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Mental Health ImpairmentGoals in MINDNCT03000153

Effectiveness of Tracking Goals in Counselling

A study testing Completing the Goals Form in people with Mental Health Impairment, run by University of Roehampton at 1 site in United Kingdom.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Recent evidence suggests that focusing on positive goals rather than problems to avoid, may be associated with better psychological health and attainment of goals. In addition, the advantages of using personalised measures have been highlighted in a number of studies. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Mental Health Impairment
What is being tested?
Completing the Goals Form
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteUnited Kingdom
Study dates
19 Oct 2017to 1 Jul 2018
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 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • All clients referred for counselling in the service.

Who cannot join

  • Service users who do not understand verbal and written communication in English

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Tower Hamlets Mind

    London

Other trials in United Kingdom

About this study

Official title: Goals in Mind: A Randomised Controlled Evaluation of the Effectiveness of Tracking Goals in Counselling

Recent evidence suggests that focusing on positive goals rather than problems to avoid, may be associated with better psychological health and attainment of goals. In addition, the advantages of using personalised measures have been highlighted in a number of studies. The Goals Form is a new measure that comprises both elements. It invites clients, in collaboration with their therapist, to identify up to seven goals for therapy typically at a first assessment session and then to rate them on a 1-7 Likert scale, with 1 being not at all achieved and 7 being completely achieved. This research is important for clinical practice as it provides the foundations to identify what might be a helpful factor in counselling and psychotherapy.

The aim of the study is to test whether the use of the Goals Form leads to better clinical outcomes in counselling and psychotherapy. Participants in this study are counsellors and service users at Tower Hamlets Mind. The design of this study is a trial, which looks at comparing outcome measure scores in 'therapy as usual' and 'therapy using the Goals Form' when participants are randomly assigned to one of the two conditions. Interventions in this study involve using the Goals Form at the start of every session and taking part in a 30 minute interview once therapy has ended to give feedback about using the form in therapy . In addition to assessing outcome, the study also serves to compare satisfaction scores across the two conditions. It is a pilot to determine the feasibility of such trial including recruitment rates over a period of a year, adherence of counsellors and clients to the protocol, and the ethical issues raised.

Read the detailed description

In recent years, there has been a rapid rise in the use of outcome and feedback measures in the counselling and psychotherapy field. In part, this is because evidence suggests that the systematic collection and integration of client feedback improves outcome across client populations, professional discipline, and model used. In a meta-analysis of five trials comparing use of a routine feedback protocol with treatment as usual (TAU) for adults receiving individual psychotherapy, there were significant gains for feedback groups over TAU, especially for clients identified as at risk for premature dropout or negative outcomes (Lambert, 2010). In a review of studies using the Partners for Change Outcome Monitoring system, clients using brief outcome measures at each session were 3.5 times more likely to experience reliable change and had half the odds of deterioration than those in TAU (Duncan, 2010, 2011; Lambert \& Shimokawa, 2011; Murphy \& Duncan, 2010). Currently, three randomized, controlled trials indicate improved outcomes using this system (Anker, Duncan, \& Sparks, 2009; Reese, Norsworthy, \& Rowlands, 2009; Reese, Toland, Slone, \& Norsworthy, 2010). Based on the overall strength of current evidence, Lambert and Shimokawa (2011, p. 72) recommended that 'clinicians seriously consider making formal methods of collecting client feedback a routine part of their daily practice'.

At present, most psychological measurement is conducted using nomothetic scales. These are based on questions chosen by professional experts and consisting of checklists of symptoms (e.g., CORE-OM, PHQ-9). These questions are selected to be acceptable to large populations. However, given the diversity of problems presenting to mental health care services, a more personalised approach to psychological measurement might seem appropriate. Such an approach would shift the emphasis of measurement away from predefined, professionally-driven criteria, replacing it with a focus on those criteria given importance by the individual client. Individualised measures are questionnaires that include questions which can be generated by clients alone or in collaboration with the practitioner. This results in clients creating their own tailor-made questionnaire which only contains items that have meaning for them. Items are rated for intensity in a similar procedure to that of standardised measures.

The advantages of using individualised measures have been highlighted in a number of studies (e.g., Ashworth et al., 2005). Client-generated measures are evidenced to be user-friendly as individuals themselves identify areas of personal concern. Clinical improvement therefore, is evaluated according to topics of relevance to the individuals concerned. Research indicates that the fact that people themselves identify their own personal problems or goals which are meaningful to them and which reflect their individual needs, leads to more engagement in therapy (Turner-Stokes, 2011). Also, individualised measures are flexible and take into account the client's idiosyncratic variables such as personality, socioeconomic status and cultural background (Sales \& Alves, 2012).

However, to date, the most commonly used personalised measures, such as the Personal Questionnaire (Elliott et al., 2015) and the PSYCHLOPS (Ashworth et al., 2005), focus on clients' difficulties rather than their goals. Research suggests that this may be problematic: there is evidence to suggest that focusing on positive goals to approach, rather than negative problems to avoid, may be associated with better psychological health and attainment of goals (Elliot \& Church, 2002; Elliot \& Friedman, 2007).

Hence, the aim of this study is to evaluate the benefits, to both the process and outcomes of therapy, of using a personalised goal form: the Goals Form. The Goals Form (Appendix 2.1) is an individualised outcome measure used to assess attainment of personal objectives for therapy. It was used as part of an initial open-label trial of pluralistic therapy (Cooper et al., 2015), and invites clients, in collaboration with their therapist, to identify up to seven goals for therapy typically at a first assessment session and then to rate them on a 1 7 Likert scale, with 1 being not at all achieved and 7 being completely achieved (Cooper, 2014). The agreed goals are then typed onto a digital copy of the form and printed off, such that the client is able to rate the same goals at regular intervals, ideally every session. Over the course of therapy, clients may choose to delete, add or modify goals, and the electronic copy of the Goals Form is revised accordingly. The Goals Form has shown satisfactory levels of internal reliability, and convergent validity against CORE-10, GAD-7 and PHQ-9. It is also sensitive to change in clinical populations (Cooper, 2014; Michael, Cooper, \& Fugard, 2015).

