Chronic Low Back PainNCT03658226
Case Series Evaluation of Psychodynamic Interpersonal Therapy in Chronic Low Back Pain
A study testing Psychodynamic Interpersonal Therapy (PIT) in people with Chronic Low Back Pain, run by Charlotte Morgan at 1 site in United Kingdom.
Trial summary
Many people in the world have chronic pain; this is pain which lasts more than twelve weeks. Pain can cause people to feel low in mood and change how they feel about themselves and others around them. Therapy for chronic pain does not always work and often people do not have lasting effects from treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Psychodynamic Interpersonal Therapy (PIT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 19 Sep 2018to 9 Sep 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Previously attended the Walton Centre pain management programme (PMP).
- Treatment resistant; six months after PMP treatment still experiencing clinically significant pain measured as 5+ on the pain distress rating scale. IMMPACT recommendations advise the use of numerical rating scales (NRS) in clinical trials of chronic pain treatments (Dworkin et al., 2005).
- Classified as "interpersonally distressed" on the West Haven Yale Multidimensional Pain Inventory (WHYMPI).
- Able to converse in English proficiently which is a requirement given the conversational nature of therapy.
- Able to commit to treatment and willing to be randomly allocated to baseline.
Who cannot join
- Other comorbid degenerative conditions and cancers.
- Psychosis
- History of prior suicide attempts.
- Active plans of self-harm and/or suicide.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Walton Centre NHS Foundation Trust
Liverpool, L9 7LJ
About this study
Official title: A Case Series Evaluation of Psychodynamic Interpersonal Therapy (PIT) in Chronic Low Back Pain (CLBP) Patients
Many people in the world have chronic pain; this is pain which lasts more than twelve weeks. Pain can cause people to feel low in mood and change how they feel about themselves and others around them. Therapy for chronic pain does not always work and often people do not have lasting effects from treatment. This study hopes to see if a different therapy, called Psychodynamic Interpersonal Therapy (PIT), can help people with chronic pain. This therapy looks at how we see ourselves and our relationships with others; it aims to help people address personal problems that make it difficult for them to manage their pain.
The study aims to show that PIT is a suitable treatment for chronic low back pain and that people will have fewer problems with their mood, how they feel about themselves and their relationships. This study will give people with chronic low back pain eight sessions of PIT and during therapy they will fill in forms about their pain, mood, relationship problems and how they feel about themselves. We will also look at practical things to do with the therapy (e.g. how many sessions people came to, reasons for stopping therapy etc.) and ask people about how they felt about the therapy they had. Three months after the study has finished, people will be asked to fill in the forms again to see if the effects have lasted.
This research could help to give people with chronic pain a new and different treatment option which has good and lasting effects.
Read the detailed description
Chronic pain is continuous, long-term pain of more than 12 weeks. Patients with chronic pain are a heterogeneous group with varied pathologies (e.g. osteoarthritis; fibromyalgia) and pain sites (e.g., chronic low back pain, CLBP; chronic widespread pain). Chronic pain affects more than two fifths of the UK population, that is, around 28 million adults. Currently, the biopsychosocial model of pain is the most widely used heuristic approach to understanding chronic pain. The biopsychosocial perspective recognises that pain emerges from a dynamic interplay of a patient's physiological state, thoughts, emotions, behaviours, and sociocultural influences. This acknowledges that pain is a subjective experience and treatment approaches are aimed at management, rather than cure, of chronic pain.
Chronic pain affects social, psychological and emotional wellbeing. Current psychological treatments (e.g. CBT and ACT) aim to support patients to cope with the impact of chronic pain and improve their quality of life. However, some critical questions remain regarding the effectiveness of these interventions. Research indicates that substantial numbers of patients do not benefit greatly from these approaches and often effects are not maintained across time. Audit data from a local Pain Management Programme (PMP) indicates that many patients remain distressed by pain after treatment, with approximately 80% scoring 5 or more out of 10 on a pain distress scale six months later. Thus, it appears that current psychological therapies are not targeting all relevant issues.
