NCT07892768

Brief Summary

This study examined whether a single 120-minute, therapist-led Acceptance and Commitment Therapy (SS-ACT) session, delivered individually and face-to-face in Urdu, was associated with reduced generalized anxiety symptoms among undergraduate students in Pakistan. Fifty full-time undergraduate students aged 18 to 25 at GIFT University (25 male, 25 female), who scored 5 or above on the GAD-7 and met DSM-5 criteria for generalized anxiety disorder on the SCID-5 interview, received the session. Anxiety symptoms (GAD-7) were measured before the session, immediately after it, and at a two-week follow-up. Psychological inflexibility (AAQ-II) was measured before and immediately after the session. The study also examined whether changes in anxiety differed between male and female participants. This was a single-group study without a control or comparison group.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 18, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 23, 2026

Completed
Last Updated

October 23, 2026

Status Verified

October 1, 2026

Enrollment Period

3 months

First QC Date

October 18, 2026

Last Update Submit

October 18, 2026

Conditions

Keywords

Acceptance and Commitment TherapySingle-Session TherapyGeneralized Anxiety SymptomsUniversity StudentsPsychological InflexibilityPakistanGAD-7AAQ-II

Outcome Measures

Primary Outcomes (1)

  • Change in generalized anxiety symptoms (GAD-7)

    Generalized anxiety symptom severity measured with the Generalized Anxiety Disorder-7 (GAD-7), a 7-item self-report scale. Total scores range from 0 to 21; higher scores indicate greater anxiety severity. Change was examined across pre-intervention, immediately post-intervention, and two-week follow-up.

    Pre-intervention (baseline), immediately post-intervention, and two-week follow-up

Secondary Outcomes (1)

  • Change in psychological inflexibility (AAQ-II)

    Pre-intervention (baseline) and immediately post-intervention

Study Arms (1)

SS-ACT

EXPERIMENTAL

Single group of 50 undergraduate students aged 18 to 25 at GIFT University (25 male, 25 female) with generalized anxiety disorder confirmed by SCID-5. All participants received one 120-minute therapist-led SS-ACT session in Urdu. GAD-7 was administered before the session, immediately after it, and at two-week follow-up; AAQ-II before and immediately after. No control or comparison group.

Behavioral: Single-Session Acceptance and Commitment Therapy (SS-ACT)

Interventions

A single 120-minute, therapist-led, individual, face-to-face ACT session in Urdu, structured in seven stages and covering the six core ACT processes: introduction and psychoeducation, present-moment awareness, cognitive defusion, acceptance, self-as-context, values clarification and committed action.

SS-ACT

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged 18 to 25 years
  • Currently enrolled as a full-time undergraduate student at GIFT University
  • GAD-7 score of 5 or above
  • Meets diagnostic criteria for Generalized Anxiety Disorder, as confirmed by the Structured Clinical Interview for DSM-5 (SCID-5)

You may not qualify if:

  • Current participation in psychotherapy or pharmacological treatment for anxiety
  • Self-reported history of severe psychiatric disorder (e.g., psychotic disorder or bipolar disorder), or any other condition judged during screening likely to interfere with participation in the intervention
  • Inability to provide informed consent or complete the study procedures independently
  • Failure to meet the study eligibility criteria during the SCID-5 screening interview

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gift University

Guiranwala, Punjab Province, 52250, Pakistan

Location

MeSH Terms

Conditions

Generalized Anxiety DisorderAnxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Single-group, quasi-experimental, repeated-measures design. All participants received the same single-session intervention; no control or comparison group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Effectiveness of Single-Session Acceptance and Commitment Therapy for Generalized Anxiety Symptoms Among University Students

Study Record Dates

First Submitted

October 18, 2026

First Posted

October 23, 2026

Study Start

May 5, 2026

Primary Completion

July 31, 2026

Study Completion

July 31, 2026

Last Updated

October 23, 2026

Record last verified: 2026-10

Data Sharing

IPD Sharing
Will not share

Data are not shared because participants consented on the basis of confidentiality and anonymised data storage.

Locations