In terms of user acceptability, clients' gave the Goals Form a mean rating of 4.2 on a 5-point helpfulness scale (SD = 1.2, n = 17), with a median and modal rating of 5 (very helpful). Ten of the 17 respondents (58.8%) gave it this highest rating. By contrast, the mean rating of the PHQ-9 was 3.7 (SD = 1.0, n = 17), with a median and modal rating of 4 (helpful). Intro to change interview (Cooper et al., 2015). In terms of why the Goals Form was helpful, five interviewees in Cooper et al.'s (2015) study said that it gave them a sense of progress, both from session to session and over the course of therapy. Interviewee 1, for instance, said: 'It kind of gave me a barometer on what I was doing'. Five of the participants said that it gave focus and structure to the therapy, reminding them of what they had come to work on and 'where you want to be at the end' (Interviewee 10). Interviewee 6, for instance, said: 'I'm a very scatty mind…because I was very depressed I couldn't concentrate and then it's helpful to have something in black and white on paper because then you knew this is what you were working at.' Two of the interviewees said the Goals Form was helpful because it encouraged them to reflect on how they had gone about achieving their objectives, and one said that they had felt challenged by it. In terms of negative aspects of the Goals Form, two participants said that they did not feel that they were good at naming goals, particular at the start of their therapy. Two of the interviewees said that they had been confused by the constant changes in goals, and one said that they felt the form needed to be explained more clearly.

Aims:

The objective of this study is to evaluate the impact of identifying and monitoring goals in therapy on clinical outcomes.

Hypothesis:

Client allocated to a goals-oriented condition will show significantly greater clinical improvement than clients in a standard counselling condition.

Procedure:

Clients will be allocated to counsellors as per standard clinic protocols. Clients allocated to the experimental condition will be asked to complete a Goals Form at the start of every session. This may then form the basis for the evolving clinical dialogue.

Clients allocated to the control condition will begin each session as they would normally do.

At the start of each session, clients in both conditions will be asked to complete the CORE-10.

At the end of therapy, all participants will fill a service satisfaction survey.

Participants in the experimental arm will also take a short quantitative questionnaire to assess the helpfulness of the CORE-10 and the Goals Form.

In addition, a random selection of participants in the experimental arm of the study will be invited back to meet with a researcher to participate in a Qualitative Interview. This will focus on their experience of using the Goals Form, and the ways in which it may, or may not, have been helpful in their therapeutic work.

Being tested
Completing the Goals Form

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Completing the Goals FormOther

    Also called Goals Form

    The Goals Form is a personalised outcome measure where clients enter their goals in collaboration with their assessor. Goals are then rated at the start of every session and open the therapeutic dialogue.

Study groups in NCT03000153
Study groupRoleWhat they receive
Completing the Goals FormExperimentalIn this arm, client participants will complete the Goals Form in collaboration with their therapists at the start of every session.
Receives: Other: Completing the Goals Form
therapy as usualNo interventionIn this arm, clients will have therapy as usual.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CORE-10

    Measured: 5 minutes

Secondary outcomes (1)
  1. Service satisfaction survey

    Measured: 5 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Dec 2016 (estimated)
  2. Study start19 Oct 2017
  3. Primary completion1 Jul 2018
  4. Study completion1 Jul 2018

Why it stopped: Organisational changes at site meant that recruitment was no longer feasible.

Resources

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
Single blind
Who is masked
Investigator
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03000153
Sponsor's protocol ID
PSYC 16/ 251
Acronym
Goals in MIND
Status last verified
Dec 2021
First submitted
17 Dec 2016
Last updated
13 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Anker MG, Duncan BL, Sparks JA. Using client feedback to improve couple therapy outcomes: a randomized clinical trial in a naturalistic setting. J Consult Clin Psychol. 2009 Aug;77(4):693-704. doi: 10.1037/a0016062.

    PubMed 19634962
  • Connell J, Barkham M, Stiles WB, Twigg E, Singleton N, Evans O, Miles JN. Distribution of CORE-OM scores in a general population, clinical cut-off points and comparison with the CIS-R. Br J Psychiatry. 2007 Jan;190:69-74. doi: 10.1192/bjp.bp.105.017657.

    PubMed 17197659
  • Duncan BL, Reese RJ. The Partners for Change Outcome Management System (PCOMS) revisiting the client's frame of reference. Psychotherapy (Chic). 2015 Dec;52(4):391-401. doi: 10.1037/pst0000026.

    PubMed 26641369
  • Farr, J., Di Malta, G. S., & Cooper, M. (2020). Pilot Randomised Controlled Trial of Counselling in a Community Mental Health Setting: Pitfalls and Learnings. Counselling and Psychotherapy Research, 20, 3-8. https://doi.org/10.1002/capr.12262

Questions about this trial

What is this clinical trial studying?

A study testing Completing the Goals Form in people with Mental Health Impairment, run by University of Roehampton 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 13 Jan 2022. 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 was stopped early (reason given: Organisational changes at site meant that recruitment was no longer feasible.). 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?

CORE-10 (time frame: 5 minutes). 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 NCT03000153, which also lists 4 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 13 Jan 2022.

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