- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07798063
Effectiveness of Solution-Focused Therapy for Generalized Anxiety Disorder in Emerging Adults
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Anxiety disorders are common worldwide, and anxiety and stress symptoms are particularly prevalent among university students in Pakistan. Emerging adulthood is a critical developmental period characterized by significant transitions, identity exploration, and heightened stress, during which Generalized Anxiety Disorder (GAD) can emerge. GAD is characterized by excessive and persistent anxiety and worry related to different areas of life, including work, family, health, or finances. Although conventional psychological therapies are available for such mental health problems, they can be time-consuming and costly. Therefore, shorter and effective psychological interventions are needed. Solution-Focused Therapy (SFT) has been supported by research as an approach in which fewer sessions may be sufficient for improving psychological symptoms. However, there is limited literature on the effectiveness of SFT for emerging adults with anxiety disorders in Pakistan, and the intervention has not been culturally validated for Pakistani emerging adults with GAD.
This study aims to examine the effectiveness of Solution-Focused Therapy for Generalized Anxiety Disorder in emerging adults in Pakistan. The study will use a randomized controlled trial design. Emerging adults aged 18-29 years will first be screened using the Generalized Anxiety Disorder 7-item (GAD-7) Scale to identify participants with mild to moderate levels of GAD. Eligible participants will then be randomly assigned to a treatment group receiving SFT or a waitlist control group. The SFT intervention will be applied to participants with GAD to examine its effectiveness in reducing their anxiety symptoms.
The study will assess changes in GAD symptoms before and after the intervention to determine the effectiveness of SFT among emerging adults with GAD in Pakistan. It is expected that participants receiving SFT will show a decline in GAD symptoms compared with the waitlist control group. The study will provide evidence regarding the effectiveness of a brief and culturally relevant SFT intervention for emerging adults with GAD in the Pakistani context.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Fariha Hayat, MS
- Telefonnummer: +92 3365288229
- E-mail: fariha.hayat87@gmail.com
Studiesteder
-
-
-
Islamabad, Pakistan, 44000
- Rekruttering
- International Islamic University Islamabad (IIUI)
-
Kontakt:
- Dr Nazia Iqbal, Post-doc
- Telefonnummer: +92-51-9019338
- E-mail: nazia.iqbal@iiu.edu.pk
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria: Participants with mild to moderate scores of generalized anxiety disorder upon baseline assessment will be included in the study.
Exclusion Criteria: Individuals will be excluded if they reported a diagnosis of psychotic disorder, and those receiving psychotherapy or counseling for anxiety.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention Group (Receiving Solution-Focused Therapy)
Participants in the intervention group will receive Solution-Focused Therapy (SFT) for mild to moderate Generalized Anxiety Disorder.
|
Participants in intervention group will receive Solution-Focused Therapy.
The program includes approximately 6-8 individual sessions (45-60 minutes) covering goal-setting, exception-finding, scaling questions, the miracle question, identification of existing strengths and resources, and construction of solution-focused action steps.
|
|
Ingen indgriben: Control Group (Waitlist Control Group)
Participants in the control group will not receive Solution-Focused Brief Therapy during the active trial period and will instead be assigned to a waitlist condition.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Generalized Anxiety Disorder 7-item (GAD-7)
Tidsramme: Baseline and Week 8
|
The Generalized Anxiety Disorder 7-item (GAD-7) scale assesses severity of anxiety symptoms.
Total scores range from 0 to 21.
Higher scores indicate more severe anxiety symptoms.
|
Baseline and Week 8
|
|
Depression Anxiety Stress Scales - Short Form (DASS-21)
Tidsramme: Baseline and Week 8
|
The Depression Anxiety Stress Scales - Short Form (DASS-21) measures emotional distress.
The total score ranges from 0 to 63 (combining depression, anxiety, and stress subscales).
Higher scores indicate more severe emotional distress.
|
Baseline and Week 8
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Intolerance of Uncertainty Scale - Short Form (IUS-12)
Tidsramme: Baseline and Week 8
|
The Intolerance of Uncertainty Scale - Short Form assesses reactions to ambiguous situations.
Total scores range from 12 to 60. Higher scores indicate a greater intolerance of uncertainty.
|
Baseline and Week 8
|
|
Negative Problem Orientation Questionnaire (NPOQ)
Tidsramme: Baseline and Week 8
|
The Negative Problem Orientation Questionnaire (NPOQ) evaluates dysfunctional cognitive attitudes toward problem-solving.
Total scores range from 12 to 60. Higher scores indicate a more negative problem orientation.
|
Baseline and Week 8
|
|
Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
Tidsramme: Baseline and Week 8
|
The Difficulties in Emotion Regulation Scale - Short Form (DERS-SF) assesses emotion dysregulation.
Total scores range from 18 to 90.
Higher scores indicate greater difficulty in regulating emotions.
|
Baseline and Week 8
|
|
Brief Resilience Scale
Tidsramme: Baseline and Week 8
|
The Brief Resilience Scale (BRS) measures the ability to recover from stress.
Total scores range from 6 to 30.
Higher scores indicate greater resilience (a better outcome).
|
Baseline and Week 8
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Fariha Hayat, MS, International Islamic University, Islamabad
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IIUI/ORIC/Bioethics/110-1928
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .