Substance Use DisordersNCT06559631
Adaptation of Community Reinforcement Approach for the Treatment of Drug Addiction
A study testing Indigenously Adapted CRA in people with Substance Use Disorders and Comorbidities and Coexisting Conditions, run by Muhammad Saghir at 2 sites in Pakistan.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Substance Use Disorders, Comorbidities and Coexisting Conditions
- What is being tested?
- Indigenously Adapted CRA
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 2 sitesPakistan
- Study dates
- 4 Feb 2022to 25 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patient admitted for treatment of drug addiction with or without comorbid psychological disorders.
Who cannot join
- Patient with no history of drug abuse.
Trial locations and contacts
2 sites in 1 country.
Pakistan2 sites
Hayat Rehab Clinic (HRC)
Islamabad, 46500
Islamabad Rehab Clinic (IRC)
Islamabad, 46500
About this study
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.
Read the 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.
- Being tested
- Indigenously Adapted CRA
- Keywords
- Substance Use Disorders, Treatment Model, Comorbid Mental Disorders, Residential Treatment
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indigenously Adapted CRABehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Experimental | 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. Receives: Behavioral: Indigenously Adapted CRA |
| Control Group: Treatment as usual | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Recovery
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.
Measured: 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 outcomes (1)
Comorbidities
comorbidities associated with substance use disorders will also be included and measured through Symptoms checklist-90 (SCL-90), 5 point rating scale.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start4 Feb 2022
- Primary completion25 Jul 2023
- Study completion25 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Research design of the study shall consists two-arms, single-blind randomized controlled trial (RCT). While Randomized Control Trial (RCT) shall consists of two groups: Active Treatment (AT) group and Control group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Saghir
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Saghir, International Islamic University, Islamabad
- Investigators
- Dr. Mazhar Iqbal Bhatti, Study chair, International Islamic University, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559631
- Sponsor's protocol ID
- Adaptation of CRA
- Status last verified
- Aug 2024
- First submitted
- 31 Jan 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptation of Community Reinforcement Approach for the Treatment of Drug Addiction
- ClinicalTrials.gov ID
- NCT06559631
- Acronym / sponsor ID
- Adaptation of CRA
- Keywords
- Substance Use Disorders, Treatment Model, Comorbid Mental Disorders, Residential Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Muhammad SaghirUniversity, hospital or other
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 25 Jul 2023 (actual)
- Study completion
- 25 Jul 2023 (actual)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Research design of the study shall consists two-arms, single-blind randomized controlled trial (RCT). While Randomized Control Trial (RCT) shall consists of two groups: Active Treatment (AT) group and Control group
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Experimental | Behavioral: Indigenously Adapted CRAExperimental 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. |
| Control Group: Treatment as usual | No intervention | –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. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patient admitted for treatment of drug addiction with or without comorbid psychological disorders.
Key exclusion criteria (1 listed)
- Patient with no history of drug abuse.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indigenously Adapted CRATreatment 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. | Behavioural | Treatment Group |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2024.
- this is the link of a cite facility, Islamabad Rehab ClinicLink provided by the sponsor.
- this is the link of a cite facility, Hayat Rehab ClinicLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Mazhar Iqbal Bhatti study chair
International Islamic University, Islamabad
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indigenously Adapted CRA in people with Substance Use Disorders and Comorbidities and Coexisting Conditions, run by Muhammad Saghir at 2 sites in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2024.