Evidence indicates that psychodynamic therapies show some efficacy in the treatment of chronic pain, demonstrating patterns of change in interpersonal problems, pain intensity and depression-anxiety. Interpersonal literature states that aspects of relating are implicated in chronic pain; for example, perceived burdensomeness (feeling a burden on others) and thwarted belongingness (loneliness and feeling alienated from others) are significantly associated with pain intensity, self-efficacy and functional limitations.
Psychodynamic Interpersonal Therapy affirms that our sense of self and ability to relate to others are important determinants of how able we are to regulate emotion, manage adversity and access social support. As such, they are likely to play a fundamental role in how we cope with chronic pain. Studies have found an association between insecure attachment and related interpersonal difficulties with poor pain self-efficacy, anxiety and poor coping. Therefore, a psychological therapy such as PIT which focuses on addressing negative relationship patterns and strengthening sense of self may be of value in the treatment of chronic pain.
Psychological interventions such as PMPs seek to address the role of relationships and social networks in self-management of pain but do not target the psychological issues underlying interpersonal problems. Where individuals report high levels of interpersonal difficulties, a more in-depth focus on these issues may be required. As PIT seeks to understand how problematic patterns of relating are contributing to a person's distress and maladaptive coping, it may be a helpful approach. A clinical example of this is a person whose pain is exacerbated by overactivity related to their inability to say no to other's demands (e.g. for fear of upsetting them or eliciting conflict and rejection). Additionally, PIT has many strengths as an approach; it is a short, manualised and evidence-based treatment which has previously demonstrated promising results in the treatment of other conditions characterised by disabling chronic pain such as multisomatoform functional syndromes disorder and irritable bowel syndrome.
Presently, the efficacy of PIT in chronic pain is unknown. With that in mind, the proposed study seeks to conduct an evaluation of the acceptability, feasibility and efficacy of PIT in a chronic pain population; treatment resistant CLBP. The outcome of this study has the potential to inform future therapeutic options for those with chronic pain. The results may support the use of an alternative 1:1 therapy for those with interpersonal difficulties as it follows that they would require a treatment for chronic pain which has an interpersonal focus.
The primary aim of this study is to conduct a preliminary evaluation of whether PIT is an acceptable and feasible therapy for patients with treatment resistant CLBP (where patients are still experiencing clinically significant pain following previous treatment) and interpersonal difficulties. This will be measured using adherence to therapy and patient satisfaction and acceptability measures.
The secondary aim is to conduct an initial evaluation of the efficacy of PIT in people with treatment resistant CLBP and interpersonal problems, including its impact on pain distress, self -efficacy, and interpersonal functioning.
- Conditions
- Chronic Low Back Pain
- Being tested
- Psychodynamic Interpersonal Therapy (PIT)
- Keywords
- Case Series, Acceptability, Feasibility, Psychodynamic Interpersonal Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychodynamic Interpersonal Therapy (PIT)Behavioural
PIT is conversational model of psychotherapy; participants will receive 8 sessions of this therapy once weekly. The first session will be 2 hours and all remaining sessions will be 50 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Therapy | Experimental | Psychodynamic Interpersonal Therapy (PIT) Receives: Behavioral: Psychodynamic Interpersonal Therapy (PIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective measure of behaviour 1 - Number of sessions attended
Measuring feasibility/acceptability of therapy
Measured: Measured at the end of therapy (at week 8).
Satisfaction questionnaire (PIT for CLBP)
Measuring acceptability of therapy (face validity). A self-reported measure of satisfaction regarding the content of the therapy. A questionnaire has been devised based on the theoretical framework of acceptability in Sekon, Cartwright \& Francis (2017). There are two versions for post session one and post session eight with slightly different wording. This outcome measure will assess change.
Measured: Administered twice in the 8 weeks of therapy after session 1 (week 1) and Session 8 (week 8); the first and last sessions of therapy.
