TreatmentCaGCBT-SUDsNCT06462131
Culturally Adapted Group Cognitive Behavior Therapy (CaGCBT-SUDs) for Substance Use Disorders and Their Caregivers
A study testing Cultural Adapted Group cognitive Behaviroal therapy (CaGCBT) in people with Treatment and Waitlist, run by National University of Modern Languages at 5 sites in Pakistan.
Trial summary
Pakistan is facing a massive rise in drug abuse. According to recent estimates, there are 6.7 million drug abusers, of which 4.25 million are drug dependents who need long-term treatments in residential setups. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- What is being tested?
- Cultural Adapted Group cognitive Behaviroal therapy (CaGCBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 5 sitesPakistan
- Study dates
- 21 Dec 2022to 31 Dec 2024
- 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 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosed individuals with substance use disorder within the age bracket of 18-64 years.
- In-patient of rehabilitation center and detoxified for 2 months
- Able to give written informed consent
- Able to read and speak Urdu
Who cannot join
- Presence of a diagnosed physical or intellectual disability as it can prevent individuals from engaging with the intervention. This will be assessed by the research team at screening stage. Any disabilities will be identified by a relevant clinician (e.g., Psychiatrist).
- Temporary resident unlikely to be available for follow-up
- Being detoxified less than 2 months
- Individuals with substance use disorder having follow up with rehabilitation center
- Having Comorbidity with psychological disturbances like depression, anxiety etc.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Pakistan5 sites
ANF rehabilitation Centre
Islamabad, Islamabad, 45000
Parwarish Rehabilitation centre
Karachi, Sindh, 05444
Life Care International Hospital
Lahore, Punjab Province, 05450
Dr. Mian Iftekhar Psychiatry Hospital
Peshawar, KPK, 25000
BMC Psychiatry
Quetta, Balochistan, 87300
About this study
Official title: Effectiveness of Culturally Adapted Group Cognitive Behavior Therapy on Adults With Substance Use Disorders and Their Caregivers: A Randomized Control Trial From Pakistan
Pakistan is facing a massive rise in drug abuse. According to recent estimates, there are 6.7 million drug abusers, of which 4.25 million are drug dependents who need long-term treatments in residential setups. Despite these shocking statistics, there is a severe lack of evidence-based treatment, preventive measures, and drug indictment policies. Consequently, the number of drug dependents continues to increase at an alarming rate of 40,000 per year, making Pakistan one of the most drug-affected countries in the world. The ever-increasing rise in drug abuse can be devastating for a country such as Pakistan where the youth population (aged <30 years) makes up a substantial 64% of the total population. It not only affects the individual's physical and mental health but also casts devastating effects on the psycho-social and economic aspects of their lives. Adults with Substance Use Disorders (SUDs) usually come across aggravated interpersonal and family problems, loss of productivity and unemployment, poverty and crimes, overall financial problems, deaths, and accidents. Furthermore, it also destroys the norms, morality, worth, and dignity of the person's well-being and effectiveness in the growth of society. Numerous studies in Pakistan showed a lack of evidence-based treatment altogether for adults suffering from SUDs. Thus, effective interventions for SUDs that also meet the clinical reality of open treatment groups are much needed to reduce the treatment gap. Further, the implementation of evidence-based approaches like Cognitive Behavior Therapy (CBT) has an advantage with SUDs clients who are motivated. The proposed project aims at the cultural adaptation of CBT-based group intervention for adults with substance use disorders (SUDs) in Pakistan by employing a Quasi-Experimental research design, followed by Randomized Control Trials to test its effectiveness in Pakistan.
Read the detailed description
Substance use has life-long impacts not only on an individual life but on their families as well. Research indicates a surge in substance use disorders in the last two decades across the globe and Pakistan has no exception. UNDP's report on drug/substance use indicates alarming prevalence rates. Furthermore, the research identifies that substance use disorder has unfavorable effects individual's quality of life and well-being. SUD places significant strain on family members and involving family caregivers in the treatment plan for opioid addiction has led to negative outcomes for the caregiver, such as depression and caregiver burden. Several researchers found that families of individuals with SUDs experience economic burden, social isolation, psychological strain, shame, embarrassment, guilt, self-blame, marital problems, and threats to their physical health. Therefore, it is important to treat SUDs as well as the burden of caregiving.
