Chronic PainALGEANCT02778737
Acceptance and Commitment Therapy and Cognitive Behavioral Therapy for Chronic Pain
A study testing ACT-based intervention and CBT-based intervention in people with Chronic Pain, run by University of Cyprus at 1 site in Greece.
Trial summary
Chronic pain is a long-term condition which is related to a number of negative consequences including reduced productivity at work, increased number of sick leave , depression and emotional difficulties among others. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Pain
- What is being tested?
- ACT-based intervention and CBT-based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2013to Jul 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Presentation of chronic pain episodes
- Significant impact of the chronic pain condition on quality of life
- Having a medical diagnosis of chronic pain
- Stable medical treatment for at least 2 months
- Reading ability sufficient to comprehend self-monitoring forms as well as competence in the Greek language
Who cannot join
- An active non pharmacologically-controlled psychotic spectrum condition or manic episode, suicidal ideation/ intent or substance use problems within the 6 months prior to recruitment
- Having a severe medical condition in the present (e.g. cancer)
- No significant cognitive impairment, as assessed using the Mini-mental Status Examination (MMSE).
- Age under 18 or above 70 years
- Receiving any other psychological intervention which is based on CBT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Innovative Psychosocial Intervention for the Treatment of Chronic Pain Patients and Their Families
Chronic pain is a long-term condition which is related to a number of negative consequences including reduced productivity at work, increased number of sick leave , depression and emotional difficulties among others. Psychological interventions, particular Cognitive Behavioral therapies (CBT) are deemed effective in reducing the negative consequences following a diagnosis of a chronic pain condition. Though research provides substantial evidence for the CBT effectiveness, not all patients manage to reduce pain intensity or improve their physical and psychosocial functioning. Also, CBT appears with only small effect sizes on variables considered to be core domains in chronic pain. Finally, there are criticism targets on the lack of clear mechanisms underlying the process of change in CBT.
New CBT therapeutic approaches, such as Acceptance and Commitment Therapy (ACT) focus on changing individuals' relation with their inner experiences. They utilize mindfulness and acceptance processes, instead of directly changing or controlling the content of internal experiences, as CBT does. ACT has received support for its effectiveness in chronic pain but there are very few clinical randomized trials to compare it with traditional CBT.
The purpose of this study is to determine whether an ACT-based intervention when compared with a CBT-based intervention designed for chronic pain patients is efficacious in reducing pain interference, pain-related disability, and psychological distress. Also this study aims to examine whether any therapeutic effects result due to the effect of acceptance, for those participating in the ACT group or control appraisal, for those participating in the CBT group. Better knowledge of the mechanism of therapeutic change can help us to recognize which patients can be benefit from which approach.
Read the detailed description
For more than 30 years cognitive behavior therapy has been the mainstream treatment approach for chronic pain patients and research evidence supporting its effectiveness . Review demonstrate that CBT for chronic pain leads in lowered pain, less emotional distress and pain-related disability, reduced medication use and healthcare utilization, and better improvement in physical and psychosocial functioning. Though CBT for chronic pain is effective, recent evidence suggest that not all patients succeed in lowering pain or improving their physical and psychosocial functioning. Also, research shows only small effects on disability and criticisms targets on the lack of clear mechanisms underlying the process of change in CBT. Researchers argue that the problem with CBT effectiveness lies on its methods. CBT attempts to manage various problems that chronic pain patients face utilizing different methods in combination. This expansion of CBT methods has created concerns among researchers and clinicians as it is not clear what works for whom. More comprehensive and integrated theoretical models encompassing various pain coping responses call for new research that can buffer the CBT expansion.
