Psychological StressNCT06840184
Culturally Adapted Cognitive Behavioral Therapy Based Self Help Intervention for Mental Health of Caregivers of Individuals With Substance Use: A Randomized Controlled Trial
A study testing Cognitive Behavioral Therapy based Intervention in people with Psychological Stress and Quality of Life (QOL), run by Fatima Jinnah Women University at 1 site in Pakistan.
Trial summary
The primary purpose of this study is to investigate whether Cognitive Behavioral Therapy based Self- Help Intervention can significantly reduce emotional problems as well as improve the mental well being and quality of life among the caregivers of individuals with substance use. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Stress, Quality of Life (QOL), Mental Health
- What is being tested?
- Cognitive Behavioral Therapy based Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Aug 2024to 15 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals aged 18 and above.
- Those who will have burden and distress above the normal levels on respective scales during baseline assessment.
- Capable of providing written informed consent.
- Residing within the catchment areas of the participating rehabilitation center.
Who cannot join
- Individuals unable to provide consent due to severe mental or physical illness.
- Individuals not capable of reading and comprehending Urdu versions of the intervention manual and scales.
- Unlikely to be accessible for outcome assessments due to temporary residence.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Islah drug Rehabilitation Center
Rawalpindi, Punjab Province, 46000
About this study
The primary purpose of this study is to investigate whether Cognitive Behavioral Therapy based Self- Help Intervention can significantly reduce emotional problems as well as improve the mental well being and quality of life among the caregivers of individuals with substance use. The study aims to contribute to the existing literature by providing evidence on the efficacy of the above mentioned therapy. This can be helpful in improving clinical practices and treatment outcomes.
Read the detailed description
The current quantitative study comprises of two phases. Pilot study for translation and validation of scales were done as a preliminary step. The first phase was a cross-sectional survey to screen out potential caregivers of substance users, with depression, anxiety and stress, higher than the normal level. A randomized controlled trial (RCT) was done in the second phase, where caregivers of substance users who had higher level of psychological distress, were categorized into two groups; control group and intervention group through randomization. Cognitive Behavioral Therapy based intervention (Self- Help Manuel named, "Khushi aur Khatoon") was provided to the intervention group in 4-6 individual and face to face sessions. Control group did not receive therapy ( on request of some of the members of control group, therapy was provided after the completion of the study). Pre and post- assessment of the study variables were done for both control and intervention groups. Difference between pre and post assessment was compared to investigate the effectiveness of Cognitive Behavioral Therapy based intervention ("Khushi aur Khatoon") among caregivers of substance users.
- Conditions
- Psychological Stress, Quality of Life (QOL), Mental Health
- Being tested
- Cognitive Behavioral Therapy based Intervention, No intervention
- Keywords
- Khushi Aur Khatoon, CBT Self Help intervention
- Medical subject headings
- Stress, Psychological, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy based InterventionBehavioural
Session 1: Introduction of CBT, Relationship between events, thoughts and behavior.
Session 2: Psychoeducation about the vicious circle of inactivity and depression, Ladder technique for task management.
Session 3: Problem solving techniques and discussion about them, Decision making techniques through "Advantages/ Disadvantages" chart.
Session 4: Identifying positive and negative emotions, Cognitive errors were explained.
Session 5: Identifying negative thoughts through Socratic questioning, Finding evidence for and against the thoughts, Challenging negative thought, Cracking firm irrational beliefs.
Session 6: Cognitive restructuring techniques, Finding alternative thoughts.
No interventionOther
No intervention was provided to the control group, except for a few members who requested for the therapy, that too after the post assessment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group which received intervention | Experimental | The experimental group was provided with CBT Self- help Intervention (Khushi aur Khatoon), a 4-6 weeks program for improvement of emotional resilience and mental well- being. Receives: Behavioral: Cognitive Behavioral Therapy based Intervention |
| Control Group | Active comparator | No intervention was provided to the control group, except for a few members who requested for the therapy, that too after the post assessment. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
DASS- 21 (Urdu)
This scale has 21- Items comprising of 3 subscales, designed to assess emotional states related to depression, anxiety, and stress (7 items each). Higher scores on the scale indicate higher levels of psychological distress and low scores indicate low psychological distress.
Measured: 3 months
Quality of Life Questionnaire (Urdu)
It is a 15-item instrument consisting of four domains: physical health, psychological health, social relationships, and environmental health; it also contains QOL and general health items. Higher score on QOLQ represents higher quality of life, whereas low scores depict low quality of life.
Measured: 3 months
Caregivers' Burden Questionnaire (Urdu)
This scale measures two aspects of burden (objective and subjective) comprising of 6 items each. This scale encompasses financial burden, disruption of routine family activities, family leisure, family interactions, and effect on physical and mental health of caregivers. Higher score on Caregivers' Burden Questionnaire represents higher level of burden caregivers, whereas low scores depict low caregivers' burden
Measured: 3 months
Warwick- Edinburgh Mental Well- Being Scale (Urdu)
The 14- items scale covers subjective well- being and psychological functioning. Higher score on the scale represents higher level of mental well- being, whereas low scores depict low mental well- being.
Measured: 3 months
Secondary outcomes (1)
Role Burden Scale (Urdu)
It measures the psychological as well as physical burden on a person due to performing multiple roles in their daily routine. Only "Item # 1" has to be scored in reverse manner. Higher score on Role Burden Scale represents higher burden on the participant due to holding multiple roles, whereas low scores depict low role burden
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2025
- Study start20 Aug 2024
- Primary completion15 Dec 2024
- Study completion15 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Psychological StressStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatima Jinnah Women University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jawairia Zia, Fatima Jinnah Women University
- Investigators
- Jawairia Zia, M Phil, Principal investigator, Fatima Jinnah Women University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06840184
- Sponsor's protocol ID
- FJWU/EC/2025/103
- Status last verified
- Feb 2025
- First submitted
- 17 Feb 2025
- Last updated
- 21 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to ethical concerns, data will not be shared. All research findings will be published in aggregate form maintaining anonymity of the participants.
Publications
Amin R, Iqbal A, Naeem F, Irfan M. Effectiveness of a culturally adapted cognitive behavioural therapy-based guided self-help (CACBT-GSH) intervention to reduce social anxiety and enhance self-esteem in adolescents: a randomized controlled trial from Pakistan. Behav Cogn Psychother. 2020 Sep;48(5):503-514. doi: 10.1017/S1352465820000284. Epub 2020 May 26.
PubMed 32450939
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Adapted Cognitive Behavioral Therapy Based Self Help Intervention for Mental Health of Caregivers of Individuals With Substance Use: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06840184
- Acronym / sponsor ID
- FJWU/EC/2025/103
- Conditions
- Psychological Stress, Quality of Life (QOL), Mental Health
- Keywords
- Khushi Aur Khatoon, CBT Self Help intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Fatima Jinnah Women UniversityUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 15 Dec 2024 (actual)
- Study completion
- 15 Dec 2024 (actual)
- First posted
- 21 Feb 2025 (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.
The primary purpose of this study is to investigate whether Cognitive Behavioral Therapy based Self- Help Intervention can significantly reduce emotional problems as well as improve the mental well being and quality of life among the caregivers of individuals with substance use. The study aims to contribute to the existing literature by providing evidence on the efficacy of the above mentioned therapy. This can be helpful in improving clinical practices and treatment outcomes.
Detailed description
The current quantitative study comprises of two phases. Pilot study for translation and validation of scales were done as a preliminary step. The first phase was a cross-sectional survey to screen out potential caregivers of substance users, with depression, anxiety and stress, higher than the normal level. A randomized controlled trial (RCT) was done in the second phase, where caregivers of substance users who had higher level of psychological distress, were categorized into two groups; control group and intervention group through randomization. Cognitive Behavioral Therapy based intervention (Self- Help Manuel named, "Khushi aur Khatoon") was provided to the intervention group in 4-6 individual and face to face sessions. Control group did not receive therapy ( on request of some of the members of control group, therapy was provided after the completion of the study). Pre and post- assessment of the study variables were done for both control and intervention groups. Difference between pre and post assessment was compared to investigate the effectiveness of Cognitive Behavioral Therapy based intervention ("Khushi aur Khatoon") among caregivers of substance users.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Parallel Assignment
| Arm | Type | Receives |
|---|---|---|
| Experimental Group which received intervention | Experimental | Behavioral: Cognitive Behavioral Therapy based InterventionThe experimental group was provided with CBT Self- help Intervention (Khushi aur Khatoon), a 4-6 weeks program for improvement of emotional resilience and mental well- being. |
| Control Group | Active comparator | Other: No interventionNo intervention was provided to the control group, except for a few members who requested for the therapy, that too after the post assessment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Individuals aged 18 and above.
