DepressionNCT06002087
Unified Protocol for Transdiagnostic Treatment for Depression and Anxiety in Adults
A study testing Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in people with Depression and Anxiety, run by National University of Science and Technology, Pakistan at 1 site in Pakistan.
Trial summary
To conduct a pilot randomized controlled trial (RCT) of a culturally adapted Unified Protocol (UP) for transdiagnostic psychological treatment in adults (age 18 and above) with anxiety and/or depression to assess the feasibility and acceptability of UP treatment. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2023to 15 Mar 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥ 18
- suffering from anxious and/or depressive disorder
Who cannot join
- suicide risk at the time of assessment
- comorbidity of pervasive developmental disorder
- comorbidity of psychotic disorders
- severe physical illness
- receiving concurrent psychotherapy
- receiving psychopharmacological treatment
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
National University of Sciences and Technology, Pakistan
Islamabad, Islamabad, 44000
About this study
Official title: Unified Protocol for Transdiagnostic Treatment: An Adaptation and Pilot RCT for the Treatment of Depression and Anxiety in Adults
To conduct a pilot randomized controlled trial (RCT) of a culturally adapted Unified Protocol (UP) for transdiagnostic psychological treatment in adults (age 18 and above) with anxiety and/or depression to assess the feasibility and acceptability of UP treatment.
The main questions it aims to answer are:
Read more
- To assess the estimates of likely recruitment rates including how many approached, volunteered, screened, retained, and complete the treatment and what is the dropout rate?
- To what degree do participants adhere and engage with the treatment procedures?
- To what extent do the participants feel satisfied with the treatment?
- To what degree do participants complete self-report and clinician-administered measures of anxiety, depression, functional impairment, and emotion regulation?
- What is the treatment outcome with regard to emotion regulation, symptoms of anxiety, depression, functional impairment, and emotion regulation?
The participants will be randomized to either the treatment group or the control group. The treatment group will receive 14 sessions of one-on-one individual treatment with the Unified Protocol. The control group will receive no treatment.
Read the detailed description
Most patients with depression and anxiety in low-resource settings don't get evidence-based treatment. Transdiagnostic approaches like UP are promising for these settings because they are multi-problem, modular, flexible, and have low complexity. The present study aimed to investigate the initial acceptability and feasibility of the adapted Unified Protocol (UP) in relation to its quantitative and qualitative effects on attendance, homework compliance, satisfaction, and perceived usefulness of the intervention. Additionally, the study aimed to evaluate the preliminary effects of the adapted UP on depression, anxiety, functional impairment, and emotion regulation among adults suffering from anxiety, depression, and/or comorbidity of both disorders.
A sample size of approximately 50 adults will be recruited from mental health facilities and online dissemination of the study. After screening through the Beck Depression Inventory-II (BDI-II) and Beck Anxiety Inventory (BAI), and assessing the inclusion and exclusion criteria, those who demonstrate moderate to severe scores on the BDI-II and BAI will be further evaluated by the principal investigator using the Structured Clinical Interviews for DSM-5 (Research Version) (SCID-5-RV) to determine their diagnosis. Once the eligibility criteria are met, participants will be randomly assigned to one of two study conditions:
Experimental group: Participants in the experimental group will receive the Unified Protocol (UP) treatment.
Control group: Participants in the control group will be placed on a waitlist and will not receive any treatment until the end of the study.
Participants from both groups will complete several assessment measures at baseline, mid-treatment (only at week 7 of the UP), and post-treatment.
To ensure protocol quality and fidelity, the therapist has a master's degree in Clinical Psychology and two years of previous supervised clinical experience in cognitive behavioral therapy (CBT). The therapist also participated in introductory and intermediate-level training workshops for the Unified Protocol (UP) and received UP Therapist Certification. The therapist has received supervision from the UP-certified psychologist and received 18 weeks of individualized supervision on a course of treatment utilizing the UP. Weekly supervision sessions were conducted via video-conferencing (Zoom), and transcripts of the sessions were reviewed for adherence to the protocol and competence in protocol delivery throughout the course of treatment.
- Conditions
- Depression, Anxiety
- Being tested
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
- Keywords
- Anxiety, Depression, Emotion Regulation, Evidence-Based Treatment, Transdiagnostic
- Medical subject headings
- Depression, Anxiety Disorders, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified Protocol for Transdiagnostic Treatment of Emotional DisordersBehavioural
Also called UP
The current researchers adapted the Unified Protocol (UP) treatment and used the adapted version in this study. UP outlines two complimentary modules for goal setting and psychoeducation followed by five core treatment modules: mindful emotion awareness, cognitive flexibility, countering emotional behaviors, awareness and tolerance of physical sensations, and emotion exposures, and an optional relapse prevention module to help people maintain their gains after treatment.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group: Unified Protocol (UP) | Experimental | Participants will receive 14 weekly individual sessions of 50-60 minutes each using the adapted UP treatment. Receives: Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders |
| Control group: Waitlist Control | No intervention | Participants in the control group will be placed on a waitlist and will not receive any treatment until the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility- Recruitment method
The number of participants recruited by each of the three methods used for recruiting. The methods will be: mental health facilities, online dissemination, and referrals and recommendations.
