Physical Exercise Augmented CBT for GAD

Generalized Anxiety Disorder Clinical Trial

— PEXACOG  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02690441
• Other study ID #: 971427272T1
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 2016
• Est. completion date: December 2023

Study information

• Verified date: May 2022
• Source: Solli Distriktspsykiatriske Senter
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 53
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Norway	Solli DPS	Bergen	Nesttun

Sponsors (7)

Lead Sponsor	Collaborator
Solli Distriktspsykiatriske Senter	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

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	Wechsler Abbreviated Scale of Intelligence	Two subtests from Wechsler Abbreviated Scale of Intelligence (WASI; Wechsler, 1999) will be administered to assess IQ level.	Baseline
Other	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
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	5-item Treatment Credibility and Expectancy Scale (CES)		Baseline