Measure of adverse reactions
A quantitative measure containing a list of anticipated/likely adverse reactions (e.g. exacerbation of pain, feeling more upset than usual, increased problems in relationships) and unanticipated/adverse reactions. It is expected that therapy may increase emotional symptoms in the short term as the participants make realisations within therapy. This is a tick box measure with a qualitative 'other' box for further input.This outcome measure will assess change.
Measured: Participants will complete this before each therapy session weekly and it will be discussed with the therapist/PI in session. As therapy is for 8 weeks, participants will complete this once weekly for eight weeks.
Objective measure of behaviour 2 - Completion rate from therapy
Measuring feasibility/acceptability of therapy
Measured: Measured at the end of therapy (at week 8).
Secondary outcomes (5)
Chronic Pain Acceptance Questionnaire-8 (CPAQ-8)
CPAQ-8 - Fish, R. A., McGuire, B., Hogan, M., et al. (2010) A short version of the CPAQ and consists of eight items which measures pain acceptance and distress.
Measured: During baseline (no therapy) this will be completed weekly for a minimum of 3 weeks and a maximum of 6 weeks (dependent on randomised baseline group). All participants will complete the measure weekly during therapy for 8 weeks.
Pain Self Efficacy Questionnaire (PSEQ)
PSEQ Nicholas, M. K (2007). The PSEQ assesses confidence in performing activities whilst in pain and beliefs about coping with pain.
Measured: During baseline (no therapy) this will be completed weekly for a minimum of 3 weeks and a maximum of 6 weeks (dependent on randomised baseline group). All participants will complete the measure weekly during therapy for 8 weeks.
The Interpersonal Needs Questionnaire for Pain (INQ-P)
INQ-P (Methley et al. 2017). A measure of interpersonal factors in chronic pain adapted from the INQ; assesses thwarted belongingness and perceived burdensomeness specific to chronic pain.
Measured: During baseline (no therapy) this will be completed weekly for a minimum of 3 weeks and a maximum of 6 weeks (dependent on randomised baseline group). All participants will complete the measure weekly during therapy for 8 weeks.
The Beck Depression Inventory (BDI)
BDI (Beck et al. 1961). The BDI is recommended as a core outcome measure of emotional functioning in chronic pain clinical trials (Dworkin at al., 2005).
Measured: During baseline (no therapy) this will be completed weekly for a minimum of 3 weeks and a maximum of 6 weeks (dependent on randomised baseline group). All participants will complete the measure weekly during therapy for 8 weeks.
Daily clinical measure (4 questions)
Four single item measures were generated using literature on interpersonal difficulties in chronic pain. All questions may be scored from 0-5; 0 being 'Not at all' and 5 being ' As good as I can feel/Extremely'.
- "How distressing has your pain been today?"
- "How lonely have you felt today?"
- "How good have you felt about your relationships with other people today?"
- "How good have you felt about yourself today?" Item 1 is based on generic numerical rating scales used to measure pain distress.
Item 2 is a measure of social distress that we would expect to be amenable to change via PIT; it is an important outcome that overlaps with but is not the same as depression.
Items 3 and 4 measure variables that PIT is designed to target and which we might expect to mediate any improvement in the other outcomes. Item 3 links with social connection (i.e., belongingness) and item 4 with perceived burdensomeness since how you feel about yourself influences whether you see yours.
Measured: During baseline (no therapy) answered daily for a minimum of 3 weeks and a maximum of 6 weeks (dependent on randomised baseline group). All participants will answer them daily during therapy for 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2018
- Study start19 Sep 2018
- Primary completion29 Mar 2019
- Study completion9 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back 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
- Not applicable
- Intervention model
- Single group
- Model description
- A series of experimental single case studies comparing individual CLBP participants' clinical outcomes during a baseline phase (receive no treatment) with those during a treatment phase (receive 8 sessions of PIT). Clinical outcomes will be the impact of treatment on pain distress/intensity, self-efficacy, mood and interpersonal functioning. There will be repeated measurement (daily/weekly) of the outcomes during baseline and intervention phases, to assess real-time change in these variables on a case-by-case basis. We will vary the length of the baseline phase randomly across participants, who will commence treatment following 3, 4, 5 or 6 weeks. This "multiple baselines" design will allow us to establish whether any improvement in clinical outcomes is caused by the intervention rather than natural change over time. We will assess feasibility/acceptability of the intervention by recording adverse reactions, side effects, adherence and participants' views about the intervention.
