- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06559631
Adaptation of Community Reinforcement Approach for the Treatment of Drug Addiction
Central idea of the study is to adapt a treatment program for drug addiction treatment indigenously and relapse prevention, and to establish its efficacy.
This study helps the society to have an evidence-based approach with proven efficacy to deal with drugs related issues in Pakistan along with minimizing the rate of relapse which is the major issue with current disease model for treatment of addiction in different rehabs within the country.
Present study's aim is to adapt culturally and islamically a robust treatment protocol: Reinforcement Approach (CRA) through randomized control trial to determine its efficacy in the field of drug addiction rehabilitation. Moreover, CRA is also be used with comorbid psychological illnesses. Because, in the treatment facilities disease model is currently prevailing which lacks empirical evidence, and they do not have proven efficacy.
Study Overview
Status
Intervention / Treatment
Detailed Description
In this study CRA is adapted and prepared as a protocol for residential treatment for drug addiction and drug induced psychosis as well. Intervention is applied to patients admitted to Islamabad Rehab Clinic (IRC). 90 days treatment plan is developed based on CRA interventions along with religious interventions. These religious interventions are based on Islamically Integrated psychotherapy. After discharge from the treatment every participant will be monitored for next 3 months through follow up session with patient and caregivers as well.
In CRA, face to face interaction is required for intervention including 8 sessions for focuses on the reality of client's social environment so that for learning real life opportunities could be focused as per client needs to enhance engagement and learning.
For internal motivation and involvement in CRA, adaptations were added to enhance CRA's effectiveness. There were two major adaptations in CRA to make it accord with the cultural relevant with the targeted population. First adaptation is based on religion Islam. It includes several sections, and these sections are adapted in CRA's counseling goals. In first section morality is being adapted with CRA, morality is about the Islamically integrated ways about hygiene, sleep, eating, clothes, meeting others, physical health, happiness and sadness related. Second section is related to internal framework of human psyche, which comprises of Cognition (Aql), Behavioral inclination (Nafs), Sprit (Ruh), Emotion (Ihsaas) and Heart (Qalb). In third section principle of change and tazkia e nafs. There are three stages in principle of change: 1.Inkishaf, 2. Itidal and 3. Itehad.
Second adaptation is about the effective coping skills related therapeutic intervention, which is comprises of four distinctive categories such as emotional management, interpersonal effectiveness: assertiveness, habit formation and relapse prevention counseling.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Islamabad, Pakistan, 46500
- Hayat Rehab Clinic (HRC)
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Islamabad, Pakistan, 46500
- Islamabad Rehab Clinic (IRC)
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patient admitted for treatment of drug addiction with or without comorbid psychological disorders.
Exclusion Criteria:
- Patient with no history of drug abuse.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment Group
Experimental group will receive the indigenously adapted Community Reinforcement Approach based psychotherapeutic sessions after the completion of drugs related detoxification (after 21 days since hospitalization) for 90-120 days in residential treatment.
|
Treatment group will receive psychotherapy based on CRA which is an evidence based approach.
This adapted version of CRA also consists emotional management, behavioral interventions, drug addiction treatment and islamically integrated psychotherapy for drug addiction and comorbid mental disorders.
|
|
No Intervention: Control Group: Treatment as usual
This group will receive treatment as usual which includes detoxification of drugs, general counselling for drug addiction prevention, 12 steps program and life skills training.
Duration of residential treatment is between 90-120 days.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recovery
Time Frame: First assessment will be conducted at the time of admission which will be completed till 21 days after admission. Second assessment after 120 days at the time of discharge. Third outcome measure during the follow up at the sixth month after discharge.
|
Staying in abstinence from the drug of abuse.
Recovery will be measured through Addiction Recovery Questionnaire (ARQ), this is a 4 point rating scale which measures normal living, abstinence and positive expectancy as recovery's subscales.
|
First assessment will be conducted at the time of admission which will be completed till 21 days after admission. Second assessment after 120 days at the time of discharge. Third outcome measure during the follow up at the sixth month after discharge.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comorbidities
Time Frame: First assessment will be conducted at the time of admission which will be completed till 21 days after admission. Second assessment after 120 days at the time of discharge. Third outcome measure during the follow up at the sixth month after discharge.
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comorbidities associated with substance use disorders will also be included and measured through Symptoms checklist-90 (SCL-90), 5 point rating scale.
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First assessment will be conducted at the time of admission which will be completed till 21 days after admission. Second assessment after 120 days at the time of discharge. Third outcome measure during the follow up at the sixth month after discharge.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Dr. Mazhar Iqbal Bhatti, International Islamic University, Islamabad
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Adaptation of CRA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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