Measured: 14 weeks
Feasibility- Recruitment rate
To assess the estimates of likely recruitment rates, including:
How many participants approached? How many participants volunteered? How many participants were screened? How many participants were retained in the study? What was the dropout rate? The number of participants completing the final assessment (assessed through a record made at each session).
Measured: 14 weeks
Feasibility- Weekly face-to-face sessions
The nature of barriers that may lead to participants dropping out of treatment can be assessed by examining the number and type of problems that they experienced while attending weekly sessions. These problems include transportation difficulties, work or educational demands, childcare difficulties, scheduling conflicts, and treatment procedures interfering with daily life. Followed by an open-ended question that will assess any other reason to discontinue the treatment.
Measured: 14 weeks
Feasibility: Eligibility criteria
Assessed through the number of participants fulfilling the eligibility criteria from the total number of participants registered, number of ineligible participants, and reasons for ineligibility.
Measured: 14 weeks
Feasibility - Treatment adherence and engagement
Engagement in treatment will be assessed using the Homework Rating Scale-Revised, a 12-item measure that assesses beliefs, consequences, and engagement with treatment homework activities. Total scores range from 0 to 48 on this scale, where higher scores indicate higher commitment to the treatment. Treatment adherence will be further assessed by tracking participant attendance, percentage of intervention completion, and number of sessions completed.
Measured: 14 weeks
Feasibility - Semi-structured Interview for treatment adherence and engagement
Semi-structured questions will be asked by an independent interviewer to assess the reasons for adherence and non-adherence to the treatment.
Measured: 14 weeks
Acceptability of randomization
The number of participants who consented to randomization, number of participants who refused, and reasons for refusal.
Measured: 14 weeks
Acceptability of the treatment
It will be measured through client satisfaction questionnaire. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Measured: 14 weeks
Acceptability of the treatment - Semi-structured interview
Semi-structured interview by an independent interviewer will be conducted to obtain responses on a number of indicators including; Participants' overall satisfaction with the treatment, understand the overall content covered in the treatment, the perceived usefulness of the techniques learned, the discomfort it generated, the likelihood that participants would choose such a treatment again, their recommendation to friends or family, what they found most, what they find least helpful, any modifications they would recommend.
Measured: 14 weeks
Feasibility of outcome measures
Feasibility of outcome measures will be assessed through the assessment completion rates by participants.
Measured: 14 weeks
Secondary outcomes (5)
Beck Depression Inventory-II
It is a 21-item self-report questionnaire to assess depressive symptoms with scores ranging from 0 to 3. Higher scores indicate worse depressive symptoms.
Measured: 14 weeks
Beck Anxiety Inventory
It is a 21-item self-report questionnaire to assess the severity of anxiety symptoms with scores ranging from 0 to 3. Higher scores indicate worse anxiety symptoms.
Measured: 14 weeks
Work and Social Adjustment Scale
It represents a simple measurement of impairment of functioning and consists of 5 items, each rated on an 8-point severity scale adding up to a maximum severity of 40 points. It is validated for use across the full spectrum of psychiatric disorders.
Measured: 14 weeks
Difficulties in Emotion Regulation Scale
It is a 36-item scale with 6 subscales that measure emotion dysregulation and emotional self-regulation strategies. The subscales are non-acceptance of emotional responses, difficulty in performing purposeful behavior, difficulty controlling impulse, lack of emotional awareness, limited access to emotion regulation strategies, and lack of clarity of emotion. The items are scored on a scale of 1 to 5, with higher scores indicating more severe difficulties in emotion regulation.
Measured: 14 weeks
Positive and Negative Affect Schedule
It is a self-report measure that assesses the two broad dimensions of affect: positive affect and negative affect. It is a 20-item scale, and items are rated on a 5-point scale, with higher scores indicating higher experience of those emotions.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Aug 2023
- Primary completion31 Dec 2023
- Study completion15 Mar 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 DepressionStudies 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
- Experimental group: Participants in the experimental group will receive the Unified Protocol (UP) treatment. Control group: Participants in the control group will be placed on a waitlist and will not receive any treatment until the end of the study.