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charlotte Morgan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Charlotte Morgan, University of Manchester
- Investigators
- Charlotte Morgan, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03658226
- Sponsor's protocol ID
- NHS001382
- Status last verified
- Sep 2019
- First submitted
- 23 May 2018
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants will be required to consent to their anonymised outcome data (clinical measures and feasibility/acceptability measures) being used in similar research studies conducted at the University of Manchester.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Series Evaluation of Psychodynamic Interpersonal Therapy (PIT) in Chronic Low Back Pain (CLBP) Patients
- ClinicalTrials.gov ID
- NCT03658226
- Acronym / sponsor ID
- NHS001382
- Conditions
- Chronic Low Back Pain
- Keywords
- Case Series, Acceptability, Feasibility, Psychodynamic Interpersonal Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Charlotte MorganUniversity, hospital or other
- Study start
- 19 Sep 2018 (actual)
- Primary completion
- 29 Mar 2019 (actual)
- Study completion
- 9 Sep 2019 (actual)
- First posted
- 5 Sep 2018 (actual)
- 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.
Many people in the world have chronic pain; this is pain which lasts more than twelve weeks. Pain can cause people to feel low in mood and change how they feel about themselves and others around them. Therapy for chronic pain does not always work and often people do not have lasting effects from treatment. This study hopes to see if a different therapy, called Psychodynamic Interpersonal Therapy (PIT), can help people with chronic pain. This therapy looks at how we see ourselves and our relationships with others; it aims to help people address personal problems that make it difficult for them to manage their pain.
The study aims to show that PIT is a suitable treatment for chronic low back pain and that people will have fewer problems with their mood, how they feel about themselves and their relationships. This study will give people with chronic low back pain eight sessions of PIT and during therapy they will fill in forms about their pain, mood, relationship problems and how they feel about themselves. We will also look at practical things to do with the therapy (e.g. how many sessions people came to, reasons for stopping therapy etc.) and ask people about how they felt about the therapy they had. Three months after the study has finished, people will be asked to fill in the forms again to see if the effects have lasted.
This research could help to give people with chronic pain a new and different treatment option which has good and lasting effects.
Detailed description
Chronic pain is continuous, long-term pain of more than 12 weeks. Patients with chronic pain are a heterogeneous group with varied pathologies (e.g. osteoarthritis; fibromyalgia) and pain sites (e.g., chronic low back pain, CLBP; chronic widespread pain). Chronic pain affects more than two fifths of the UK population, that is, around 28 million adults. Currently, the biopsychosocial model of pain is the most widely used heuristic approach to understanding chronic pain. The biopsychosocial perspective recognises that pain emerges from a dynamic interplay of a patient's physiological state, thoughts, emotions, behaviours, and sociocultural influences. This acknowledges that pain is a subjective experience and treatment approaches are aimed at management, rather than cure, of chronic pain.
Chronic pain affects social, psychological and emotional wellbeing. Current psychological treatments (e.g. CBT and ACT) aim to support patients to cope with the impact of chronic pain and improve their quality of life. However, some critical questions remain regarding the effectiveness of these interventions. Research indicates that substantial numbers of patients do not benefit greatly from these approaches and often effects are not maintained across time. Audit data from a local Pain Management Programme (PMP) indicates that many patients remain distressed by pain after treatment, with approximately 80% scoring 5 or more out of 10 on a pain distress scale six months later. Thus, it appears that current psychological therapies are not targeting all relevant issues.
