- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07798063
Effectiveness of Solution-Focused Therapy for Generalized Anxiety Disorder in Emerging Adults
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Fariha Hayat, MS
- Telefonnummer: +92 3365288229
- E-post: fariha.hayat87@gmail.com
Studieorter
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-
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Islamabad, Pakistan, 44000
- Rekrytering
- International Islamic University Islamabad (IIUI)
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Kontakt:
- Dr Nazia Iqbal, Post-doc
- Telefonnummer: +92-51-9019338
- E-post: nazia.iqbal@iiu.edu.pk
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Intervention Group (Receiving Solution-Focused Therapy)
Participants in the intervention group will receive Solution-Focused Therapy (SFT) for mild to moderate Generalized Anxiety Disorder.
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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.
|
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Inget ingripande: 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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Generalized Anxiety Disorder 7-item (GAD-7)
Tidsram: Baseline and Week 8
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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.
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Baseline and Week 8
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Depression Anxiety Stress Scales - Short Form (DASS-21)
Tidsram: Baseline and Week 8
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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.
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Baseline and Week 8
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Intolerance of Uncertainty Scale - Short Form (IUS-12)
Tidsram: 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.
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Baseline and Week 8
|
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Negative Problem Orientation Questionnaire (NPOQ)
Tidsram: 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
|
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Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
Tidsram: Baseline and Week 8
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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.
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Baseline and Week 8
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Brief Resilience Scale
Tidsram: Baseline and Week 8
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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).
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Baseline and Week 8
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Samarbetspartners och utredare
Utredare
- Huvudutredare: Fariha Hayat, MS, International Islamic University, Islamabad
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IIUI/ORIC/Bioethics/110-1928
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