- Those who will have burden and distress above the normal levels on respective scales during baseline assessment.
- Capable of providing written informed consent.
- Residing within the catchment areas of the participating rehabilitation center.
Key exclusion criteria (3 listed)
- Individuals unable to provide consent due to severe mental or physical illness.
- Individuals not capable of reading and comprehending Urdu versions of the intervention manual and scales.
- Unlikely to be accessible for outcome assessments due to temporary residence.
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 |
|---|---|---|
| Cognitive Behavioral Therapy based InterventionSession 1: Introduction of CBT, Relationship between events, thoughts and behavior. Session 2: Psychoeducation about the vicious circle of inactivity and depression, Ladder technique for task management. Session 3: Problem solving techniques and discussion about them, Decision making techniques through "Advantages/ Disadvantages" chart. Session 4: Identifying positive and negative emotions, Cognitive errors were explained. Session 5: Identifying negative thoughts through Socratic questioning, Finding evidence for and against the thoughts, Challenging negative thought, Cracking firm irrational beliefs. Session 6: Cognitive restructuring techniques, Finding alternative thoughts. | Behavioural | Experimental Group which received intervention |
| No interventionNo intervention was provided to the control group, except for a few members who requested for the therapy, that too after the post assessment. | Other | Control Group |
Primary outcome
DASS- 21 (Urdu)
Time frame: 3 months
This scale has 21- Items comprising of 3 subscales, designed to assess emotional states related to depression, anxiety, and stress (7 items each). Higher scores on the scale indicate higher levels of psychological distress and low scores indicate low psychological distress.
Quality of Life Questionnaire (Urdu)
Time frame: 3 months
It is a 15-item instrument consisting of four domains: physical health, psychological health, social relationships, and environmental health; it also contains QOL and general health items. Higher score on QOLQ represents higher quality of life, whereas low scores depict low quality of life.
Caregivers' Burden Questionnaire (Urdu)
Time frame: 3 months
This scale measures two aspects of burden (objective and subjective) comprising of 6 items each. This scale encompasses financial burden, disruption of routine family activities, family leisure, family interactions, and effect on physical and mental health of caregivers. Higher score on Caregivers' Burden Questionnaire represents higher level of burden caregivers, whereas low scores depict low caregivers' burden
Warwick- Edinburgh Mental Well- Being Scale (Urdu)
Time frame: 3 months
The 14- items scale covers subjective well- being and psychological functioning. Higher score on the scale represents higher level of mental well- being, whereas low scores depict low mental well- being.
1 secondary outcome
Role Burden Scale (Urdu)
Time frame: 3 months
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 21 Feb 2025.
- Background: PubMed 32450939Amin R, Iqbal A, Naeem F, Irfan M. Effectiveness of a culturally adapted cognitive behavioural therapy-based guided self-help (CACBT-GSH) intervention to reduce social anxiety and enhance self-esteem in adolescents: a randomized controlled trial from Pakistan. Behav Cogn Psychother. 2020 Sep;48(5):503-514. doi: 10.1017/S1352465820000284. Epub 2020 May 26.
- Effectiveness of a culturally adapted cognitive behavioural therapy-based guided self-help (CACBT-GSH) intervention to reduce social anxiety and enhance self-esteem in adolescents: a randomized controlled trial from Pakistan.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Due to ethical concerns, data will not be shared. All research findings will be published in aggregate form maintaining anonymity of the participants.
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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.
Jawairia Zia, M Phil principal investigator
Fatima Jinnah Women University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy based Intervention in people with Psychological Stress and Quality of Life (QOL), run by Fatima Jinnah Women University at 1 site 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 3 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 21 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
DASS- 21 (Urdu) (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06840184, which also lists 1 linked publication.
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 21 Feb 2025; AzTrials last refreshed its copy on 30 Oct 2026.