Registrant information
Name
Robabeh Soleimani Talemi
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 981333666268
Email address
soleimani_dr@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
University Of Medical Sciences Guilan,Vice chancellor for research
Expected recruitment start date
2017-04-09, 1396/01/20
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial of effectiveness of acceptance and commitment therapy for patients with chronic low back pain
Public title
Clinical trial of effectiveness of acceptance and commitment therapy for patients with chronic low back pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: no drug consumer; no psychiatric disorders; completed high school; participants have no absence more than one session. Exclusion criteria: psychiatric disorders; drugs or alcohol consumption; smoking cigarette.
Age
From 30 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Block Randomization: In this study after obtaining informed consent from qualified individuals, these people will be divided randomly into two groups. This means that patients who entered the study will be randomly assigned number. This number identifies a person in one group will arrive.
Secondary Ids
1
Registry name
-
Secondary trial Id
-
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Ethics committee of Guilan University of Medical Sciences,Shahid Beheshti Blvd,Opposite to the Sepah bank, Above Iran Radiator Representation. Building Of Assistance Research and Technology, Rasht, Iran
City
Rasht
Postal code
4193893345
Approval date
2017-01-14, 1395/10/25
Ethics committee reference number
IR.GUMS.REC.1395.308
Health conditions studied
1
Description of health condition studied
Low back pain
ICD-10 code
M54.5
ICD-10 code description
Low back pain
Primary outcomes
1
Description
Low back pain
Timepoint
before the treatment and two week after the treatment and three month after the treatment
Method of measurement
McGill Pain questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: changes in individual function and reduction of chronic pain and commitment to the actions which helps them to reach the clarified values .Session 1: Introduction and the Treatment Agenda(-Providing the opportunity for patients to become familiar with each other and the treatment aims.;-Determine the change agenda through the use of a “creative hopelessness”;Exercise.;-Homework.).Session 2: Behavior Change and Mindfulness (-Potential Values and an Issue of Choice.;-Introduce the behavioral model and the concept of behavior change.;-Mindfulness Practice; Homework.).Session 3: Values (-“Acceptance”.;-Values.-Mindfulness.;–Homework). Session 4: Values Clarification and Goals(-Values Clarification;-Barriers.;-Goal Setting and Introducing Committed Action.;-Mindfulness.;-Homework.). Session 5: Defusion (- Homework Review and Pacing.;-Defusing the threats of language.; -Mindfulness.; -Homework).Session 6 – Committed Action (-Treatment review.;-Committed action.;-Mindfulness and Observing Self-Exercises.;-Homework).Session 7 – Willingness(- Primary and secondary suffering;-Commitment and barriers to willingness.; -Walking Mindfulness. ; -Homework). Session 8: Wrap-up & Conclusions (- Values clarification).
Category
Other
2
Description
Contro Group: After completing the research and data collection in brief interventions will have a plan in 4 sessions.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi university Center Specialty and Subspecialty of Psychiatry Clinic of Rasht
Full name of responsible person
Dr Robabeh Soleimani
Street address
Razi university Center Specialty and Subspecialty of Psychiatry Clinic of Rasht, Sardarjangal Avenue, Razi Hospital,Rasht, Iran
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University Of Medical Sceinces Guilan,Vice chancellor for research
Full name of responsible person
Dr Shadman Nemati
Street address
University Of Medical Sceinces Guilan,Vice chancellor for research,Shahid Beheshti Blvd, Opposite to the Sepah Bank, above Iran Radiator Representation، Rasht, Iran
City
Rasht
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University Of Medical Sceinces Guilan,Vice chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Guilan University Of Medical Sciences
Full name of responsible person
Dr Robabeh Soleimani
Position
Psychiatrist, Associate Professor
Other areas of specialty/work
Street address
Guilan University Of Medical Sciences,15 khordad avenue, Shafa Hospital, Rasht, Iran
City
Rasht
Postal code
4193955599
Phone
+98 13 3366 6268
Fax
+98 13 3366 6268
Email
soleimani.dr@ gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University Of Medical Sciences
Full name of responsible person
Dr Robabeh Soleimani
Position
Psychiatrist, Associate Professor
Other areas of specialty/work
Street address
Guilan University Of Medical Sciences,15 khordad avenue, Shafa Hospital, Rasht, Iran
City
Rasht
Postal code
4193955599
Phone
+98 13 3366 6268
Fax
+98 13 3366 6268
Email
soleimani.dr@ gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University Of Medical Sciences
Full name of responsible person
Zinat sadat Mirpoor
Position
Counselling PhD Student
Other areas of specialty/work
Street address
Guilan University Of Medical Sciences,Razi university Center Specialty and Subspecialty of Psychiatry Clinic of Rasht, Sardarjangal Avenue, Razi Hospital,Rasht, Iran
City
Rasht
Postal code
41448
Phone
+98 13 3354 1001
Fax
+98 13 3366 6268
Email
zinat.mirpoor@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)