Many treatment modules have been developed to treat SUDs. Among them, group therapy was found more effective than individual therapy. CSAT lists five effective group therapy models: (1) psychoeducational groups, (2) skill development groups, (3) cognitive-behavior or problem-solving groups, (4) support groups, and (5) interpersonal groups. Furthermore, a lot of treatment modules for SUDs have been in practice. Among them, group therapy was found to be most effective in treating psychiatric or psychological issues. Furthermore, group CBT was found as effective as individual CBT. Cognitive therapy attempts to reduce excessive emotional reactions and self-defeating behaviors that are prevalent in adults with substance use disorders by modifying faulty and erroneous thinking and maladaptive beliefs that underlie these reactions. CBT for SUDs developed by Liese \& Beck is based on a collaborative (trust-building), active, based on open-ended questions to a large degree, highly structured, and focused approach that gives more advantages to this therapy as compared to other therapy modalities.
Cognitive Behavior Therapy helps adults with substance use disorders to overcome their problems leading to emotional distress and helps them to visualize in a broader perspective their dependence on drugs of their choice for pleasure / or relief of discomfort. Moreover, CBT also helps to reduce the intensity and frequency of the urges by addressing their underlying beliefs and teaching them relevant techniques to not only control and manage their urges but also help them remain abstinent from the use of drugs, manage their daily life problems and thus have a more enjoyable and fulfilling life.
The following research project is based on the Cognitive-behavioral Model of problem-solving because it is a goal-directed approach that focuses on the current position of patients and mainly targets the patient's maladaptive cognitive, behavioral, and emotional patterns. Additionally, CBT techniques and planning of treatment particularly target the patient's core beliefs. If the patient's illogical beliefs change into logical and rational beliefs, the patient starts to believe that he can cope with his problems and that his problems are manageable. Core beliefs, underlying assumptions, and even the content of automatic thoughts vary across cultures. Cultural and sub-cultural backgrounds also influence beliefs about well-being, causes of illness and its cure, help-seeking behaviors, healing systems, and even the healers. The group therapy for SUDs has been developed in the West, therefore, by culturally adapting the intervention, benefits can be broadened in areas other than the West. In Pakistan, CBT has been culturally adapted for internalizing disorders such as depression and anxiety. There is a dearth of research that focuses on cultural adaptation of Group CBT especially for individuals diagnosed with SUDs.
Keeping in the backdrop to the premise, our focal point of the study would be to culturally adapt group CBT for Substance Use Disorders by Liese and Beck and to check its effectiveness on adults with substance use disorders. Further to check the effectiveness of culturally adapted CBT to treat depression and anxiety symptoms in the caregivers of SUDs in Pakistan.
- Being tested
- Cultural Adapted Group cognitive Behaviroal therapy (CaGCBT)
- Keywords
- Group CBT, SUDs, Cultural Adaptation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cultural Adapted Group cognitive Behaviroal therapy (CaGCBT)Behavioural
In first session, introduction of the therapist/facilitator and group members will be made. Group rules will be discussed with members. Group members' introduction primarily focuses on participant/clients' expectations, addictive behaviors and its status, and goals. Moreover, it also emphasize on identification of any other significant issue that is contributing in burden of disease.
| Study group | Role | What they receive |
|---|---|---|
| CaGCBT with TAU | Experimental | In this group, CaGCBT-SUD along with TAU will be provided. Receives: Behavioral: Cultural Adapted Group cognitive Behaviroal therapy (CaGCBT) |
| CBTAG with TAU and with caregivers | Active comparator | In this group, CaGCBT-SUD along with TAU will be provided. Moreover caregivers will be provided psychoeducation Receives: Behavioral: Cultural Adapted Group cognitive Behaviroal therapy (CaGCBT) |
| No intervention only TAU | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Addiction Severity Index-Lite Version
The ASI covers the following areas: medical, employment/support, drug and alcohol use, legal, family/social, and psychiatric. The ASI obtains lifetime information about problem behaviors, as well as problems within the previous 30 days. The ASI-Lite contains 22 fewer questions than the ASI, and omits items relating to severity ratings, and a family history grid. The higher a subject scores on the ASI, the greater the indication of a need for treatment.