Following the CBT criticisms, new treatment approaches stemming from the third wave of cognitive behavior therapy abandon traditional approaches to directly change or control the content of internal experiences, and give more emphasis on changing individuals' relation with their inner experience. In doing so, they use mindfulness and acceptance approached along with value-committed actions to produce behavioral changes. One of these approaches, known as Acceptance and Commitment Therapy, has extensively researched in the area of chronic pain and recently the division 12 of the APA listed ACT as an empirically treatment with strong research support for general chronic pain conditions. Indeed, ACT has received amounting evidence in chronic pain and research outcomes demonstrate strong effects on physical and psychosocial disability, mood and daily functioning. Though ACT has received support for its effectiveness in chronic pain, there are yet very few clinical randomized trials to compare it with traditional CBT.
The primary aim of the Algea study is to investigate the efficacy of an ACT-based intervention designed for general chronic pain patients and compare it with a CBT intervention. Specific hypotheses include: (1) ACT will demonstrate improvements in pain indices (pain severity and interference), psychological distress, and quality of life when compared with the CBT group; (2) ACT will present with long-term effects (i.e., 6 months) and patients will report better satisfaction with this treatment than the CBT group; and (3) pain acceptance and values-based actions are considered mechanism of change variables that mediate treatment response in ACT, while control appraisal will mediate treatment response in CBT.
Better knowledge of the differences and similarities of the two CBT approaches (i.e., traditional CBT for chronic pain and ACT) in managing chronic pain can help us formulate treatments that can be tailored to patients needs.
- Conditions
- Chronic Pain
- Being tested
- ACT-based intervention, CBT-based intervention
- Keywords
- ACT, CBT, Randomized controlled trial, Chronic Pain
- Medical subject headings
- Chronic Pain, Color Vision Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACT-based interventionBehavioural
Treatment sessions will be conducted weekly by two co-therapists in groups of approximately 8-10 participants for 1 ½ hours. Although each session has specific objectives, therapists within the time frame, are encouraged to accommodate participants' discussion or other group dynamic issues that may arise.
Participants will receive their AP-ACT handbook including outlines of each session, activity plan assignments, and a CD with recorded mindfulness exercises.
Session highlights and AP-ACT activities relevant to each session will be given at each meeting, so that participants will follow along with the treatment protocol. Individuals missing more than two consecutive sessions will be considered as dropouts.
CBT-based interventionBehavioural
Treatment sessions will be conducted weekly by two co-therapists in groups of approximately 8-10 participants for 1 ½ hours. Although each session has specific objectives, therapists within the time frame, are encouraged to accommodate participants' discussion or other group dynamic issues that may arise.
Participants will receive their AP-CBT handbook including outlines of each session, activity plan assignments, and a CD with recorded relaxation exercises.
Session highlights and AP-CBT activities relevant to each session will be given at each meeting, so that participants will follow along with the treatment protocol. Individuals missing more than two consecutive sessions will be considered as dropouts.
| Study group | Role | What they receive |
|---|---|---|
| ACT-based intervention | Experimental | The Acceptance and Commitment Therapy + MTAU consists of an unpublished manual developed for the purposes of the project (Karekla et al., 2013). The 8, 90-min weekly group sessions focus in fostering psychological flexibility or the capacity to engage or change behaviors based on what a situation affords and an individual's goals, needs, and desires (Hayes et al., 2004). The ACT protocol involves helping patients to engage in values-based behaviors while remain in contact with pain, especially, when efforts to control or reduce it fail or contribute to suffering. Receives: Behavioral: ACT-based intervention |
| CBT-based intervention | Active comparator | The Cognitive Behavioral group + MTAU consists of an unpublished manual developed by Kalantzi-Azizi \& Karademas (2003). It includes 8, 90-min weekly group session and primarily focuses on teaching patients to manage their pain by utilizing various techniques, such as activity pacing, muscle relaxation(i.e., progressive muscle relaxation, diaphragmatic breathing, guided imagery), pain recording, thought challenging, problem solving skills, relapse prevention, etc. The CBT protocol involves helping patients to learn to control their pain and to modify dysfunctional thoughts that accompany it. Receives: Behavioral: CBT-based intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain intensity as assessed with the Greek Brief Pain Inventory (G-BPI)
is an 11-item measure of intensity and interference of pain in 7 life dimensions: work, mood, activity, sleep, relationships, walking and enjoyment, rated on a scale with 0="no pain" and 10="pain as bad as you can imagine". The G-BPI has shown good reliability, Cronbach's alpha=.80 and sufficient validity with constructs considered theoretically related.