Evidence indicates that psychodynamic therapies show some efficacy in the treatment of chronic pain, demonstrating patterns of change in interpersonal problems, pain intensity and depression-anxiety. Interpersonal literature states that aspects of relating are implicated in chronic pain; for example, perceived burdensomeness (feeling a burden on others) and thwarted belongingness (loneliness and feeling alienated from others) are significantly associated with pain intensity, self-efficacy and functional limitations.
Psychodynamic Interpersonal Therapy affirms that our sense of self and ability to relate to others are important determinants of how able we are to regulate emotion, manage adversity and access social support. As such, they are likely to play a fundamental role in how we cope with chronic pain. Studies have found an association between insecure attachment and related interpersonal difficulties with poor pain self-efficacy, anxiety and poor coping. Therefore, a psychological therapy such as PIT which focuses on addressing negative relationship patterns and strengthening sense of self may be of value in the treatment of chronic pain.
Psychological interventions such as PMPs seek to address the role of relationships and social networks in self-management of pain but do not target the psychological issues underlying interpersonal problems. Where individuals report high levels of interpersonal difficulties, a more in-depth focus on these issues may be required. As PIT seeks to understand how problematic patterns of relating are contributing to a person's distress and maladaptive coping, it may be a helpful approach. A clinical example of this is a person whose pain is exacerbated by overactivity related to their inability to say no to other's demands (e.g. for fear of upsetting them or eliciting conflict and rejection). Additionally, PIT has many strengths as an approach; it is a short, manualised and evidence-based treatment which has previously demonstrated promising results in the treatment of other conditions characterised by disabling chronic pain such as multisomatoform functional syndromes disorder and irritable bowel syndrome.
Presently, the efficacy of PIT in chronic pain is unknown. With that in mind, the proposed study seeks to conduct an evaluation of the acceptability, feasibility and efficacy of PIT in a chronic pain population; treatment resistant CLBP. The outcome of this study has the potential to inform future therapeutic options for those with chronic pain. The results may support the use of an alternative 1:1 therapy for those with interpersonal difficulties as it follows that they would require a treatment for chronic pain which has an interpersonal focus.
The primary aim of this study is to conduct a preliminary evaluation of whether PIT is an acceptable and feasible therapy for patients with treatment resistant CLBP (where patients are still experiencing clinically significant pain following previous treatment) and interpersonal difficulties. This will be measured using adherence to therapy and patient satisfaction and acceptability measures.
The secondary aim is to conduct an initial evaluation of the efficacy of PIT in people with treatment resistant CLBP and interpersonal problems, including its impact on pain distress, self -efficacy, and interpersonal functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A series of experimental single case studies comparing individual CLBP participants' clinical outcomes during a baseline phase (receive no treatment) with those during a treatment phase (receive 8 sessions of PIT). Clinical outcomes will be the impact of treatment on pain distress/intensity, self-efficacy, mood and interpersonal functioning. There will be repeated measurement (daily/weekly) of the outcomes during baseline and intervention phases, to assess real-time change in these variables on a case-by-case basis. We will vary the length of the baseline phase randomly across participants, who will commence treatment following 3, 4, 5 or 6 weeks. This "multiple baselines" design will allow us to establish whether any improvement in clinical outcomes is caused by the intervention rather than natural change over time. We will assess feasibility/acceptability of the intervention by recording adverse reactions, side effects, adherence and participants' views about the intervention.
| Arm | Type | Receives |
|---|---|---|
| Therapy | Experimental | Behavioral: Psychodynamic Interpersonal Therapy (PIT)Psychodynamic Interpersonal Therapy (PIT) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Previously attended the Walton Centre pain management programme (PMP).
- Treatment resistant; six months after PMP treatment still experiencing clinically significant pain measured as 5+ on the pain distress rating scale. IMMPACT recommendations advise the use of numerical rating scales (NRS) in clinical trials of chronic pain treatments (Dworkin et al., 2005).
- Classified as "interpersonally distressed" on the West Haven Yale Multidimensional Pain Inventory (WHYMPI).
- Able to converse in English proficiently which is a requirement given the conversational nature of therapy.
