Transdiagnostic Versus Diagnosis-specific Cognitive-behavioral Therapy

NCT05249543 | Active Not Recruiting

• 1 other identifier: KI-2021-05587-01
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of the pilot study is to investigate the feasibility of conducting a randomized controlled trial (RCT) comparing the effects of transdiagnostic and diagnosis-specific cognitive-behavioral therapy (CBT) for patients with anxiety disorders in routine psychiatric outpatient care in Stockholm, Sweden. It is hypothesized that an RCT is feasible in terms of recruitment, retention, therapist competence and adherence to treatments, and that the treatments are well received by participants.

Conditions

Obsessive-Compulsive Disorder; Posttraumatic Stress Disorder; Panic Disorder; Generalized Anxiety Disorder; Social Anxiety Disorder

Keywords

Transdiagnostic Treatment; Unified Protocol; Cognitive-Behavioral Therapy; Anxiety Disorders; Pilot Study

Outcome Measures

Primary Outcomes (6)

• Feasibility measure 1

  Recruitment of participants: the number of participants per diagnosis included in the study

  Prior to pre assessment, up to 1 month

• Feasibility measure 2

  Attrition: the number of participants dropping out of treatment

  During treatment, up to 18 weeks

• Feasibility measure 3

  Therapist competence in and adherence to the unified protocol according to the UP Adherence and Competence Scale, and diagnosis-specific cognitive-behavioral therapy according to the Cognitive Therapy Scale-Revised

  Prior to pre assessment, up to 6 months

• Feasibility measure 4

  Treatment credibility and expectancy of improvement according to the Credibility/Expectancy Questionnaire

  During treatment Week 2

• Feasibility measure 5

  Treatment satisfaction according to the Client Satisfaction Questionnaire

  At post assessment, up to 18 weeks

• Feasibility measure 6

  Adverse effects according to the Negative Effects Questionnaire

  At post assessment, up to 18 weeks

Secondary Outcomes (7)

• Change in Clinical Severity Rating - primary outcome measure for preliminary exploration of treatment effects

  Change from baseline at up to 18 weeks

• Change in Overall Anxiety Severity and Impairment Scale

  Change from baseline at up to 18 weeks

• Change in Overall Depression Severity and Impairment Scale

  Change from baseline at up to 18 weeks

• Change in Diagnosis-specific symptoms measures

  Change from baseline at up to 18 weeks

• Change in World Health Organization Disability Assessment Schedule

  Change from baseline at up to 18 weeks

Study Arms (2)

Unified protocol

EXPERIMENTAL

Transdiagnostic cognitive-behavioral therapy focusing on emotional processes central to the development and maintenance of anxiety disorders, particularly neuroticism.

Behavioral: Unified protocol

Diagnosis-specific cognitive-behavioral therapy

ACTIVE COMPARATOR

Cognitive-behavioral therapy specifically designed for a particular anxiety disorder as specified in evidence-based treatment protocols, which are commonly based on a specific theory or model of the development and maintenance of an anxiety disorder.

Behavioral: Diagnosis-specific cognitive-behavioral therapy

Interventions

Unified protocol BEHAVIORAL

Transdiagnostic cognitive-behavioral therapy

Unified protocol

Diagnosis-specific cognitive-behavioral therapy BEHAVIORAL

Diagnosis-specific cognitive-behavioral therapy

Diagnosis-specific cognitive-behavioral therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Gender Eligibility Details: Self-representation of gender identity: female, male, other.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age,
• Being able to speak Swedish without interpreter support,
• A principal diagnosis of panic disorder, generalized anxiety disorder, social anxiety disorder, obsessive-compulsive disorder, or posttraumatic stress disorder, and
• Pharmacological treatment (if any) that is stable six weeks prior to treatment start

You may not qualify if:

• Current diagnosis of psychotic disorder, bipolar disorder, or moderate to severe substance use disorder,
• Moderate to severe risk of suicide,
• Psychiatric, somatic, or social problems which require other management or intervention than cognitive-behavioral therapy, and
• Other simultaneous psychological treatment

Sponsors & Collaborators

• Karolinska Institutet: lead

Study Sites (1)

WeMind

Stockholm, 11357, Sweden

Location

MeSH Terms

Conditions

Panic Disorder; Generalized Anxiety Disorder; Phobia, Social; Obsessive-Compulsive Disorder; Stress Disorders, Post-Traumatic; Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Benjamin Bohman, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators are blinded to treatment condition in the analysis phase. Outcome assessors conducting diagnostic interviews and clinical severity ratings are blinded to treatment condition at post assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Model Details: Participants are consecutively included in the study and randomly allocated to treatment condition using a 1:1 ratio.

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: February 21, 2022
• Study Start: March 1, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)