Physical Exercise Augmented CBT for GAD (PEXACOG)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Behavioral: Cognitive Behavioural Therapy; Behavioral: Physical Exercise; Behavioral: Placebo control

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Nesttun
    • Bergen, Nesttun, Norway, 5228
      • Solli DPS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBT augmented with physical exercise; Patients receive 10 sessions of cognitive behavioural therapy for generalized anxiety disorder. Patients also receive 5 weeks of physical exercise pre-treatment, and 10 weeks of physical exercise alongside CBT. Both treatment and physical exercise is administered individually.	Behavioral: Cognitive Behavioural Therapy; Cognitive behavioural therapy conducted individually. 10 weekly sessions, first session lasts 90 minutes, the remaining sessions last 45 minutes.; Behavioral: Physical Exercise; Manualised exercise. 15 weekly sessions with instructor, and two weekly unsupervised sessions performed individually.
Active Comparator: CBT and placebo control; Patients receive 10 sessions of cognitive behavioural therapy for generalized anxiety disorder. Patients also receive 5 weeks of placebo control (15 minutes telephone follow-up call each week) pre-treatment, and 10 weeks of attention placebo alongside CBT. Both treatment and placebo control is administered individually.	Behavioral: Cognitive Behavioural Therapy; Cognitive behavioural therapy conducted individually. 10 weekly sessions, first session lasts 90 minutes, the remaining sessions last 45 minutes.; Behavioral: 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.; Other Names: Telephone follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in The Penn State Worry Questionnaire	Assesses symptom severity of GAD	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
Change in clinical diagnosis after treatment assessed by independent, blinded rater with Anxiety Disorders Interview Schedule (ADIS-IV)	Remission rates. Assessed by independent, blinded rater with Anxiety Disorders Interview Schedule (ADIS-IV)	Baseline and post-treatment (up to 20 weeks after baseline)

Secondary Outcome Measures

Outcome Measure	Time Frame
Geriatric Anxiety Inventory	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
Generalized Anxiety Disorder 7-item scale (GAD-7)	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
Beck Anxiety Inventory	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
Beck Depression Inventory - II	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
Bergen Insomnia Scale	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
Quality of Life Inventory	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
International Physical Activity Questionnaire (IPAQ)	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-item Treatment Credibility and Expectancy Scale (CES)	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Function and structure of prefrontal lobes and limbic system	Functional Magnetic Resonance Imaging (fMRI) conducted with a 3-Tesla scanner.	Baseline, post-treatment (up to 20 weeks after baseline) and 12 months follow-up
Blood samples	Serum concentrations of mature and pro brain-derived neurotropic factor	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
Saliva samples	To measure cortisol	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
Three subtests from Delis-Kaplan Executive Function System battery (D-KEFS; Delis, Kaplan & Kramer, 2001)	Measures executive function	Baseline, post-treatment (up to 20 weeks after baseline) and 12 months follow-up
Wisconsin Card Sorting Test: Computer Version 4 research edition (WCST-CV4; Heaton, PAR staff & Goldin 2003).	Measures executive function	Baseline, post-treatment (up to 20 weeks after baseline) and 12 months follow-up
The California Verbal Learning Test (CVLT; Delis, Kramer & Kaplan, 1994).	Measures memory	Baseline, post-treatment (up to 20 weeks after baseline) and 12 months follow-up
Wechsler Abbreviated Scale of Intelligence	Two subtests from Wechsler Abbreviated Scale of Intelligence (WASI; Wechsler, 1999) will be administered to assess IQ level.	Baseline
Ambulatory Electrocardiogram (ECG)	Measures heart rate variability (HRV)	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
Ekblom-Bak submaximal ergometer cycle test	Test for prediction of VO2 max, which gives an indication of physical fitness	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
Strength test battery	Measures submaximal physical strength, which gives an indication of physical fitness.	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

Collaborators and Investigators

• Sponsor: Solli Distriktspsykiatriske Senter
• Collaborators: University of Oslo; University of California, Berkeley; University of Bergen; Norwegian University of Science and Technology; Ohio State University; William Paterson University of New Jersey
• Investigators: Principal Investigator: Anders Hovland, PhD, Solli DPS, University of Bergen

Publications and helpful links

General Publications

• Stavestrand SH, Sirevag K, Nordhus IH, Sjobo T, Endal TB, Nordahl HM, Specht K, Hammar A, Halmoy A, Martinsen EW, Andersson E, Hjelmervik H, Mohlman J, Thayer JF, Hovland A. Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): study protocol for a randomized controlled trial. Trials. 2019 Mar 18;20(1):174. doi: 10.1186/s13063-019-3268-9. Erratum In: Trials. 2020 Apr 6;21(1):317.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2016
• Primary Completion (Anticipated): November 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: February 5, 2016
• First Submitted That Met QC Criteria: February 18, 2016
• First Posted (Estimate): February 24, 2016

Study Record Updates

• Last Update Posted (Actual): November 25, 2022
• Last Update Submitted That Met QC Criteria: November 23, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Older adults; Physical exercise; CBT; GAD
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 971427272T1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No