Measured: Upto 8-12 weeks
Revised Mental Health Inventory- 5
The MHI-5 was developed for its use with the general population, and it includes items on psychological well-being. The total score ranges from 0 to 15, with higher scores indicating better mental health.
Measured: Upto 8-12 weeks
The Readiness to Change Questionnaire
designed to assess stages of change in substance abusers, in terms of the Prochaska and DiClemente stages of change model. The score ranges for each scale is -10 through 0 to +10. Score towards positive end indicates patients' readiness to change.
Measured: Upto 8-12 weeks
Secondary outcomes (5)
Relapse Risk Scale
It is a 44-item self-report multidimensional instrument, which proposes to measure relapse risk among substance dependents. Lower scores indicate low risk of relapse while high scores are indicative of higher risk of relapse.
Measured: Upto 8-12 weeks
Coping Strategies Scale
The CSS is comprised of 48 items intended to tap potential coping strategies that might be used by patients in to remain abstinent. Respondents rate the frequency (from 1 = never to 4 = frequently) of using specific strategies in the past 3 months. Total coping on the CSS was calculated by taking the mean across all 48 items.
Measured: Upto 8-12 weeks
WHO Quality of Life- Brief version
It consists of 24 items to assess perception of quality of life in four domains, including physical health, psychological, social relationships and environment, and two items on overall QOL and general health. A higher score indicated a better quality of life.
Measured: Upto 8-12 weeks
Subjective Well-being Scale
Subjective well-being will be measured by using following three scales: 1. PANAS (Use 5 point Likert scale to identify the positive or negative emotion experienced across week); 2. SWL(measures individuals' global cognitive judgments of their life as a whole in relation to a self-imposed ideal using five items (e.g., "In most ways my life is close to my ideal") and a seven point Likert scale (1 = strongly disagree, 7 = strongly agree); 3. HLS (assess a person's global sense of harmony in life and consists of five statements (e.g., "My lifestyle allows me to be in harmony") for which respondents are asked to indicate degree of agreement on a seven-point Likert scale (1 = strongly disagree, 7 = strongly agree).
Measured: Upto 8-12 weeks
Family Burden Interview Schedule
It has 24 items each rated on a three-point scale: 0, no burden; 1. moderate burden; and 2, severe burden.
Measured: Upto 8-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2024
- Study start21 Dec 2022
- Primary completion30 Jun 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TreatmentStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Modern Languages
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anila Sadaf, PhD, Principal investigator, NUMLRizwana Amin, Study director, Bahria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06462131
- Sponsor's protocol ID
- Ref No.20-16628/NRPU/R&D/HEC/
- Acronym
- CaGCBT-SUDs
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2024
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Culturally Adapted Group Cognitive Behavior Therapy on Adults With Substance Use Disorders and Their Caregivers: A Randomized Control Trial From Pakistan
- ClinicalTrials.gov ID
- NCT06462131
- Acronym / sponsor ID
- CaGCBT-SUDs / Ref No.20-16628/NRPU/R&D/HEC/
- Keywords
- Group CBT, SUDs, Cultural Adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- National University of Modern LanguagesUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 17 Jun 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.