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Science and Technology, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asma Nisa, National University of Science and Technology, Pakistan
- Investigators
- Salma Siddiqui, Study chair, National University of Science and Technology, PakistanAmantia A. Ametaj, Study director, Harvard School of Public Health (HSPH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06002087
- Sponsor's protocol ID
- 0988/Ethic/01/S3H/083/DBS
- Status last verified
- Jun 2025
- First submitted
- 3 Aug 2023
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nisa A, Siddiqui S, Ametaj AA. Feasibility and acceptability of the Unified Protocol for anxiety and depression in Pakistan: a pilot randomized controlled trial. BMC Psychiatry. 2026 Sep 21;26(1):739. doi: 10.1186/s12888-026-08345-x.
PubMed 42768329
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unified Protocol for Transdiagnostic Treatment: An Adaptation and Pilot RCT for the Treatment of Depression and Anxiety in Adults
- ClinicalTrials.gov ID
- NCT06002087
- Acronym / sponsor ID
- 0988/Ethic/01/S3H/083/DBS
- Conditions
- Depression, Anxiety
- Keywords
- Anxiety, Depression, Emotion Regulation, Evidence-Based Treatment, Transdiagnostic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- National University of Science and Technology, PakistanUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 21 Aug 2023 (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.
To conduct a pilot randomized controlled trial (RCT) of a culturally adapted Unified Protocol (UP) for transdiagnostic psychological treatment in adults (age 18 and above) with anxiety and/or depression to assess the feasibility and acceptability of UP treatment.
The main questions it aims to answer are:
- To assess the estimates of likely recruitment rates including how many approached, volunteered, screened, retained, and complete the treatment and what is the dropout rate?
- To what degree do participants adhere and engage with the treatment procedures?
- To what extent do the participants feel satisfied with the treatment?
- To what degree do participants complete self-report and clinician-administered measures of anxiety, depression, functional impairment, and emotion regulation?
- What is the treatment outcome with regard to emotion regulation, symptoms of anxiety, depression, functional impairment, and emotion regulation?
The participants will be randomized to either the treatment group or the control group. The treatment group will receive 14 sessions of one-on-one individual treatment with the Unified Protocol. The control group will receive no treatment.
Detailed description
Most patients with depression and anxiety in low-resource settings don't get evidence-based treatment. Transdiagnostic approaches like UP are promising for these settings because they are multi-problem, modular, flexible, and have low complexity. The present study aimed to investigate the initial acceptability and feasibility of the adapted Unified Protocol (UP) in relation to its quantitative and qualitative effects on attendance, homework compliance, satisfaction, and perceived usefulness of the intervention. Additionally, the study aimed to evaluate the preliminary effects of the adapted UP on depression, anxiety, functional impairment, and emotion regulation among adults suffering from anxiety, depression, and/or comorbidity of both disorders.
A sample size of approximately 50 adults will be recruited from mental health facilities and online dissemination of the study. After screening through the Beck Depression Inventory-II (BDI-II) and Beck Anxiety Inventory (BAI), and assessing the inclusion and exclusion criteria, those who demonstrate moderate to severe scores on the BDI-II and BAI will be further evaluated by the principal investigator using the Structured Clinical Interviews for DSM-5 (Research Version) (SCID-5-RV) to determine their diagnosis. Once the eligibility criteria are met, participants will be randomly assigned to one of two study conditions:
Experimental group: Participants in the experimental group will receive the Unified Protocol (UP) treatment.
Control group: Participants in the control group will be placed on a waitlist and will not receive any treatment until the end of the study.
Participants from both groups will complete several assessment measures at baseline, mid-treatment (only at week 7 of the UP), and post-treatment.
To ensure protocol quality and fidelity, the therapist has a master's degree in Clinical Psychology and two years of previous supervised clinical experience in cognitive behavioral therapy (CBT). The therapist also participated in introductory and intermediate-level training workshops for the Unified Protocol (UP) and received UP Therapist Certification. The therapist has received supervision from the UP-certified psychologist and received 18 weeks of individualized supervision on a course of treatment utilizing the UP. Weekly supervision sessions were conducted via video-conferencing (Zoom), and transcripts of the sessions were reviewed for adherence to the protocol and competence in protocol delivery throughout the course of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental group: Participants in the experimental group will receive the Unified Protocol (UP) treatment. Control group: Participants in the control group will be placed on a waitlist and will not receive any treatment until the end of the study.
