Generalized Anxiety DisorderPEXACOGNCT02690441
Physical Exercise Augmented CBT for GAD
A study testing Cognitive Behavioural Therapy and Physical Exercise in people with Generalized Anxiety Disorder, run by Solli Distriktspsykiatriske Senter at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 60 to 75 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Cognitive Behavioural Therapy and Physical Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2016to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary diagnosis of GAD
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Cognitive Behavioural Therapy, Physical Exercise, Placebo control
- Keywords
- GAD, CBT, Physical exercise, Older adults
- Medical subject headings
- Generalized Anxiety Disorder, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural TherapyBehavioural
Cognitive behavioural therapy conducted individually. 10 weekly sessions, first session lasts 90 minutes, the remaining sessions last 45 minutes.
Physical ExerciseBehavioural
Manualised exercise. 15 weekly sessions with instructor, and two weekly unsupervised sessions performed individually.
Placebo controlBehavioural
Also called Telephone follow-up
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 group | Role | What they receive |
|---|---|---|
| CBT augmented with physical exercise | Experimental | 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. Receives: Behavioral: Cognitive Behavioural Therapy; Behavioral: Physical Exercise |
| CBT and placebo control | Active comparator | 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. Receives: Behavioral: Cognitive Behavioural Therapy; Behavioral: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in The Penn State Worry Questionnaire
Assesses symptom severity of GAD
Measured: 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)
Measured: Baseline and post-treatment (up to 20 weeks after baseline)
Secondary outcomes (8)
Geriatric Anxiety Inventory
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2023
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solli Distriktspsykiatriske Senter
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen, Norwegian University of Science and Technology, University of Oslo, University of California, Berkeley, William Paterson University of New Jersey, Ohio State University
- Responsible party
- Sponsor
- Investigators
- Anders Hovland, PhD, Principal investigator, Solli DPS, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02690441
- Sponsor's protocol ID
- 971427272T1
- Acronym
- PEXACOG
- Status last verified
- Apr 2026
- First submitted
- 5 Feb 2016
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sirevag K, Stavestrand SH, Sjobo T, Endal TB, Nordahl HM, Andersson E, Nordhus IH, Rekdal A, Specht K, Hammar A, Halmoy A, Mohlman J, Hjelmervik H, Thayer JF, Hovland A. Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): a feasibility study for a randomized controlled trial. Biopsychosoc Med. 2023 Jul 19;17(1):25. doi: 10.1186/s13030-023-00280-7.
PubMed 37468978Stavestrand 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.
PubMed 30885256
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise Augmented Cognitive Behaviour Therapy for Older Adults With Generalised Anxiety Disorder
- ClinicalTrials.gov ID
- NCT02690441
- Acronym / sponsor ID
- PEXACOG / 971427272T1
- Conditions
- Generalized Anxiety Disorder
- Keywords
- GAD, CBT, Physical exercise, Older adults
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Solli Distriktspsykiatriske SenterUniversity, hospital or other
- Collaborators
- University of Bergen, Norwegian University of Science and Technology, University of Oslo, University of California, Berkeley, William Paterson University of New Jersey, Ohio State University
- Study start
- Mar 2016 (actual)
- Primary completion
- Oct 2023 (actual)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT augmented with physical exercise | Experimental | Behavioral: Cognitive Behavioural Therapy, Behavioral: Physical ExercisePatients 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. |
| CBT and placebo control | Active comparator | Behavioral: Cognitive Behavioural Therapy, Behavioral: Placebo controlPatients 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. |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary diagnosis of GAD
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioural TherapyCognitive behavioural therapy conducted individually. 10 weekly sessions, first session lasts 90 minutes, the remaining sessions last 45 minutes. | Behavioural | CBT and placebo control, CBT augmented with physical exercise |
| Physical ExerciseManualised exercise. 15 weekly sessions with instructor, and two weekly unsupervised sessions performed individually. | Behavioural | CBT augmented with physical exercise |
| Placebo controlAlso: Telephone follow-upOne 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. | Behavioural | CBT and placebo control |
Primary outcome
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
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)
8 secondary outcomes
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
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
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
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
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
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
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
5-item Treatment Credibility and Expectancy Scale (CES)
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Derived from this study: PubMed 37468978Sirevag K, Stavestrand SH, Sjobo T, Endal TB, Nordahl HM, Andersson E, Nordhus IH, Rekdal A, Specht K, Hammar A, Halmoy A, Mohlman J, Hjelmervik H, Thayer JF, Hovland A. Physical exercise augmented cognitive behaviour therapy for older adults with generalised anxiety disorder (PEXACOG): a feasibility study for a randomized controlled trial. Biopsychosoc Med. 2023 Jul 19;17(1):25. doi: 10.1186/s13030-023-00280-7.
- Derived from this study: PubMed 30885256Stavestrand 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anders Hovland, PhD principal investigator
Solli DPS, University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy and Physical Exercise in people with Generalized Anxiety Disorder, run by Solli Distriktspsykiatriske Senter at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02690441, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.