Pakistan is facing a massive rise in drug abuse. According to recent estimates, there are 6.7 million drug abusers, of which 4.25 million are drug dependents who need long-term treatments in residential setups. Despite these shocking statistics, there is a severe lack of evidence-based treatment, preventive measures, and drug indictment policies. Consequently, the number of drug dependents continues to increase at an alarming rate of 40,000 per year, making Pakistan one of the most drug-affected countries in the world. The ever-increasing rise in drug abuse can be devastating for a country such as Pakistan where the youth population (aged <30 years) makes up a substantial 64% of the total population. It not only affects the individual's physical and mental health but also casts devastating effects on the psycho-social and economic aspects of their lives. Adults with Substance Use Disorders (SUDs) usually come across aggravated interpersonal and family problems, loss of productivity and unemployment, poverty and crimes, overall financial problems, deaths, and accidents. Furthermore, it also destroys the norms, morality, worth, and dignity of the person's well-being and effectiveness in the growth of society. Numerous studies in Pakistan showed a lack of evidence-based treatment altogether for adults suffering from SUDs. Thus, effective interventions for SUDs that also meet the clinical reality of open treatment groups are much needed to reduce the treatment gap. Further, the implementation of evidence-based approaches like Cognitive Behavior Therapy (CBT) has an advantage with SUDs clients who are motivated. The proposed project aims at the cultural adaptation of CBT-based group intervention for adults with substance use disorders (SUDs) in Pakistan by employing a Quasi-Experimental research design, followed by Randomized Control Trials to test its effectiveness in Pakistan.
Detailed description
Substance use has life-long impacts not only on an individual life but on their families as well. Research indicates a surge in substance use disorders in the last two decades across the globe and Pakistan has no exception. UNDP's report on drug/substance use indicates alarming prevalence rates. Furthermore, the research identifies that substance use disorder has unfavorable effects individual's quality of life and well-being. SUD places significant strain on family members and involving family caregivers in the treatment plan for opioid addiction has led to negative outcomes for the caregiver, such as depression and caregiver burden. Several researchers found that families of individuals with SUDs experience economic burden, social isolation, psychological strain, shame, embarrassment, guilt, self-blame, marital problems, and threats to their physical health. Therefore, it is important to treat SUDs as well as the burden of caregiving.
Many treatment modules have been developed to treat SUDs. Among them, group therapy was found more effective than individual therapy. CSAT lists five effective group therapy models: (1) psychoeducational groups, (2) skill development groups, (3) cognitive-behavior or problem-solving groups, (4) support groups, and (5) interpersonal groups. Furthermore, a lot of treatment modules for SUDs have been in practice. Among them, group therapy was found to be most effective in treating psychiatric or psychological issues. Furthermore, group CBT was found as effective as individual CBT. Cognitive therapy attempts to reduce excessive emotional reactions and self-defeating behaviors that are prevalent in adults with substance use disorders by modifying faulty and erroneous thinking and maladaptive beliefs that underlie these reactions. CBT for SUDs developed by Liese \& Beck is based on a collaborative (trust-building), active, based on open-ended questions to a large degree, highly structured, and focused approach that gives more advantages to this therapy as compared to other therapy modalities.
Cognitive Behavior Therapy helps adults with substance use disorders to overcome their problems leading to emotional distress and helps them to visualize in a broader perspective their dependence on drugs of their choice for pleasure / or relief of discomfort. Moreover, CBT also helps to reduce the intensity and frequency of the urges by addressing their underlying beliefs and teaching them relevant techniques to not only control and manage their urges but also help them remain abstinent from the use of drugs, manage their daily life problems and thus have a more enjoyable and fulfilling life.
The following research project is based on the Cognitive-behavioral Model of problem-solving because it is a goal-directed approach that focuses on the current position of patients and mainly targets the patient's maladaptive cognitive, behavioral, and emotional patterns. Additionally, CBT techniques and planning of treatment particularly target the patient's core beliefs. If the patient's illogical beliefs change into logical and rational beliefs, the patient starts to believe that he can cope with his problems and that his problems are manageable. Core beliefs, underlying assumptions, and even the content of automatic thoughts vary across cultures. Cultural and sub-cultural backgrounds also influence beliefs about well-being, causes of illness and its cure, help-seeking behaviors, healing systems, and even the healers. The group therapy for SUDs has been developed in the West, therefore, by culturally adapting the intervention, benefits can be broadened in areas other than the West. In Pakistan, CBT has been culturally adapted for internalizing disorders such as depression and anxiety. There is a dearth of research that focuses on cultural adaptation of Group CBT especially for individuals diagnosed with SUDs.
