Recruiting

Observational Study

Sponsor:

Kessler Foundation

Code:

NCT05953519

Conditions

Multiple Sclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Unified Protocol

Study Details

Brief summary:

The primary objectives of this study is to examine the efficacy of the Unified Protocol in decreasing depression and anxiety among individuals with MS and the secondary outcomes (e.g., improved well-being, QOL, coping, etc.) that may occur in tandem.

Conditions

Multiple Sclerosis

Study ID

NCT05953519

Start date

Apr 10, 2023

Status verified date

Jul, 2023

Completion date

Apr 30, 2026

Anticipated

Primary completion date

Apr 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of multiple sclerosis
  • 18 years of age or older
  • Experiencing significant depression and/or anxiety
  • English-speaking
  • Able to provide informed consent
  • Access to the internet

Exclusion Criteria:

  • History of any other neurological illness (e.g. traumatic brain injury, epilepsy, dementia)
  • Current participation in another randomized controlled trial
  • Cognitive impairment that would affect my ability to fully participate in the group
  • Unable to attend group sessions
  • Active participation in another formal clinical group or psychological therapy
  • Any other medical or psychological condition that, in the judgement of the investigators, prevents successful participation in the study

Study Design

Enrollment

24 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Unified Protocol intervention

The Unified Protocol consists of 12-weeks, virtual, group sessions focused on reducing depression and anxiety through: (1) Increasing emotional awareness; (2) Cognitive restructuring against dysfunctional beliefs; (3) Changing action tendencies associated with disordered emotions; (4) Preventing emotional avoidance and utilizing emotion exposure techniques; (5) Providing mutual help among group members; and (6) Providing opportunities for corrective experiences.

no intervention: Control group

The control group will not receive any intervention and will complete the same baseline and follow-up assessments.

Interventions

Unified Protocol

The Unified Protocol is a transdiagnostic intervention developed to treat depression and anxiety.

Primary outcome measure

  • Hospital Anxiety and Depression Scale (HADS) - Change in Depression [ Time Frame: Baseline, 12 weeks, 24 weeks ]
  • Hospital Anxiety and Depression Scale (HADS) - Change in Anxiety [ Time Frame: Baseline, 12 weeks, 24 weeks ]

Central Contacts and Locations

Central contacts

Belinda L Washington, BA

973-324-8446bwashington@kesslerfoundation.org

Lauren B Strober, PhD

973-324-8459lstrober@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

East Hanover, New Jersey, United States, 07936

Contacts

Belinda Washington, B.A.

973-324-8446bwashington@kesslerfoundation.org

Lauren B Strober, PhD

973-324-8459lstrober@kesslerfoundation.org

Principal Investigator:

Lauren Strober, PhD

More Information

Sponsor

Kessler Foundation

Last update posted

Jul 20, 2023

Last verified

Jul, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2023-07-20.