- Able to commit to treatment and willing to be randomly allocated to baseline.
Key exclusion criteria (4 listed)
- Other comorbid degenerative conditions and cancers.
- Psychosis
- History of prior suicide attempts.
- Active plans of self-harm and/or suicide.
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 |
|---|---|---|
| Psychodynamic Interpersonal Therapy (PIT)PIT is conversational model of psychotherapy; participants will receive 8 sessions of this therapy once weekly. The first session will be 2 hours and all remaining sessions will be 50 minutes. | Behavioural | Therapy |
Primary outcome
Objective measure of behaviour 1 - Number of sessions attended
Time frame: Measured at the end of therapy (at week 8).
Measuring feasibility/acceptability of therapy
Satisfaction questionnaire (PIT for CLBP)
Time frame: Administered twice in the 8 weeks of therapy after session 1 (week 1) and Session 8 (week 8); the first and last sessions of therapy.
Measuring acceptability of therapy (face validity). A self-reported measure of satisfaction regarding the content of the therapy. A questionnaire has been devised based on the theoretical framework of acceptability in Sekon, Cartwright \& Francis (2017). There are two versions for post session one and post session eight with slightly different wording. This outcome measure will assess change.
Measure of adverse reactions
Time frame: Participants will complete this before each therapy session weekly and it will be discussed with the therapist/PI in session. As therapy is for 8 weeks, participants will complete this once weekly for eight weeks.
A quantitative measure containing a list of anticipated/likely adverse reactions (e.g. exacerbation of pain, feeling more upset than usual, increased problems in relationships) and unanticipated/adverse reactions. It is expected that therapy may increase emotional symptoms in the short term as the participants make realisations within therapy. This is a tick box measure with a qualitative 'other' box for further input.This outcome measure will assess change.
Objective measure of behaviour 2 - Completion rate from therapy
Time frame: Measured at the end of therapy (at week 8).
Measuring feasibility/acceptability of therapy
5 secondary outcomes
Chronic Pain Acceptance Questionnaire-8 (CPAQ-8)
Time frame: During baseline (no therapy) this will be completed weekly for a minimum of 3 weeks and a maximum of 6 weeks (dependent on randomised baseline group). All participants will complete the measure weekly during therapy for 8 weeks.
Pain Self Efficacy Questionnaire (PSEQ)
Time frame: During baseline (no therapy) this will be completed weekly for a minimum of 3 weeks and a maximum of 6 weeks (dependent on randomised baseline group). All participants will complete the measure weekly during therapy for 8 weeks.
The Interpersonal Needs Questionnaire for Pain (INQ-P)
Time frame: During baseline (no therapy) this will be completed weekly for a minimum of 3 weeks and a maximum of 6 weeks (dependent on randomised baseline group). All participants will complete the measure weekly during therapy for 8 weeks.
The Beck Depression Inventory (BDI)
Time frame: During baseline (no therapy) this will be completed weekly for a minimum of 3 weeks and a maximum of 6 weeks (dependent on randomised baseline group). All participants will complete the measure weekly during therapy for 8 weeks.
Daily clinical measure (4 questions)
Time frame: During baseline (no therapy) answered daily for a minimum of 3 weeks and a maximum of 6 weeks (dependent on randomised baseline group). All participants will answer them daily during therapy for 8 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Individual participant dataSharing planned: Yes. Participants will be required to consent to their anonymised outcome data (clinical measures and feasibility/acceptability measures) being used in similar research studies conducted at the University of Manchester.
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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.
Charlotte Morgan principal investigator
University of Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychodynamic Interpersonal Therapy (PIT) in people with Chronic Low Back Pain, run by Charlotte Morgan at 1 site in United Kingdom.
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 4 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: finished, as of the sponsor's last update on 25 Sep 2019. 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Objective measure of behaviour 1 - Number of sessions attended (time frame: Measured at the end of therapy (at week 8).). The study lists 4 primary outcomes in all. 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 25 Sep 2019.