Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT02690441

Physical Exercise Augmented CBT for GAD

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Behavior Mental Disorders Motor Activity

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Solli DPS

Bergen, Nesttun, 5228, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive Behavioural Therapy

Behavioral

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

Physical exercise

Behavioral

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

Placebo control

Behavioral

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.

Other names: Telephone follow-up

Primary outcomes

  1. Changes in The Penn State Worry Questionnaire

    Time frame: 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

  2. Change in clinical diagnosis after treatment assessed by independent, blinded rater with Anxiety Disorders Interview Schedule (ADIS-IV)

    Time frame: Baseline and post-treatment (up to 20 weeks after baseline)

    Remission rates. Assessed by independent, blinded rater with Anxiety Disorders Interview Schedule (ADIS-IV)

Secondary outcomes

  1. Geriatric Anxiety Inventory

    Time frame: 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

  2. Generalized Anxiety Disorder 7-item scale (GAD-7)

    Time frame: 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

  3. Beck Anxiety Inventory

    Time frame: 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

  4. Beck Depression Inventory - II

    Time frame: 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

  5. Bergen Insomnia Scale

    Time frame: 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

  6. Quality of Life Inventory

    Time frame: 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

  7. International Physical Activity Questionnaire (IPAQ)

    Time frame: 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

  8. 5-item Treatment Credibility and Expectancy Scale (CES)

    Time frame: Baseline

Other outcomes

  1. Function and structure of prefrontal lobes and limbic system

    Time frame: Baseline, post-treatment (up to 20 weeks after baseline) and 12 months follow-up

    Functional Magnetic Resonance Imaging (fMRI) conducted with a 3-Tesla scanner.

  2. Blood samples

    Time frame: 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

    Serum concentrations of mature and pro brain-derived neurotropic factor

  3. Saliva samples

    Time frame: 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

    To measure cortisol

  4. Three subtests from Delis-Kaplan Executive Function System battery (D-KEFS; Delis, Kaplan & Kramer, 2001)

    Time frame: Baseline, post-treatment (up to 20 weeks after baseline) and 12 months follow-up

    Measures executive function

  5. Wisconsin Card Sorting Test: Computer Version 4 research edition (WCST-CV4; Heaton, PAR staff & Goldin 2003).

    Time frame: Baseline, post-treatment (up to 20 weeks after baseline) and 12 months follow-up

    Measures executive function

  6. The California Verbal Learning Test (CVLT; Delis, Kramer & Kaplan, 1994).

    Time frame: Baseline, post-treatment (up to 20 weeks after baseline) and 12 months follow-up

    Measures memory

  7. Wechsler Abbreviated Scale of Intelligence

    Time frame: Baseline

    Two subtests from Wechsler Abbreviated Scale of Intelligence (WASI; Wechsler, 1999) will be administered to assess IQ level.

  8. Ambulatory Electrocardiogram (ECG)

    Time frame: 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

    Measures heart rate variability (HRV)

  9. Ekblom-Bak submaximal ergometer cycle test

    Time frame: 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

    Test for prediction of VO2 max, which gives an indication of physical fitness

  10. Strength test battery

    Time frame: 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

    Measures submaximal physical strength, which gives an indication of physical fitness.

Sponsors and collaborators

Lead sponsor

Solli Distriktspsykiatriske Senter

Other

Collaborators

  • Norwegian University of Science and Technology
  • Ohio State University
  • University of Bergen
  • University of California, Berkeley
  • University of Oslo
  • William Paterson University of New Jersey

Registry information

Official study title

Physical Exercise Augmented Cognitive Behaviour Therapy for Older Adults With Generalised Anxiety Disorder

Acronym: PEXACOG

Important dates

Study start
2016
Primary completion
2023
Study completion
2026
First posted
Feb 24, 2016
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.