Case Series Evaluation of Psychodynamic Interpersonal Therapy in Chronic Low Back Pain

NCT03658226 | Completed

• 1 other identifier: NHS001382
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Chronic Low Back Pain

Keywords

Case Series; Acceptability; Feasibility; Psychodynamic Interpersonal Therapy

Outcome Measures

Primary Outcomes (4)

• Objective measure of behaviour 1 - Number of sessions attended

  Measuring feasibility/acceptability of therapy

  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.

  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.

  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 at the end of therapy (at week 8).

Secondary Outcomes (5)

• Chronic Pain Acceptance Questionnaire-8 (CPAQ-8)

  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)

  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)

  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)

  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)

  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.

Study Arms (1)

Therapy

EXPERIMENTAL

Psychodynamic Interpersonal Therapy (PIT)

Behavioral: Psychodynamic Interpersonal Therapy (PIT)

Interventions

Psychodynamic Interpersonal Therapy (PIT) BEHAVIORAL

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.

Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Other comorbid degenerative conditions and cancers.
• Psychosis
• History of prior suicide attempts.
• Active plans of self-harm and/or suicide.

Sponsors & Collaborators

• Charlotte Morgan: lead

Study Sites (1)

The Walton Centre NHS Foundation Trust

Liverpool, L9 7LJ, United Kingdom

Location

Study Officials

• Charlotte Morgan

  University of Manchester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The PI/therapist will be blind to the outcome measures. All measures will be marked with a participant ID by an alternative researcher so that the therapist/PI will be unaware of individual participants' scores when analysing the data.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Trainee Clinical Psychologist

Model Details: 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.

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: September 5, 2018
• Study Start: September 19, 2018
• Primary Completion: March 29, 2019
• Study Completion: September 9, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available within 6 months of study completion.
• Access Criteria: Requesters will be required to sign a data access agreement.

Locations

GB (1)