Measured: Change from baseline pain intensity through study completion, an average of 1 year
Secondary outcomes (3)
Change in the Quality of life as assessed with the Short Form Health Survey (SF-36; Greek version 1.0; Pappa, Kontodimopoulos & Niakas, 2005)
The SF-36 is a 36 items multipurpose measure assessing physical and mental health indexes. It yields a total score indicating a general health index. SF-36 uses a Likert-type scale and higher scores indicate better overall quality of life. The SF-36 is widely used in clinical studies and evidence across studies indicate that it presents with high validity when compared with theoretically related scales. Also across studies SF-36 yields sufficinet chronbach alpha reliability.
Measured: Change in levels of QoL from baseline through study completion, an average of 1 year
Change in insomnia as assessed with the Athens Insomnia Scale (AIS; Soldatos, Digeos, Paparrigopoulos, 2000)
The AIS is an 8 item scale assessing difficulty with sleep induction, awakenings during the night, early morning awakening, total sleep time, and overall quality of sleep. It uses a Likert-type scale with items ranging from 0= no problem at all to 3= serious problem. AIS has a long and brief version.The long version utilizes the entire eight-item scale (AIS-8) with a total score ranging from 0 (i.e., absence of any sleep-related problem) to 24 (i.e. the most severe degree of insomnia) and assesses a full range of insomnia symptoms reflecting the disorder as it is described in the ICD-10. The brief five-item version (AIS-5) is limited to the first five items, and yields a total score ranged from 0 to 15. AIS-5 evaluates difficulties with sleep quantity and quality. The AIS (both versions) demonstrates good convergent validity when assessed with theoretically related scales and excellent reliability (a=.89 for the AIS-8 and a=.88 for the AIS-5).
Measured: Change in insomnia from baseline through study completion, an average of 1 year
Change in the levels of psychological distress as assessed with the Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983)
HADS is a 14 item questionnaire assessing levels of anxiety and depression symptomatology. Each subscale consists of 7 items rated on a 4-point scale (0-3). Higher scores indicate greater psychological distress. The Greek version presents with high internal consistency (Cronbach's alpha=.88) and sufficient validity when compared with scales considered theoretically related (Michopoulos et al., 2008).
Measured: Changes in the levels of psychological distress from baseline through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2016 (estimated)
- Study startSep 2013
- Primary completionJun 2016 (estimated)
- Study completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cyprus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Crete
- Responsible party
- Principal investigator, Maria Karekla, University of Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02778737
- Sponsor's protocol ID
- K3_K1_0b
- Acronym
- ALGEA
- Status last verified
- May 2016
- First submitted
- 12 May 2016
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be available upon request and after the sponsor's permission.
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Innovative Psychosocial Intervention for the Treatment of Chronic Pain Patients and Their Families
- ClinicalTrials.gov ID
- NCT02778737
- Acronym / sponsor ID
- ALGEA / K3_K1_0b
- Conditions
- Chronic Pain
- Keywords
- ACT, CBT, Randomized controlled trial, Chronic Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University of CyprusUniversity, hospital or other
- Collaborators
- University of Crete
- Study start
- Sep 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jul 2016 (estimated)
- First posted
- 20 May 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.
Chronic pain is a long-term condition which is related to a number of negative consequences including reduced productivity at work, increased number of sick leave , depression and emotional difficulties among others. Psychological interventions, particular Cognitive Behavioral therapies (CBT) are deemed effective in reducing the negative consequences following a diagnosis of a chronic pain condition. Though research provides substantial evidence for the CBT effectiveness, not all patients manage to reduce pain intensity or improve their physical and psychosocial functioning. Also, CBT appears with only small effect sizes on variables considered to be core domains in chronic pain. Finally, there are criticism targets on the lack of clear mechanisms underlying the process of change in CBT.