Keeping in the backdrop to the premise, our focal point of the study would be to culturally adapt group CBT for Substance Use Disorders by Liese and Beck and to check its effectiveness on adults with substance use disorders. Further to check the effectiveness of culturally adapted CBT to treat depression and anxiety symptoms in the caregivers of SUDs in Pakistan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CaGCBT with TAU | Experimental | Behavioral: Cultural Adapted Group cognitive Behaviroal therapy (CaGCBT)In this group, CaGCBT-SUD along with TAU will be provided. |
| CBTAG with TAU and with caregivers | Active comparator | Behavioral: Cultural Adapted Group cognitive Behaviroal therapy (CaGCBT)In this group, CaGCBT-SUD along with TAU will be provided. Moreover caregivers will be provided psychoeducation |
| No intervention only TAU | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosed individuals with substance use disorder within the age bracket of 18-64 years.
- In-patient of rehabilitation center and detoxified for 2 months
- Able to give written informed consent
- Able to read and speak Urdu
Key exclusion criteria (5 listed)
- Presence of a diagnosed physical or intellectual disability as it can prevent individuals from engaging with the intervention. This will be assessed by the research team at screening stage. Any disabilities will be identified by a relevant clinician (e.g., Psychiatrist).
- Temporary resident unlikely to be available for follow-up
- Being detoxified less than 2 months
- Individuals with substance use disorder having follow up with rehabilitation center
- Having Comorbidity with psychological disturbances like depression, anxiety etc.
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 |
|---|---|---|
| Cultural Adapted Group cognitive Behaviroal therapy (CaGCBT)In first session, introduction of the therapist/facilitator and group members will be made. Group rules will be discussed with members. Group members' introduction primarily focuses on participant/clients' expectations, addictive behaviors and its status, and goals. Moreover, it also emphasize on identification of any other significant issue that is contributing in burden of disease. | Behavioural | CBTAG with TAU and with caregivers, CaGCBT with TAU |
Primary outcome
Addiction Severity Index-Lite Version
Time frame: Upto 8-12 weeks
The ASI covers the following areas: medical, employment/support, drug and alcohol use, legal, family/social, and psychiatric. The ASI obtains lifetime information about problem behaviors, as well as problems within the previous 30 days. The ASI-Lite contains 22 fewer questions than the ASI, and omits items relating to severity ratings, and a family history grid. The higher a subject scores on the ASI, the greater the indication of a need for treatment.
Revised Mental Health Inventory- 5
Time frame: Upto 8-12 weeks
The MHI-5 was developed for its use with the general population, and it includes items on psychological well-being. The total score ranges from 0 to 15, with higher scores indicating better mental health.
The Readiness to Change Questionnaire
Time frame: Upto 8-12 weeks
designed to assess stages of change in substance abusers, in terms of the Prochaska and DiClemente stages of change model. The score ranges for each scale is -10 through 0 to +10. Score towards positive end indicates patients' readiness to change.
5 secondary outcomes
Relapse Risk Scale
Time frame: Upto 8-12 weeks
Coping Strategies Scale
Time frame: Upto 8-12 weeks
WHO Quality of Life- Brief version
Time frame: Upto 8-12 weeks
Subjective Well-being Scale
Time frame: Upto 8-12 weeks
Family Burden Interview Schedule
Time frame: Upto 8-12 weeks
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 17 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Anila Sadaf, PhD principal investigator
NUML
Rizwana Amin study director
Bahria University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cultural Adapted Group cognitive Behaviroal therapy (CaGCBT) in people with Treatment and Waitlist, run by National University of Modern Languages at 5 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 4 inclusion and 5 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 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Addiction Severity Index-Lite Version (time frame: Upto 8-12 weeks). The study lists 3 primary outcomes in all. 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 17 Jun 2025.