Physical Exercise Augmented CBT for GAD

NCT02690441 · tracked via the Priya Life Science Norway tracker

Sponsor

Solli Distriktspsykiatriske Senter

Phase

Not applicable

Started

2016-03

Last updated

2026-04-28

Condition(s) studied

Generalized Anxiety Disorder

Investigational drug(s) / intervention(s)

Cognitive Behavioural TherapyPhysical ExercisePlacebo control

Cognitive Behavioural Therapy: Cognitive behavioural therapy conducted individually. 10 weekly sessions, first session lasts 90 minutes, the remaining sessions last 45 minutes.

Physical Exercise: Manualised exercise. 15 weekly sessions with instructor, and two weekly unsupervised sessions performed individually.

Placebo control: One follow-up telephone call à 15 minutes each week for 15 weeks. Aims to control for therapist contact in physical exercise condition and total duration of treatment.

Study summary

Generalised anxiety disorder (GAD) is a severe and debilitating anxiety disorder that is highly prevalent among older adults. Anxiety and GAD is a well-documented risk factor for the development of other severe conditions such as depression and dementia, and effective treatments are called for. However, recommended treatment for GAD has consistently been found to yield blunted response rates for older adults compared to younger patients.

The purpose of this study is to evaluate the effects of exercise-augmented cognitive behaviour therapy for older adults with GAD. Exercise augmented CBT is expected to yield better results than standard CBT in terms of greater reduction of symptoms and increased rates of remission. The investigators will also investigate the effects of treatment on biological, physiological and neuropsychological measures.

Eligibility

Sex

ALL

Min age

60 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: * Primary diagnosis of GAD Exclusion Criteria: * Substance abuse * Use of benzodiazepines, use of antipsychotica * Lack of ability to stabilize other psychotropic medication during participating in the study * Medical condition that precludes participation in physical exercise * Severe major depression as determined by the MINI International Neuropsychiatric Interview * Life-time history of psychosis and/or mania * Participation in other ongoing psychotherapy * Organic brain disease * Positive screening for dementia with Mini Mental State Examination * Currently engaged in a regular physical exercise program

Primary outcome measure(s)

Changes in The Penn State Worry Questionnaire — Baseline, after pre-treatment (up to 8 weeks after baseline), post-treatment (up to 20 weeks after baseline), 6 months follow-up and 12 months follow-up
Assesses symptom severity of GAD
Change in clinical diagnosis after treatment assessed by independent, blinded rater with Anxiety Disorders Interview Schedule (ADIS-IV) — Baseline and post-treatment (up to 20 weeks after baseline)
Remission rates. Assessed by independent, blinded rater with Anxiety Disorders Interview Schedule (ADIS-IV)

Trial sites (1)

Facility	City	Region	Status
Solli DPS	Bergen	Nesttun

More Solli Distriktspsykiatriske Senter trials in Norway

High Intensity Training for Adults With ADHD in Specialised Mental Health Care Enrolling by invitation

A Combined Aerobic and Resistance Training Program for Adults With Psychotic Disorders Active, not recruiting

eBehandling - Health and Work for Patients in Specialist Mental Health Care Recruiting

Other trials for the same condition

Group vs. Individual Metacognitive Therapy for Generalized Anxiety Disorder Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02690441 on ClinicalTrials.gov ↗ ← All trials in Norway