New CBT therapeutic approaches, such as Acceptance and Commitment Therapy (ACT) focus on changing individuals' relation with their inner experiences. They utilize mindfulness and acceptance processes, instead of directly changing or controlling the content of internal experiences, as CBT does. ACT has received support for its effectiveness in chronic pain but there are very few clinical randomized trials to compare it with traditional CBT.
The purpose of this study is to determine whether an ACT-based intervention when compared with a CBT-based intervention designed for chronic pain patients is efficacious in reducing pain interference, pain-related disability, and psychological distress. Also this study aims to examine whether any therapeutic effects result due to the effect of acceptance, for those participating in the ACT group or control appraisal, for those participating in the CBT group. Better knowledge of the mechanism of therapeutic change can help us to recognize which patients can be benefit from which approach.
Detailed description
For more than 30 years cognitive behavior therapy has been the mainstream treatment approach for chronic pain patients and research evidence supporting its effectiveness . Review demonstrate that CBT for chronic pain leads in lowered pain, less emotional distress and pain-related disability, reduced medication use and healthcare utilization, and better improvement in physical and psychosocial functioning. Though CBT for chronic pain is effective, recent evidence suggest that not all patients succeed in lowering pain or improving their physical and psychosocial functioning. Also, research shows only small effects on disability and criticisms targets on the lack of clear mechanisms underlying the process of change in CBT. Researchers argue that the problem with CBT effectiveness lies on its methods. CBT attempts to manage various problems that chronic pain patients face utilizing different methods in combination. This expansion of CBT methods has created concerns among researchers and clinicians as it is not clear what works for whom. More comprehensive and integrated theoretical models encompassing various pain coping responses call for new research that can buffer the CBT expansion.
Following the CBT criticisms, new treatment approaches stemming from the third wave of cognitive behavior therapy abandon traditional approaches to directly change or control the content of internal experiences, and give more emphasis on changing individuals' relation with their inner experience. In doing so, they use mindfulness and acceptance approached along with value-committed actions to produce behavioral changes. One of these approaches, known as Acceptance and Commitment Therapy, has extensively researched in the area of chronic pain and recently the division 12 of the APA listed ACT as an empirically treatment with strong research support for general chronic pain conditions. Indeed, ACT has received amounting evidence in chronic pain and research outcomes demonstrate strong effects on physical and psychosocial disability, mood and daily functioning. Though ACT has received support for its effectiveness in chronic pain, there are yet very few clinical randomized trials to compare it with traditional CBT.
The primary aim of the Algea study is to investigate the efficacy of an ACT-based intervention designed for general chronic pain patients and compare it with a CBT intervention. Specific hypotheses include: (1) ACT will demonstrate improvements in pain indices (pain severity and interference), psychological distress, and quality of life when compared with the CBT group; (2) ACT will present with long-term effects (i.e., 6 months) and patients will report better satisfaction with this treatment than the CBT group; and (3) pain acceptance and values-based actions are considered mechanism of change variables that mediate treatment response in ACT, while control appraisal will mediate treatment response in CBT.