| Arm | Type | Receives |
|---|---|---|
| Experimental group: Unified Protocol (UP) | Experimental | Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional DisordersParticipants will receive 14 weekly individual sessions of 50-60 minutes each using the adapted UP treatment. |
| Control group: Waitlist Control | No intervention | –Participants in the control group will be placed on a waitlist and will not receive any treatment until the end of the study. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age ≥ 18
- suffering from anxious and/or depressive disorder
Key exclusion criteria (6 listed)
- suicide risk at the time of assessment
- comorbidity of pervasive developmental disorder
- comorbidity of psychotic disorders
- severe physical illness
- receiving concurrent psychotherapy
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 |
|---|---|---|
| Unified Protocol for Transdiagnostic Treatment of Emotional DisordersAlso: UPThe current researchers adapted the Unified Protocol (UP) treatment and used the adapted version in this study. UP outlines two complimentary modules for goal setting and psychoeducation followed by five core treatment modules: mindful emotion awareness, cognitive flexibility, countering emotional behaviors, awareness and tolerance of physical sensations, and emotion exposures, and an optional relapse prevention module to help people maintain their gains after treatment. | Behavioural | Experimental group: Unified Protocol (UP) |
Primary outcome
Feasibility- Recruitment method
Time frame: 14 weeks
The number of participants recruited by each of the three methods used for recruiting. The methods will be: mental health facilities, online dissemination, and referrals and recommendations.
Feasibility- Recruitment rate
Time frame: 14 weeks
To assess the estimates of likely recruitment rates, including: How many participants approached? How many participants volunteered? How many participants were screened? How many participants were retained in the study? What was the dropout rate? The number of participants completing the final assessment (assessed through a record made at each session).
Feasibility- Weekly face-to-face sessions
Time frame: 14 weeks
The nature of barriers that may lead to participants dropping out of treatment can be assessed by examining the number and type of problems that they experienced while attending weekly sessions. These problems include transportation difficulties, work or educational demands, childcare difficulties, scheduling conflicts, and treatment procedures interfering with daily life. Followed by an open-ended question that will assess any other reason to discontinue the treatment.
Feasibility: Eligibility criteria
Time frame: 14 weeks
Assessed through the number of participants fulfilling the eligibility criteria from the total number of participants registered, number of ineligible participants, and reasons for ineligibility.
Feasibility - Treatment adherence and engagement
Time frame: 14 weeks
Engagement in treatment will be assessed using the Homework Rating Scale-Revised, a 12-item measure that assesses beliefs, consequences, and engagement with treatment homework activities. Total scores range from 0 to 48 on this scale, where higher scores indicate higher commitment to the treatment. Treatment adherence will be further assessed by tracking participant attendance, percentage of intervention completion, and number of sessions completed.
Feasibility - Semi-structured Interview for treatment adherence and engagement
Time frame: 14 weeks
Semi-structured questions will be asked by an independent interviewer to assess the reasons for adherence and non-adherence to the treatment.
Acceptability of randomization
Time frame: 14 weeks
The number of participants who consented to randomization, number of participants who refused, and reasons for refusal.
Acceptability of the treatment
Time frame: 14 weeks
It will be measured through client satisfaction questionnaire. Total scores range from 8 to 32, with the higher number indicating greater satisfaction.
Acceptability of the treatment - Semi-structured interview
Time frame: 14 weeks
Semi-structured interview by an independent interviewer will be conducted to obtain responses on a number of indicators including; Participants' overall satisfaction with the treatment, understand the overall content covered in the treatment, the perceived usefulness of the techniques learned, the discomfort it generated, the likelihood that participants would choose such a treatment again, their recommendation to friends or family, what they found most, what they find least helpful, any modifications they would recommend.
Feasibility of outcome measures
Time frame: 14 weeks
Feasibility of outcome measures will be assessed through the assessment completion rates by participants.
5 secondary outcomes
Beck Depression Inventory-II
Time frame: 14 weeks
Beck Anxiety Inventory
Time frame: 14 weeks
Work and Social Adjustment Scale
Time frame: 14 weeks
Difficulties in Emotion Regulation Scale
Time frame: 14 weeks
Positive and Negative Affect Schedule
Time frame: 14 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 29 Jun 2025.
- Derived from this study: PubMed 42768329Nisa A, Siddiqui S, Ametaj AA. Feasibility and acceptability of the Unified Protocol for anxiety and depression in Pakistan: a pilot randomized controlled trial. BMC Psychiatry. 2026 Sep 21;26(1):739. doi: 10.1186/s12888-026-08345-x.
- 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.
Salma Siddiqui study chair
National University of Science and Technology, Pakistan
Amantia A. Ametaj study director
Harvard School of Public Health (HSPH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in people with Depression and Anxiety, run by National University of Science and Technology, Pakistan 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 2 inclusion and 6 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 29 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 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?
Feasibility- Recruitment method (time frame: 14 weeks). The study lists 10 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 NCT06002087, 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 29 Jun 2025.