Better knowledge of the differences and similarities of the two CBT approaches (i.e., traditional CBT for chronic pain and ACT) in managing chronic pain can help us formulate treatments that can be tailored to patients needs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ACT-based intervention | Experimental | Behavioral: ACT-based interventionThe Acceptance and Commitment Therapy + MTAU consists of an unpublished manual developed for the purposes of the project (Karekla et al., 2013). The 8, 90-min weekly group sessions focus in fostering psychological flexibility or the capacity to engage or change behaviors based on what a situation affords and an individual's goals, needs, and desires (Hayes et al., 2004). The ACT protocol involves helping patients to engage in values-based behaviors while remain in contact with pain, especially, when efforts to control or reduce it fail or contribute to suffering. |
| CBT-based intervention | Active comparator | Behavioral: CBT-based interventionThe Cognitive Behavioral group + MTAU consists of an unpublished manual developed by Kalantzi-Azizi \& Karademas (2003). It includes 8, 90-min weekly group session and primarily focuses on teaching patients to manage their pain by utilizing various techniques, such as activity pacing, muscle relaxation(i.e., progressive muscle relaxation, diaphragmatic breathing, guided imagery), pain recording, thought challenging, problem solving skills, relapse prevention, etc. The CBT protocol involves helping patients to learn to control their pain and to modify dysfunctional thoughts that accompany it. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Presentation of chronic pain episodes
- Significant impact of the chronic pain condition on quality of life
- Having a medical diagnosis of chronic pain
- Stable medical treatment for at least 2 months
- Reading ability sufficient to comprehend self-monitoring forms as well as competence in the Greek language
Key exclusion criteria (5 listed)
- An active non pharmacologically-controlled psychotic spectrum condition or manic episode, suicidal ideation/ intent or substance use problems within the 6 months prior to recruitment
- Having a severe medical condition in the present (e.g. cancer)
- No significant cognitive impairment, as assessed using the Mini-mental Status Examination (MMSE).
- Age under 18 or above 70 years
- Receiving any other psychological intervention which is based on CBT
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 |
|---|---|---|
| ACT-based interventionTreatment sessions will be conducted weekly by two co-therapists in groups of approximately 8-10 participants for 1 ½ hours. Although each session has specific objectives, therapists within the time frame, are encouraged to accommodate participants' discussion or other group dynamic issues that may arise. Participants will receive their AP-ACT handbook including outlines of each session, activity plan assignments, and a CD with recorded mindfulness exercises. Session highlights and AP-ACT activities relevant to each session will be given at each meeting, so that participants will follow along with the treatment protocol. Individuals missing more than two consecutive sessions will be considered as dropouts. | Behavioural | ACT-based intervention |
| CBT-based interventionTreatment sessions will be conducted weekly by two co-therapists in groups of approximately 8-10 participants for 1 ½ hours. Although each session has specific objectives, therapists within the time frame, are encouraged to accommodate participants' discussion or other group dynamic issues that may arise. Participants will receive their AP-CBT handbook including outlines of each session, activity plan assignments, and a CD with recorded relaxation exercises. Session highlights and AP-CBT activities relevant to each session will be given at each meeting, so that participants will follow along with the treatment protocol. Individuals missing more than two consecutive sessions will be considered as dropouts. | Behavioural | CBT-based intervention |
Primary outcome
Change in pain intensity as assessed with the Greek Brief Pain Inventory (G-BPI)
Time frame: Change from baseline pain intensity through study completion, an average of 1 year
is an 11-item measure of intensity and interference of pain in 7 life dimensions: work, mood, activity, sleep, relationships, walking and enjoyment, rated on a scale with 0="no pain" and 10="pain as bad as you can imagine". The G-BPI has shown good reliability, Cronbach's alpha=.80 and sufficient validity with constructs considered theoretically related.
3 secondary outcomes
Change in the Quality of life as assessed with the Short Form Health Survey (SF-36; Greek version 1.0; Pappa, Kontodimopoulos & Niakas, 2005)
Time frame: Change in levels of QoL from baseline through study completion, an average of 1 year
Change in insomnia as assessed with the Athens Insomnia Scale (AIS; Soldatos, Digeos, Paparrigopoulos, 2000)
Time frame: Change in insomnia from baseline through study completion, an average of 1 year
Change in the levels of psychological distress as assessed with the Hospital Anxiety and Depression Scale (HADS; Zigmond & Snaith, 1983)
Time frame: Changes in the levels of psychological distress from baseline through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
- Individual participant dataSharing planned: Yes. Data will be available upon request and after the sponsor's permission.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACT-based intervention and CBT-based intervention in people with Chronic Pain, run by University of Cyprus at 1 site in Greece.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 May 2016. 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 Greece. 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?
Results are not available in the source record.
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?
Change in pain intensity as assessed with the Greek Brief Pain Inventory (G-BPI) (time frame: Change from baseline pain intensity through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 May 2016.